mRNA Drug List

Citeline Drug ID Generic Drug Name Drug Names
178101 2019-nCoV prophylactic 2019-nCoV prophylactic vaccine, Arcturus

125439 vaccine, Arcturus Therapeutics
A-001, eTheRNA Therapeutics;
A 001, eTheRNA ARCT 021; ARCT-021;A-001,
Immunotherapies; ARCT021;
eTheRNA
114349 Immunotherapies
ARCT-810 Immunotherapies; A001, eTheRNA Immunotherapies;
ARCT 810; ARCT-810; ARCT810; LUNAR OTC;
131582 autogene cevumeran LUNAR-OTC; LUNAROTC
autogene cevumeran; BNT 121; BNT 122; BNT-121;
123283 AZD-8601 BNT-122; BNT121;
AZD 8601; AZD 8601 BNT122; IVACAZD
(epicardial); mutanome
8601 cancer
201881 BD-111 (Intradermal);
BD 111; BD-111;AZD-8601;
BD111 AZD-8601 (epicardial); AZD-
89678 BNT-111 BNT 111; BNT-111; BNT111; BNT111 FixVac; Lipo-
156829 BNT-112 MERIT, BioNTech;
anticancer NT-0003;BioNTech-1;
immunotherapy, NT0003; RB_0003;
BNT 112;
108160 BNT-113 BNT-112;
BNT 113; BNT-113; BNT113; HPV RNA WP1
BNT112; W_pro1, BioNTech; cancer
vaccine,
89746 BNT-114 BioNTech; HPV114;
BN_0002; BNT vaccine, BioNTech
BNT-114; BNT114; IVAC
171394 BNT-115 mutanome breast cancer vaccine,
BNT 115; BNT-115; BNT115; ovarian BioNTech; IVAC
cancer vaccine,
171222 BNT-151 BioNTech; W_ova1 Vaccine,
BNT 151; BNT-151; BNT151 BioNTech
171224 BNT-152 BNT 152; BNT-152; BNT152
176133 BNT-153 BNT 153; BNT-153; BNT153
84326 Chikungunya virus vaccine, anti-infective mRNA therapeutics, Moderna
185352 Moderna Therapeutics
CLDN6 RNA-LPX, BioNTech Therapeutics;
CLDN6 RNA-LPX, Chikungunya
BioNTechvirus vaccine, Moderna
136134 CMV vaccine, Moderna CMV vaccine, Moderna; mRNA 1647; mRNA-1647;
193733 COVID-19 mRNA vaccine, mRNA1647
CoV-2 SAM vaccine, GlaxoSmithKline; CoV2 SAM
191430 GlaxoSmithKline
COVID-19 mRNA vaccine, (LNP) vaccine,
COVID-19 mRNAGlaxoSmithKline; COVID-19
vaccine, Providence mRNA
Therapeutics;
ProvidencemRNA
178849 COVID-19 Therapeutics
vaccine, COVID-19 mRNA
COVID-19 vaccine,vaccine,
Biological E.-1; PTX-COVID19-B;
Stemirna Therapeutics; DF
Stemirna Therapeutics
183210 COVID-19 mRNA vaccine, 104B1; DF-104B1; DF104B1; SARS-CoV-2
ARCoV; COVID-19 mRNA vaccine, Academy mRNA
of Military
176782 Walvax Biotechnology
COVID-19 vaccine, CureVac Science; COVID-19 mRNA vaccine, Suzhou
2019-nCoV vaccine, CureVac; COVID-19 vaccine, Abogen
176256 COVID-19 vaccine, Moderna CureVac;
2019-nCoV CV07050101; CVnCoV;
vaccine, Moderna; nCoV-2019
COVID-19 vaccine,
vaccine,
194161 COVID-19 vaccine, Moderna Moderna;
COVID-19Elasomeran; mRNA 1273;
multivalent vaccine, ModernamRNA-1273;
Therapeutics;
178895 Therapeutics-2
COVID-19 vaccine, Translate COVID-19 vaccine, Moderna Therapeutics-2;
COVID-19 vaccine, Sanofi-1; COVID-19 vaccine, mRNA
194077 Bio
COVID-19, Moderna Translate
COVID-19Bio;
nextMRT 5500; MRT-5500;
generation MRT5500; novel
vaccine, Moderna
83482 Therapeutics-1
CV-9202 Therapeutics; COVID-19, BI1361849;
BI 1361849; BI-1361849; Moderna Therapeutics-1;
CV 9202; CV-
122832 HBV antigen specific TCR 9202; CV9202;
autologous RNActive-derived
T-cells transduced withcancer vaccine,
retroviral vector
180314 redirected
HDT-301 T cells, Lion TCR encoding
COVID-19HBV
mRNAantigen-specific T-cell receptor;
vaccine, Gennova
193853 herpes simplex virus Type 2 Biopharmaceuticals; COVID-19 vaccine,
GSK 4108771A; GSK-4108771A; HDT Bio Corp;
GSK4108771A;
118960 vaccine, GlaxoSmithKline
LUNAR-RARE1 herpes
LUNARsimplex
RARE1;virus Type 2 vaccine,
LUNAR-GSD3; GlaxoSmithKline;
LUNAR-GSDIII;
161850 MEDI-1191 LUNAR-RARE1;
MEDI LUNARRARE1;
1191; MEDI-1191; MEDI1191 mRNA therapeutics,
136135 Metapneumoviru + hMPV/PIV3 vaccine, Moderna Therapeutics;
202119 Parainfluenza
mRNA 1273.617 virus vaccine, Metapneumoviru
COVID-19 booster + vaccine,
Parainfluenza virusTherapeutics-2;
Moderna vaccine,
180175 mRNA COVID-19 vaccine, mRNA 1273.617;
DS 5670; mRNA-1273.617;
DS-5670; mRNA-1273.617.2;
DS-5670 a; DS-5670-a; DS-5670a;
Daiichi influenza
181740 mRNA Sankyo vaccine, DS5670;
mRNA LNP-encapsulated
influenza (mRNA)
vaccine, Sanofi; mRNAvaccine, Daiichi
influenza
Translate Bio
192408 mRNA-1273.351 vaccine, Translate Bio; MRT 5400; MRT 5401;
COVID-19 booster vaccine, Moderna Therapeutics; MRT-
177237 mRNA-1345 mRNA
mRNA 1273.351; mRNA-1273.351;
1345; mRNA-1345; mRNA1273.351
mRNA1345; paediatric
121829 mRNA-1851 respiratory syncytial virus (RSV) vaccine, Moderna
H7N9 influenza vaccine, Moderna Therapeutics; mRNA
144819 mRNA-1893 1851; mRNA-1851;
mRNA mRNA1851;
1893; mRNA-1893; VAL 339851;
mRNA1893; VAL-
Zika virus
148703 mRNA-1944 mRNA vaccine,
Chikungunya Moderna
virus Therapeutics
antibody, Moderna Therapeutics;
119013 mRNA-2752 mRNA 1944; mRNA-1944; mRNA1944
anticancer therapies, Onkaido; mRNA 2752; mRNA
187013 mRNA-3705 therapeutics, Onkaido; mRNA-2752;
mRNA 3705; mRNA-3705; mRNA3705 mRNA2752;
148700 mRNA-3927 mRNA 3927; mRNA-3927; mRNA3927
128183 mRNA-4157 mRNA 4157; mRNA cancer vaccine, Merck; mRNA
144945 mRNA-5671 cancer vaccine, Merck
KRAS inhibitor, Moderna Therapeutics;
& Co.; mRNA-4157;
KRAS inhibitor, Moderna
176054 mRNA-6231 Therapeutics; mRNA 5671; mRNA-5671;
mRNA 6231; mRNA-6231; mRNA6231 mRNA5671;
144160 MRT-5005 cystic fibrosis therapy, Translate Bio; MRT 5005; MRT-
150920 personalized mRNA tumour 5005; MRT5005
personalized mRNA tumour vaccine, Stemirna
191797 vaccine, Stemirna
quadrivalent Therapeutics
influenza mRNA Therapeutics
mRNA 1010; mRNA-1010; mRNA1010; quadrivalent
vaccine, Moderna Therapeutics
170437 rabies glycoprotein G vaccine, influenza mRNA vaccine,
GSK 3903133A; ModernaGSK3903133A;
GSK-3903133A; Therapeutics
148995 GlaxoSmithKline
rabies vaccine, RNActive, rabies
CV 7202;glycoprotein
CV-7202;GCV7202;
vaccine,rabies
GlaxoSmithKline; RG-
vaccine, RNActive,
27041 CureVac- 2 T
rocapuldencel CureVac-
AGS-003; 2AGS003; autologous dendritic cell therapy,
166858 RSV vaccine, Moderna CoImmune;
mRNA 1172;CMN 001; CMN-001;
mRNA-1172; CMN001;
mRNA1172; RSVdendritic
vaccine,
148609 SAR-441000 Moderna; V 172; V-172; V172
BNT 131; BNT-131; BNT131; cytokine mRNA therapy,
178511 tozinameran Sanofi;
BNT 162; SARBNT441000;
162b2 SAR-441000; SAR441000
(large LNP); BNT 162b3; BNT
162c2; BNT-162; BNT-162a1; BNT-162b2 (large LNP);
Summary Global Status
ARCT-021 an RNA based prophylactic vaccine LUNAR- Phase II Clinical Trial
COV19 in collaboration with Duke-National University of
A-001 (ECI-006) (TriMix-MEL) is an in vivo injectable mRNA- Phase II Clinical Trial
based
ARCT-810immunotherapy,
(LUNAR-OTC) under
is adevelopment by eTheRNA
mRNA therapeutic, under Phase I Clinical Trial
development by Arcturus Therapeutics for the treatment of
Autogene cevumeran (RG-6180) is a novel poly-neo-epitopic Phase II Clinical Trial
coding
mRNA-8601RNA vaccine
(AZD-8601)targeting the unique mutation
is a VEGF-A-coded signature
messenger RNA Phase II Clinical Trial
that triggers the cellular machinery to produce
BD-111 is a mRNA therapy under development by Bdgene specific Phase II Clinical Trial
Technology, using its BDmRNA delivery technology
BNT-111 is an mRNA-based immunotherapy anticancer that Phase II Clinical Trial
vaccine
BNT-112designed to elicit animmunotherapy
is a mRNA-based immune response to four
under Phase II Clinical Trial
development by BioNTech using its fixed combination
BNT-113 is an mRNA-based vaccine against HPV16-derived of Phase II Clinical Trial
tumour antigens, under development by BioNTech using a
NT-0005 is a poly-neo-epitopic coding RNA vaccine targeting Phase I Clinical Trial
the uniqueismutation
BNT-115 signatureimmunotherapy,
an mRNA-based of an individual under
patient, under Phase I Clinical Trial
development
BNT-151 is a by BioNTech(mRNA-encoded
ribocytokine using fixed combinations of shared Phase II Clinical Trial
cytokines)
targeting
BNT-152 is a ribocytokines (mRNA-encoded cytokines) for Phase I Clinical Trial
optimized IL-2, under development by BioNTech
targeting
BNT-153 interleukin-7 (IL-7),(mRNA-encoded
is a ribocytokines under development by BioNTech Phase I Clinical Trial
cytokines)
targeting
mRNA-1388 interleukin-2 (IL-2),isunder
(VAL-181388) development
a messenger RNA by BioNTech Phase I Clinical Trial
vaccine,
under development
BioNTech by Valera
is developing CLDN6 (Moderna
RNA-LPX Therapeutics) for the Phase II Clinical Trial
(RNA-lipoplexes)
against Claudin-6
mRNA-1647 is an for the treatment
intramuscular of solid
vaccine tumours
which utilizes V1GL, Phase II Clinical Trial
under development by Moderna Therapeutics for
GlaxoSmithKline is developing GSK4184258A, a COVID-19 the Phase I Clinical Trial
self-amplifying
PTX-COVID19-B mRNA (SAM) COVID-19
is a mRNA vaccine formulated
vaccine, using
under lipid Phase I Clinical Trial
development
DF-104B1 by mRNA-based
is an Providence Therapeutics against
vaccine, under COVID-19
development by Phase I Clinical Trial
Stemirna Therapeutics using its mRNA synthesis
ARCoV is a messenger RNA (mRNA) vaccine against and LPP Phase III Clinical Trial
COVID-19
CVnCoV isinfection, under development
an mRNA-based by Walvax
vaccine, under development by Phase III Clinical Trial
CureVac
mRNA-1273for the prevention
(TAK-919) is aof COVID-19
lipid infection
nanoparticle (LNP)-(Press Launched
encapsulated
mRNA-1273.211 mRNA-based vaccine,
is a multivalent under
booster development
vaccine against by Phase III Clinical Trial
COVID-19, that combines mRNA-1273 and mRNA-1273.351,
MRT-5500 (SP-0254) is a Lipid Nanoparticle (LNP)-mRNA Phase II Clinical Trial
vaccine,
mRNA-1283under development
is a by Translate
next generation vaccine, Bio, in collaboration
focused specifically Phase I Clinical Trial
on receptor binding domain (RBD) and N-terminal
CV-9202 is a mRNA cancer vaccine, under development by domain Phase II Clinical Trial
CureVac
Lion TCRusing its RNActive
is developing HBVtechnology, for the
antigen-specific treatment
TCR of
redirected Phase I Clinical Trial
T-cells
HDT-301 transduced
(HGC-019) with retroviral
is a vector or (LION/repRNA-
repRNA-CoV2S transfected with Phase II Clinical Trial
CoV2S), immunogenic
GSK-4108771A vaccine
is a gE/gI comprisedmRNA
self-amplifying of an RNA
(SAM)replicon Phase I Clinical Trial
vaccine formulated
LUNAR-RARE1 in a lipid
(UX-053) is nanoparticle
an intravenous (LNP),
mRNAunder Phase II Clinical Trial
therapeutic, is
MEDI-1191 under development by Arcturus
an immuno-oncology Therapeutics for
mRNA therapeutic Phase I Clinical Trial
encoding interleukin 12, under development
mRNA-1653 is a multivalent intramuscular vaccine, Moderna under Phase I Clinical Trial
development
mRNA-1273.617 is under development by Moderna as an of
by Moderna therapeutics for the prophylaxis Phase III Clinical Trial
emerging
DS-5670 isvariant
a mRNA booster candidate
vaccine against the B.1.617.2
under development by Daiichi Phase II Clinical Trial
Sankyo, using
MRT-5401 its nucleicSP-0273)
(MRT-5400; acid delivery technology
Sanofi againstwith
in collaboration Phase I Clinical Trial
Translate
mRNA-1273.351 is under development by Modernavaccine
Bio are developing a prophylactic mRNA as an Phase II Clinical Trial
emerging
mRNA-1345 variant booster candidate
is a paediatric against
prophylactic the B.1.351
vaccine, under Phase I Clinical Trial
development by Moderna using its mRNA platform
mRNA-1851 is a mRNA based infectious disease vaccine, against Phase I Clinical Trial
under development
mRNA-1893 byvirus
is a Zika Valera (Moderna
mRNA Therapeutics)
vaccine, under for the Phase II Clinical Trial
development by Moderna Therapeutics using a
mRNA-1944 is an mRNA therapeutic that encodes for an Japanese Phase I Clinical Trial
antibody
mRNA-2752that iscan neutralize the combination
a co-formulated chikungunyaofvirus circulating
mRNAs Phase I Clinical Trial
encoding
mRNA-3705 human OX40L,
is a next IL-23 and
generation IL-36 gamma,
candidate, under under Phase II Clinical Trial
development isbyaModerna
mRNA-3927 for the treatment
mRNA therapeutic of Methylmalonic
that combines mRNA- Phase II Clinical Trial
encoded proteins for both the PCCA and PCCB enzyme
mRNA-4157 is an intramuscular novel messenger RNA Phase II Clinical Trial
(mRNA)-based personalized
V-941 (mRNA-5671) cancer
is a modified vaccine, under
messenger RNA (mRNA) Phase I Clinical Trial
vaccine,
mRNA-6231 is an mRNA encoding for a long-acting IL-2for the
under development by Moderna Therapeutics Phase I Clinical Trial
mutein designed
MRT-5005 to preferentially
is an mRNA activate
therapy that and
targets theexpand
CFTR the Phase II Clinical Trial
pathway, under development
Stemirna Therapeutics by TranslateBio
is developing (RNA mRNA
a personalized Phase II Clinical Trial
tumour vaccine by using its mRNA synthesis
mRNA-1010 is a quadrivalent mRNA vaccine, under and LPP Phase II Clinical Trial
development
GSK-3903133A by is
Moderna
a rabiesTherapeutics
glycoprotein for prophylactic
G (RG) vaccine,use Phase I Clinical Trial
under development
CV-7202 by GlaxoSmithKline
is an mRNA-based prophylacticusing
rabiesSelf-Amplifying
vaccine Phase I Clinical Trial
encoding the viral
Rocapuldencel glycoprotein,
T (CMN-001; RABV-G,
AGS-003) is formulated with a
a lead autologous Phase II Clinical Trial
dendritic cell vaccine, one of a series, under
mRNA-1172 (V-172) is a modified messenger RNA (mRNA)development by Phase I Clinical Trial
prophylactic
SAR-441000vaccine, undermRNA
is a cytokine development by Moderna
intratumoral immunotherapy Phase II Clinical Trial
targeting interleukin -12 (IL-12)sc, interleukin -15 (IL-15)sushi, Launched
Tozinameran (Comirnaty) is a lipid nanoparticle formulated,
nucleoside-modified, messenger RNA-based vaccine,
Development Status Drug Disease
Active Infection, coronavirus, novel coronavirus prophylaxis
Active Cancer, melanoma
Active Cancer,
Ornithinemelanoma
transcarbamylase deficiency
Active Ornithine transcarbamylase deficiency
Cancer, colorectal
Heart failure
Active Heart failure
Keratitis, herpetic
Active Cancer,
Cancer, melanoma
prostate
Active Cancer,
Cancer, prostate
head and neck
Active Cancer,
Cancer, head
breastand neck
Active Cancer,
Cancer, breast
ovarian
Active Cancer, solid, unspecified
Active Infection, Chikungunya virus prophylaxis
Active Infection, cytomegalovirus prophylaxis
Active Infection, coronavirus, novel coronavirus
Active Infection,
Infection, coronavirus,
coronavirus, novel
novel coronavirus
coronavirus prophylaxis
prophylaxis
Active Infection,
Infection, coronavirus, novel coronavirus prophylaxis
coronavirus, novel coronavirus prophylaxis
Active Infection,
Active Infection,
Active Infection, coronavirus, novel coronavirus
Active Infection,
Infection, coronavirus,
coronavirus, novel
novel coronavirus
Active Cancer, lung, non-small cell
Active Cancer,
Cancer, lung,
liver non-small cell
Active Infection,
Infection, coronavirus, novel
herpes simplex coronavirus prophylaxis
virus
Active Cori's disease
Active Cori's disease
Cancer, solid, unspecified
Active Cancer,
Infection,solid,
human unspecified
metapneumovirus prophylaxis
Active Infection, parainfluenza viruscoronavirus
Infection, coronavirus, novel prophylaxis prophylaxis
Active Infection, influenza virus prophylaxis
Active Infection,
Infection, influenza virus
coronavirus, prophylaxis
novel coronavirus prophylaxis
Active Infection, respiratory syncytial virus prophylaxis
Active Infection, influenza virus prophylaxis
Active Infection, Zika virus prophylaxis
Active Infection,
Infection, Zika virus prophylaxis
Chikungunya virus prophylaxis
Active Cancer, lymphoma, unspecified
Methylmalonic acidaemia
Active Propionic acidemia
Active Cancer,
Cancer, melanoma
colorectal
Active Cancer, colorectal
Autoimmune disease, unspecified
Active Cystic fibrosis
Active Cancer, colorectal
Active Cancer,
Infection,gastrointestinal, stromal
influenza virus prophylaxis
Active Infection, rabies prophylaxis
Active Infection, rabies prophylaxis
Active Cancer, renal
Active Infection, respiratory syncytial virus prophylaxis
Active Infection, respiratory
Cancer, solid, syncytial virus prophylaxis
unspecified
Active Cancer,
Infection,solid, unspecified
Company Originator / Company HQ Company HQ
Arcturus Therapeutics Licensee
Originator Country
USA State
CA
eTheRNA Immunotherapies Originator Belgium
eTheRNA Immunotherapies
Arcturus Therapeutics Originator
Originator Belgium
USA CA
Arcturus
BioNTechTherapeutics Originator
Originator USA
Germany CA
BioNTech
AstraZeneca Originator
Licensee Germany
UK
AstraZeneca
Bdgene Technology Licensee
Originator UK
China
BioNTech Originator Germany
BioNTech
BioNTech Originator
Originator Germany
Germany
BioNTech
BioNTech Originator
Originator Germany
Germany
BioNTech
BioNTech Originator
Originator Germany
Germany
BioNTech
BioNTech Originator
Originator Germany
Germany
Moderna Therapeutics Originator USA MA
GlaxoSmithKline Originator UK
Providence Therapeutics Originator Canada ON
Stemirna Therapeutics Originator China
Suzhou Abogen Biosciences Originator
Originator China
China
Walvax
Bayer Biotechnology Licensee
Licensee China
Germany
Bayer
Moderna Therapeutics Licensee
Originator Germany
USA MA
Moderna
Moderna Therapeutics
Therapeutics Originator
Originator USA
USA MA
MA
Sanofi Licensee France
Translate Bio
Moderna Therapeutics Originator
Originator USA
USA MA
MA
Boehringer Ingelheim Licensee Germany
CureVac
Lion TCR Originator
Originator Germany
Singapore
Emcure Pharmaceuticals Originator India
HDT Bio Corp.
GlaxoSmithKline Licensee
Originator USA
UK WA
Arcturus Therapeutics Originator USA CA
Ultragenyx Pharmaceutical
AstraZeneca Licensee
Licensee USA
UK CA
Moderna
Originator USA
USA MA
MA
Moderna
Originator USA
USA MA
MA
Daiichi Sankyo Originator Japan
Sanofi Licensee France
Translate Bio
Originator USA
USA MA
MA
Moderna
Originator USA
USA MA
MA
Moderna
Originator USA
USA MA
MA
Merck & Co. Licensee USA NJ
Merck & Co. Originator
Licensee USA
USA MA
NJ
Moderna
Originator USA
USA MA
MA
Translate Bio Originator USA MA
Stemirna Therapeutics Originator China
Originator China
USA MA
GlaxoSmithKline Originator UK
CureVac Originator Germany
SCM Lifescience Originator South Korea
Merck & Co. Licensee USA NJ
Moderna
BioNTechTherapeutics Originator
Licensee USA
Germany MA
Sanofi
BioNTech Originator
Originator France
Germany
Company HQ City Company HQ Postal Code Company
San Diego 92121 (Subsidiary/Acquiree)
Niel 2845
Niel
San Diego 2845
92121
San
MainzDiego 92121
55131
Mainz
Cambridge 55131
CB4 0WG
Cambridge
Shanghai CB4 0WG
Mainz 55131
Mainz
Mainz 55131
55131
Mainz
Mainz 55131
55131
Mainz
Mainz 55131
55131
Mainz
Mainz 55131
55131
Mainz 55131
Mainz 55131
Mainz 55131
Cambridge 02139 Valera
Mainz 55131
Cambridge 02139
Brentford TW8 9GS
Toronto M5G 0B7
Shanghai
Shanghai
Kunming
Leverkusen 650106
51368
Leverkusen
Cambridge 51368
02139
Cambridge
Cambridge 02139
02139
Paris 75008
Cambridge
Cambridge 02139
02139
Ingelheim 55216
Tubingen 72076
069113
Pune 411 026 Gennova Biopharmaceuticals
Seattle
Brentford 98102
TW8 9GS
San Diego 92121
Novato
Cambridge 94949
CB4 0WG
Cambridge
Cambridge 02139
02139
Cambridge
Cambridge 02139
02139
Tokyo 103-8426
Paris 75008
Cambridge
Cambridge 02139
02139
Cambridge 02139
Cambridge 02139 Valera
Cambridge 02139
Cambridge
Cambridge 02139
02139
Cambridge 02139
Cambridge
Cambridge 02139
02139
Cambridge 02139
Kenilworth 07033
Cambridge
Kenilworth 02139
07033
Cambridge
Cambridge 02139
02139
Cambridge 02139
Shanghai
Shanghai
Cambridge 02139
Brentford TW8 9GS
Tubingen 72076
Incheon 400-712 CoImmune
Kenilworth 07033
Cambridge
Mainz 02139
55131
Paris
Mainz 75008
55131
Mainz 55131
Company Company Company Company
(Subsidiary/Acquiree (Subsidiary/A (Subsidiary/Acquiree) HQ (Subsidiary/Acquiree) HQ
USA MA Cambridge
India Pune 411 026
USA MA Cambridge
USA NC Durham 27704
Drug Country Drug Country Current Status Launch Year Highest Status Reached
Singapore Region
Asia Phase II Clinical Trial Phase II Clinical Trial
Belgium Europe, EU Phase II Clinical Trial Phase II Clinical Trial
Spain
New Zealand Europe,
Oceania EU Phase
Phase II ClinicalTrial
I Clinical Trial Phase
I Clinical Trial
USA
USA North
North America
America Phase
Phase IIIClinical
ClinicalTrial
Trial Phase
Phase IIIClinical
ClinicalTrial
Trial
Australia
Finland Oceania
Europe, EU Phase
Phase II Clinical
II Clinical Trial
Trial Phase
Phase II Clinical
II Clinical Trial
Trial
Germany
China Europe,
Asia EU Phase
Phase II Clinical Trial
II Clinical Trial Phase
II Clinical Trial
Australia Oceania Phase II Clinical Trial Phase II Clinical Trial
Italy
Germany Europe,
Europe, EU
EU Phase
Phase II
II Clinical
Clinical Trial
Trial Phase
Phase II
II Clinical
Clinical Trial
Trial
Hungary
Austria Europe,
Europe, EU
EU Phase
Phase II Clinical
II Clinical Trial
Trial Phase
Phase II Clinical
II Clinical Trial
Trial
UK
Germany Europe,
Europe, EU
EU Phase II Clinical Trial
Phase I Clinical Trial Phase II Clinical Trial
Phase I Clinical Trial
Sweden
Netherlands Europe,
Europe, EU
EU Phase
Phase II Clinical
Clinical Trial
Trial Phase
Phase II Clinical
Clinical Trial
Trial
USA North America Phase II Clinical Trial Phase II Clinical Trial
USA North America Phase I Clinical Trial Phase I Clinical Trial
Netherlands Europe, EU Phase II Clinical Trial Phase II Clinical Trial
Canada North America Phase I Clinical Trial Phase I Clinical Trial
China Asia Phase I Clinical Trial Phase I Clinical Trial
China
Mexico Asia
North America Phase
Phase IIIIClinical
ClinicalTrial
Trial Phase
Phase IIIIClinical
ClinicalTrial
Trial
Mexico
Germany North America
Europe, EU Phase
Phase III Clinical Trial
III Clinical Trial Phase
III Clinical Trial
Mexico
Canada North America
North America Phase III
Launched Clinical Trial 2020 Phase III
Launched Clinical Trial
Hungary
USA Europe, EU
North America Launched
Phase III Clinical Trial 2021 Launched
France Europe, EU Phase II Clinical Trial Phase II Clinical Trial
USA
USA North
North America
America Phase
I Clinical Trial
USA
China North
Asia America Phase
I Clinical Trial
India Asia Phase II Clinical Trial Phase II Clinical Trial
USA
USA North
North America
America Phase
I Clinical Trial
USA
USA North America
North America Phase IIIClinical
Phase ClinicalTrial
Trial Phase IIIClinical
Phase ClinicalTrial
Trial
USA
USA North
North America
America Phase I Clinical Trial
Phase I Clinical Trial Phase I Clinical Trial
USA
USA North
North America
America Phase
Phase IIIIClinical
ClinicalTrial
Trial Phase
Phase IIIIClinical
ClinicalTrial
Trial
Japan Asia Phase II Clinical Trial Phase II Clinical Trial
USA
USA North
North America
America Phase
Phase IIIClinical
ClinicalTrial
Trial Phase
Phase IIIClinical
ClinicalTrial
Trial
Puerto Rico North America Phase II Clinical Trial Phase II Clinical Trial
USA
USA North
North America
America Phase
I Clinical Trial
USA
Canada North
North America
America Phase
Phase IIIClinical
ClinicalTrial
Trial Phase
Phase IIIClinical
ClinicalTrial
Trial
USA
USA North
North America
America Phase
I Clinical Trial
USA
USA North
North America
America Phase
Phase II Clinical
Clinical Trial
Trial Phase
Phase II Clinical
Clinical Trial
Trial
China Asia Phase II Clinical Trial Phase II Clinical Trial
China
USA Asia
North America Phase
Phase II
II Clinical
Clinical Trial
Trial Phase
Phase II
II Clinical
Clinical Trial
Trial
Germany Europe, EU Phase I Clinical Trial Phase I Clinical Trial
USA
Germany North America
Europe, EU Phase
Phase IIIClinical
ClinicalTrial
Trial Phase
Phase IIIClinical
ClinicalTrial
Trial
France
Austria Europe,
Europe, EU
EU Phase II
Launched Clinical Trial 2020 Phase II
Belgium Europe, EU Launched 2020 Launched
Partnering Availability: Latest Change Latest Change Event Date
Country Date 8/20/2021 Completion of Phase I/II trial (ARCT-021- 2020/08/11
Argentina; Australia; Austria; 01) for COVID-19
7/30/2021 Expected timing ofinfection
Phase IIreported
trial reported 2020/07/21
2021/07/30
Belgium; Brazil; Canada; Chile; 7/30/2021 Approval in the UK for Phase II trial for 2021/05/19
2020/05/18
9/8/2021 OTC deficiency
Additional detailsreported
of Phase II trial 2020/03/11
2021/03/30
8/9/2021 Completion reported
(GO40558) of Phase IIa trial 2021/02/04
2019/10/01
(D9150C00003)
8/3/2021 New product entry for heart failure reported 2018/01/09
2021/08/03
6/18/2021 Details of Phase II trial (BNT111-01; 2020- 2021/04/26
6/17/2021 002195-12)
Ongoing Phase for melanoma
I developmentreported
confirmed 2020/07/30
2019/09/16
per NCT04382898
6/1/2021 Initiation of Phase II trial (AHEAD-MERIT) 2019/08/02
2019/09/14
11/18/2020 for HPV16+
Interim Phasehead and
I trial neck squamous
(BN_0002-01) cell
results 2018/02/05
2019/09/17
9/28/2020 for
Phasecancer breast reported
I development for ovarian cancer 2016/10/13
2020/09/28
reported
3/4/2021 Ongoing development confirmed per 2019/09/13
2021/02/23
7/2/2021 BioNTech
Initiation ofpipeline
Phase Iand trialNCT04455620
(BNT152-01C) for 2019/09/11
2021/07/02
solid tumours reported
7/2/2021 Initiation of Phase I trial (BNT152-01C) for 2021/02/28
2021/07/02
2/19/2021 solid tumours
Completion of reported
Phase I trial (VAL-181388- 2020/01/17
2017/09/14
P101)results
7/22/2021 Initial reportedof Phase I/IIa trial (BNT211- 2016/09/07
2020/10/14
8/4/2021 01; 2019-004323-20)
Ongoing Phase II trialfor solid tumours
(mRNA-1647-P202- 2020/08/18
2020/01/09
EXT)product
2/18/2021 New reportedentry 2018/01/08
2021/02/18
7/13/2021 Additional details of Phase Ia/Ib trial (PRO- 2021/06/01
CL-001) for
6/7/2021 Planned COVID-19
Phase II trial andinfection reported
preclinical 2021/01/26
2021/05/01
results reported
9/1/2021 Planned Phase III trial in Nepal and 2021/01/05
2021/08/19
8/28/2021 ongoing
WithdrawalPhase II trial III
of Phase (NCT04990544)
trial (CV-NCOV- 2021/05/19
2021/03/30
012) for COVID-19
9/9/2021 Planned booster dose infection reported
in Ireland reported 2021/01/07
2021/09/04
9/7/2021 Additional details of Phase II/III trial 2021/09/03
2021/06/15
(mRNA-1273-P205)
8/3/2021 Revised reportedfiling reported
timing of regulatory 2021/03/10
2021/03/12
3/25/2021 Additional details of Phase I trial (mRNA- 2020/03/30
2021/03/15
8/25/2021 1283-P101)
Ongoing Phase reported
II development for NSCLC 2021/02/26
2018/01/24
confirmedPhase I trial (SAFE-T-HBV) for
2/11/2021 Planned 2017/12/22
2017/07/03
9/5/2021 liver cancer
Planned reported
Phase II/III trials for COVID-19 2016/02/23
2021/08/16
infection reported
3/19/2021 Initiation of Phase I trial (213830) reported 2021/04/13
2021/03/18
9/7/2021 Initiation of Phase I/II trial (UX053-CL101) 2021/02/23
2021/09/07
for glycogen
2/23/2021 Ongoing Phase storage disease Type
I development III
confirmed 2021/07/27
2019/05/23
per Oct 2020 pipeline
8/10/2021 Update of Phase Ib trial for hMPV and 2019/01/07
2018/01/08
PIV3 prophylaxis reported
9/7/2021 Ongoing Phase II/III trial (mRNA-1273- 2017/01/25
2021/09/06
P205) for COVID-19 prophylaxis
8/3/2021 Expected timing of confirmatory trial and reported 2021/08/06
2021/03/22
Japanese
8/3/2021 Drug synonymfiling as
reported
SP-0273 reported 2020/04/25
2021/06/22
6/24/2021 Details of agreement with Tabuk 2020/05/29
2021/03/10
Pharmaceutical in Saudi Arabia
8/4/2021 US fast track status for RSV reported reported 2021/01/25
2021/08/03
2/19/2021 Ongoing Phase I development confirmed 2020/09/29 2017/01/09
from Jan of
7/5/2021 Initiation 2021 pipeline
Phase II trial (mRNA-1893- 2016/07/26
2021/07/02
2/19/2021 Ongoing development confirmed per Oct 2019/08/19
P201) reported 2019/02/04
2/19/2021 Ongoing development confirmed per Oct 2018/01/12
2020 pipeline 2018/11/23
8/20/2021 Planned IND and CTA filing confirmed from 2018/11/15
2020 pipeline 2021/08/09
Moderna of
3/17/2021 Initiation Therapeutics Press
Phase I/II trial release
(mRNA-3927- 2020/09/21
2021/03/16
P101) for propionic acidaemia reported 2019/10/22
11/15/2020 Interim results of Phase I trial (mRNA- 2019/08/07
11/9/2020 4157-P101;
Ongoing Phase PCV) for solid cancers
I development confirmed 2019/04/04
2019/07/17
per Moderna Oct 2020 Pipeline
8/4/2021 Initiation of Phase I trial (mRNA-6231- 2018/05/03
2021/08/02
7/27/2021 P101)
Ongoing reported
Phase I/II development confirmed 2020/01/16
2020/03/26
per Jun 2021 presentation
7/23/2021 Ongoing development confirmed per 2020/02/26
2020/07/14
7/12/2021 Route as intramuscular pipeline
Stemirna Therapeutics injection reported 2019/04/12
2021/07/07
12/7/2020 Ongoing Phase I development confirmed 2021/01/12
2019/10/30
3/10/2021 from GlaxoSmithKline
Ongoing pipeline
Phase I trial for rabies infection 2019/08/21
2018/10/19
Argentina; Australia; Austria; confirmed per NCT03713086
6/30/2021 Ongoing Phase II development confirmed 2018/01/23
2020/09/25
Belgium; Brazil; Canada; Chile; 10/15/2020 per May 2021
Regaining the SCM
productLifescience report
rights from Merck 2018/04/19
2019/11/06
reported
1/15/2021 Ongoing Phase I/II trial reported 2019/05/14
2021/01/12
9/9/2021 Planned booster dose in Ireland, EU 2019/09/13
2021/09/06
submission of CMA for booster dose, 2021/08/23
Event Type Event Details
Global Status Advance Phase II Clinical Trial
IND FilingPhase Change
Disease Singapore; Infection,
Cancer, liver; coronavirus,
No development novel coronavirus prophylaxis
reported
Disease PhaseAdvance
Global Status Change Cancer, breast; No
Phase I Clinical Trialdevelopment reported
IND Filing
Nonproprietary Name Granted The US; Ornithine transcarbamylase deficiency
BNT-122
Disease
Disease Phase
Phase Change
Change Cancer, lung, non-small
Wound healing; cell; Preclinical
No development reported
Global Status
Drug Added Advance Phase II Clinical Trial
Global Status Reversion
Lead Identified Phase I Clinical
anticancer Trial
immunotherapy, BioNTech-1
Global Status Advance
Lead Identified Phase II Clinical
HPV RNA vaccine, Trial
BioNTech
Drug
Lead Added
Identified Phase II Clinical Trial
IVAC mutanome breast cancer vaccine, BioNTech
Global
Global Status
Status Advance
Advance Phase I Clinical Trial
Drug Added
Global Status Advance Preclinical
Drug
GlobalAdded
Status Advance Preclinical
IND Filing
Global Status Advance The
PhaseUS; Cancer,Trial
I Clinical solid, unspecified
Drug
GlobalAdded
The US; Phase I clinical trial
New Disease
Global Status Advance Infection,
Phase Zika virus;
II Clinical TrialZika virus prophlaxis
Drug
GlobalAdded
Drug Added Phase
Phase II Clinical
Clinical Trial
Trial
New Licensee Biological E.; India
Global Status
Advance Phase II Clinical
Phase Clinical Trial
Trial
IND Filing
Global Status Advance China;
Phase III Clinical coronavirus,
Infection, Trial novel coronavirus; Infection, coronavirus,
New
New Licensee
Licensee Suzhou
Celonic; Abogen
WorldwideBiosciences; China
New Licensee Approval
Supplemental Bayer; Worldwide
Australia; Infection, coronavirus, novel coronavirus prophylaxis; individuals
Emergency Use
Global Status Authorization Granted
Advance 12yr and older
Global Status Advance Phase
Phase II
II Clinical
Clinical Trial
Trial
Drug
GlobalAdded
Drug Added
New Patent Preclinical
EP2814961
Global Status
Orphan Advance
Drug Status Granted Phase
The II Hepatocellular
US; Clinical Trial carcinoma
Drug Added
New Licensee Phase
Quratis;I Clinical
Asia Trial
Global
Global Status
Status Advance
Advance Phase
Phase I/II Clinical
I Clinical Trial
Trial
Drug Added
OrphanStatus
Global Drug Status Granted
Advance The EU;
Phase Cori's disease
I Clinical Trial
Drug Added
Drug
GlobalAdded
Drug Added
Phase I/II Clinical Trial
Drug Added
Drug Added
Drug Added
Expedited Review Designation Granted Preclinical
The US; Infection, respiratory syncytial virus prophylaxis; Fast track
Global Status
New Disease Advance Phase I Clinical
Infection, Trialvirus prophylaxis
influenza
Global Status
Advance Phase II
Phase I Clinical
ClinicalTrial
Trial
Expedited Review Designation
Global Status Advance Granted The US; Infection,
Phase I Clinical TrialZika virus prophylaxis; Fast Track
Drug
GlobalAdded
New Disease
Global Status Advance Cancer,
Phase II lymphoma,
Clinical Trialunspecified; Cancer, solid, unspecified
Drug Added
Expedited Review Designation Granted The US; Propionic acidemia; Fast track
New Disease
Global Status Advance Cancer, melanoma
New Licensee
Global Status Advance Merck & Co.; Worldwide
New
Expedited Review Designation Granted interleukin
Target 2; 3558
The US; Cystic fibrosis; Rare Pediatric Disease designation
Global Status Advance Granted The
Phase II Clinicalfibrosis;
US; Cystic Trial Fast track
New Disease
Global Status Advance Cancer,
Phase II Clinical Trial cell
lung, non-small
Drug
GlobalAdded
Drug Added
Drug
GlobalAdded
Global
Global Status
Status Reversion
Advance Phase
I Clinical Trial
Drug Added
New
New Target
Launch Interleukin 12; 107653060,
Chile; Infection, coronavirus,Interleukin 15; 3600,prophylaxis;
novel coronavirus GM-CSF; 1437 & aged
subjects
New Approval 12yr and above
Therapeutic Class Therapeutic Class Status
Prophylactic vaccine, anti-infective Phase II Clinical Trial
Messenger
Messenger RNA RNA Phase
Phase II
II Clinical
Clinical Trial
Trial
Anticancer,
Messenger RNA immunological Phase II Clinical Trial
Gene therapy
Messenger RNA Phase
Phase IIIClinical
ClinicalTrial
Trial
Anticancer,
Messenger RNA vaccine Phase
Phase II Clinical
II Clinical Trial
Trial
Cardiovascular
Messenger RNA Phase
II Clinical Trial
Antiviral,
Messenger other
RNA Phase
II Clinical Trial
Anticancer,
Anticancer, vaccine
vaccine Phase
Phase II
II Clinical
Clinical Trial
Trial
Anticancer, immunological
Messenger RNA Phase
Phase II Clinical
II Clinical Trial
Trial
Recombinant
Messenger RNA vaccine Phase II Clinical Trial
Anticancer, vaccine
Messenger RNA Phase
Phase II Clinical
Clinical Trial
Trial
Anticancer, vaccine
Messenger RNA Phase
I Clinical Trial
Cytokine
Messenger RNA Phase
I Clinical Trial
Cytokine
Messenger RNA Phase
Phase II Clinical
Clinical Trial
Trial
Cytokine
Messenger RNA Phase
I Clinical Trial
ProphylacticRNA
Messenger vaccine, anti-infective Phase II
Phase I Clinical
ClinicalTrial
Trial
Messenger RNA Phase
Phase II
II Clinical
Clinical Trial
Trial
Prophylactic
Messenger RNAvaccine, anti-infective Phase II Clinical Trial
Prophylactic
Messenger RNAvaccine, anti-infective Phase
Phase II Clinical
Clinical Trial
Trial
ProphylacticRNA
Messenger vaccine, anti-infective Phase II Clinical
Phase Clinical Trial
Trial
Prophylactic
Phase III ClinicalTrial
I Clinical Trial
Prophylactic
III Clinical Trial
Prophylactic
Messenger RNA vaccine, anti-infective Phase III Clinical Trial
Launched
Prophylactic
Messenger RNA vaccine, anti-infective Launched
Prophylactic
Messenger RNA vaccine, anti-infective Phase
Phase III ClinicalTrial
II Clinical Trial
Prophylactic
I Clinical Trial
Prophylactic
Phase IIIClinical
ClinicalTrial
Trial
Anticancer,
Cellular vaccine
therapy, T cell receptor Phase IIIClinical
Phase ClinicalTrial
Trial
Messenger
Messenger RNA
RNA Phase
Phase IIIClinical
ClinicalTrial
Trial
Prophylactic
Messenger RNAvaccine, anti-infective Phase II Clinical Trial
Therapeutic
Phase IIIClinical
ClinicalTrial
Trial
Gene therapy
Messenger RNA Phase IIIClinical
Phase ClinicalTrial
Trial
Messenger RNA Phase I Clinical Trial
Prophylactic
Phase IIIIClinical
ClinicalTrial
Trial
Prophylactic
Messenger RNAvaccine, anti-infective Phase III Clinical Trial
ProphylacticRNA
Messenger vaccine, anti-infective Phase IIIClinical
Phase ClinicalTrial
Trial
Prophylactic
Messenger RNAvaccine, anti-infective Phase I Clinical Trial
Prophylactic
Prophylactic vaccine,
vaccine, anti-infective
anti-infective Phase
I Clinical Trial
Messenger
Phase II Clinical
Clinical Trial
Trial
ProphylacticRNA
Messenger vaccine, anti-infective Phase II
Phase I Clinical
ClinicalTrial
Trial
Prophylactic
Messenger RNA vaccine, anti-infective Phase II Clinical Trial
Antiviral, other other
Recombinant, Phase
Phase II Clinical
Clinical Trial
Trial
Messenger
I Clinical Trial
Metabolic and
Messenger RNAenzyme disorders Phase II
Phase II Clinical
Clinical Trial
Trial
Metabolic and enzyme disorders Phase II Clinical Trial
Messenger RNA Phase II Clinical Trial
Anticancer,
I Clinical Trial
Anticancer,
Phase II Clinical
Clinical Trial
Trial
Anti-inflammatory
Messenger RNA Phase
I Clinical Trial
Cystic fibrosis
Messenger RNAtreatment Phase
II Clinical Trial
Anticancer,
Phase II
II Clinical
Clinical Trial
Trial
Prophylactic
Messenger RNA vaccine, anti-infective Phase II Clinical Trial
Prophylactic
Prophylactic vaccine,
vaccine, anti-infective
anti-infective Phase
Phase II Clinical
Clinical Trial
Trial
Messenger RNA other
Cellular therapy, Phase
Phase IIIClinical
ClinicalTrial
Trial
Messenger
Messenger RNARNA Phase II ClinicalTrial
Prophylactic
Cytokine vaccine, anti-infective Phase
Phase IIIClinical
ClinicalTrial
Trial
Messenger
Messenger RNARNA Phase II
Prophylactic vaccine, anti-infective Launched
Mechanism Of Action Delivery Route Delivery Medium
Immunostimulant Injectable; Injectable, Solution
Immuno-oncology therapy intramuscular
Injectable; Injectable,
Unidentified pharmacological activity intralymphatic
Immuno-oncology therapy intravenous
Vascular endothelial growth factor (VEGF) intravenous
receptor agonist
Genome editing intracardiac; Injectable,
Immunostimulant intraocular
Injectable; Injectable, Solution
Immunostimulant intravenous
Immunostimulant; Immuno-oncology intradermal
therapy
Injectable
Immuno-oncology therapy Injectable; Injectable,
Claudin 6 antagonist; Immuno-oncology intramuscular
therapy
Immunostimulant intramuscular
Unspecified
Immunostimulant Injectable; Injectable,
Unidentified pharmacological activity intramuscular
Immuno-oncology therapy; T cell stimulant intradermal
Injectable
Unidentified pharmacological activity intramuscular
Interleukin 12 agonist; Immuno-oncology intravenousInjectable,
Injectable;
therapy
Immunostimulant intratumoral
Injectable
Injectable
Immunostimulant Injectable, intramuscular
Immunostimulant Injectable Solution
Immunostimulant Injectable, intravenous
Immuno-oncology therapy; Tumour Injectable; Injectable,
necrosis factor
Unidentified ligand 4 agonist;
pharmacological Immune
activity intratumoral
Unidentified pharmacological activity intravenous
intravenous
Immuno-oncology therapy Injectable; Injectable,
K-Ras inhibitor intramuscular
Interleukin 2 agonist intramuscular
CF transmembrane conductance regulator subcutaneous
Inhaled; Inhaled, bronchial
agonist
Immunostimulant subcutaneous
Immunostimulant; T cell stimulant; intramuscular
Immuno-oncology
Immunostimulant therapy intradermal
Injectable
Immuno-oncology therapy Injectable; Injectable, Solution
Immunostimulant intratumoral
intramuscular
Delivery Technology Target Target Entrez
Nanoparticles Not applicable Gene ID
Not Applicable
Unspecified Not Applicable
Nanoparticles Unspecified Not Applicable
vascular endothelial growth factor A 7422
Liposomes; Nanoparticles cancer/testis antigen 1B 1485
MAGE family member A3
Unspecified 4102
Not Applicable
Not applicable Not Applicable
interleukin 2 3558
interleukin 7 3574
interleukin 2 3558
claudin 6 9074
UL55, cytomegalovirus 1487750
Nanoparticles Not applicable Not Applicable
Nanoparticles interleukin 12A 3592
interleukin
Unspecified12B 3593
Not Applicable
Liposomes; Nanoparticles Not applicable Not Applicable
TNF superfamily member 4 7292
interleukin
Unspecified23 subunit alpha 51561
Not Applicable
KRAS proto-oncogene, GTPase 3845
interleukin 2 3558
Nebulized CF transmembrane conductance 1080
regulator
interleukin 12A 3592
Nanoparticles interleukin 15
Not applicable 3600
Not Applicable
Target Family Target EC Number Trialtrove Trial Count
5
5
2
5
Cytokine/Growth factor > Growth 2
factor, non-cytokine 0
3
1
3
2
1
Cytokine/Growth factor > Cytokine > 1
Interleukin
Interleukin
Interleukin 1
1
4
1
5
5
6
10
128
2
2
1
4
7
5
1
1
Interleukin 2
1
1
1
3
1
1
2
1
Tumour necrosis factor 1
1
2
1
Interleukin
Enzyme; Transporter > ABC driven 3.6.3.49 1
superfamily; Ion channel > Chloride 3
1
1
1
15
1
Interleukin 226
Origin NCE Molecular Weight
Biological, nucleic acid, non- No
viral vectornucleic acid
Biological, No
Biological, nucleic acid No
Biological, No
Chemical, synthetic, nucleic No
acid
Biological, protein No
Biological, No
Biological, No
viral vectorcellular, autologous
Biological, No
Biological, cellular, autologous No
Chemical Name
Autogene cevumeran
Autologous, mature dendritic cells co-electroplated with in
vitro transcribed RNAs encoding autologous cancer antigens
Chemical structure (SMILES format) Molecular Formula
CAS Number LogP H Bond Donors H Bond Acceptors
2365453-34-3
Rotatable Bonds Patent Number Patent Priority
Country & Date
EP2814961 WO 2012/02/15
Marketing
Approvals
_______________
Orphan drug Designation
________________
Filings
________________
Emergency Use Authorization

________________
Approvals
________________
Approvals
________________
Approvals
__________________
Orphan Drug Status

________________
Orphan Drug Status

________________
Filings
________________
Approvals
________________
________________
________________

_________________
Orphan Drug Status
------------------------------------
Orphan Drug Status
_______________
Approvals
_________________
Approvals
________________
Licensing
Agreements
_____________
Agreement
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
----------------
Agreements
__________________
Agreements
________________
Agreements
_______________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
_____________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
________________
Agreements
Agreements
________________
Agreements
_______________
Phase III
A Phase III trial is expected in the 2nd qtr of 2021 (Press
release, Arcturus Therapeutics, 26 Jul 2020,
Infection, cytomegalovirus prophylaxis

A randomized, observer-blind, placebo-controlled, pivotal
Biological E.
Walvax
Infection,Biotechnology
CureVac
Moderna
Infection, Therapeutics
It is in an open-label,
Infection, coronavirus,non-randomized, sequential-assignment
novel coronavirus; Infection,
Infection, coronavirus prophylaxis; Infection, coronavirus,


Infection, coronavirus,non-randomized, sequential-assignment
An active-controlled, non-inferiority confirmatory trial is
Cancer, renal
A randomized, open-label, parallel assignment, international,

BioNTech; Pfizer
Phase II
A randomized,
Cancer, double-blind, placebo-controlled, parallel-
melanoma
It is in a Phase
Approval Ib/II received
has been trial in Belgium and Spain todouble-blind,
for a randomized, evaluate
placebo-controlled,
A first-line adjuvant nested singletrial
solid cancer andinmultiple ascending
combination with
atezolizumab
Heart failure (Tecentriq) in 2020 was planned (JP Morgan
AstraZeneca
Keratitis, herpetic
It is in a Phase
Cancer, I/II trial in China to evaluate the safety,
melanoma
BioNTech
Cancer, prostate
It is in a first-in-human,
Cancer, head and neck;dose titration
Infection, and expansion,
human Phase
papilloma virus
It is in an open-label, randomized, parallel-assignment Phase

It is in an open-label, first-in-human, dose-escalation and

Infection, non-randomized,
cytomegalovirus prophylaxis first-in-human, dose-
It is in an open-label, non-randomized, long-term extension
Providence
A Therapeutics
Phase II trial to evaluate mRNACOVID-19 vaccine is
planned (Press release,novel
Infection, coronavirus, Reuters, 3 Jun 2021,
Suzhou Abogen Biosciences; Walvax Biotechnology
Infection, coronavirus prophylaxis; Infection, coronavirus,
novel coronavirus
Infection, prophylaxis
It is in a Phase II (KidCOVE) trial in the paediatric
Infection, coronavirus, novel coronavirus population
prophylaxis
It is in a randomized, observer-blind, placebo-controlled,
Infection, coronavirus, novel coronavirus; Infection,
Cancer, lung, non-small cell
It is a non-randomized,
Cancer, liver open-label, multi-centred 2-arm Phase
An open label, single-arm, Phase I/II
Infection, coronavirus prophylaxis; trial in China
Infection, and
coronavirus,
Cori's disease
Ultragenyx Pharmaceutical

It is in a randomized, double-blind, parallel-assignment Phase
Infection, Zika virus prophylaxis

Methylmalonic acidaemia
Propionic acidaemia global, dose-optimization Phase I/II trial
It is in an open-label, non-randomized, dose-escalation,
Cancer, melanoma
It is in an open label, randomized, parallel assignment, Phase
Cystic fibrosis
It is in a randomized,
Cancer, double-blinded,
colorectal; Cancer, placebo-controlled,
esophageal; Cancer,
gastrointestinal, stromal; Cancer, pancreatic
It is in a randomized, stratified, observer-blind, dose-ranging,
parallel-assignment Phase I/II trial (mRNA-1010-P101) in the
Cancer, renal
It is in an open-label, randomized, parallel-assignment Phase
BioNTech; Sanofi
BioNTech; Pfizer
Phase I
A clinical trial to ECI-006 either as an immune activator in

combination
A randomized, with antigens or asplacebo-controlled,
double-blinded, a tumour environment
dose-
escalation, ascending
Cancer, solid, unspecifieddose, parallel-assignment Phase I trial
BioNTech; Genentech
Diabetes, Type 2
AstraZeneca
It is in an open-label, single-group assignment, first-in-human
dose escalation Phase I trial (RB_0003-01; LIPO-MERIT) in
Cancer, breast
It is in anovarian
Cancer, open-label, single-group assignment, non-
It is in an open label, single group assignment, Phase I
Cancer, open-label, non-randomized, dose-
solid, unspecified
Infection, open-label,
chikungunya virus non-randomized, dose-
prophylaxis
A randomized, placebo-controlled, dose-ranging, parallel
Infection, cytomegalovirus prophylaxis
A randomized,
Infection, observer-blind,
coronavirus, placebo-controlled,
novel coronavirus dose-
prophylaxis
Infection, open-label,
coronavirus, novel non-randomized,
coronavirus prophylaxis dose-
Providence
It Therapeutics
is in a randomized, double-blind, placebo-controlled Phase I
trial
Infection, coronavirus, novelhealthy
in China in 240 healthy susceptible
coronavirus populations
prophylaxis
Suzhou
CureVac;AbogenBayer Biosciences
It is in a randomized,
Infection, coronavirus,partially blind, placebo-controlled,
novel coronavirus prophylaxis dose-
It is in a randomized, observer-blind, dose-ranging, parallel-
It is in a randomized, observer-blind, dose-ranging, parallel-

assigment
Cancer, lung, Phase I trial (mRNA-1283-P101)
non-small cell in the US in 125
An open-label,
Cancer, liver single group assignment Phase Ib trial (CV-
An
An open-label,
IND approval single-group
for a Phaseassignment Phase
I trial in South I trial
Korea to (SAFE-
evaluate
HDT-301 has been approved.
Infection, herpes simplex virus Initation is planned (Press
It is in a first-time-in-human, randomized, single-blind,
AstraZeneca
dose-ranging, sequential assignment Phase Ib trial (mRNA-
It is in a US Phase I trial, to assess the safety and

immunogenicity (immune
Infection, coronavirus, response)
novel of theprophylaxis
coronavirus monovalent
It
It is
is in
in an open-label, observer-blind,
a randomized, randomized, parallel-assignment
placebo-controlled,Phase
dose-escalation, parallel-assignment,
A randomized, double-blind, Phase I trial
placebo-controlled, (mRNA-
dose-
escalationZika
Infection, Phase I trial
virus (VAL-339851-P101) in the US in 156
prophylaxis
A randomized, observer-blind,
A randomized, placebo-controlled, placebo-controlled, dose-
dose-ranging, sequential
assignment Phase I unspecified;
Cancer, lymphoma, trial (mRNA-1944-P101) in unspecified
Cancer, solid, the US in 32
It
AnisIND/CTA
in a multi-centre,
is planned open-label, non-randomized,
(Press release, Moderna parallel
Therapeutics, 17 Sep 2020,
It is in ancolorectal;
Cancer, open label, non-randomized,
Cancer, pancreatic;sequential
Cancer, lung, non-
small cell
It is in an open-label, non-randomized, dose-escalation,
sequential-assignment Phase I trial (mRNA-6231-P101) in
Infection, rabies prophylaxis

It
It is
is in
in a
anrandomized,
open-label, sequential assignment
non-randomized, Phasedose-
controlled, I trial
escalation, parallel
A Phase I study assignment Phase
demonstrated I trial (CV-7202-104;
immunopotency and a
favourable
Merck safety profile (Press release, Argos, 31 Jan 2007).
It is in Phase
Cancer, solid,I unspecified
trials (Press release, Moderna, 6 Nov 2019,
BioNTech; Sanofi
A clinical trial in India to evaluate BNT-162 is planned (Press
Preclinical Record URL
Preclinical studies have demonstrate that neutralizing https://citeline.informa.com/drugs/details/178101?qId=a1afc06d-
antibody levels in response to a single administration of https://citeline.informa.com/drugs/details/125439?qId=a1afc06d-
It is at the IND-enabling stage (Company pipeline, Arcturus https://citeline.informa.com/drugs/details/114349?qId=a1afc06d-
Therapeutics, 12 Jun 2015, 1 Jun 2017 & 15 Jun 2018 https://citeline.informa.com/drugs/details/131582?qId=a1afc06d-
In vivo https://citeline.informa.com/drugs/details/123283?qId=a1afc06d-
In a swine model, AZD-8601 single cardiac administration https://citeline.informa.com/drugs/details/201881?qId=a1afc06d-
https://citeline.informa.com/drugs/details/89678?qId=a1afc06d-1
https://citeline.informa.com/drugs/details/156829?qId=a1afc06d-
It was at the GMP stage (Company pipeline, BioNTech, 23 https://citeline.informa.com/drugs/details/89746?qId=a1afc06d-1
Aug 2014,
It was http://www.biontech.de/products-and-pipeline/).
in preclinical development (Company pipeline, https://citeline.informa.com/drugs/details/171394?qId=a1afc06d-
BioNTech, 16 Sep 2019, https://biontech.de/wp-
It was in preclinical development (Company pipeline, https://citeline.informa.com/drugs/details/171222?qId=a1afc06d-
BioNTech, 17 Jan 2020,
It was in preclinical https://biontech.de/science/pipeline).
development (Company pipeline, https://citeline.informa.com/drugs/details/84326?qId=a1afc06d-1
Moderna, 27 Jan 2016, http://modernatx.com/our-pipeline). https://citeline.informa.com/drugs/details/185352?qId=a1afc06d-
GLP toxicology studies were successfully completed for https://citeline.informa.com/drugs/details/136134?qId=a1afc06d-
mRNA-1647
In rat models,(Press release, Moderna,
GSK-4184258A produced 14aSep
high2017,
level of https://citeline.informa.com/drugs/details/193733?qId=a1afc06d-
immune
In vivo response. It also showed quick, strong immune https://citeline.informa.com/drugs/details/191430?qId=a1afc06d-
PTX-COVID19-B
In wasDF-104B1
preclinical studies, chosen among
foundthree
to becandidates after
effective against https://citeline.informa.com/drugs/details/178849?qId=a1afc06d-
variants spreading in South Africa, Brazil and India (Press https://citeline.informa.com/drugs/details/183210?qId=a1afc06d-
In a study of 6 non-human primates, boost vaccination with 4 https://citeline.informa.com/drugs/details/176782?qId=a1afc06d-
µg of CVnCoVstudy
A preliminary 28 days post that
showed prime
thevaccination
antibodiesresulted
generatedin by https://citeline.informa.com/drugs/details/176256?qId=a1afc06d-
the vaccine were less effective at binding the mutated spike https://citeline.informa.com/drugs/details/194161?qId=a1afc06d-
In vivo
In Balb/c mice,
In preclinical mRNA-1273.211
studies, increased
two immunizations neutralizing
of the titers https://citeline.informa.com/drugs/details/178895?qId=a1afc06d-
mRNA vaccine
induced high neutralizing antibody levels that are comparable https://citeline.informa.com/drugs/details/194077?qId=a1afc06d-
Patents https://citeline.informa.com/drugs/details/83482?qId=a1afc06d-1
EP2814961,
In vitro covering nucleic acid sequence, comprising or https://citeline.informa.com/drugs/details/122832?qId=a1afc06d-
In in-vitro studies, assessed
Intramuscular injection virological and gene-expression
of LION/repRNA-CoV2S elicits robust https://citeline.informa.com/drugs/details/180314?qId=a1afc06d-
anti-SARS-CoV-2 spike protein IgG antibody isotypes https://citeline.informa.com/drugs/details/193853?qId=a1afc06d-
It was in IND-enabling studies (Company pipeline, Arcturus https://citeline.informa.com/drugs/details/118960?qId=a1afc06d-
Therapeutics,
Preclinical 9 Jan 2018has
development & 19 Juncompleted
been 2018, (Form S-1, https://citeline.informa.com/drugs/details/161850?qId=a1afc06d-
Moderna Therapeutics, 9 Nov 2018, Page 150,
Pre-clinical studies of hMPV and PIV3 combination vaccine https://citeline.informa.com/drugs/details/136135?qId=a1afc06d-
demonstrate ability to generate robust neutralizing antibody https://citeline.informa.com/drugs/details/202119?qId=a1afc06d-
In preclinical studies it has showed positive safety and https://citeline.informa.com/drugs/details/180175?qId=a1afc06d-
efficacy
In results
preclinical (Pressthe
studies, release, Daiichi
vaccine Sankyo, 22
demonstrated Mar 2021, https://citeline.informa.com/drugs/details/181740?qId=a1afc06d-
promising
safety
In vivo and immunogenicity (Press release, Sanofi, 22 Jun https://citeline.informa.com/drugs/details/192408?qId=a1afc06d-
In Balb/c mice, mRNA-1273.351 increased neutralizing titers
It is in preclinical development (Company pipeline, Moderna https://citeline.informa.com/drugs/details/177237?qId=a1afc06d-
Therapeutics, 13 Feb 2020, https://citeline.informa.com/drugs/details/121829?qId=a1afc06d-
In vivo https://citeline.informa.com/drugs/details/144819?qId=a1afc06d-
In mice models,
IND-enabling during pregnancy,
toxicology studies aremRNA-1893 im induced a
complete (Company https://citeline.informa.com/drugs/details/148703?qId=a1afc06d-
pipeline, Modernadevelopment
It is in preclinical Therapeutics, 12 Jan 2018,
(Company Pipeline, Moderna, https://citeline.informa.com/drugs/details/119013?qId=a1afc06d-
15 Nov
In vivo 2018, https://www.modernatx.com/pipeline). https://citeline.informa.com/drugs/details/187013?qId=a1afc06d-
In vivo
In mice model, mRNA-3705 showed greater potency and https://citeline.informa.com/drugs/details/148700?qId=a1afc06d-
In a mouse model, mRNA-3927 demonstrated reduction in
It has completed GLP toxicology studies (Company pipeline, https://citeline.informa.com/drugs/details/128183?qId=a1afc06d-
Moderna
In vivo therapeutics, 8 Jun 2017, https://citeline.informa.com/drugs/details/144945?qId=a1afc06d-
In
In mouse model,
preclinical CD8mRNA-6231
studies, T cell responses
showedto KRAS antigens
a 12-fold https://citeline.informa.com/drugs/details/176054?qId=a1afc06d-
expansion of studies,
In preclinical T regulatory cells without
successful significant
delivery increase
of MRT-5005 https://citeline.informa.com/drugs/details/144160?qId=a1afc06d-
resulted in the production of fully functional CFTR protein https://citeline.informa.com/drugs/details/150920?qId=a1afc06d-
It is in preclinical development (Press release, CureVac, 10 https://citeline.informa.com/drugs/details/148995?qId=a1afc06d-
Jan 2018, http://www.curevac.com/news/curevac-highlights-
In vivo https://citeline.informa.com/drugs/details/27041?qId=a1afc06d-1
In a mouse
It is in modeldevelopment
preclinical of renal cell (Company
carcinoma,pipeline,
Murine DCs with
Moderna https://citeline.informa.com/drugs/details/166858?qId=a1afc06d-
Therapeutics, 14 May 2019, https://citeline.informa.com/drugs/details/148609?qId=a1afc06d-
Results from the blood from people who were vaccinated with https://citeline.informa.com/drugs/details/178511?qId=a1afc06d-
the two-shot regimens, showed that the vaccines will provide
gs/details/178101?qId=a1afc06d-1e8e-481a-87c6-472205ff4057
(Therapeutic Class is Messenger RNA) AND [(Most Advanced Current Status is
Launched) OR (Most Advanced Current Status is Registered) OR (Most Advanced
Current Status is Pre-registration) OR (Most Advanced Current Status is Phase III
Clinical Trial) OR (Most Advanced Current Status is Phase II Clinical Trial) OR
(Most Advanced Current Status is Phase I Clinical Trial)]
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mRNA Drug List

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Citeline Drug ID Generic Drug Name Drug Names

178101 2019-nCoV prophylactic 2019-nCoV prophylactic vaccine, Arcturus

India Pune 411 026

Emergency Use Authorization

Orphan Drug Status

Orphan Drug Status

Expedited Review Designation

Infection, cytomegalovirus prophylaxis

Infection, coronavirus prophylaxis; Infection, coronavirus,

Infection, coronavirus, novel coronavirus prophylaxis

Infection, coronavirus, novel coronavirus prophylaxis

Cancer, solid, unspecified

Cancer, solid, unspecified

Infection, coronavirus, novel coronavirus prophylaxis

Infection, Zika virus prophylaxis

A clinical trial to ECI-006 either as an immune activator in

It is in a randomized, observer-blind, dose-ranging, parallel-

It is in a US Phase I trial, to assess the safety and

Infection, rabies prophylaxis

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