Molnupiravir - PharmaKB

Molnupiravir

Molnupiravir is a small molecule pharmaceutical. It is currently being investigated in clinical studies.

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Events

FDA approval date

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New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

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FDA

EMA

Brand Name	Status	Last Update
lagevrio	Use Authorization	2024-06-18
molnupiravir	Use Authorization	2022-05-23

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Agency Specific

FDA

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ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors

— J05AB18: Molnupiravir

HCPCS

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Clinical

Clinical Trials

30 clinical trials

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Indications Phases 4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	—	1	5	9	—	7	19
Coronavirus infections	D018352	EFO_0007224	B34.2	1	—	2	—	—	3
Severe acute respiratory syndrome	D045169	EFO_0000694	J12.81	—	—	2	—	—	2
Infections	D007239	EFO_0000544	—	—	—	1	—	1	2
Respiratory distress syndrome	D012128	EFO_1000637	J80	—	—	1	—	—	1
Syndrome	D013577	—	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Human influenza	D007251	EFO_0007328	J11.1	1	1	—	—	1	3
Virus diseases	D014777	—	B34	—	2	—	—	1	3
Respiratory syncytial viruses	D012136	—	—	—	2	—	—	—	2
Sars-cov-2	D000086402	—	—	—	1	—	—	—	1
Human respiratory syncytial virus	D018113	—	—	—	1	—	—	—	1
Dengue	D003715	—	A90	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	1	—	—	—	1	2
Coronavirus	D017934	—	—	1	—	—	—	—	1
Renal insufficiency	D051437	HP_0000083	N19	1	—	—	—	—	1
Liver diseases	D008107	HP_0002910	K70-K77	1	—	—	—	—	1
Hepatic insufficiency	D048550	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Molnupiravir
INN	molnupiravir
Description	Molnupiravir is a nucleoside analogue that is N(4)-hydroxycytidine in which the 5'-hydroxy group is replaced by a (2-methylpropanoyl)oxy group. It is the prodrug of the active antiviral ribonucleoside analog N(4)-hydroxycytidine (EIDD-1931), has activity against a number of RNA viruses including SARS-CoV-2, MERS-CoV, and seasonal and pandemic influenza viruses. It is currently in phase III trials for the treatment of patients with COVID-19. It has a role as a prodrug, an anticoronaviral agent and an antiviral drug. It is a nucleoside analogue, an isopropyl ester and a ketoxime. It is functionally related to a N(4)-hydroxycytidine.
Classification	Small molecule
Drug class	antivirals: treatments of SARS-CoV-2 infection, inhibiting viral RNA replication
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)C(=O)OC[C@H]1O[C@@H](n2cc/c(=N\O)[nH]c2=O)[C@H](O)[C@@H]1O