MedPath

Molnupiravir

Generic Name
Molnupiravir
Drug Type
Small Molecule
Chemical Formula
C13H19N3O7
CAS Number
2349386-89-4
Unique Ingredient Identifier
YA84KI1VEW

Overview

Molnupiravir (EIDD-2801, MK-4482) is the isopropylester prodrug of N4-hydroxycytidine. With improved oral bioavailability in non-human primates, it is hydrolyzed in vivo, and distributes into tissues where it becomes the active 5’-triphosphate form. The active drug incorporates into the genome of RNA viruses, leading to an accumulation of mutations known as viral error catastrophe. Recent studies have shown molnupiravir inhibits replication of human and bat coronaviruses, including SARS-CoV-2, in mice and human airway epithelial cells. A remdesivir resistant mutant mouse hepatitis virus has also been shown to have increased sensitivity to N4-hydroxycytidine. Molnupiravir was granted approval by the UK's Medicines and Health products Regulatory Agency (MHRA) on 4 November 2021 to prevent severe outcomes such as hospitalization and death due to COVID-19 in adults. Molnupiravir was also granted emergency use authorization by the FDA on December 23, 2021; however, it is not yet fully approved.

Indication

N4-hydroxycytidine and its prodrug molnupiravir are being studied for its activity against a number of viral infections including influenza, MERS-CoV, and SARS-CoV-2. Molnupiravir is approved in the UK for reducing the risk of hospitalization and death in mild to moderate COVID-19 cases for patients at increased risk of severe disease (eg. with obesity, diabetes mellitus, heart disease, or are over 60 years old). In the US, molnupiravir is authorized for emergency use for the treatment of high-risk adults With mild to moderate COVID-19.

Associated Conditions

  • Death
  • Hospitalizations

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-6841
ORAL
200 mg in 1 1
10/3/2023
AX Pharmaceutical Corp
73377-332
NOT APPLICABLE
1 g in 1 g
8/26/2025
Merck Sharp & Dohme LLC
0006-5055
ORAL
200 mg in 1 1
10/3/2023

EMA Drug Approvals

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Authorization Holder
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Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
LAGEVRIO molnupiravir 200 mg capsules bottle
372650
Medicine
A
1/20/2022

Health Canada Drug Approvals

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Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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