Last reviewed 2026-04-23 · How we verify

Molnupiravir (Esperavir)

Promomed, LLC · Phase 3 active Small molecule

Molnupiravir (Esperavir) is a Nucleoside analog antiviral Small molecule drug developed by Promomed, LLC. It is currently in Phase 3 development for COVID-19 (treatment of mild to moderate disease in adults at high risk of progression), Influenza (investigational). Also known as: JCBC00101.

Molnupiravir is a nucleoside analog that induces viral mutagenesis by causing errors during viral RNA replication, leading to viral extinction.

Molnupiravir is a nucleoside analog that induces viral mutagenesis by causing errors during viral RNA replication, leading to viral extinction. Used for COVID-19 (treatment of mild to moderate disease in adults at high risk of progression), Influenza (investigational).

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Molnupiravir (Esperavir)
Also known as	JCBC00101
Sponsor	Promomed, LLC
Drug class	Nucleoside analog antiviral
Target	Viral RNA-dependent RNA polymerase
Modality	Small molecule
Therapeutic area	Infectious Disease / Virology
Phase	Phase 3

Mechanism of action

Molnupiravir is a prodrug that is converted intracellularly to the active form, which acts as a nucleoside analog that pairs ambiguously with both purines and pyrimidines during viral RNA-dependent RNA polymerase-mediated replication. This causes a high rate of mutations in the viral genome, ultimately leading to viral inactivation through error catastrophe. The mechanism is effective against RNA viruses including SARS-CoV-2 and influenza.

Approved indications

COVID-19 (treatment of mild to moderate disease in adults at high risk of progression)
Influenza (investigational)

Common side effects

Nausea
Diarrhea
Headache
Dizziness

Key clinical trials

Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19 (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Molnupiravir (Esperavir) CI brief — competitive landscape report
Molnupiravir (Esperavir) updates RSS · CI watch RSS
Promomed, LLC portfolio CI

Frequently asked questions about Molnupiravir (Esperavir)

What is Molnupiravir (Esperavir)?

Molnupiravir (Esperavir) is a Nucleoside analog antiviral drug developed by Promomed, LLC, indicated for COVID-19 (treatment of mild to moderate disease in adults at high risk of progression), Influenza (investigational).

How does Molnupiravir (Esperavir) work?

Molnupiravir is a nucleoside analog that induces viral mutagenesis by causing errors during viral RNA replication, leading to viral extinction.

What is Molnupiravir (Esperavir) used for?

Molnupiravir (Esperavir) is indicated for COVID-19 (treatment of mild to moderate disease in adults at high risk of progression), Influenza (investigational).

Who makes Molnupiravir (Esperavir)?

Molnupiravir (Esperavir) is developed by Promomed, LLC (see full Promomed, LLC pipeline at /company/promomed-llc).

Is Molnupiravir (Esperavir) also known as anything else?

Molnupiravir (Esperavir) is also known as JCBC00101.

What drug class is Molnupiravir (Esperavir) in?

Molnupiravir (Esperavir) belongs to the Nucleoside analog antiviral class. See all Nucleoside analog antiviral drugs at /class/nucleoside-analog-antiviral.

What development phase is Molnupiravir (Esperavir) in?

Molnupiravir (Esperavir) is in Phase 3.

What are the side effects of Molnupiravir (Esperavir)?

Common side effects of Molnupiravir (Esperavir) include Nausea, Diarrhea, Headache, Dizziness.

What does Molnupiravir (Esperavir) target?

Molnupiravir (Esperavir) targets Viral RNA-dependent RNA polymerase and is a Nucleoside analog antiviral.

Drug class: All Nucleoside analog antiviral drugs
Target: All drugs targeting Viral RNA-dependent RNA polymerase
Manufacturer: Promomed, LLC — full pipeline
Therapeutic area: All drugs in Infectious Disease / Virology
Indication: Drugs for COVID-19 (treatment of mild to moderate disease in adults at high risk of progression)
Indication: Drugs for Influenza (investigational)
Also known as: JCBC00101

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing