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Drug

Tecovirimat

Approved · EMA
Late-stage development

Also known as Tpoxx.

RxNorm2055104ChEMBLCHEMBL1257073UNIIF925RR824R
3
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase III, Multi-country, Randomized, Placebo-controlled, Double-blinded Trial to Assess the Efficacy and Safety of Tecovirimat Antiviral Treatment for Patients With Monkeypox Virus Disease

Clinical trial2026-05-26Results expected Q3 2026 · ClinicalTrials.gov

A Phase 1, Open-Label (JYNNEOS®), Double-Blind (TPOXX® And Placebo), Multicenter, Randomized, Placebo-Controlled, Drug-Vaccine Interaction Study To Evaluate the Impact of TPOXX on JYNNEOS Immunogenicity

Clinical trial2026-04-02Results expected Q1 2027 · ClinicalTrials.gov

Placebo-controlled Randomized Trial of Tecovirimat in Non-hospitalized Patients With Monkeypox: Canadian Feasibility Study (PLATINUM-CAN)

Clinical trial2026-03-31Suspended · ClinicalTrials.gov

European Randomised Clinical Trial on mPOX Infection

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease

Clinical trial2025-10-09Results posted · ClinicalTrials.gov

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease

Clinical trial2025-02-22Terminated · ClinicalTrials.gov

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

Clinical trial2024-12-27Results posted · ClinicalTrials.gov

Approval: Tecovirimat SIGA (EMA)

Regulatory2022-01-06EMA

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Clinical trial2017-11-28Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tecovirimat
Aliases & brands
Tpoxx
RxNorm CUI
2055104
ChEMBL ID
CHEMBL1257073
UNII
F925RR824R
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-01-06
Latest approval
2022-01-06
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-01-06Approval
Approval: Tecovirimat SIGA (EMA)
Indication: Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13kg: Smallpox Cowpox Tecovirimat SIGA is also… Show full indication

Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13kg: Smallpox Cowpox Tecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13kg . Tecovirimat SIGA should be used in accordance with official recommendations.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
8
registered trials across all phases
LATEST COMPLETION 2024
3
Active studies
1
Recruiting
6
Late-stage (III+)
3
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 8
Phase 22Phase 34Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

European Randomised Clinical Trial on mPOX Infection

RecruitingPH IVMiquel Ekkelenkampn=1502026

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

CompletedPH IVSIGA Technologiesn=442023

A Phase III, Multi-country, Randomized, Placebo-controlled, Double-blinded Trial to Assess the Efficacy and Safety of Tecovirimat Antiviral Treatment for Patients With Monkeypox Virus Disease

Active, not recruitingPH IIIANRS, Emerging Infectious Diseasesn=4802026

Placebo-controlled Randomized Trial of Tecovirimat in Non-hospitalized Patients With Monkeypox: Canadian Feasibility Study (PLATINUM-CAN)

SuspendedPH IIIMarina Kleinn=1202026

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease

TerminatedPH IIINational Institute of Allergy and Infectious Diseases (NIAID)n=7192025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=5972024

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

CompletedPH IVSIGA Technologiesn=442023

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

CompletedPH IIISIGA Technologiesn=4492016
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.