Tecovirimat

Generic Name
Tecovirimat
Brand Names
Tpoxx, Tecovirimat SIGA
Drug Type
Small Molecule
Chemical Formula
C19H15F3N2O3
CAS Number
869572-92-9
Unique Ingredient Identifier
F925RR824R
Background

The World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980. However, there have been longstanding concerns that smallpox may be used as a bioweapon. Tecovirimat is an antiviral drug that was identified via a high-throughput screen in 2002. It is effective against all orthopoxviruses, including vaccinia, cowpox, ectromelia, rabbitpox, monkeypox, and Variola (smallpox) virus.

Tecovirimat was approved by the FDA in July 2018 as the first drug ever approved to treat smallpox. Tecovirimat was later approved by Health Canada in December 2021, followed by the approval from the European Commission in January 2022. Other than smallpox, tecovirimat is also indicated to treat complications due to replication of the vaccinia virus following vaccination against smallpox, and to treat monkeypox and cowpox in adults and children. Tecovirimat is available as both oral and intravenous formulations.

Indication

Tecovirimat is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. The efficacy of tecovirimat may be reduced in immunocompromised patients. In Europe, it is also indicated to treat complications due to replication of the vaccinia virus following vaccination against smallpox.

In Europe, tecovirimat is also used to treat monkeypox and cowpox in adults and children.

Associated Conditions
Complication of Smallpox Vaccination, Cow pox, Monkeypox, Variola Major (Smallpox)
Associated Therapies
-

Assessment of the Efficacy and Safety of Tecovirimat in Patients with Monkeypox Virus Disease

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2022-10-28
Last Posted Date
2024-10-09
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
150
Registration Number
NCT05597735
Locations
🇨🇭

Pr Alexandra Calmy, Geneva, Switzerland

🇦🇷

Fundación Huésped, Ciudad Autonoma de Buenos Aires, Argentina

🇧🇷

Faculty of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil

and more 9 locations

Tecovirimat in Non-hospitalized Patients With Monkeypox

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2022-09-09
Last Posted Date
2024-02-29
Lead Sponsor
Marina Klein
Target Recruit Count
120
Registration Number
NCT05534165
Locations
🇨🇦

St. Michael's Hospital, Toronto, Ontario, Canada

🇨🇦

St. Paul's Hospital, BC Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada

🇨🇦

Toronto General Hospital, Toronto, Ontario, Canada

Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days

Phase 3
Completed
Conditions
Interventions
First Posted Date
2021-07-21
Last Posted Date
2024-10-23
Lead Sponsor
SIGA Technologies
Target Recruit Count
467
Registration Number
NCT04971109
Locations
🇺🇸

Midwest Clinical Research Center, Dayton, Ohio, United States

🇺🇸

Coastal Carolina Research Center, North Charleston, South Carolina, United States

🇺🇸

Meridian Clinical Research, Omaha, Nebraska, United States

and more 6 locations

Study to Assess the Safety and Pharmacokinetics of TPOXX® When Administered Orally for 28 Days With JYNNEOS

First Posted Date
2021-07-12
Last Posted Date
2024-08-01
Lead Sponsor
SIGA Technologies
Target Recruit Count
100
Registration Number
NCT04957485
Locations
🇺🇸

Meridian Clinical Research, Omaha, Nebraska, United States

🇺🇸

Aventiv Research Inc, Columbus, Ohio, United States

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

First Posted Date
2020-07-24
Last Posted Date
2024-10-09
Lead Sponsor
SIGA Technologies
Target Recruit Count
44
Registration Number
NCT04485039
Locations
🇺🇸

PPD Phase I Clinic, Austin, Texas, United States

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

Phase 4
Completed
Conditions
Interventions
First Posted Date
2020-05-19
Last Posted Date
2020-05-21
Lead Sponsor
SIGA Technologies
Target Recruit Count
34
Registration Number
NCT04392739
Locations
🇺🇸

PPD Phase I Clinic, Austin, Texas, United States

A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-06-18
Last Posted Date
2017-11-28
Lead Sponsor
SIGA Technologies
Target Recruit Count
449
Registration Number
NCT02474589
Locations
🇺🇸

Paradigm Research, San Diego, California, United States

🇺🇸

Sundance Clinical Research LLC, Saint Louis, Missouri, United States

🇺🇸

Center for Pharmaceutical Research, Kansas City, Missouri, United States

and more 6 locations

Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

First Posted Date
2014-03-06
Last Posted Date
2022-07-25
Lead Sponsor
U.S. Army Medical Research and Development Command
Registration Number
NCT02080767

Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2007-02-06
Last Posted Date
2017-07-27
Lead Sponsor
SIGA Technologies
Target Recruit Count
30
Registration Number
NCT00431951
Locations
🇺🇸

Orlando Clinical Research, Orlando, Florida, United States

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