TPOXX FDA Approval History
Last updated by Judith Stewart, BPharm on June 1, 2022.
FDA Approved: Yes (First approved July 13, 2018)
Brand name: TPOXX
Generic name: tecovirimat
Dosage form: Capsules and Injection
Company: SIGA Technologies, Inc.
Treatment for: Smallpox
TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.
- Smallpox is a contagious, disfiguring and often deadly disease caused by the variola virus. Naturally occurring smallpox was eradicated worldwide by 1980 through a global immunization campaign. Samples of smallpox virus have been kept in laboratories for research purposes, leading to concerns of potential use as a biological warfare agent.
- TPOXX works as an antiviral by inhibiting the orthopoxvirus VP37 envelope wrapping protein.
- TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.
- TPOXX capsules are taken every 12 hours (patients 40 kg to less than 120 kg) or every 8 hours (patients over 120 kg) for 14 days. The capsules should be taken within 30 minutes after a full meal of moderate or high fat. The intravenous infusion is administered over a period of six hours every 12 hours for 14 days.
- Common adverse reactions to the capsules include headache, nausea, abdominal pain, and vomiting. Common adverse reactions to the injection include administration site reactions and headache.
Development timeline for TPOXX
Further information
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