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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

Oct 12, 2022Monkeypox Treatment Trial Begins in the Democratic Republic of the Congo
May 19, 2022Approval SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of TPOXX (tecovirimat)
Jul 13, 2018Approval FDA Approves TPOXX (tecovirimat) as the First Drug for the Treatment of Smallpox
May  1, 2018SIGA Technologies Announces Favorable Outcome of Advisory Committee In Support of TPOXX
Feb  7, 2018SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox
Dec 11, 2017SIGA Technologies Announces FDA Submission of its New Drug Application for oral TPOXX (tecovirimat) to Treat Smallpox

Further information

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