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Tembexa FDA Approval History

Last updated by Judith Stewart, BPharm on June 8, 2021.

FDA Approved: Yes (First approved June 4, 2021)
Brand name: Tembexa
Generic name: brincidofovir
Dosage form: Tablets and Oral Suspension
Company: Chimerix, Inc.
Treatment for: Smallpox

Tembexa (brincidofovir) is a nucleotide analog broad-spectrum antiviral indicated for use as a medical countermeasure for smallpox.

  • Smallpox is a highly contagious disease caused by the variola virus, which belongs to the orthopoxvirus family of viruses. Tembexa inhibits orthopoxvirus replication by inhibiting viral DNA polymerase-mediated synthesis of viral DNA.
  • Tembexa is administered once weekly for 2 doses, on Days 1 and 8.
  • The Tembexa product label carries a boxed warning for increased risk for mortality when used for a duration longer than at the recommended dosage.
  • Common adverse reactions include diarrhea, nausea, vomiting, and abdominal pain.

Development timeline for Tembexa

DateArticle
Jun  4, 2021Approval FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox
Dec  7, 2020Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
Apr 28, 2020Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
Nov 13, 2014Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa
Oct  6, 2014Chimerix Announces Emergency Investigational NDA for Brincidofovir Authorized by FDA for Patients With Ebola Virus Disease

Further information

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