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Klisyri FDA Approval History

Last updated by Judith Stewart, BPharm on June 13, 2024.

FDA Approved: Yes (First approved December 14, 2020)
Brand name: Klisyri
Generic name: tirbanibulin
Dosage form: Ointment
Company: Almirall
Treatment for: Actinic Keratosis

Klisyri (tirbanibulin) is a first-in-class dual Src Kinase and tubulin polymerization inhibitor for the topical treatment of actinic keratosis on the face or scalp.

Development timeline for Klisyri

DateArticle
Jun 10, 2024Approval FDA Approves Almirall’s Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on Expanded Area of Face or Scalp
Dec 15, 2020Approval FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp
Mar  9, 2020Almirall Announces FDA Acceptance for Filing of U.S. New Drug Application (NDA) for Tirbanibulin in Actinic Keratosis
Mar  9, 2020Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
Feb 20, 2018Athenex Announces Phase II Clinical Study Results for KX2-391 Ointment for the Treatment of Actinic Keratosis

Further information

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