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Klisyri FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved December 14, 2020)
Brand name: Klisyri
Generic name: tirbanibulin
Dosage form: Ointment
Company: Athenex, Inc.
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.

  • Klisyri is applied to the treatment area on the face or scalp once daily for 5 consecutive days using a single-dose packet per application.
  • The FDA approved Klisyri based on the data from two pivotal, randomized, double-blind, vehicle-controlled Phase 3 studies that evaluated the efficacy and safety of Klisyri in 702 adults with actinic keratosis of the face or scalp. Klisyri demonstrated complete clearance of actinic keratosis lesions at day 57 in treated areas in a significantly higher number of patients (44% and 54%) compared to vehicle (5% and 13%).
  • Klisyri may cause may cause eye irritation and patients should avoid getting the ointment in, around, or near the eyes. Common adverse reactions (incidence ≥2%) include local skin reactions, application site pruritus, and application site pain.

Development timeline for Klisyri

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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