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# Athenex NDA for Topical Actinic Keratosis Drug
- URL: https://www.fdaweb.com/athenex-nda-for-topical-actinic-keratosis-drug/
- Published: 2020-12-15T12:00:00.000Z
- Updated: 2026-09-14T16:40:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148305

FDA has approved an Athenex NDA for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis on the face or scalp. Approval is based on data from two pivotal, randomized, double-blind, vehicle-controlled Phase 3 studies (KX01-AK-003 and KX01-AK-004) that evaluated tirbanibulin ointment 1% in 702 adults with actinic keratosis on the face or scalp. In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for the vehicle treated groups, the company says. In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with tirbanibulin and 13% for vehicle treated groups. The most common adverse events were application site pruritus and pain reported by 9% and 10% of treated patients, respectively, it says. Actinic keratosis is a pre-cancerous skin lesion and is said to be the second most common diagnosis made by dermatologists in the U.S.