Treats actinic keratosis on the face or scalp. NDA 213189, held by Almirall. Tirbanibulin.
As of Nov 13, 2026, NDA 213189 (Klisyri), held by Almirall, was first approved by FDA on Dec 14, 2020, with 3 approved supplements and 0 published complete response letters.
KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp. KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.
| Jun 7, 2024 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Klisyri1% · ointment;topical | Tirbanibulin | RxReference drug |
| Jun 7, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Jun 7, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Jun 7, 2024 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2020 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
