General Information

Klisyri (tirbanibulin) is a microtubule inhibitor.

Klisyri is specifically indicated for the topical treatment of actinic keratosis on the face or scalp.

Klisyri is supplied as an ointment for topical administration. Apply sufficient amount of Klisyri to evenly cover up to 25 cm2 treatment field on the face or scalp once daily for 5 consecutive days using 1 single-dose packet per application.

Wash hands immediately with soap and water after application. Avoid washing and touching the treated area for approximately 8 hours after application of Klisyri. Avoid transfer of Klisyri to the eye area. Avoid application near and around the mouth and lips.

Mechanism of Action

Klisyri (tirbanibulin) is a microtubule inhibitor. The mechanism of action for the topical treatment of actinic keratosis is unknown.

Side Effects

Adverse effects associated with the use of Klisyri may include, but are not limited to, the following:

• local skin reactions
• application site pruritus
• application site pain

Clinical Trial Results

The FDA approval of Klisyri was based on two double-blind, placebo controlled, randomized, parallel group, multicenter, Phase III studies (KX01-AK-003 and KX01-AK-004). The studies enrolled a total of 702 adults with actinic keratosis on the face or scalp across 62 sites in the U.S. Klisyri ointment 1% (10 mg/g) or placebo was self-administered to 25 cm2 of the face or scalp encompassing 4-8 typical AK lesions, once daily for 5 consecutive days.

The primary endpoint was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas. Both studies achieved statistical significance on this endpoint. In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for the placebo treated groups. In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with tirbanibulin and 13% for the placebo treated groups.