FDA Approves Tirbanibulin for Actinic Keratosis on Larger Areas of Face, Scalp

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The new approval expands the treatment area by 4 times the previously approved area—from 25 cm2 to 100 cm2.

The US Food and Drug Administration (FDA) has expanded the use of tirbanibulin (Klisyri) for the treatment of actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm2, according to a press release from Almirall.1 The convenient 5-day topical field treatment for the condition—the shortest of any topical treatment for AK—is now approved in a 350 mg package size in addition to the established 250 mg size for smaller areas.

The new approval expands the treatment area by 4 times the previously approved area—from 25 cm2 to 100 cm2.1

“The FDA’s approval of the use of Klisyri for actinic keratosis on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists,” said Karl Ziegelbauer, Chief Scientific Officer at Almirall.1 “With patients experiencing AK over larger surface areas, dermatologists are looking for ways to treat the entire affected area to help prevent further lesion progression.”

AK is the most common pre-cancerous dermatological condition and affects between 11% and 25% of people living in the US. It generally occurs in areas that have been exposed to ultraviolet (UV) radiation for extended periods of time, such as the face, ears, scalp, lips, forearms, lower legs, and the posterior side of the hands. As providers are unable to predict which lesions will eventually develop into squamous cell carcinoma, all lesions must be treated by a dermatologist.1

Originally approved in December 2020, the FDA’s decision to extend the use of the ointment, a novel microtubule inhibitor, to larger areas was based on data from a phase 3, multicenter, open-label, clinical safety study of more than 100 patients living in the US. Primary endpoints included the assessment of safety and tolerability of applying the ointment to approximately 100 cm2 on the face or balding scalp of patients with AK. Results were consistent with previous data examining the effects of the drug on an area of 25 cm2 in terms of local skin reactions and treatment-related adverse events. The most common adverse reactions included application site pain, local skin reactions, and application site pruritus.1

The efficacy of the drug in treating a larger area was also evaluated, with results revealing a percent reduction in lesion count that aligned with previous data.1

“With this new FDA approval, clinicians can now treat up to 4 times the surface area, allowing increased flexibility to provide treatment of actinic keratoses and achieve effective results with a good safety and tolerability profile for more patients,” said Neal Bhatia, MD, lead investigator for the larger treatment area pivotal study.1


  1. FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2. News release. Almirall. June 10, 2024. Accessed June 10, 2024.