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FDA Approves Expanded Use of Tirbanibulin for Actinic Keratosis


Phase 3 clinical trial results showed that the safety and tolerability profiles were consistent with those observed in the original pivotal trials.

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Almirall announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for tirbanibulin (Klisyri). This approval extends the use of tirbanibulin to treat actinic keratosis (AK) over larger areas of the face or scalp, up to 100 cm², quadrupling the previously approved treatment area of 25 cm². This development marks a significant advancement in the management of this common pre-cancerous skin condition.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," stated Karl Ziegelbauer, chief scientific officer at Almirall, in a press release. "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."

Expanded Approval Based on New Clinical Evidence

The expanded approval of tirbanibulin was supported by a phase 3, multicenter, open-label clinical safety study involving over 100 patients in the US. This study aimed to evaluate the safety and tolerability of applying tirbanibulin to a 100 cm² field on the face or balding scalp of adults with AK. The results showed that the safety and tolerability profiles were consistent with those observed in the original pivotal trials, which were based on a 25 cm² treatment area. Local skin reactions and treatment-related adverse events (AEs) were in line with previous findings, demonstrating that the drug can be safely used over a larger surface area.

“The study showed consistent results with the original pivotal trials conducted on an area of 25 cm², for both local skin reactions and treatment-related adverse events,” noted Neal Bhatia, MD, dermatologist at Therapeutics Dermatology in San Diego, California, who served as the principal investigator for the study.

Addressing AK

AK, or solar keratosis, is the most common pre-cancerous dermatological condition, with a reported prevalence of between 11% and 25% in the US. It typically manifests in areas exposed to prolonged ultraviolet (UV) radiation, such as the face, scalp, ears, and forearms. Given its potential to progress to squamous cell carcinoma, a form of skin cancer, timely and effective treatment of AK lesions is critical.2

"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," Bhatia emphasized in the press release.

Tirbanibulin Prescribing Information 

Tirbanibulin, a microtubule inhibitor ointment, is a topical field treatment for AK, applied over a five-day period. It will now be available in 2 package sizes: a 250 mg package for treating areas up to 25 cm², and a new 350 mg package for areas up to 100 cm². This flexibility offers significant convenience for both patients and dermatologists, enabling the treatment of more extensive AK manifestations.

Almirall said that patients using tirbanibulin should be aware of potential adverse reactions, including local skin reactions such as erythema, flaking/scaling, and application site pain. Reports of eye irritation during trials indicate the importance of not transferring the drug to the eyes or periocular area. Investigators report patients should wash their hands immediately after application and seek medical care in case of accidental exposure.


  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. https://www.almirall.com/newsroom/news/fda-approves-almirall-s-klisyri-tirbanibulin-for-the-treatment-of-actinic-keratosis-on-expanded-area-of-face-or-scalp-up-to-100-cm2
  2. Berman B, Grada A, Berman DK. Profile of Tirbanibulin for the Treatment of Actinic Keratosis. J Clin Aesthet Dermatol. 2022;15(10 Suppl 1):S3-S10.
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