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FDA Approves Expanded Use of Almirall’s Klisyri for the Treatment of Actinic Keratosis


Klisyri is now available in a 350 mg package size as a topical treatment for actinic keratosis on the face or scalp.

Blisters caused by cryotherapy fro solar keratosis on skin of 64 year old Caucasian male. Image Credit: Adobe Stock Images/Peter

Image Credit: Adobe Stock Images/Peter

The FDA has approved Almirall’s supplemental New Drug Application (sNDA) to expand the treatment area for Klisyri (tirbanibulin) for the treatment of actinic keratosis (AK). Now approved for the treatment of AK up to 100 cm2, the medication will be available in 350 mg as a five-day topical treatment for AK on the face or scalp. Prior to the approval, klisyri was available for treating areas up to 25 cm². According to the company, the approval was based on positive results from a Phase III clinical safety study evaluating the safety of 100 cm2 tirbanibulin.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. 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,” said Karl Ziegelbauer, chief scientific officer, Almirall, in a press release.

Almirall’s Phase III study was a multicenter, open-label, clinical safety trial, which enrolled over 100 patients. The study’s primary endpoints were to evaluate the safety and tolerability of applying Klisyri to the face or balding scalp of adult patients with AK.

Results of the study determined that safety was consistent with the previous trial for 25 cm², for both local skin reactions and treatment-related adverse events (AEs).1

Klisyri was first approved by the FDA in December 2020 based on results from its previous Phase III clinical studies, KX01-AK-003 and KX01-AK-004. In those studies, 702 patients were enrolled across 62 sites in the United States. Results indicated that tirbanibulin demonstrated a significantly higher number of patients with complete clearance of AK lesions in the treated area compared to vehicle (44% vs. 5% in study 1 and 54% vs. 13% in study 2). Additionally, a secondary endpoint of lesion clearance was achieved at ≥75%.2

According to News Medical Life Sciences, the rate of AK in the United States is an estimated 10.2% in females and 26.5% in males. In most cases, it affects people with white skin and is connected to consistent exposure to UV radiation. This makes it more likely in elderly people, those who live close to the equator, and those who frequently spend time outside.3

“The prognosis of actinic keratosis is generally positive. With watchful waiting and treatment techniques, each of the skin patches can by treated individually, without the need for systemic treatment,” said Yolanda Smith, B.Pharm, writing for News Medical Life Sciences. “The exact rate of progression from actinic keratosis to squamous cell carcinoma is unclear and is likely to depend on several factors, such as the sun protection of the individual following diagnosis.”

Smith continued to explain that less than one in 1000 patches are at risk for becoming cancerous in a year; however, other research suggests that the number is actually every one in 10 patches. In recent years, incidence of malignant and premalignant skin lesions has increased from 3% to 8%.3

Klisyri ointment is classified as a microtubule inhibitor indicated for the topical field treatment of AK. Its five-day application period is the shortest topical treatment for AK, according to Almirall.1

“With this new FDA approval, clinicians can now treat up to four 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, principal investigator for the larger treatment area pivotal study, in the press release.


1. FDA approves Almirall’s Klisyri® (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2. 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. Almirall announces FDA approval of Klisyri® (tirbanibulin), a new innovative topical treatment for actinic keratosis. Almirall. December 15, 2020. Accessed June 10, 2024. https://www.almirall.com/newsroom/news/almirall-announces-fda-approval-of-klisyri%C2%AE-tirbanibulin-a-new-innovative-topical-treatment-for-actinic-keratosis

3. Actinic Keratosis Epidemiology. News Medical Life Sciences. Accessed June 10, 2024. https://www.news-medical.net/health/Actinic-Keratosis-Epidemiology.aspx#:~:text=Comparably%2C%20the%20overall%20rate%20of,females%20and%2026.5%25%20in%20males.

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