Tirbanibulin (Klisyri, Almirall) performs as well in real-world practice as it does in clinical trials for actinic keratosis (AK), according to new analyses of Phase III, phase IV, and real-world studies presented at the 2025 American Academy of Dermatology’s annual meeting in Orlando, FL.
Tirbanibulin is U.S. Food and Drug Administration-approved for the treatment of AKs on the face or scalp up to 100 cm2. It is available in two package sizes, 250 mg (NDC 16110-391-05) for the treatment of up to 25 cm2, and 350 mg (NDC 16110-391-55)] for up to 100 cm2.
In all studies, tirbanibulin was applied once daily for five days, according to the prescribing information.
In the efficacy evaluations, the clearance rates and reductions in AK lesion counts achieved with tirbanibulin in randomized controlled trials approximated results achieved in an open-label phase IV study and in real-world clinical practice. In the safety poster, tirbanibulin showed a low risk for serious or severe adverse events and that severe local skin responses were uncommon with tirbanibulin.
In related data presented at the meeting, patient-reported outcomes from two large studies indicated that >70% of patients who used tirbanibulin were satisfied with this treatment for their AK and skin appearance and would consider using it again. Researchers used the AK Expert Panel Questionnaire (AK-EPQ) to assess patients’ perceptions regarding effects of tirbanibulin on overall appearance, willingness to retreat, how skin looks, and overall satisfaction in two post-registration studies.
“Patient satisfaction is a significant aspect of treatment outcomes,” says Darrell Rigel, MD, MS, Clinical Professor, Mount Sinai Icahn School of Medicine in New York, NY, in a news release. ”The results of these studies with tirbanibulin indicate notable improvements in patient satisfaction in real-world scenarios, which supports adherence to AK treatment protocols thus paving the way for more sustainable outcomes. By prioritizing patient experience and addressing their needs, the effectiveness of therapies can be enhanced, which can lead to an overall improvement in the quality of care.”
