Tirbanibulin

(Klisyri®)

Klisyri®

Drug updated on 12/11/2024

Dosage FormOintment (topical; 1%)
Drug ClassMicrotubule inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the topical treatment of actinic keratosis of the face or scalp.

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Tirbanibulin 1% ointment demonstrated significant effectiveness in the treatment of actinic keratosis (AK), with an odds ratio (OR) of 11.1 (95% confidence interval (CI): 6.2-20.9) for complete clearance of lesions, comparable to treatments like ingenol mebutate (OR 12.5) and photodynamic therapy (OR 11.7). However, it is less effective than fluorouracil 4% and 5% (OR 30.3 and 35.0, respectively).
  • The effectiveness of tirbanibulin is better than that of diclofenac 3% (OR 2.9), highlighting its value as a treatment option for AK. These findings apply to general populations with AK, with no specific subgroup analyses mentioned.
  • The safety profile of tirbanibulin 1% for AK was assessed qualitatively and found to be favorable, with no specific adverse effects or safety concerns reported in the available evidence.
  • Long-term efficacy and safety data for tirbanibulin 1% are not currently available, according to the systematic review.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Klisyri (tirbanibulin) Prescribing Information.2024Almirall, LLC, Exton, PA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Focused update: Guidelines of care for the management of actinic keratosis2022Journal of the American Academy of Dermatology
Guidelines of care for the management of actinic keratosis.2021 Journal of the American Academy of Dermatology