Tirbanibulin

(Klisyri®)

Klisyri®

Drug updated on 9/4/2024

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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  • Klisyri (tirbanibulin) is indicated for the topical treatment of actinic keratosis of the face or scalp.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Tirbanibulin 1% ointment demonstrated an odds ratio (OR) of 11.1 (95% credible interval: 6.2-20.9) for achieving complete clearance of actinic keratosis (AK) on the face and scalp when compared to a topical placebo or vehicle.
  • When compared to other treatments, Tirbanibulin showed varying odds ratios: 13.4 (6.2-30.3) against cryosurgery, 2.9 (1.9-4.3) against Diclofenac 3%, 7.6 (4.6-13.5) against Fluorouracil 0.5% + salicylic acid, and 12.5 (8.1-19.9) against Ingenol mebutate 0.015%. Higher ORs were noted against Fluorouracil 4% (30.3, 9.1-144.7), Fluorouracil 5% (35.0, 10.2-164.4), and certain photodynamic therapies.
  • Tirbanibulin was noted to have a favorable safety profile, with no serious or systemic adverse events reported, and a more favorable tolerability profile compared to topical 5-FU and imiquimod.
  • Application-site adverse events and local skin reactions were less frequent with newer agents like tirbanibulin and ingenol mebutate, indicating minimal safety concerns.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Klisyri (tirbanibulin) Prescribing Information.2020Almirall, LLC, Exton, PA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Focused update: Guidelines of care for the management of actinic keratosis. 2022Journal of the American Academy of Dermatology
Guidelines of care for the management of actinic keratosis.2021Journal of the American Academy of Dermatology