Drug updated on 5/17/2024

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


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

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  • Tirbanibulin (Klisyri) is indicated for the topical treatment of actinic keratosis of the face or scalp. It has been assessed across multiple documents for its role in treating this condition, focusing on its effectiveness and safety profile.
  • Three systematic reviews/meta-analyses were reviewed to gather information about Klisyri's comparative effectiveness and safety profiles against various treatments for actinic keratosis.
  • In terms of comparison to other treatments, tirbanibulin received a clinical recommendation grade C, placing it alongside calcipotriol/5-fluorouracil, imiquimod, and combination therapies involving sunscreen but behind 5-Fluorouracil/salicylic acid (grade A) and diclofenac sodium (grade B).
  • The Bayesian network meta-analysis suggests that while fluorouracil 5% and photodynamic therapy with aminolevulinic acid have higher odds ratios indicating greater efficacy, tirbanibulin also shows promising results with an odds ratio of 11.1, suggesting competitive effectiveness.
  • Regarding safety and tolerability, newer agents like tirbanibulin are reported to have more favorable safety profiles compared to older treatments such as 5-FU and imiquimod, according to one study specifically addressing these aspects among FDA-approved topical agents for AK.
  • While detailed subgroup analyses based on age, gender, or severity are not explicitly discussed; overall evaluations suggest that the therapeutic landscape involves selecting treatment options that balance efficacy with safety and tolerability, implying considerations for use in populations prioritizing minimal side effects or having concerns regarding tolerability.

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