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Oncology · FDA Approved

Tirbanibulin (Klisyri)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Tirbanibulin is a synthetic small-molecule (non-peptide) inhibitor of tubulin polymerization and Src kinase signaling (PMID 33567191). It is applied topically as a 1% ointment to treat actinic keratosis, a precursor of squamous cell carcinoma.

It disrupts the microtubule network and induces cell cycle arrest in proliferating keratinocytes, and studies suggest it may also induce apoptosis and interfere with Src activity (PMID 40627585). Its localized application over 5 days is intended to limit systemic exposure.

02 · Research summary & key findings

Two identically designed phase 3 trials (NEJM 2021) in 702 adults found complete clearance at day 57 in 44% and 54% of patients on tirbanibulin versus 5% and 13% on vehicle after a 5-day course, with recurrence in 47% of complete responders at 1 year (PMID 33567191). The FDA approved tirbanibulin in 2020 for actinic keratosis of the face or scalp (PMID 40627585). Local reactions were mostly erythema and flaking, and a later phase 3 study treating a field of about 100 cm2 found a similar safety and tolerability profile (PMID 39268198).

03 · Regulatory status

Tirbanibulin (Klisyri) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Tirbanibulin (Klisyri) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Topical

References

  1. [1]Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis N Engl J Med, 2021. PMID 33567191
  2. [2]Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm(2) of the face or scalp in patients with actinic keratosis: A phase 3 study JAAD Int, 2024. PMID 39268198
  3. [3]Tirbanibulin 1% Ointment: The Mechanism of Action of a Novel Topical Therapy for Actinic Keratosis J Drugs Dermatol, 2025. PMID 40627585

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.