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OncologyFDA Approved

Tirbanibulin (Klisyri)

Topical
Written by Peptide Association Editorial TeamMedically reviewed by Ian Justl Ellis, MD, CPTLast reviewed Editorial policy

Overview

Tirbanibulin is a small molecule synthetic peptide mimetic that inhibits tubulin polymerization and disrupts Src kinase signaling pathways. It is applied topically as a 1% ointment to treat actinic keratosis, a precancerous skin condition caused by chronic sun exposure.

Mechanism of Action

The dual mechanism targets both the cytoskeleton and oncogenic signaling in hyperproliferative keratinocytes. Its localized application minimizes systemic exposure while achieving targeted antiproliferative effects.

Research Summary & Key Findings

Two phase III trials (KX01-AK-003 and KX01-AK-004) demonstrated superior complete clearance of actinic keratosis lesions compared to vehicle, with a five-day treatment course (Journal of the American Academy of Dermatology, 2021). The FDA approved tirbanibulin in December 2020 for topical treatment of actinic keratosis on the face or scalp. Post-marketing use has confirmed favorable tolerability with primarily local skin reactions.

Clinical Status

FDA Approved

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

Administration Routes

Topical

References

Primary literature

Study-level citations for this compound are being verified against the primary sources before publication. The database queries above return the current indexed literature in the meantime.

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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.