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Tirbanibulin: First Approval

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Abstract

Tirbanibulin (Klisyri®) is a first-in-class Src kinase signaling inhibitor and tubulin polymerisation inhibitor being developed by Athenex in conjunction with global partners for the topical treatment of actinic keratosis, and psoriasis. Based on the data from two pivotal phase III trials the drug was recently approved for marketing in the US as a topical treatment for actinic keratosis. This article summarizes the milestones in the development of tirbanibulin leading to this first approval.

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Authors and Affiliations

  1. Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand

    Anthony Markham & Sean Duggan

Authors
  1. Anthony Markham
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  2. Sean Duggan
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Correspondence to Anthony Markham.

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Funding

The preparation of this review was not supported by any external funding.

Authorship and conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis International Ltd/Springer Nature and S. Duggan is a salaried employee of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A., Duggan, S. Tirbanibulin: First Approval. Drugs 81, 509–513 (2021). https://doi.org/10.1007/s40265-021-01479-0

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