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Published in: Drugs 4/2021

01-03-2021 | Actinic Keratosis | AdisInsight Report

Tirbanibulin: First Approval

Authors: Anthony Markham, Sean Duggan

Published in: Drugs | Issue 4/2021

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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.
Literature
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Kasner MT, Ritchie EK, Cutler D, et al. A phase 1b dose escalation study to evaluate safety, tolerability and pharmacokinetics of oral monotherapy with KX2-391 in elderly subjects with acute myeloid leukemia who are refractory to or have declined standard induction therapy [abstract no. 7043]. J Clin Oncol. 2017;35(15 (Suppl 1)).
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Antonarakis ES, Heath EI, Posadas EM, et al. A phase 2 study of KX2-391, an oral inhibitor of Src kinase and tubulin polymerization, in men with bone-metastatic castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2013;71(4):883–92.CrossRef
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Kinex Pharmaceuticals L. L. C., Hanmi Pharmaceutical. Kinex Pharmaceuticals and Hanmi Pharmaceutical announce first patient has been enrolled in phase 1b/IIa clinical trial in Korea [media release]. 7 Jan 2013. http://​www.​kinexpharma.​com.
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Athenex. Athenex announces FDA approval of Klisyri® (tirbanibulin) for the treatment of actinic keratosis on the face or scalp [media release]. 15 Dec 2020. http://​www.​athenex.​com.
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Athenex. Athenexs partner Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for tirbanibulin ointment in actinic keratosis [media release]. 2 Mar 2020. http://​www.​athenex.​com.
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Kinex Pharmaceuticals L. L. C., Hanmi Pharmaceutical. Hanmi Pharmaceuticals to acquire the rights for a promising phase II anti-cancer Src kinase/pretubulin dual inhibitor from Kinex Pharmaceuticals, in selected asian territories [media release]. 20 Apr 2011. http://​www.​kinexpharma.​com.
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Athenex, Hanmi Pharmaceutical. Athenex and its collaborative partner, Hanmi Pharmaceutical, announce strategic realignment of their joint projects [media release]. 12 Sept 2018. http://​www.​athenex.​com.
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Kinex Pharmaceuticals L. L. C., PharmaEssentia Corp. PharmaEssentia acquires certain asian rights for dermatology preparations of Kinex Pharmaceuticals' promising novel dual Src/pretubulin inhibitor, KX01 [media release]. 3 Dec 2012. http://​www.​kinexpharma.​com.
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Athenex. Athenex and PharmaEssentia announce positive early signals of clinical activity of KX2-391 (INN: tirbanibulin) in patients with psoriasis [media release]. 7 Jun 2019. http://​www.​athenex.​com.
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Athenex. Athenex expands its strategic partnership with Guangzhou Xiangxue Pharmaceutical through a licensing agreement for its product candidates oral paclitaxel and oral irinotecan, as well as tirbanibulin ointment, in China, Hong Kong and Macao [media release]. 16 Dec 2019. http://​www.​athenex.​com.
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Yavel R, Overcash JS, Zhi J, et al. Phase I maximal use pharmacokinetic study of tirbanibulin ointment 1% in subjects with actinic keratosis [poster]. SKIN J Cutan Med. 2020;4(6):s199.
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Blauvelt A, Kempers S, Lain E, et al. Phase 3 trials of tirbanibulin ointment for actinic keratosis. N Engl J Med. 2021;384(6):512–20.CrossRef
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Blauvelt A, Kempers S, Puig S, et al. Tirbanibulin, a novel inhibitor of tubulin polymerisation and src kinase signaling, for actinic keratosis (AK): results of two phase-3 studies and 1-year follow-up data [abstract no. LB918]. J Investig Dermatol. 2020;140(7 Suppl):B3.CrossRef
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Jarratt M, Kempers S, Forman S, et al. Phase II study of KX2-391 ointment 1%, a novel field treatment for actinic keratosis, based on Src/tubulin polymerization inhibition [abstract no. 6134]. J Am Acad Dermatol. 2018;79(3 Suppl 1):AB220.
Metadata
Title
Tirbanibulin: First Approval
Authors
Anthony Markham
Sean Duggan
Publication date
01-03-2021
Publisher
Springer International Publishing
Published in
Drugs / Issue 4/2021
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-021-01479-0

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