Tirbanibulin

Overview

Tirbanibulin (KX-O1 or KX2–391) is a dual inhibitor of Src Kinase and tubulin. On December 14, 2020, tirbanibulin was approved by the FDA for the topical treatment of actinic keratosis on the face or scalp. It is marketed under the brand name Klisyri. Actinic keratosis is a chronic condition characterized by lesions, which can potentially transform into invasive squamous cell carcinoma with a risk of 1% over 10 years. Tirbanibulin blocks the molecular pathways that promote the proliferation, survival, and metastasis of malignant cells. Tirbanibulin exhibits antitumour effects in vitro and in vivo and has been investigated for its antitumor efficacy in the management of various cancers, such as prostate cancer and breast cancer.

Indication

Tirbanibulin is indicated for the topical treatment of actinic keratosis on the face or scalp.

Associated Conditions

Actinic Keratoses of the face
Actinic Keratoses of the scalp

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment	2025/06/08	NCT07010692	Phase 1	Recruiting	Bruce Robinson, MD
Tirbanibulin for Pediatric Warts	2025/01/24	NCT06791525	Phase 4	Recruiting	The Skin Center Dermatology Group
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis	2023/11/18	NCT06135415	Phase 3	Active, not recruiting	Almirall, S.A.
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	2023/11/01	NCT06112522	Phase 2	Recruiting	Centre Hospitalier Universitaire de Nice
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands	2023/09/07	NCT06026358	Phase 4	Withdrawn	Medical University of Graz
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face	2023/06/12	NCT05900258	Phase 4	Completed	Medical University of Graz
A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses	2023/02/23	NCT05741294	Phase 4	Completed	Almirall, S.A.
Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults	2023/02/06	NCT05713760	Phase 2	Completed	Austin Institute for Clinical Research
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp	2022/05/24	NCT05387525	Phase 4	Active, not recruiting	Almirall, S.A.
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis	2022/03/15	NCT05279131	Phase 3	Completed	Almirall, S.A.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Klisyri	Almirall, LLC	16110-391	TOPICAL	10 mg in 1 g	12/18/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Klisyri	Almirall, S.A.,Ronda General Mitre, 151,ES-08022 Barcelona,Spain	Authorised	7/16/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ONAKTA tirbanibulin 1% w/w ointment sachet	391198	Seqirus Pty Ltd	Medicine	A	2/23/2024

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