MedPath

Tirbanibulin

Generic Name
Tirbanibulin
Brand Names
Klisyri
Drug Type
Small Molecule
Chemical Formula
C26H29N3O3
CAS Number
897016-82-9
Unique Ingredient Identifier
4V9848RS5G
Background

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
Associated Therapies
-

A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

Phase 3
Recruiting
Conditions
Keratosis, Actinic
Interventions
Drug: Tirbanibulin
Other: Vehicle ointment
First Posted Date
2023-11-18
Last Posted Date
2024-05-01
Lead Sponsor
Almirall, S.A.
Target Recruit Count
270
Registration Number
NCT06135415
Locations
🇩🇪

Site 2, Hamburg, Germany

🇪🇸

Site 15, Valencia, Spain

🇪🇸

Site 12, Barcelona, Spain

and more 13 locations

Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Phase 2
Recruiting
Conditions
Cell Carcinoma
Interventions
First Posted Date
2023-11-01
Last Posted Date
2024-03-18
Lead Sponsor
Centre Hospitalier Universitaire de Nice
Target Recruit Count
50
Registration Number
NCT06112522
Locations
🇫🇷

CHU de Nice - Hôpital de l'Archet, Nice, Alpes-maritimes, France

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Phase 4
Withdrawn
Conditions
Actinic Keratoses
Interventions
First Posted Date
2023-09-07
Last Posted Date
2024-05-30
Lead Sponsor
Medical University of Graz
Registration Number
NCT06026358

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Phase 4
Completed
Conditions
Actinic Keratosis
Interventions
First Posted Date
2023-06-12
Last Posted Date
2023-11-14
Lead Sponsor
Medical University of Graz
Target Recruit Count
22
Registration Number
NCT05900258
Locations
🇦🇹

Medizinische Universität Graz, Graz, Austria

Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis

Completed
Conditions
Keratosis, Actinic
Interventions
First Posted Date
2022-03-02
Last Posted Date
2023-07-21
Lead Sponsor
Almirall, S.A.
Target Recruit Count
300
Registration Number
NCT05260073
Locations
🇺🇸

Almirall Investigational Site 1, Charleston, South Carolina, United States

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