Tirbanibulin

Generic Name: Tirbanibulin

Brand Names: Klisyri

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₉N_₃O_₃

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

Clinical Trials

Tirbanibulin for Pediatric Warts

Phase 4

Recruiting

Conditions: Warts Hand

Interventions: Drug: Tirbanibulin ointment 1%

First Posted Date: 2025-01-24

Last Posted Date: 2025-05-15

Lead Sponsor: The Skin Center Dermatology Group

Target Recruit Count: 10

Registration Number: NCT06791525

Locations: 🇺🇸
The Skin Center Dermatology Group, New City, New York, United States

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

Phase 3

Active, not recruiting

Conditions: Keratosis, Actinic

Interventions: Drug: Tirbanibulin
Other: Vehicle ointment

First Posted Date: 2023-11-18

Last Posted Date: 2025-02-13

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 280

Registration Number: NCT06135415

Locations: 🇩🇪
Site 17, Augsburg, Germany
🇩🇪
Site 1, Bad Bentheim, Germany
🇩🇪
Site 3, Bochum, Germany

and more 32 locations

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

Phase 2

Recruiting

Conditions: Cell Carcinoma

Interventions: Drug: Tirbanibulin

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: Drug: Tirbanibulin

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: Drug: Tirbanibulin

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

A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

Phase 4

Completed

Conditions: Actinic Keratosis

Interventions: Drug: Tirbanibulin 2.5 mg ointment

First Posted Date: 2023-02-23

Last Posted Date: 2025-02-20

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 334

Registration Number: NCT05741294

Locations: 🇪🇸
Almirall Investigational Site 1, Alcorcón, Spain
🇪🇸
Almirall Investigational Site 2, Alicante, Spain
🇪🇸
Almirall Investigational Site 3, Badalona, Spain

and more 27 locations

Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults

Phase 2

Completed

Conditions: Superficial Basal Cell Carcinoma

Interventions: Drug: Tirbanibulin Ointment 1%

First Posted Date: 2023-02-06

Last Posted Date: 2024-07-19

Lead Sponsor: Austin Institute for Clinical Research

Target Recruit Count: 5

Registration Number: NCT05713760

Locations: 🇺🇸
Austin Institute for Clinical Research, Inc., Pflugerville, Texas, United States

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

Phase 4

Active, not recruiting

Conditions: Keratosis, Actinic

Interventions: Drug: Diclofenac Sodium 3% Gel
Drug: Tirbanibulin (Klisyri®) 10 mg/g ointment

First Posted Date: 2022-05-24

Last Posted Date: 2025-02-11

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 447

Registration Number: NCT05387525

Locations: 🇩🇪
Almirall Investigational Site 207, Marburg, Germany
🇮🇹
Almirall Investigational Site 302, Brescia, Italy
🇵🇱
Almirall Investigational Site 401, Wrocław, Poland

and more 46 locations

A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

Phase 3

Completed

Conditions: Keratosis, Actinic

Interventions: Drug: Tirbanibulin ointment 1%

First Posted Date: 2022-03-15

Last Posted Date: 2024-01-23

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 105

Registration Number: NCT05279131

Locations: 🇺🇸
Almirall Investigational Site 1, College Station, Texas, United States
🇺🇸
Almirall Investigation Site 7, Hot Springs, Arkansas, United States
🇺🇸
Almirall Investigation Site 3, Sweetwater, Florida, United States

and more 4 locations

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

Completed

Conditions: Keratosis, Actinic

Interventions: Drug: Tirbanibulin

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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