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
Research Report
Tirbanibulin (Klisyri®): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Role in Dermatology
Executive Summary
Tirbanibulin is a first-in-class topical medication approved for the treatment of actinic keratosis (AK) on the face or scalp. Marketed under the brand name Klisyri®, it represents a significant advancement in dermatological therapy, distinguished by a novel, dual-action mechanism of action that inhibits both tubulin polymerization and Src kinase signaling.[1] This unique molecular activity allows for the targeted disruption of key pathways involved in the proliferation and survival of neoplastic keratinocytes characteristic of AK.[3]
The most notable clinical feature of Tirbanibulin is its remarkably short treatment duration, requiring only a once-daily application for five consecutive days.[5] This abbreviated regimen contrasts sharply with the weeks or months of therapy required for many established topical agents, addressing a critical unmet need for treatments that enhance patient adherence and satisfaction.[7] Its clinical profile is further defined by a favorable safety and tolerability profile. Adverse events are almost exclusively localized to the application site, consisting of predictable, transient, and manageable local skin reactions (LSRs) such as erythema and scaling, which typically resolve within a few weeks of treatment completion.[9]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/08 | Phase 1 | Recruiting | Bruce Robinson, MD | ||
2025/01/24 | Phase 4 | Recruiting | The Skin Center Dermatology Group | ||
2023/11/18 | Phase 3 | Completed | |||
2023/11/01 | Phase 2 | Recruiting | |||
2023/09/07 | Phase 4 | Withdrawn | Medical University of Graz | ||
2023/06/12 | Phase 4 | Completed | Medical University of Graz | ||
2023/02/23 | Phase 4 | Completed | |||
2023/02/06 | Phase 2 | Completed | |||
2022/05/24 | Phase 4 | Active, not recruiting | |||
2022/03/15 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Almirall, LLC | 16110-391 | TOPICAL | 10 mg in 1 g | 12/18/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/16/2021 | ||
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 | Medicine | A | 2/23/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ONAKTA | avir pharma inc. | 02537818 | Ointment - Topical | 1 % / W/W | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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