Tirbanibulin Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 570

Clinical Trials

Numerous clinical trials evaluate the therapeutic application of tirbanibulin (KX2-391) across Phase 1 through Phase 4 investigations, primarily targeting actinic keratosis, basal cell carcinoma, and cutaneous warts. Sponsored by both pharmaceutical entities and academic institutions, these studies range in recruitment status from not yet recruiting to active and completed protocols. Together, they reflect the ongoing global assessment of the drug's topical safety and efficacy across diverse dermatological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07010692	RECRUITING	Keratinocyte Carcinoma; Basal Cell Carcinomas; Squamous Cell Carcinoma; Skin Cancer	Bruce Robinson, MD	2025-05-16	PHASE1; PHASE2
NCT07273656	NOT_YET_RECRUITING	Keratosis; Actinic Keratoses	University Hospital, Lille	2026-11-30	PHASE3
NCT06112522	RECRUITING	Cell Carcinoma	Centre Hospitalier Universitaire de Nice	2024-02-16	PHASE2
NCT05387525	ACTIVE_NOT_RECRUITING	Keratosis, Actinic	Almirall, S.A.	2022-10-24	PHASE4
NCT06791525	RECRUITING	Warts Hand	The Skin Center Dermatology Group	2025-05-01	PHASE4
NCT06135415	COMPLETED	Keratosis, Actinic	Almirall, S.A.	2023-12-21	PHASE3
NCT06026358	WITHDRAWN	Actinic Keratoses	Medical University of Graz	2023-10	PHASE4
NCT05713760	COMPLETED	Superficial Basal Cell Carcinoma	Austin Institute for Clinical Research	2023-04-17	PHASE2
NCT05741294	COMPLETED	Actinic Keratosis	Almirall, S.A.	2023-01-20	PHASE4
NCT05900258	COMPLETED	Actinic Keratosis	Medical University of Graz	2023-05-11	PHASE4
NCT05900258	Completed	Actinic Keratosis	Medical University of Graz	2023-05-11	Phase 4
NCT05741294	Completed	Actinic Keratosis	Almirall S.A.	2023-01-17	Phase 4
NCT05279131	COMPLETED	Keratosis, Actinic	Almirall, S.A.	2022-06-28	PHASE3
NCT03575780	Completed	Actinic Keratoses	Athenex Inc.\|TKL Research Inc.	2018-09-07	Phase 1
NCT02838628	Completed	Actinic Keratosis	Almirall S.A.\|Athenex Inc.	2016-04-11	Phase 2

(data from https://clinicaltrials.gov, updated on 2025-09-17)

Check the Tirbanibulin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tirbanibulin is a non-ATP competitive peptidomimetic inhibitor that specifically binds to the peptide substrate binding site of Src tyrosine kinase and suppresses microtubule polymerization, thereby blocking downstream oncogenic signaling cascades and disrupting mitotic spindle assembly. This dual inhibition prevents aberrant tumor cell proliferation and promotes cell death, providing the mechanistic rationale for its clinical efficacy in managing hyperproliferative dermatological conditions such as actinic keratosis and basal cell carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).