Tirbanibulin is a synthetic small-molecule pharmaceutical active ingredient and a microtubule inhibitor. It is used topically for the treatment of actinic keratosis of the face or scalp and is marketed in the United States as a 1% topical ointment.
Tirbanibulin has the CAS Number 897016-82-9, molecular formula C₂₆H₂₉N₃O₃, and molecular weight 431.5 g/mol. FDA describes the active pharmaceutical ingredient as a white to off-white solid.
Tirbanibulin is a specialized dermatological API belonging to the microtubule-inhibitor class. It was developed for topical pharmaceutical treatment of actinic keratosis and has also been investigated for broader antiproliferative and oncology-related applications.
The API is a chemically defined, achiral small molecule. FDA identifies Tirbanibulin as a microtubule inhibitor, although the precise mechanism responsible for its clinical effect in actinic keratosis has not been fully established.
Product Name: Tirbanibulin
CAS Number: 897016-82-9
Molecular Formula: C₂₆H₂₉N₃O₃
Molecular Weight: 431.5 g/mol
Chemical Name: N-benzyl-2-[5-[4-(2-morpholin-4-ylethoxy)phenyl]-2-pyridinyl]acetamide
Development Codes: KX2-391, KX-01
Chemical Class: Pyridine derivative
Pharmacological Class: Microtubule inhibitor
Therapeutic Area: Dermatology / oncology
Appearance: White to off-white solid
Stereochemistry: Achiral; no stereocenter
Tirbanibulin is freely soluble in dimethyl sulfoxide, slightly soluble in ethanol and ethyl acetate, and insoluble in water according to the FDA chemistry review.
Tirbanibulin is classified as a microtubule inhibitor. It interferes with microtubule function and produces antiproliferative effects.
For its approved topical use, the FDA states that the precise mechanism of action of Tirbanibulin in the treatment of actinic keratosis is unknown. Tirbanibulin has also been characterized in research as a compound affecting tubulin and Src-related signaling pathways.
Tirbanibulin API is primarily associated with topical pharmaceutical formulations for the treatment of actinic keratosis of the face or scalp.
The approved product is a 1% Tirbanibulin ointment, containing 10 mg of Tirbanibulin per gram of ointment. Treatment is applied topically once daily for five consecutive days according to the FDA-approved labeling.
Tirbanibulin has also been investigated in preclinical and clinical research for antiproliferative and oncology-related applications.
Tirbanibulin is a synthetic small-molecule API requiring appropriate chemical and pharmaceutical quality controls.
Typical analytical controls may include:
The FDA chemistry review confirms that Tirbanibulin is a synthetic drug substance and reports that its drug-substance quality assessment was considered adequate.
Swapnroop Drugs and Pharmaceuticals provides quality-focused pharmaceutical API manufacturing and technical documentation solutions for specialized active pharmaceutical ingredients.
Tirbanibulin is a specialized dermatological API requiring appropriate control of chemical identity, assay, related substances, residual solvents and physical properties.
Swapnroop provides Tirbanibulin API with a specification-focused approach to analytical quality and pharmaceutical documentation for qualified pharmaceutical requirements.
Tirbanibulin API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination, moisture and inappropriate environmental exposure.
The FDA-approved Tirbanibulin ointment is stored at room temperature and should not be refrigerated or frozen. API storage conditions should instead follow the approved drug-substance specification, validated stability data and applicable Certificate of Analysis.
Technical documentation for Tirbanibulin API may include:
Tirbanibulin is a specialized dermatological API requiring specification-driven control of identity, purity and chemical quality.
Swapnroop focuses on pharmaceutical API quality, analytical testing and technical documentation for specialized active ingredients.
Tirbanibulin API from Swapnroop is positioned for pharmaceutical customers seeking a quality-focused source of this specialized microtubule-inhibitor API for topical pharmaceutical development and manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |