Tivozanib API is a small-molecule oral tyrosine kinase inhibitor belonging to the vascular endothelial growth factor receptor (VEGFR) inhibitor class. The pharmaceutical active ingredient is supplied as Tivozanib Hydrochloride Hydrate, which selectively inhibits VEGFR-1, VEGFR-2 and VEGFR-3 signaling involved in tumor angiogenesis. Tivozanib is used in oncology, particularly for the treatment of advanced renal cell carcinoma (RCC).
Swapnroop Pharma offers Tivozanib Hydrochloride API for pharmaceutical formulation, drug development and bulk API requirements. The API is identified by CAS Number 682745-41-1, with a molecular formula of C₂₂H₂₂Cl₂N₄O₆ and molecular weight of 509.34 g/mol.
Tivozanib is a potent and selective inhibitor of vascular endothelial growth factor receptors. It inhibits VEGFR signaling, thereby reducing processes involved in endothelial-cell proliferation, migration and tumor angiogenesis.
The marketed pharmaceutical form is Tivozanib Hydrochloride Hydrate. FDA documentation describes the active ingredient as a white to light-brown crystalline powder that is practically insoluble in water, with reported aqueous solubility of approximately 0.09 mg/mL.
Tivozanib is marketed as FOTIVDA for specific advanced renal cell carcinoma indications.
Product Name: Tivozanib Hydrochloride Hydrate
API Name: Tivozanib
CAS Number: 682745-41-1
Molecular Formula: C₂₂H₂₂Cl₂N₄O₆
Molecular Weight: 509.34 g/mol
Active Moiety: Tivozanib
Free Tivozanib CAS: 475108-18-0
Pharmacological Class: Tyrosine Kinase Inhibitor
Target: VEGFR-1, VEGFR-2 and VEGFR-3
Therapeutic Area: Oncology
Drug Class: Antiangiogenic / Antineoplastic Agent
Development Codes: AV-951; KRN-951
Brand: FOTIVDA
Physical Form: White to light-brown crystalline powder
Water Solubility: Approximately 0.09 mg/mL
Dosage Form: Oral capsule in the approved finished product
Tivozanib selectively inhibits vascular endothelial growth factor receptor tyrosine kinases, particularly VEGFR-1, VEGFR-2 and VEGFR-3.
VEGFR signaling plays an important role in angiogenesis and tumor vascularization. By inhibiting these receptors, tivozanib suppresses VEGF-mediated signaling and can reduce endothelial-cell proliferation and migration associated with tumor angiogenesis.
Tivozanib Hydrochloride API is primarily used in oncology pharmaceutical development and manufacturing.
Key applications include:
The approved FOTIVDA regimen is indicated for adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.
Swapnroop Pharma offers Tivozanib Hydrochloride API for qualified pharmaceutical manufacturers, formulation developers, distributors and international buyers.
Our Tivozanib API supply supports pharmaceutical companies seeking oncology APIs for formulation development and commercial manufacturing.
Product-specific specifications, analytical documentation and regulatory documentation can be provided according to applicable product grade and customer requirements.
Tivozanib Hydrochloride Hydrate can be supplied for qualified bulk pharmaceutical requirements.
The API has limited aqueous solubility, and particle-size control is an important consideration in pharmaceutical manufacturing. The EMA assessment report notes that milling of Tivozanib Hydrochloride is used during active-substance manufacturing to provide consistency in the particle size of the material used for finished-product manufacture.
Bulk supply can be supported with:
Tivozanib Hydrochloride is a small-molecule API and can be characterized using conventional pharmaceutical analytical techniques.
Relevant quality attributes may include:
The EMA assessment of the finished product confirms use of HPLC-based identification, assay and impurity testing, together with dosage-unit uniformity, dissolution and microbiological testing.
Tivozanib Hydrochloride should be packaged in a suitable pharmaceutical-grade container that protects the material from unsuitable environmental conditions.
The finished FOTIVDA product is packaged in an HDPE bottle with a polypropylene cap and induction seal.
Storage conditions for bulk API should follow the actual approved manufacturer specification and stability data.
Documentation may include:
For pharmaceutical companies seeking Tivozanib API in India, Swapnroop Pharma provides Tivozanib Hydrochloride API sourcing support for oncology formulation development and pharmaceutical manufacturing.
Contact Swapnroop Pharma for Tivozanib Hydrochloride API availability, specifications, documentation, packaging and bulk requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 99.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Melting Point | 220–233°C³ |