Nintedanib esylate

Nintedanib Esylate is the pharmaceutically preferred salt form of nintedanib, a multi‑target tyrosine kinase inhibitor with potent biochemical activity against VEGFR (IC₅₀: 13–34 nM), FGFR (IC₅₀: 37–108 nM), and PDGFR (IC₅₀: 59–65 nM) . Nintedanib Esylate is the active ingredient in OFEV® (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF) and in Vargatef® for non‑small cell lung cancer in combination with docetaxel . Nintedanib Esylate inhibits angiogenesis and fibrotic pathways by blocking the receptor‑mediated signaling of VEGF, FGF, and PDGF, thereby reducing proliferation, migration, and transformation of fibroblasts and endothelial cells . Nintedanib Esylate demonstrates excellent solubility in DMSO, water, and ethanol, facilitating both in vitro and in vivo research applications .

Product Parameters

Product Advantages

 Triple Kinase Inhibition Profile

Nintedanib Esylate simultaneously inhibits VEGFR1/2/3, FGFR1/2/3, and PDGFRα/β with IC₅₀ values in the low nanomolar range (13–108 nM) . This multi‑target profile is clinically validated for both anti‑angiogenic and anti‑fibrotic applications.

 Excellent Solubility Profile

Nintedanib Esylate is freely soluble in DMSO and water (89 mg/mL) and moderately soluble in ethanol (4 mg/mL), enabling flexible formulation for both in vitro and in vivo studies .

 Clinically Approved Esylate Salt Form

Nintedanib Esylate is the active pharmaceutical ingredient in OFEV® (idiopathic pulmonary fibrosis) and Vargatef® (non‑small cell lung cancer), with established clinical safety and efficacy profiles .

Versatile Research Application

Nintedanib Esylate is widely used in cancer research for studying angiogenesis inhibition, in fibrosis research for investigating fibroblast proliferation pathways, and in drug discovery for screening multi‑target kinase inhibitors .

Storage Conditions

Store Nintedanib Esylate at −20 °C as a lyophilized powder in a tightly sealed container . For short‑term storage (up to 3 months), 2–8 °C is acceptable. Protect from moisture and light. Allow the sealed container to reach ambient temperature before opening to minimize moisture condensation.

Shelf life: Long‑term stability is maintained when stored at −20 °C in sealed containers. Stability summaries are available upon request.

Handling precautions: Use in a fume hood. Wear chemical‑resistant gloves, safety goggles, and a lab coat. For research purposes only. Not for human or therapeutic use.

Product Quality Assurance

Cosperpharm has established a comprehensive quality assurance system for Nintedanib Esylate meeting the rigorous expectations of research and pharmaceutical applications:

Thorough analytical characterization. Each batch undergoes multi‑technique analytical release testing: HPLC purity (≥98%), identity confirmation by NMR/HPLC/MS, and solubility verification in DMSO and water .

Full batch traceability. From raw material procurement through synthesis and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with retention samples.

Stability monitoring program. Cosperpharm conducts ongoing stability studies for Nintedanib Esylate under recommended storage conditions (−20 °C, lyophilized powder). Stability summaries are available upon request.

Documentation ready for research and regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch‑specific purity and characterization data, and a Material Safety Data Sheet (SDS).

Customer‑initiated quality audits. Qualified customers are welcome to audit Cosperpharm‘s manufacturing and quality control facilities.

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