Savolitinib is a selective, orally active mesenchymal-epithelial transition (MET) tyrosine kinase inhibitor developed for targeted treatment of cancers driven by abnormalities in the MET signaling pathway. It is also known by the development codes AZD6094, HMPL-504 and volitinib. The compound has the CAS Number 1313725-88-0, molecular formula C₁₇H₁₅N₉, and molecular weight 345.36 g/mol. FDA's Substance Registration System confirms its chemical identity, absolute stereochemistry and molecular composition.
Savolitinib selectively targets the MET receptor tyrosine kinase, which is encoded by the MET gene and functions as the receptor for hepatocyte growth factor. Abnormal MET signaling can contribute to tumor-cell proliferation, survival, invasion, migration and metastasis. Savolitinib works by inhibiting MET kinase activity and reducing downstream MET signaling. The National Cancer Institute describes it as a potent and selective small-molecule MET kinase inhibitor, while clinical research has characterized it as an orally bioavailable selective MET inhibitor.
The API is particularly relevant to precision oncology because MET exon 14 skipping alterations represent an actionable molecular abnormality in a subset of non-small-cell lung cancers (NSCLC). Savolitinib received conditional approval in China in 2021 for previously treated advanced or metastatic NSCLC with MET exon 14 skipping alterations. In January 2025, the NMPA granted full approval for this setting and expanded the indication to include treatment-naïve patients.
Savolitinib has subsequently gained additional regulatory development in China for MET-driven malignancies. In June 2025, the NMPA approved savolitinib in combination with osimertinib for EGFR-mutated NSCLC with MET amplification following prior EGFR tyrosine kinase inhibitor treatment. In June 2026, HUTCHMED reported NMPA approval for savolitinib in third-line gastric cancer with MET amplification. These developments demonstrate the continuing pharmaceutical importance of selective MET inhibition and the expanding clinical development of savolitinib.
From an API manufacturing perspective, Savolitinib is a chemically defined small molecule with one defined stereocenter. FDA records identify the absolute stereochemistry and list the systematic chemical name as 1-((S)-1-(imidazo[1,2-a]pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)-triazolo[4,5-b]pyrazine.
The compound belongs structurally to the triazolopyrazine class and contains fused heterocyclic functionality, making appropriate control of identity, purity, stereochemistry, residual solvents and related substances important during pharmaceutical API development and manufacturing. Public chemical databases report Savolitinib as a crystalline solid, with research-grade material commonly characterized by chromatographic purity and analytical identification. However, commercial research-grade purity specifications should not be presented as universal pharmacopoeial API specifications.
For pharmaceutical manufacturing, Savolitinib API should therefore be controlled through a validated, stability-indicating analytical specification covering identity, assay, related substances, stereochemical purity, residual solvents, elemental impurities, water content and other applicable quality attributes. Since I did not identify a current public USP, Ph. Eur. or IP monograph establishing universal numerical release limits for Savolitinib, numerical API limits should be taken from the applicable approved or customer-specific specification rather than invented or attributed to a pharmacopoeia.
Savolitinib represents an important targeted-oncology API for research, development and commercial pharmaceutical manufacturing programs focused on MET-driven cancers, MET exon 14 skipping NSCLC and other emerging MET-amplified indications. Its defined chemical identity, selective mechanism and expanding clinical/regulatory use make it a relevant active pharmaceutical ingredient for oncology-focused API development.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |