Glecirasib API Manufacturer in India

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Glecirasib API

Glecirasib, also known as JAB-21822, is an investigational small-molecule KRAS G12C inhibitor developed for targeted cancer therapy research. It is designed to selectively target the KRAS protein carrying the G12C mutation, an important oncogenic alteration found in several solid tumors. By binding to the mutant KRAS G12C protein, glecirasib inhibits KRAS-mediated signaling pathways involved in cancer-cell proliferation and survival.

Glecirasib is being investigated as an oral targeted anticancer agent, particularly in patients with KRAS G12C-mutated advanced solid tumors. Its development represents an approach to precision oncology in which treatment is directed toward a specific molecular alteration within tumor cells.

Mechanism of Action

KRAS is a signaling protein that regulates cellular growth, proliferation and survival. The G12C mutation substitutes glycine with cysteine at position 12, creating a unique binding site that can be targeted by covalent KRAS G12C inhibitors.

Glecirasib is designed to interact selectively with the mutant KRAS G12C protein and lock it in an inactive state. This reduces downstream signaling through pathways such as the RAF–MEK–ERK and PI3K–AKT pathways. Inhibition of these pathways can reduce proliferation and survival of KRAS G12C-mutated cancer cells.

Pharmaceutical Applications

Glecirasib is being investigated for pharmaceutical and oncology applications including:

  • KRAS G12C-mutated solid tumors
  • Non-small cell lung cancer research
  • Colorectal cancer research
  • Advanced solid-tumor studies
  • Targeted oncology drug development
  • KRAS inhibitor research
  • Combination anticancer therapy research
  • Oral formulation development
  • Pharmaceutical analytical research
  • Impurity and stability studies

API Information

Glecirasib is a synthetic small-molecule investigational API. It is identified by the development code JAB-21822 and is being studied for its selective activity against mutant KRAS G12C.

The compound has the molecular formula C₂₉H₃₁ClF₂N₆O₃ and a molecular weight of approximately 600.06 g/mol. It is intended for oral pharmaceutical development.

Quality and Analytical Characterization

Glecirasib API can be characterized using modern pharmaceutical analytical techniques, including HPLC/UPLC, LC-MS, NMR and FTIR. Quality evaluation may include assay, related substances, degradation products, residual solvents, water content and solid-state characteristics.

For investigational material, the exact numerical acceptance criteria should be taken from the applicable manufacturer's validated specification and Certificate of Analysis rather than being represented as pharmacopoeial limits.

Pharmaceutical Development

Glecirasib is of interest in precision oncology and molecularly targeted drug development because KRAS G12C represents a genetically defined cancer target. Its development involves evaluation of pharmacological activity, oral bioavailability, formulation characteristics, stability, impurity profiles and analytical methods.

Regulatory Status

Glecirasib is an investigational drug candidate and should not be described as an approved therapeutic product. Its clinical development is focused on evaluating the safety, pharmacokinetics and efficacy of KRAS G12C inhibition in patients with appropriate molecularly selected cancers.

Storage and Handling

Glecirasib API should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Handling should follow the manufacturer's SDS, CoA and applicable laboratory safety requirements.

Glecirasib API Manufacturer in India

We provide information and supply support for Glecirasib API (JAB-21822) for pharmaceutical research, analytical development and investigational drug-development applications. Product documentation may include Certificate of Analysis (CoA), Safety Data Sheet (SDS), analytical data, impurity profile and stability information, subject to material availability and applicable regulatory requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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