Dirozalkib is a next-generation anaplastic lymphoma kinase (ALK) inhibitor and orally active small-molecule pharmaceutical compound. It is being developed and used as a targeted antineoplastic therapy for patients with ALK-rearranged advanced non-small cell lung cancer (NSCLC).
Dirozalkib is identified by CAS No. 1893419-37-8. Its molecular formula is C27H32ClN5O4S and its molecular weight is approximately 558.09 g/mol.
Dirozalkib belongs to the -alkib class of ALK inhibitors. It is designed to inhibit the kinase activity of ALK and has demonstrated activity against ALK fusion-positive cancer cells and several resistance-associated ALK mutations.
Dirozalkib is a targeted tyrosine kinase inhibitor with activity against anaplastic lymphoma kinase (ALK). Preclinical and clinical research has demonstrated inhibitory activity against ALK-rearranged cancer models and several mutations associated with resistance to earlier ALK inhibitors.
Dirozalkib binds to the ATP-binding site of the ALK kinase domain, inhibiting ALK-mediated signaling. Suppression of aberrant ALK signaling can inhibit proliferation and survival of ALK-driven tumor cells.
Research has reported activity against several ALK resistance mutations, including G1202R and I1171N, and evidence of intracranial antitumor activity.
Dirozalkib is associated with targeted oncology treatment for:
Its approved indications should be confirmed against the current regulatory label for the target market.
Dirozalkib is relevant to pharmaceutical manufacturers and formulation-development organizations working on targeted oncology and ALK inhibitor products.
It is associated with oral pharmaceutical dosage forms, including tablets.
Dirozalkib API quality evaluation may include:
For a newly approved oncology API, the exact acceptance criteria should be taken from the current approved specification and batch-specific CoA, rather than using generic numerical limits.
Dirozalkib intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements.
The current regulatory status should be verified for each intended market. Dirozalkib has been reported as approved by China's NMPA in 2025.
A batch-specific Certificate of Analysis (CoA) should provide relevant analytical results and acceptance criteria.
Dirozalkib should be stored in tightly closed, appropriately labelled containers under the manufacturer's recommended storage conditions. Appropriate protection from heat, moisture, light and unsuitable environmental exposure should be maintained according to the approved specification.
Dirozalkib is relevant to pharmaceutical organizations involved in targeted oncology API sourcing, ALK inhibitor development and formulation manufacturing.
For commercial applications, customers should verify the API identity, chemical form, grade, assay, purity, impurity profile, regulatory status, analytical documentation and batch-specific CoA before use.
Consistent Dirozalkib API quality is important for reliable oncology formulation development and manufacturing. Control of identity, assay, purity and related substances supports reproducible pharmaceutical quality.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |