Zorifertinib API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Zorifertinib API Overview

Zorifertinib API, also known by its development code AZD3759, is an orally active, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It has been developed to inhibit EGFR signaling and has a particular research focus on EGFR-mutant non-small cell lung cancer (NSCLC) involving the central nervous system.

Zorifertinib has been designed with high blood-brain-barrier penetration, making it an important compound in research involving EGFR-mutant NSCLC and brain or CNS metastases. Clinical studies have evaluated its systemic and intracranial antitumor activity.

Zorifertinib has the molecular formula C₂₂H₂₃ClFN₅O₃, molecular weight of approximately 459.9 g/mol, and CAS Number 1626387-80-1.

SDP provides sourcing and supply support for Zorifertinib API, subject to product availability, applicable specifications, regulatory requirements and customer requirements.

Key Features

  • Active Pharmaceutical Ingredient (API)
  • Also known as AZD3759
  • EGFR tyrosine kinase inhibitor
  • Orally active small molecule
  • High blood-brain-barrier penetration
  • CAS No.: 1626387-80-1
  • Molecular Formula: C₂₂H₂₃ClFN₅O₃
  • Molecular Weight: 459.9 g/mol
  • Investigated in EGFR-mutant NSCLC
  • Particularly studied in patients with CNS/brain metastases
  • Suitable for qualified pharmaceutical and research requirements

Chemical Information

ParameterDetails
Product NameZorifertinib
Development CodeAZD3759
CAS Number1626387-80-1
Molecular FormulaC₂₂H₂₃ClFN₅O₃
Molecular Weight459.9 g/mol
PubChem CID78209992
ChEMBL IDCHEMBL3623290
DrugBank IDDB14795
UNII67SX9H68W2
InChIKeyMXDSJQHFFDGFDK-CYBMUJFWSA-N
XLogP3-AA4.1
H-Bond Donors1
H-Bond Acceptors8
Topological Polar Surface Area79.8 Ų

These identifiers and calculated physicochemical properties are reported by PubChem.

What is Zorifertinib API?

Zorifertinib is a targeted anticancer compound that inhibits EGFR tyrosine kinase activity. EGFR is an important signaling protein involved in cellular proliferation and survival.

Certain activating EGFR mutations can drive the growth of non-small cell lung cancer. EGFR-TKIs such as Zorifertinib have therefore been investigated for selectively inhibiting EGFR signaling in tumors carrying sensitizing EGFR mutations.

A major area of interest for Zorifertinib is its ability to penetrate the blood-brain barrier, supporting research into treatment of EGFR-mutant NSCLC with CNS involvement.

Mechanism of Action

Zorifertinib acts as an EGFR tyrosine kinase inhibitor.

EGFR activation triggers intracellular signaling pathways involved in cell growth, proliferation and survival. In EGFR-mutant cancers, abnormal EGFR signaling can contribute to uncontrolled tumor growth.

By inhibiting EGFR kinase activity, Zorifertinib can interfere with EGFR-mediated signaling pathways. Its CNS penetration has also made it a subject of research for EGFR-mutant tumors with brain metastases.

Pharmaceutical Applications

EGFR-Mutant NSCLC

Zorifertinib has been investigated for EGFR-mutant non-small cell lung cancer, particularly cancers with sensitizing EGFR mutations.

CNS Metastases

One of the major research areas for Zorifertinib is NSCLC with central nervous system metastases. Its ability to penetrate the blood-brain barrier has been evaluated in clinical development.

Targeted Oncology Research

Zorifertinib is also relevant to research involving:

  • EGFR signaling
  • EGFR-mutant cancers
  • Targeted oncology
  • Brain metastasis research
  • CNS drug penetration
  • EGFR tyrosine kinase inhibition

A Phase 3 EVEREST trial reported significantly longer systemic and intracranial progression-free survival with zorifertinib compared with first-generation EGFR-TKIs in the studied population of EGFR-mutant NSCLC patients with CNS metastases.

API Specifications

Use your actual approved Zorifertinib specification/CoA for numerical limits.

ParameterSpecification
IdentificationIR & HPLC compliant
AssayAs per approved product specification
Related SubstancesAs per approved product specification
Loss on DryingAs per approved product specification
Residue on IgnitionAs per approved product specification
Heavy Metals / Elemental ImpuritiesComplies with applicable specification
Residual SolventsComplies with applicable specification
Water ContentAs per approved product specification
Particle SizeAs per applicable specification

Do not enter assumed numerical limits unless they are available in your actual Zorifertinib specification or CoA.

Quality & Documentation

Depending on product availability and customer requirements, Zorifertinib API supply may be supported by applicable documentation such as:

  • Certificate of Analysis (CoA)
  • Product specification
  • Batch information
  • Analytical documentation
  • Residual solvent information
  • Elemental impurity information
  • Packaging information
  • Storage requirements
  • Technical documentation
  • Regulatory documentation, where applicable

Packaging & Supply

Zorifertinib API can be supplied in packaging appropriate to the required quantity, product handling requirements and customer specifications.

Customers can contact SDP regarding:

  • MOQ
  • Bulk quantity
  • Packaging
  • Batch availability
  • Lead time
  • CoA
  • Pricing
  • Technical documentation
  • Export requirements

Storage conditions should follow the applicable manufacturer's approved specification and stability information.

FAQ

What is Zorifertinib?

Zorifertinib is a small-molecule EGFR tyrosine kinase inhibitor, also known by the development code AZD3759.

What is the CAS number of Zorifertinib?

The CAS number is 1626387-80-1.

What is the molecular formula of Zorifertinib?

The molecular formula is C₂₂H₂₃ClFN₅O₃.

What is the molecular weight of Zorifertinib?

The molecular weight is approximately 459.9 g/mol.

What is AZD3759?

AZD3759 is the development code for Zorifertinib.

What does Zorifertinib target?

Zorifertinib targets the epidermal growth factor receptor (EGFR) tyrosine kinase.

Why is Zorifertinib important for CNS research?

Zorifertinib has demonstrated high blood-brain-barrier penetration and has therefore been investigated in EGFR-mutant NSCLC patients with CNS metastases.

What is Zorifertinib being studied for?

Zorifertinib has been studied primarily in EGFR-mutant non-small cell lung cancer, including disease involving CNS metastases.

Is Zorifertinib available in bulk?

Bulk availability, MOQ, pricing, documentation and lead time depend on current product availability and applicable regulatory requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
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