Tezacaftor

Tezacaftor is a CFTR corrector approved as part of the triple-combination therapy TRIKAFTA® for the treatment of cystic fibrosis in patients aged 2 years and older with at least one F508del mutation in the CFTR gene . As one of the three active components in TRIKAFTA®, Tezacaftor works alongside elexacaftor and ivacaftor to improve the function of defective CFTR proteins . The combination of Tezacaftor with elexacaftor and ivacaftor has been shown to significantly improve lung function and reduce the frequency of pulmonary exacerbations in patients with cystic fibrosis . In analytical and quality control contexts, Tezacaftor serves as the primary reference standard for analytical method development, method validation, and quality control applications for Abbreviated New Drug Applications (ANDA). The well-characterized pharmacology of Tezacaftor makes it an essential reference material for research into CFTR modulation, cystic fibrosis therapeutics, and the development of next-generation CFTR correctors.

Product Parameters

Bioactivity

Tezacaftor (VX-661) is the second F508del CFTR corrector drug that assists the CFTR protein in reaching the cell surface. Phase 2.

In vitro study

VX-661 is a CFTR corrector drug that prevents the F508del mutant channel from degradation and facilitates its translocation to the cell membrane.

Product Quality Assurance

Cosperpharm has established a comprehensive quality assurance system for Tezacaftor that meets the rigorous expectations of research and pharmaceutical development applications:

Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing, including HPLC purity verification, identity confirmation by mass spectrometry and NMR, residual solvent analysis, and water content determination.

Full batch traceability with retention samples. From raw material procurement through synthesis, purification, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with sufficient retention samples maintained in accordance with Cosperpharm quality procedures.

Documentation ready for research and regulatory support. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. Custom quality documentation is available upon request.

Customer-initiated quality audits. Qualified customers are welcome to audit Cosperpharm's manufacturing, quality control, and documentation facilities. Please contact our regulatory team to schedule an audit.

Contact Us

Need Tezacaftor for your cystic fibrosis drug development, analytical method validation, or CFTR research program? Cosperpharm is your trusted partner for high-quality reference materials. Contact us today — we're here to help.