Apalutamide is a potent androgen receptor antagonist approved by FDA for treating prostate cancer. As a leading apalutamide API manufacturer and apalutamide supplier, we provide high-quality Apalutamide API to our clients. Here is an in-depth look at Apalutamide API:

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What is Apalutamide API?

Apalutamide API, also known as 4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide, is the active pharmaceutical ingredient in the drug Erleada which is used for treating prostate cancer. Its chemical formula is C21H15F4N5O2S and molecular weight is 477.43g/mol.Apalutamide API is a white to light yellow powder. As a reliable apalutamide manufacturer, we produce Apalutamide API in different grades like regular grade and micronized grade (D90<10μm). Our Apalutamide API conforms to pharmacopeial specifications and contains less than 0.5% total impurities. We ensure no detectable residues of solvents or other harmful impurities in the final product.

Mechanism of Action of Apalutamide API

Apalutamide API acts as a potent antagonist of the androgen receptor (AR). It selectively binds to the ligand-binding domain of AR and inhibits the function of androgens by preventing the nuclear translocation and DNA binding of AR in prostate tumor cells.

Actions of Apalutamide API Effects
Blocks the binding of androgens like testosterone and dihydrotestosterone (DHT) to the androgen receptor Inhibits the growth and spread of prostate cancer cells which depend on androgens for survival and proliferation
Prevents the nuclear translocation of activated androgen receptor complex Blocks the interaction of the androgen receptor with DNA and inhibits the transcription of androgen-regulated genes crucial for prostate cancer progression

By competitively inhibiting androgen signaling through multiple mechanisms, Apalutamide API demonstrates strong antitumor activity against castration-resistant prostate cancer (CRPC). As a trusted apalutamide supplier, we ensure high purity and potency of our Apalutamide API.

Clinical Usefulness of Apalutamide API

In clinical trials, Apalutamide API showed promising results for treating metastatic CRPC and non-metastatic CRPC:

  • When added to androgen deprivation therapy, Apalutamide API significantly reduced the risk of metastases or death in patients with non-metastatic CRPC (SPARTAN trial).
  • As monotherapy in patients with metastatic CRPC whose disease had progressed despite prior docetaxel chemotherapy, Apalutamide API significantly increased metastasis-free survival and overall survival compared to placebo (TITAN trial).

Based on these results, the FDA approved Apalutamide (trade name Erleada) in 2018 for the treatment of nmCRPC and mCRPC. As a reputed apalutamide manufacturer, we ensure stable supply of high-quality Apalutamide API to support its clinical usage.

Why Choose Us as Your Apalutamide API Supplier?

As a leading apalutamide API manufacturer and supplier, we have many advantages:

  • FDA and European cGMP approved manufacturing facility
  • Over 10 years of experience and track record in API production
  • In-house QC laboratory with analytical methods validation as per ICH guidelines
  • Stable production capacity and reliable long-term supply
  • Strict quality control to meet global regulatory standards like USP, EP, JP etc.
  • Online platform for order placement and convenient payment options
  • Professional technical support and after-sales services

We also offer value-addedservices like custom synthesis, process development and scale-up. Feel free to contact us for high-quality Apalutamide API at competitive prices.

Conclusion

In this detailed guide, we discussed Apalutamide API in depth covering its mechanism of action, clinical usefulness and our capabilities as a trusted manufacturer and supplier. If you need reliable source for Apalutamide API, feel free to get in touch with us. We ensure consistent supply while maintaining the highest quality and regulatory compliance.