A Comprehensive List of Polypeptide AIPs and Their Regulatory Status

Introduction

Polypeptide Active Pharmaceutical Ingredients (AIPs) are essential components in the development of various therapeutic and cosmetic products. This article presents a comprehensive list of polypeptide AIPs, along with their current regulatory status and potential applications.

Beauty Polypeptide AIPs

1. Levosimendan
2. Semaglutide
3. Bivalirudin
4. Thymosin alpha1
5. Degarelix
6. Eptifibatide
7. Enfuvirtide
8. Exenatide
9. Liraglutide
10. Octreotide Acetate
11. Teduglutide
12. Icatibant Acetate
13. Somatostatin
14. Cetrorelix
15. Octreotide Acetate
16. Thymopentin
17. Tirzepatide
18. Teriparatide Acetate
19. Carbetocin
20. Ziconotide Acetate
21. Ganirelix Acetate
22. Atosiban
23. Linaclotide

Chinese cGMP APIs

1. Levosimendan – GMP Certificate No. SC20120022
2. Thymosin alpha1 – GMP Certificate No. SC20140047
3. Enfuvirtide – GMP Certificate No. SC20140098
4. Octreotide Acetate – GMP Certificate No. SC20150121
5. Somatostatin – GMP Certificate No. SC20150121
6. Thymopentin – GMP Certificate No. SC20150121
7. Carbetocin – GMP Certificate No. SC20160013
8. Atosiban – GMP Certificate No. SC20170065

Research Peptide APIs for Regulatory Market

1. Semaglutide – US-DMF File Point: In the middle of 2023, Stage: PV finished
2. Degarelix – US-DMF File Point: By the end of 2023, Stage: PV finished
3. Exenatide – US-DMF File Point: By the end of 2023, Stage: PV finished
4. Teduglutide – US-DMF File Point: By the end of 2024, Stage: small trial
5. Cetrorelix – US-DMF File Point: By the end of 2023, Stage: PV finished
6. Tirzepatide – US-DMF File Point: In the middle of 2024, Stage: small trial finished

Discussion

Polypeptide AIPs have a wide range of applications in the pharmaceutical, biotechnology, and beauty industries. Levosimendan, a calcium sensitizer, is used for the treatment of heart failure. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is employed in the management of type 2 diabetes and obesity. Bivalirudin, an anticoagulant, finds application in the prevention of blood clotting during certain medical procedures.

In the beauty industry, peptides like Enfuvirtide are used in cosmetic formulations for their anti-aging properties. Exenatide and Liraglutide have also shown potential for weight management and are being studied for cosmetic purposes.

Chinese cGMP APIs are polypeptide AIPs that meet the standards of China’s Good Manufacturing Practice regulations, ensuring their quality and safety for use in various medicinal products.

Research peptides like Tirzepatide are currently in the development stage, with ongoing clinical trials to assess their safety and efficacy for potential regulatory approval.

Conclusion

Polypeptide AIPs are invaluable in the development of drugs, cosmetics, and therapeutic products. The wide array of applications and ongoing research on various peptides underscore their significance in advancing healthcare and improving the quality of life for individuals worldwide. As these peptides continue to undergo research and regulatory evaluations, they hold the promise of unlocking novel treatment options for a range of medical conditions and beauty-related needs.