Three Regulatory Categories

Not all peptides are treated equally from a regulatory standpoint. Some have been approved drugs for decades, others are classified as FDA Category 2 bulk substances that compounding pharmacies may no longer use, and still others have never undergone a formal approval process.

Approved Drugs

Semaglutide (Ozempic/Wegovy), tirzepatide (Mounjaro/Zepbound), tesamorelin (Egrifta), sermorelin (Geref, historically), and bremelanotide/PT-141 (Vyleesi) are examples of compounds that have gone through formal FDA approval processes.

FDA Category 2 and WADA-Listed Substances

BPC-157, TB-500, GHK-Cu (injectable), IGF-1 LR3, DSIP, and MOTS-c are among the substances classified as FDA Category 2 and/or prohibited by WADA – an indication that they are receiving increasing regulatory attention without being officially approved.

Pure Research Compounds

Peptides such as epitalon, selank, and semax are approved as prescription drugs in Russia but hold no approval status whatsoever in the US or EU – an example of how significantly regulatory classification can differ by country.

Why This Matters

Regulatory status says nothing about safety or efficacy, but it does show how far along clinical evaluation of different compounds actually is.

Sources

  • Wilding JPH, et al. NEJM. 2021;384(11):989–1002. PMID 33567185
  • Jastreboff AM, et al. NEJM. 2022;387(3):205–216.
  • Falutz J, et al. J Acquir Immune Defic Syndr. 2010;53(3):311–322. PMID 20101189
  • Clayton AH, et al. Obstet Gynecol. 2019;134(5):899–908. PMID 31599840

References without a PMID can be located via the respective publisher.