Evidence
The regulatory picture for peptides
PSI maintains a live tracker of every peptide compound's regulatory status. The landscape is more nuanced than "approved" or "not approved." A handful of peptides have completed the full FDA pathway and are prescribed as conventional medications: semaglutide, tirzepatide, liraglutide, tesamorelin, and a small number of others. A much larger group, including most peptides studied in functional medicine, is not FDA approved but is allowed through compounding pharmacies, legally prescribed by physicians. A third group was restricted in recent FDA actions and is under active reclassification review.
For any specific peptide, regulatory status changes over time, sometimes quickly. The tracker reflects the current state and is updated as the FDA publishes actions.
"Not FDA approved" does not usually mean "does not work." It usually means no company had a patent strong enough to pay for the trial.
PSI editorial, April 2026