Therapeutic Peptides: evidence grades and FDA status
Therapeutic peptides act on specific biological pathways, tissue repair, hormone signaling, immune modulation, rather than a single metabolic axis. The clinical evidence spans approved drugs to preclinical-only candidates, so each one below carries an independent A-to-D evidence grade and its FDA status.
20 compounds graded
| Compound | Evidence | FDA status | Summary |
|---|---|---|---|
| Tesamorelin | A | FDA approved | Tesamorelin (brand name Egrifta, Egrifta SV, and Egrifta WR) is an FDA-approved synthetic analogue of growth hormone-releasing |
| Bremelanotide | A | FDA approved | Bremelanotide (Vyleesi) is FDA-approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in |
| Setmelanotide | A | FDA approved | Setmelanotide (Imcivree) is FDA-approved for chronic weight management in patients with obesity arising from specific rare |
| Afamelanotide | A | FDA approved | Afamelanotide (Scenesse) is FDA-approved to increase pain-free light exposure in adults with a history of phototoxic reactions |
| Gonadorelin | C | Withdrawn | Gonadorelin (GnRH) is a synthetic decapeptide identical to the body's own gonadotropin-releasing hormone. It has a documented |
| Oxytocin | A | FDA approved | Oxytocin is FDA-approved in intravenous and intramuscular forms for obstetric indications: induction or augmentation of labor in |
| Sermorelin | C | Not FDA approved | Sermorelin is a synthetic 29-amino-acid fragment of growth hormone-releasing hormone (GHRH) with a prior FDA approval history as |
| BPC-157 | C | Not FDA approved | Human evidence for BPC-157 is limited to a small number of uncontrolled pilot studies from a single research group; no randomized |
| Thymosin Beta-4 | D | Not FDA approved | Evidence is limited primarily to animal and preclinical studies; the evidence base for systemic injectable use in humans is early |
| Thymosin Alpha-1 | B | Not FDA approved | Thymosin alpha-1 (thymalfasin; brand name Zadaxin) is not FDA-approved in the United States for any indication, though it holds |
| Elamipretide | A | FDA approved | Elamipretide (Forzinity, SS-31) received FDA accelerated approval on September 19, 2025, to improve muscle strength in adult and |
| Kisspeptin | B | Not FDA approved | Kisspeptin is not FDA-approved for any indication in the United States and is classified as investigational. Human clinical |
| Larazotide | B | Not FDA approved | Larazotide acetate (AT-1001) is a synthetic octapeptide that acts as a tight-junction regulator, developed specifically as a |
| LL-37 | C | Not FDA approved | Human clinical evidence for LL-37 is limited to topical wound healing; there is no published human trial of systemic or |
| KPV | D | Not FDA approved | KPV has no verified human evidence. The FDA explicitly stated it lacked human exposure data for any route of administration at |
| Glutathione | B | Not FDA approved | Glutathione is an endogenous tripeptide antioxidant synthesized by virtually all human cells; its supplementation is marketed for |
| Cerebrolysin | B | Not FDA approved | Cerebrolysin is a standardized injectable mixture of low-molecular-weight neuropeptides and free amino acids derived from porcine |
| hCG | A | FDA approved | hCG (human chorionic gonadotropin) is an FDA-approved prescription drug with well-established indications, and this distinguishes |
| Thymulin | C | Not FDA approved | Thymulin (facteur thymique serique, FTS) is a nonapeptide naturally secreted by thymic epithelial cells in a zinc-dependent |
| Thymalin | C | Not FDA approved | Thymalin is a calf-thymus polypeptide extract developed in the Soviet Union, with the first publications appearing around 1982 |
Evidence grades: Grade A: Approved and proven; Grade B: Human evidence, not approved for this use; Grade C: Preliminary or limited human evidence; Grade D: Preclinical or anecdotal only. How we grade. Browse the 503B facility directory for compounding sources.