Peptides one by one: status, evidence and open questions

A quick note on the 2026 regulatory picture

The FDA's list of bulk substances that may present significant safety risks now shows BPC-157, TB-500, KPV, MOTS-c, epithalon and DSIP as nominations withdrawn by their nominators, as of April 2026. Its earlier safety notes cited immunogenicity, peptide impurities and missing human safety data. On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee voted on whether each should be placed on the 503A bulks list. AJMC reported that FDA staff had recommended against all of them and that the committee's votes were close.

These votes are advice, not law, and they addressed whether pharmacies may compound the substances, not whether they work. Compounding rules for these peptides remain unsettled, and we will update this page as the FDA acts.

Sermorelin

Sermorelin is a shortened version of the hormone that tells your pituitary to release growth hormone. Because it works upstream, your body's normal feedback controls still apply, so the rise in growth hormone and IGF-1 is usually modest. It was FDA-approved as Geref, discontinued by its maker in 2008, and later found by the FDA not to have been withdrawn for safety or effectiveness reasons. Today it is compounded, from $199 per month as an oral dissolving tablet through HealifyMD, and is not FDA-approved.

Your clinician may check IGF-1 to gauge response. Because growth hormone signaling can affect cell growth, active cancer or a recent cancer history needs careful review before starting.

BPC-157

BPC-157 is a synthetic peptide derived from a protein found in stomach juice and has been studied for tissue repair and gut lining protection, almost entirely in animals. USADA notes there are no human clinical trials establishing its effectiveness, and it is prohibited in sport. At the July 2026 meeting, which reviewed it for ulcerative colitis, the committee voted 8 to 6 with one abstention to recommend it. It is offered through HealifyMD as a compounded preparation from $250 per month and is not a substitute for proven treatment of inflammatory bowel disease.

TB-500 and the Wolverine Stack

TB-500 is a synthetic fragment related to thymosin beta-4, a naturally occurring protein involved in cell movement and repair. The FDA's safety notes said there were no human exposure data. The committee recommended it, reviewed for wound healing, by 8 to 6 with one abstention. The Wolverine Stack combines BPC-157 and TB-500 from $350 per month; no trial has tested whether the combination works better than either alone, and stacking adds uncertainty about which ingredient causes any effect or side effect.

KPV and the Repair and Recovery Stack

KPV is a three-amino-acid fragment of a hormone involved in inflammation and skin pigmentation, studied mainly in cell and animal models of gut and skin inflammation. The FDA noted no human exposure data. The committee recommended it by 8 to 6 with one abstention. The Repair and Recovery Stack, which includes KPV, is from $300 per month. KPV is not a treatment for Crohn's disease or ulcerative colitis.

DSIP

Delta sleep-inducing peptide, called emideltide by the FDA, was identified in the 1970s and studied in small, older human trials with mixed results for sleep. The FDA reviewed it for opioid withdrawal, chronic insomnia and narcolepsy, and the committee voted 7 to 6 with one abstention against recommending it, the only peptide in the group to be rejected. It is offered through HealifyMD as a compounded preparation from $200 per month. Persistent poor sleep often has treatable causes, such as sleep apnea, that should be checked first.

Epithalon and MOTS-c

Epithalon, also spelled epitalon, is a synthetic four-amino-acid peptide based on a pineal gland extract. Most research comes from a small number of laboratories, and claims about telomere lengthening and lifespan rest on cell and animal studies. The committee narrowly recommended it after reviewing it for insomnia. MOTS-c is a peptide encoded in mitochondrial DNA that affects metabolism in cells and animals and is sometimes called an exercise mimetic; it is not a reason to train less. The committee recommended it 7 to 5 with two abstentions after reviewing it for obesity and osteoporosis. Through HealifyMD, each is a compounded preparation: epithalon from $320 per month and MOTS-c from $275 per month.