Peptide & GLP-1 Regulatory Status

FDA-approved for type 2 diabetes and weight management. Shortage declared resolved 21 Feb 2025; compounding enforcement discretion ended 22 Apr 2025 (503A) and 22 May 2025 (503B). FDA proposed excluding it from the 503B bulks list on 30 Apr 2026; comments closed 29 Jun 2026 and no final rule has issued.

FDA-approved for type 2 diabetes and weight management, and off the shortage list. Covered by the same proposed 503B bulks-list exclusion as semaglutide (proposed 30 Apr 2026, not final).

Investigational, not approved anywhere. Five positive Phase 3 TRIUMPH trials reported through Jul 2026, up to 22.6% weight loss at 80 weeks in TRIUMPH-3. Lilly says it plans to submit a BLA to FDA in Q1 2027.

FDA accelerated approval 19 Sep 2025 as Forzinity, for Barth syndrome only. Prescription. Any other use, including mitochondrial or anti-aging claims, is off-label and unproven.

FDA-approved (2019) for hypoactive sexual desire disorder in premenopausal women. Prescription. Use in men is off-label.

FDA-approved for HIV-associated lipodystrophy. Prescription. Not approved for body composition or anti-aging use.

Removed from the interim 503A Category 2 list 22 Apr 2026. PCAC voted on 23-24 Jul 2026 to recommend adding it to the 503A bulks list. FDA has not completed rulemaking, so it is still not an approved drug and not yet lawfully compoundable.

Removed from Category 2 on 22 Apr 2026 and recommended by PCAC on 23-24 Jul 2026 for the 503A bulks list. Awaiting FDA rulemaking. Prohibited in sport by WADA.

Removed from Category 2 on 22 Apr 2026 and recommended by PCAC on 23-24 Jul 2026 for the 503A bulks list. Awaiting FDA rulemaking.

Removed from Category 2 on 22 Apr 2026 and recommended by PCAC on 23-24 Jul 2026 for the 503A bulks list. Awaiting FDA rulemaking.

Removed from Category 2 on 22 Apr 2026 and recommended by PCAC on 23-24 Jul 2026 for the 503A bulks list. Awaiting FDA rulemaking. No FDA-approved use.

Removed from Category 2 on 22 Apr 2026 and recommended by PCAC on 23-24 Jul 2026 for the 503A bulks list. Awaiting FDA rulemaking. Prescription nootropic in Russia; no FDA-approved use.

PCAC voted against recommending emideltide for the 503A bulks list on 23-24 Jul 2026, the only one of the seven peptides reviewed to be rejected. Not FDA-approved.

Remains on the interim 503A Category 2 list (added 29 Sep 2023), the list of substances FDA considers to present significant safety risks in compounding. Not FDA-approved. Prohibited in sport by WADA.

Nomination withdrawn and removed from Category 2 on 22 Apr 2026, but not added to the 503A bulks list, so compounding is still not permitted. Not FDA-approved. Prohibited in sport by WADA.

Removed from Category 2 on 22 Apr 2026 but not yet reviewed by PCAC for the 503A bulks list. FDA has scheduled a further PCAC meeting before the end of February 2027. Not FDA-approved.

Not FDA-approved. Approved in a number of other countries for hepatitis B and as an immune adjuvant. Nomination withdrawn and removed from Category 2 on 22 Apr 2026.

Sold lawfully as a cosmetic ingredient in topical skincare. No FDA-approved drug use; injectable preparations are not approved and the nomination for compounding was withdrawn on 22 Apr 2026.

Not FDA-approved, never nominated for the 503A bulks list, and sold only as a research chemical. No human trials.