Peptide status checker

Regulatory standing

Held FDA approval historically, as Factrel (NDA 018123) and the Lutrepulse Kit (NDA 019687), for diagnostic and fertility use. Both read Discontinued in FDA's database, and gonadorelin is not on any of FDA's three 503A nomination lists. Supply now is commonly compounded.

Regulatory standing

The firmest regulatory footing of any peptide here: Vyleesi (bremelanotide, NDA 210557) is approved for HSDD in premenopausal women and still actively marketed, so unlike the peptides whose only approvals are discontinued, this one remains a component of a currently approved drug. Also supplied compounded, off-label.

Regulatory standing

Approved as Egrifta for HIV‑associated lipodystrophy — and since March 2020 regulated as a licensed biologic rather than a drug, when its NDA was deemed a BLA and it moved to the Purple Book. The 503A and 503B compounding pathways cover drugs, not licensed biologics, so compounded tesamorelin has no route through a licensed US pharmacy. Off‑label use of the approved product is a separate question.

Regulatory standing

No FDA approval as a drug, though NAD sits in category 1 of FDA's 503A nomination list — under evaluation, and FDA has said it does not intend to act against pharmacies compounding with category 1 substances. Reaches people either as a compounded injectable or IV, or over the counter as the precursors NR and NMN.

Regulatory standing

Approved once as Geref, for diagnostic use — both applications (EMD Serono, NDA 019863 and NDA 020443) now read Discontinued in FDA's own database, so nothing branded is on the market. Everything dispensed today is compounded. Sermorelin is not on any of FDA's three 503A nomination lists, so unlike most peptides its status is not being actively evaluated.

Regulatory standing

Unapproved, and not on the 503A Bulks List, so a licensed pharmacy has no lawful route to compound it. Both nominations to that list were withdrawn; FDA is evaluating the substance on its own initiative and its May 2026 briefing to the Pharmacy Compounding Advisory Committee recommends against adding it. The human data remains largely preclinical.

Regulatory standing

Not FDA-approved. The ipamorelin half carries a restriction the CJC-1295 half does not: FDA lists ipamorelin acetate among the bulk substances that may present significant safety risks in outsourcing-facility (503B) compounding, on a list last updated April 2026. Supply is compounded.

Regulatory standing

Unremarkable as a cosmetic ingredient, and the injectable form is the one to watch. FDA dropped GHK-Cu from its category 1 evaluation list on 22 April 2026 when the nominations were withdrawn, then reinstated it on 5 May for non-injectable routes only — the list now reads “GHK-Cu (except for injectable routes of administration)”. Injectable GHK-Cu therefore sits outside that cover, and FDA has said it will consult its compounding advisory committee before the end of February 2027.

Regulatory standing

Carries no FDA approval for anti-aging or for skin lightening, but it does sit in category 1 of FDA's 503A nomination list — under evaluation, and FDA has said it does not intend to act against pharmacies compounding with category 1 substances. Supplied compounded for injection or IV, or as an oral supplement.

Regulatory standing

Not FDA-approved, and one of the few peptides FDA still lists as possibly presenting significant safety risks in compounding. Ipamorelin acetate is named there for outsourcing-facility (503B) use, on a list last updated April 2026, so a 503B facility has no route to supply it.

Regulatory standing

No FDA approval, and not on the 503A Bulks List, so a licensed pharmacy has no lawful route to compound it. FDA took TB‑500 to its Pharmacy Compounding Advisory Committee in July 2026 to consider adding it; the outcome was not published as of August 2026. What circulates is sold for research use, on an evidence base that has not reached human outcome trials.

Regulatory standing

No FDA approval for any indication and no DailyMed listing at all. It is not on the 503A Bulks List either; FDA took MOTS‑c to its Pharmacy Compounding Advisory Committee in July 2026 to consider adding it, and the outcome was not published as of August 2026. Sold online almost entirely as an unregulated research chemical.