FDA Unapproved is a recurring topic in our peptide coverage. This hub collects every article tagged FDA Unapproved, newest first, each evidence-graded and tied to real, verifiable sources.
An evidence-graded look at the melanocortin 'tanning peptides' — separating the one FDA-approved rare-disease drug (afamelanotide) from the unregulated, illegal-to-sell melanotan-2 'tan jabs' linked to melanoma, priapism and rhabdomyolysis.
An evidence-graded look at the melanocortin peptides marketed for a tan or 'natural photoprotection' — separating the one FDA-approved rare-disease drug (afamelanotide) from the unregulated, illegal-to-sell melanotan products linked to melanoma and priapism.
A clinical monograph on Noopept (omberacetam) — the proline-glycine dipeptide nootropic and cycloprolylglycine prodrug. Small Russian human trials in cognitive impairment, a deep preclinical mechanism, and an unsettled 2026 legal status.
A clinical monograph on Melanotan II (MT-II) — the non-selective melanocortin agonist sold illegally for tanning. Thin 1990s human data, a high-risk safety profile, and an unapproved 2026 legal status.
A clinical monograph on Cardiogen (AEDR; H-Ala-Glu-Asp-Arg-OH), the cardiac-targeted Khavinson bioregulator tetrapeptide. Coherent in-vitro mechanism, zero human trials, and an unapproved 2026 legal status.
A clinical monograph on hexarelin (examorelin) — one of the most potent growth-hormone-releasing peptides. Real human GH-provocation and acute cardiac data (Grade B), preclinical cardioprotection claims (Grade C), and a 2026 status that is unapproved and banned in sport.
A clinical monograph on GHRP-6 — the first-generation ghrelin-receptor agonist that reliably triggers a growth hormone pulse and a potent appetite surge. Real but small human data, no therapeutic RCTs, and a restricted 2026 legal status.
A clinical monograph on cagrilintide — the long-acting amylin analogue and amylin half of CagriSema. Genuine phase 3 human RCTs, ~22.7% combination weight loss, and an unapproved 2026 legal status.
A clinical monograph on Actovegin — the deproteinized calf-blood hemodialysate marketed abroad for diabetic neuropathy, post-stroke cognition and sports recovery. Two human RCTs, an ill-defined composition, and an unapproved U.S. status.
FDA Unapproved is a topic our editors cover across the site. This hub aggregates the related, evidence-graded guidance.
This hub updates automatically whenever a new article is tagged FDA Unapproved, so the latest coverage appears first.
Yes. Every article here grades its efficacy claims A-D and cites real, verifiable studies, regulatory documents or trial registries.
The majority of compounds documented here are not approved by the FDA for human use. Approved drugs (e.g. semaglutide, tirzepatide) are noted explicitly and require a licensed prescriber.
Many peptides — including BPC-157 and GHK-Cu in injectable form — are sold strictly "for research use only — not for human consumption." Purity, identity, and dosing of such products are not regulated or guaranteed.
Several compounds are banned in competitive sport under the WADA Prohibited List. Athletes risk sanction regardless of intent or formulation.
Always consult a qualified, licensed healthcare professional before considering any compound. Individual risk depends on your full medical context.
This content is for informational and educational purposes only · No physician–patient relationship is created · Evidence grades reflect published data as of the stated revision and may change.