FDA Category 2 is a recurring topic in our peptide coverage. This hub collects every article tagged FDA Category 2, newest first, each evidence-graded and tied to real, verifiable sources.
A clinical monograph on MOTS-c — the 16-amino-acid mitochondrial-derived peptide marketed as an 'exercise mimetic' and metabolic regulator. Striking rodent data, no completed human efficacy trial, and an unsettled 2026 legal status.
A clinical monograph on MGF (IGF-1Ec) — the mechanosensitive IGF-1 splice variant marketed for muscle repair and satellite-cell activation. Compelling rodent mechanism, contested preclinical data, zero human trials, and an unsettled 2026 legal and anti-doping status.
A clinical monograph on MK-677 (ibutamoren) — the oral, non-peptide ghrelin-receptor agonist that reliably raises GH and IGF-1, yet failed its clinical disease endpoints and carries a congestive-heart-failure safety signal.
A clinical monograph on LL-37 — the only human cathelicidin antimicrobial peptide. Small topical wound-healing RCTs (grade B), strong preclinical mechanism, and a sharply double-edged immune profile.
A clinical monograph on Livagen (KEDA; Lys-Glu-Asp-Ala) — a Khavinson 'bioregulator' tetrapeptide proposed to decondense aged chromatin and protect the liver. Single-lab preclinical signals only, no human trials.
A clinical monograph on ipamorelin — the selective growth-hormone secretagogue famous for the CJC-1295 stack. One human PD study, one failed RCT, and an unsettled 2026 legal status.
A clinical monograph on the tesamorelin + ipamorelin stack — a GHRH-analog plus ghrelin-receptor agonist combination marketed for body composition. Sound mechanism, Grade-A component data, but zero RCTs of the combination itself.
A clinical monograph on GHK-Cu (copper tripeptide-1) — the endogenous copper-binding peptide with genuine topical human data for skin and wound healing, and a speculative injectable story with no controlled human evidence.
A clinical monograph on epithalamin — the bovine pineal-gland peptide extract that is the natural precursor of synthetic epitalon. A provocative single-program human mortality dataset, no independent RCT, and an unsettled 2026 legal status.
A clinical monograph on DSIP (delta sleep-inducing peptide / emideltide) — the endogenous nonapeptide marketed for sleep, withdrawal and pain. Thin, dated human data, an unidentified receptor, and a pivotal 2026 FDA compounding review.
A clinical monograph on dihexa — the angiotensin IV-derived nootropic peptide promoted for cognition. Its evidence is preclinical only, its foundational mechanism papers were retracted for fraud, and its clinical prodrug failed an Alzheimer's trial.
A clinical monograph on CJC-1295 without DAC (Mod GRF 1-29) — the short-acting, pulse-preserving GHRH analog. Solid preclinical pharmacology, no human RCT of the no-DAC molecule, and an unsettled 2026 legal status.
A clinical monograph on the arginate (di-L-arginine) salt of BPC-157 — the same peptide with an arginine counterion. The storage and gastric-acid stability advantage is real; the headline oral-bioavailability claims are unproven marketing.
A clinical monograph on AOD-9604 — the hGH-fragment fat-loss peptide that completed six human RCTs and largely failed to beat placebo. Strong safety data, a failed pivotal weight-loss trial, and an unsettled 2026 legal status.
A clinical monograph on BPC-157 — the stable gastric pentadecapeptide marketed for tendon, gut and wound healing. Deep preclinical data, no completed human RCT, and an unsettled 2026 legal status.
FDA Category 2 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 Category 2, 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.