Regulatory reference · updated 2026-07-18
FDA-approved peptides, and what everything else on the shelf actually is
Most pages that rank for this query are run by a clinic with a booking button at the bottom. This one is not. It is the status table from Peptra's own compound reference — 32 peptides, sorted into four regulatory categories, with the review dates we have and a plain statement of where the data is unsettled.
This is a transparency reference, not a recommendation. A status label tells you where a compound stands with regulators. It does not tell you whether it is right for you, and it is not a substitute for a conversation with a clinician.
The four statuses
Peptra labels every compound in its reference with one of four statuses. They are not a ranking from "safe" to "dangerous" — they answer a narrower, factual question: does a lawful pathway exist for a licensed party to prepare or prescribe this, and has the FDA formally approved a specific product containing it.
- FDA-approved — the FDA has approved a specific manufacturer's product containing this peptide, for a specific indication, through a New Drug Application or Biologics License Application. This is the only status backed by required clinical trial data reviewed by the agency.
- 503A compounded — not an approved finished product, but a licensed pharmacist may legally prepare it against a patient-specific prescription under Section 503A of the Food, Drug & Cosmetic Act, typically because it appears on FDA's list of permitted bulk drug substances.
- Not compoundable — the FDA has not placed the substance on that permitted list, often after finding insufficient safety data, or after an unfavorable review. There is no lawful 503A pathway for it in the US right now.
- Research-only — sold labeled "for laboratory research use," "not for human consumption." No FDA-regulated manufacturing, testing, or compounding oversight applies to this material at all.
For the full explanation of what each status legally means — including what "research use only" labeling does and does not exempt a seller or user from — see what 503A, 503B, and research-only actually mean.
FDA-approved
A specific product from a specific manufacturer has cleared FDA review for a stated indication.
| Compound | Sold / marketed as | Status | Note |
|---|---|---|---|
| Semaglutide | Ozempic, Wegovy, Rybelsus | ✓ Approved | Weight loss and type-2 diabetes. Boxed warning for medullary thyroid carcinoma / MEN2. |
| Tirzepatide | Mounjaro, Zepbound | ✓ Approved | Dual GIP/GLP-1 agonist. Same boxed warnings as semaglutide. |
| Liraglutide | Victoza, Saxenda | ✓ Approved | Older, shorter-acting daily GLP-1 agonist. |
| Orforglipron | Foundayo | ✓ Approved | First oral small-molecule GLP-1, approved April 2026. |
| Tesamorelin | Egrifta | ✓ Approved | Approved for HIV-associated lipodystrophy. Off-label use elsewhere is a prescriber decision. |
| SS-31 | Marketed under the research name "SS-31"; the approved drug is elamipretide (Bendavia) | ✓ Approved (narrow) | Approved only for Barth syndrome. Most "SS-31" sold in wellness contexts is unapproved research material, not the approved product. |
| PT-141 | Bremelanotide, sold as Vyleesi | ✓ Approved (narrow) | Approved only for premenopausal HSDD. Off-label male use and compounded/nasal versions are common but are not the approved product. |
503A compounded
No FDA-approved finished product, but a licensed compounding pharmacist may legally prepare these against a prescription.
| Compound | Category | Status | Note |
|---|---|---|---|
| Sermorelin | Growth hormone axis | ℞ 503A | Previously FDA-approved (Geref); remains 503A-compoundable. |
| CJC-1295 | Growth hormone axis | ℞ 503A | Currently under Pharmacy Compounding Advisory Committee (PCAC) review for the permanent 503A bulks list — status may change. |
| Ipamorelin | Growth hormone axis | ℞ 503A | Under the same pending PCAC review. |
| NAD+ injectable | Longevity / mitochondrial | ℞ 503A | Category 1, "under evaluation" with interim compounding discretion. Not eligible for 503B outsourcing. |
| Glutathione injectable | Antioxidant | ℞ 503A | Commonly compounded. No FDA approval exists for skin-lightening marketing claims specifically. |
Not compoundable
The largest group on this list — 12 of the 32 compounds Peptra tracks. All were removed from FDA Category 2 in April 2026 and most sit under active PCAC review scheduled for July 23–24, 2026. That review had not concluded as of this writing.
| Compound | Category | Status | Note |
|---|---|---|---|
| BPC-157 | Healing / recovery | ✕ Not compoundable | Animal data only for its marketed uses. FDA cites insufficient safety data. PCAC review Jul 23, 2026. |
| TB-500 / TB4 | Healing / recovery | ✕ Not compoundable | Often paired with BPC-157. PCAC review Jul 23, 2026. |
| KPV | Healing / recovery | ✕ Not compoundable | PCAC review Jul 23, 2026. |
| LL-37 | Immune | ✕ Not compoundable | Gray-zone, largely research-use in practice. |
| Thymosin Alpha-1 | Immune | ✕ Not compoundable | PCAC voted 4-17 against 503A Bulks inclusion in Dec 2024 — an explicit unfavorable review, not just a pending one. |
| Semax | Cognitive / neuro | ✕ Not compoundable | Used clinically in Russia; not FDA-reviewed for US compounding. PCAC review Jul 24, 2026. |
| Epitalon | Longevity / mitochondrial | ✕ Not compoundable | Human evidence from small studies only. PCAC review Jul 24, 2026. |
| MOTS-c | Longevity / mitochondrial | ✕ Not compoundable | PCAC review Jul 23, 2026. |
| Melanotan II | Sexual health | ✕ Not compoundable | FDA and dermatology societies specifically warn against it, independent of compounding status. |
| GHK-Cu (injectable) | Skin / beauty | ✕ Not compoundable | Topical GHK-Cu is a cosmetic and is not restricted the same way. Its own PCAC evaluation is scheduled for Feb 2027. |
| DSIP | Sleep | ✕ Not compoundable | Also under review as "Emideltide." PCAC review Jul 24, 2026. |
| GLOW / KLOW blend | Skin / beauty (blend) | ✕ Not compoundable | A blend of GHK-Cu, BPC-157, TB-500 (and sometimes KPV). A blend inherits the status of its most restricted component — this one is all four. |
Research-only
Sold as laboratory chemicals, not as drugs. No FDA-regulated manufacturing, purity testing, or compounding oversight applies.
| Compound | Category | Status | Note |
|---|---|---|---|
| Retatrutide | GLP-1 / metabolic | ⚠ Research-only | Investigational triple agonist. FDA sent 50+ warning letters to sellers in September 2025; poison-center exposure reports rose sharply. |
| Cagrilintide | GLP-1 / metabolic | ⚠ Research-only | Investigational amylin analog, studied alongside semaglutide. |
| 5-Amino-1MQ | GLP-1 / metabolic | ⚠ Research-only | Minimal human data. |
| AOD-9604 | GLP-1 / metabolic | ⚠ Research-only | Failed its phase 2b trial. |
| MK-677 | Growth hormone axis | ⚠ Research-only | Oral ghrelin-mimetic; failed trials for its studied indication. |
| DiHexa | Cognitive / neuro | ⚠ Research-only | Preclinical only. Its potency raises a theoretical tumor-growth concern worth flagging on its own. |
| Selank | Cognitive / neuro | ⚠ Research-only | Not on the PCAC's July 2026 docket at all. |
| Humanin | Longevity / mitochondrial | ⚠ Research-only | Emerging protocol item with limited published human data. |
What this list does not tell you
A status is not a verdict on effectiveness, and it is not a purity guarantee. A compound can be legally compoundable and still have weak evidence for the use it is marketed for. A compound can be research-only and still be the subject of active, legitimate scientific study — the label describes a regulatory lane, not a scientific conclusion. And a status can change: fourteen of these substances moved off FDA Category 2 in a single month (April 2026) and most are mid-review as this page is published. Treat any specific status as accurate as of the date above, not as permanent.
For the legal framework behind these categories — what "research use only" actually exempts, and what enforcement has looked like — see research peptides and the law.
Peptra ships this exact table, in the app, on every compound. Open any of the 32 compounds and the status, safety flags, and review notes come before anything else — including before you can log a dose. Get the app →
Related reading
- What 503A, 503B, and research-only actually mean.
- Research peptides and the law — the legal framework, not legal advice.
- How to reconstitute a peptide.
- All guides.