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FDA-approved peptides: the real list
Approved, compoundable or research-only? Here's where every popular peptide actually stands, with a primary FDA source on every row.
The short version: nine of the peptides people ask about are real FDA-approved drugs. Retatrutide is close but still investigational. The trendy ones, BPC-157, TB-500, ipamorelin, CJC-1295, MOTS-c, Semax and Selank, are not approved, and compounders can't currently use them either.
FDA-approved peptide drugs
| Compound | Status | Brand / what it's for | Can it be compounded? | Primary source |
|---|---|---|---|---|
| Semaglutide | FDA-approved | Ozempic, Wegovy (injections), Rybelsus (pill) | Not anymore for copies of the brand: the shortage is over and FDA's grace periods ended in 2025 (FDA). In April 2026 FDA proposed excluding it from the 503B bulk list (FDA). | Ozempic, Wegovy, Rybelsus (Drugs@FDA) |
| Tirzepatide | FDA-approved | Mounjaro, Zepbound | Same as semaglutide: shortage resolved, grace periods over (FDA); proposed 503B exclusion in April 2026 (FDA). | Mounjaro, Zepbound (Drugs@FDA) |
| Liraglutide | FDA-approved | Victoza, Saxenda, plus approved generics | Not covered on this page. | Victoza, Saxenda (Drugs@FDA) |
| Dulaglutide | FDA-approved | Trulicity (type 2 diabetes) | Generally no: it's approved as a biologic (BLA), and biologics aren't eligible for the compounding exemptions (FDA). | Trulicity (Drugs@FDA) |
| Tesamorelin | FDA-approved | Egrifta WR (HIV-associated belly fat) | Generally no: it's a biological product, and biologics aren't eligible for the compounding exemptions (FDA). Egrifta was deemed a biologic in 2020 (FDA list). | Egrifta WR label (DailyMed) |
| Bremelanotide (PT-141) | FDA-approved | Vyleesi (low desire in premenopausal women) | Not covered on this page. | Vyleesi label (DailyMed); Drugs@FDA |
| Elamipretide (SS-31) | FDA-approved | Forzinity (Barth syndrome), approved Sept 2025 | Not covered on this page. | Forzinity label (DailyMed); Drugs@FDA |
| Oxytocin | FDA-approved | Pitocin and generics (used in labor and delivery, in hospital) | Not covered on this page. | Pitocin (Drugs@FDA) |
| hCG (chorionic gonadotropin) | FDA-approved | Pregnyl, Novarel and generic chorionic gonadotropin (fertility) | Generally no: it's a biological product, and biologics aren't eligible for the compounding exemptions (FDA). FDA names hCG specifically. | Pregnyl, Novarel (Drugs@FDA); FDA biologics list |
"Not covered on this page" means we haven't verified a compounding status for that drug, so we don't state one. Approval is for the brand and use on its label only.
Close, but not peptides or not approved
| Compound | Status | Brand / what it's for | Can it be compounded? | Primary source |
|---|---|---|---|---|
| Orforglipron | FDA-approved | Foundayo, approved April 1, 2026. A GLP-1 pill, but a small molecule, not a peptide | Not covered on this page. | Drugs@FDA |
| Retatrutide | Investigational | Lilly's triple agonist, still in phase 3. Not approved; Lilly plans to file in Q1 2027 | No. FDA says it can't be used in compounding under federal law (FDA). | FDA; our FDA status tracker |
Research-only peptides
None of these is an FDA-approved drug. The column on the right is what FDA's compounding lists say.
| Compound | Status | Can it be compounded? (FDA source) |
|---|---|---|
| BPC-157 | Research purposes only | Not on FDA's category 1 list (FDA 503A list). FDA lists it as nominated, then withdrawn, with safety concerns (FDA). PCAC voted in favor in July 2026 (non-binding). |
| TB-500 | Research purposes only | Not on FDA's category 1 list (FDA 503A list). FDA lists it as nominated, then withdrawn, with safety concerns (FDA). PCAC voted 8–6–1 in favor in July 2026 (non-binding). |
| GHK-Cu | Research purposes only | Topical and other non-injectable forms are on FDA's category 1 list; injectable GHK-Cu is not (FDA 503A list). |
| Ipamorelin | Research purposes only | No. Placed in category 2 (safety concerns) (FDA); PCAC voted 0–12–1 against in Oct 2024 (FDA minutes). |
| CJC-1295 | Research purposes only | Not on FDA's category 1 list (FDA 503A list). FDA lists it as nominated, then withdrawn, with safety concerns (FDA). |
| MOTS-c | Research purposes only | Not on FDA's category 1 list (FDA 503A list). FDA lists it as nominated, then withdrawn, with safety concerns (FDA). PCAC voted 7–5–2 in favor in July 2026 (non-binding). |
| Semax | Research purposes only | Not on FDA's category 1 list (FDA 503A list). FDA lists it as nominated, then withdrawn, with safety concerns (FDA). PCAC voted 8–5–1 in favor in July 2026 (non-binding). |
| Selank | Research purposes only | Not on FDA's category 1 list (FDA 503A list). FDA lists it as nominated, then withdrawn, with safety concerns (FDA). |
Not FDA-approved; sold for research only. Known risks: not well studied in people; FDA cites immunogenicity, impurity and limited-safety-data concerns for several of these (FDA). Choose a tested source.
What could change next
- The July 2026 PCAC votes. FDA's compounding advisory committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon for the 503A list (FDA meeting page; vote report). The votes are advice. FDA hasn't added any of them yet.
- An interim access policy. FDA sent "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94) to White House review on Oct 14, 2026 (OIRA EO 12866 review entry, reginfo.gov). It hasn't appeared in the Unified Agenda or the Federal Register, isn't in effect, and which peptides it covers isn't public.
- Injectable GHK-Cu. FDA says it plans to take GHK-Cu to the PCAC by the end of February 2027 (FDA 503A list).
- Retatrutide. Lilly plans to submit to FDA in Q1 2027. Track it on our retatrutide FDA status page.
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FDA status FAQ
Is BPC-157 FDA-approved?
No. BPC-157 is not an approved drug and is sold for research only. It's also not on FDA's list of bulk substances compounders can use while under review (FDA). A July 2026 advisory committee vote in its favor is a recommendation, not an approval.
Which GLP-1s are FDA-approved?
Semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda) and dulaglutide (Trulicity), per Drugs@FDA. Orforglipron (Foundayo) is approved too, but it's a small molecule, not a peptide. Retatrutide is still investigational.
Can a pharmacy compound peptides like BPC-157 or TB-500?
Not under current FDA policy. Neither is on FDA's category 1 list, and FDA lists both as nominated, then withdrawn, with safety concerns (FDA). The PCAC voted for them in July 2026, but FDA hasn't acted on that vote.
What is the FDA's interim peptide compounding policy?
A notice titled "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94) reached White House review on Oct 14, 2026 (OIRA EO 12866 review entry, reginfo.gov). It hasn't appeared in the Unified Agenda or the Federal Register, isn't in effect, and its details aren't public yet.
Not medical advice. Education only. Talk to a licensed clinician about your health.