Is BPC-157 FDA approved?

No. An FDA advisory committee recommended BPC-157 for the 503A compounding bulks list on 23 July 2026 (8-6, 1 abstention), but that is not a drug approval, and the FDA had not completed rulemaking as of October 2026.

Is TB-500 FDA approved?

No. TB-500 was recommended for the 503A compounding bulks list on 23 July 2026 (8-6, 1 abstention); rulemaking was pending in October 2026. It is Schedule 4 in Australia and named under S2.3 by WADA.

Is GHK-Cu FDA approved?

No. Non-injectable GHK-Cu is in the FDA's 503A Category 1, injectable GHK-Cu nominations were withdrawn in 2026, and an advisory committee review is due before the end of February 2027. Topical copper tripeptide-1 is sold as a cosmetic ingredient.

No. The July 2026 vote (8-6, 1 abstention) was a non-binding recommendation about pharmacy compounding, not a drug approval.

Is MOTS-c FDA approved?

No. An FDA advisory committee recommended it for the 503A bulks list 7-5 with 2 abstentions in July 2026; rulemaking was pending in October 2026. WADA names it under S4.4.1.

Is epitalon FDA approved?

No. An FDA advisory committee recommended epitalon for the 503A bulks list on 24 July 2026 (7-4, 1 abstention), against the FDA staff proposal; rulemaking was pending in October 2026.

Is NAD+ FDA approved?

No NAD+ injection is FDA approved. NAD and NADH are in Category 1 of the FDA's 503A list, so licensed pharmacies may compound them under the FDA's interim policy while they are evaluated.

Which peptides are FDA approved?

Of the compounds in this chart, only elamipretide, as the product Forzinity, approved on 19 September 2025 for Barth syndrome. Research-grade SS-31 is not an approved drug.

legal · 7 min read · updated 24 Oct 2026

Scientifically reviewed by Dr Stephan Hansberg

Is It FDA Approved? Peptide Status Chart 2026 - Only Elamipretide Has an Approval

FDA, MHRA, TGA and WADA status for 10 compounds in one table, as of October 2026. Only elamipretide (SS-31, as Forzinity) is FDA approved, for Barth syndrome. BPC-157, TB-500 and KPV won 8-6 PCAC votes and MOTS-c 7-5 in July 2026, with rulemaking pending; BPC-157 and TB-500 are Schedule 4 in Australia; WADA names BPC-157 (S0), TB-500 (S2.3) and MOTS-c (S4.4.1).

Key takeaways

•Only one compound in this chart has an FDA approval: elamipretide, approved on 19 September 2025 as Forzinity for Barth syndrome under accelerated approval. Research-grade SS-31 is not an approved drug.
•On 23-24 July 2026 an FDA advisory committee recommended BPC-157, TB-500 and KPV (each 8-6, 1 abstention), MOTS-c (7-5, 2 abstentions) and epitalon (7-4, 1 abstention) for the 503A compounding bulks list. Those votes are not approvals, and rulemaking was still pending in October 2026.
•Non-injectable GHK-Cu and NAD are in the FDA's 503A Category 1; GHK-Cu and LL-37 are on the agenda for the next advisory committee meeting, due before the end of February 2027.
•In Australia BPC-157, TB-500 and thymosin beta-4 are named in Schedule 4; for the others we found no named Poisons Standard entry, but unapproved therapeutic goods rules apply.
•WADA names BPC-157 (S0), thymosin beta-4 and TB-500 (S2.3) and MOTS-c (S4.4.1) on its 2026 List, and from 1 January 2027 names peptides in general in S0.

The short answer

No. Apart from elamipretide, none of the peptides commonly sold for research is an FDA-approved drug, and none has a UK or Australian marketing authorisation that we could find. The 2026 news about "FDA unbanning peptides" concerns pharmacy compounding, not drug approval: an advisory committee recommended several peptides for the 503A bulks list in July 2026, and the FDA had not completed rulemaking as of October 2026.

On 15 October 2026 HHS sent a peptides "interim access policy" to the White House Office of Management and Budget for review. STAT reported, citing two people familiar with the plan, that it would let pharmacies temporarily compound some peptides, including BPC-157, under enforcement discretion. That would not be an approval.

Status chart by compound (October 2026)

Each row summarises the dated, sourced status on our full status page for that compound, listed in the last column and linked below the table. The 503A categories govern what licensed US pharmacies may compound, not what research suppliers may sell.

Compound	FDA approved?	FDA compounding (503A) and Jul 2026 PCAC	UK (MHRA)	Australia (TGA)	WADA 2026	Full status page
BPC-157	No	Category 2 from Sep 2023, off in Apr 2026; PCAC recommended for bulks list 23 Jul 2026 (8-6, 1 abstention); rulemaking pending	Not licensed; not a controlled drug; treated as a medicine if presented as one	Schedule 4 and Appendix D since 1 Jun 2024 (possession without authority illegal)	S0, named	Is BPC-157 legal?
TB-500	No	Category 2 from Sep 2023, off in Apr 2026; PCAC recommended 23 Jul 2026 (8-6, 1 abstention); rulemaking pending	Not licensed; not a controlled drug	Schedule 4 with Appendix D possession offence (since 2016)	S2.3, named (thymosin beta-4 derivatives)	Is TB-500 legal?
Thymosin beta-4	No (RGN-259 eye drops investigational)	Full-length thymosin beta-4 not on the Jul 2026 agenda	No UK marketing authorisation	Named in Schedule 4	S2.3, named	What is thymosin beta-4?
GHK-Cu	No	Injectable: Category 2 from Sep 2023, nominations withdrawn 2026. Non-injectable: Category 1 (May 2026). PCAC review due before end Feb 2027	Cosmetic ingredient (copper tripeptide-1) in skincare; not licensed as a medicine	Cosmetics sold; therapeutic or injectable products unapproved; named in TGA and CMO statement, 19 Jun 2026	Not named	Is GHK-Cu legal?
KPV	No	Category 2 from Sep 2023, off in Apr 2026; PCAC recommended 23 Jul 2026 (8-6, 1 abstention); rulemaking pending	Not licensed; not a controlled drug	No named Poisons Standard entry found; unapproved therapeutic good if supplied for human use	Not named; S0 catch-all	Is KPV legal?
MOTS-c	No	Category 2 from Sep 2023, off in Apr 2026; PCAC recommended 23 Jul 2026 (7-5, 2 abstentions); rulemaking pending	Not licensed; not a controlled drug	No named Poisons Standard entry found; unapproved therapeutic good if supplied for human use	S4.4.1, named (AMPK activator)	Is MOTS-c legal?
Epitalon	No	Category 2 from Sep 2023; PCAC recommended 24 Jul 2026 (7-4, 1 abstention); rulemaking pending	No UK marketing authorisation	Not named in the Poisons Standard (Oct 2026 instrument)	Not named; S0 catch-all	What is epitalon?
SS-31 (elamipretide)	Yes, one product: Forzinity, 19 Sep 2025, accelerated approval for Barth syndrome. Research-grade SS-31 is not approved	Not applicable to the approved product	No UK marketing authorisation identified	Not named in the Poisons Standard; no Australian registration identified	Not named; check with your anti-doping organisation	What is SS-31 (elamipretide)?
LL-37	No	Not on the Jul 2026 agenda; listed for the next PCAC meeting, due before end Feb 2027	No UK marketing authorisation	Not named in the Poisons Standard (Oct 2026 instrument)	Not named; S0 catch-all	What is LL-37?
NAD+	No approved NAD+ injection	NAD and NADH in Category 1 (compounding allowed under interim policy); beta-NAD disodium salt trihydrate in Category 3	Injection or drip used as a medicine is a medicinal product; no licensed injectable found	Not a scheduled poison; not a permitted ingredient in listed medicines (TGA alert, Apr 2025)	Not prohibited; IV over 100 mL per 12 h prohibited (M2.2)	Is NAD+ injection legal?

Full status page for each compound

Each page gives the dated history, the regulator's wording and the primary sources:

Blends: WOLVERINE, GLOW and KLOW

A blend has no status of its own. None of these combinations is an approved medicine anywhere, and each component keeps its own status: a product containing BPC-157 and TB-500 contains two Schedule 4 substances in Australia and two substances named on the WADA List. In August 2026 the TGA seized a BPC-157 and TB-500 combination product from premises in New South Wales.

Approved, compounded, research grade: three different things

An FDA-approved drug is a specific manufactured product with an approved label, like Forzinity. A compounded drug is made by a licensed pharmacy for an individual patient from a bulk substance the FDA allows under section 503A. A research-grade peptide is neither: it is sold for laboratory work, and the FDA has issued warning letters where sellers labelled products for research while their websites showed they were intended for people.

An advisory committee vote is a recommendation to the FDA. Even a favourable FDA decision on the 503A bulks list would allow pharmacy compounding, not approve a drug, and it would not change a substance's WADA status.

Where Celyfe fits

Celyfe supplies NAD+, BPC-157, TB-500, GHK-Cu and KPV only as pre-filled research pens (NAD+ Precision Pen, WOLVERINE, GLOW and KLOW), for laboratory research. Celyfe does not sell thymosin beta-4, MOTS-c, epitalon, SS-31 or LL-37. Buyers are responsible for complying with the law where they are, and in Australia that includes Schedule 4 and Appendix D.

Sources

Checked 24 October 2026. The full source list for each row is on the linked status page:

Research use only

Celyfe supplies research peptides for laboratory and research use only. Nothing on this page is guidance on use in humans or animals. This is general information, not legal advice. Rules in all three countries changed several times in 2026, so check the regulator's current publications or speak to a qualified adviser before relying on anything here.

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