Which Peptides Are Actually Approved?
A status table for every compound on this site: approved as a medicine or not, whether US pharmacies may compound it, and where the anti-doping rules land.
“Approved” is the single most abused word in this subject. It gets applied to substances that have never been reviewed by a regulator, and withheld from ones that have been on the market for fifteen years.
This page is the reference table. It answers one question per compound — what is its actual status — and nothing about what anyone should take.
What does “approved” actually mean?
A medicine is approved when a national regulator has reviewed a dossier of safety and efficacy data and issued a marketing authorisation for a specific product, for a specific indication, at a specific strength and route.
In EU law the requirement is stated plainly in Article 6(1) of Directive 2001/83/EC: no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued. The US equivalent runs through the FDA’s new drug application process.
Three things are routinely confused with approval, and none of them is:
- Being studied in a clinical trial. A registered trial means someone is asking the question, not that it has been answered.
- Being eligible for pharmacy compounding. That is a separate list with a separate legal basis. A pharmacist may compound certain substances on prescription; those substances have not been through efficacy review.
- Being sold. Availability is a fact about a supply chain, not about a regulator.
The status table
Every compound covered on this site, plus the growth-hormone peptides most often asked about alongside them.
| Compound | Approved as a medicine? | US pharmacy compounding (503A) |
|---|---|---|
| Semaglutide | Yes — FDA and EMA, multiple indications | Not on the 503B bulks list; the shortage exemption has ended |
| Tirzepatide | Yes — FDA and EMA | Same position as semaglutide |
| Tesamorelin | Yes — FDA, 2010, for HIV-associated lipodystrophy | Approved product exists, so compounding a copy is restricted |
| Semax | In Russia only — never assessed by the EMA or FDA | Recommended for the bulks list in July 2026; not yet permitted |
| BPC-157 | No — nowhere | Recommended July 2026; not yet permitted |
| TB-500 | No — nor is thymosin β4 | Recommended July 2026; not yet permitted |
| KPV | No — nowhere | Recommended July 2026; not yet permitted |
| MOTS-c | No — nowhere | Recommended July 2026; not yet permitted |
| Epitalon | No — nowhere | Recommended July 2026; not yet permitted |
| Emideltide (DSIP) | No — nowhere | Rejected by the committee in July 2026 |
| Ipamorelin | No — nowhere | Not recommended; remains outside the permitted set |
| CJC-1295 | No — nowhere | Not recommended; remains outside the permitted set |
| GHK-Cu (injectable) | No as an injectable medicine | Under separate review; a committee consultation is expected by early 2027 |
Two rows in that table are worth pausing on.
Tesamorelin is the counter-example. It is a growth-hormone-releasing hormone analogue — the same broad mechanism class as the compounds sold without approval — and it has been an approved medicine since 2010. What separates it is not the molecule being more interesting. It is that a sponsor ran the trials, filed the dossier and accepted a narrow indication. That route is available; it is simply expensive and slow, and it ends in a label that says what the drug is for.
Emideltide is the other end. It is the one substance the FDA’s advisory committee looked at in July 2026 and declined to recommend, on the grounds that the safety and efficacy data did not support it and the compound was not adequately characterised. It is a useful reminder that the committee was not rubber-stamping.
Does “not banned in sport” mean anything?
Very little, and the two systems are worth keeping apart.
Anti-doping rules and medicines law answer different questions. WADA decides what an athlete under its jurisdiction may have in their body. A medicines regulator decides what may be sold as a treatment and on what evidence. Neither is a proxy for the other.
The catch-all matters here. WADA’s S0 category covers substances with no current approval from any government health authority for human therapeutic use — which means an unapproved compound does not need to be named individually to be prohibited. BPC-157 was added explicitly in 2022; thymosin β4 and its derivatives, TB-500 among them, are named under growth factors. For a competing athlete the practical reading is that “not on the list by name” is not a clearance.
None of this is a safety statement in either direction. An approved medicine has been reviewed, which is a real difference from one that has not — but approval is a judgement about a specific product for a specific indication, not a general endorsement of a molecule. The authority for any particular product is its own labelling and the prescriber.
Why this page has no doses in it
Because status and dosage are different questions, and only one of them has a public, checkable answer.
For an approved medicine the dose is in the prescribing information, which is linked in the sources and is a better authority than any article. For an unapproved one there is no established human dose to report — for most of these compounds there is not even a published human half-life, which is what a dosing interval would have to be derived from.
Where arithmetic genuinely is needed — converting a quantity and a volume into a reading on a syringe — that is a conversion rather than a recommendation, and the reconstitution calculator does it without suggesting an amount.
The pattern worth taking away
Regulatory status changes, and it has changed three times for some of these compounds in under a year. Two habits survive that churn.
The first is to check the date on anything you read about status, including this page. The second is to notice which question a source is answering. A great deal of writing about peptides moves between “approved”, “legal to compound”, “legal to possess” and “not banned in sport” as though they were one thing. They are four things, and a compound can sit differently on each.
Frequently asked questions
Which peptides are actually approved as medicines?
Of the compounds covered on this site, three hold marketing authorisation from a major regulator: semaglutide, tirzepatide and tesamorelin. Semax is registered in Russia but has never been assessed by the EMA or the FDA. BPC-157, TB-500, KPV, MOTS-c and Epitalon hold no marketing authorisation anywhere.
Does being removed from the FDA Category 2 list mean a peptide is approved?
No, and this is the most common misreading of the 2026 changes. Category 2 is a list of substances presenting significant safety risks for pharmacy compounding. Removal from it is a procedural step about compounding eligibility. It says nothing about whether a substance has been reviewed for safety and efficacy as a medicine, and it does not create approval.
Is a compound legal just because it is not on the WADA Prohibited List?
No. Anti-doping rules and medicines law are separate systems answering separate questions. WADA decides what an athlete under its jurisdiction may have in their body. A medicines regulator decides what may be sold as a treatment. A substance can be unapproved as a medicine and still not named on the WADA list, and that combination means nothing reassuring.
What does "research use only" on a label mean legally?
It is a labelling statement made by a seller, not a regulatory category that changes what a substance is. In EU law the classification of a medicinal product turns on its composition and on how it is presented or used, not on a disclaimer printed on the vial.
Sources
- FDA — Briefing Document, Pharmacy Compounding Advisory Committee meeting, July 2026
- FDA — EGRIFTA SV (tesamorelin) prescribing information
- FDA — Ozempic (semaglutide) prescribing information
- FDA — Mounjaro (tirzepatide) prescribing information
- World Anti-Doping Agency — The Prohibited List
- Directive 2001/83/EC — Community code relating to medicinal products for human use