FDA approved, MHRA licensed, or neither?

This is the most-asked question about every compound on this site, and it is usually answered badly in both directions — by sellers implying that no ruling means no problem, and by critics implying that no approval means a finding of harm.

Neither is right. Here is the actual position, compound by compound, for material supplied for laboratory research use only.

Four states, not two

• Approved or licensed. A regulator has assessed a dossier for a specific indication, at a specific dose, in a specific population, and permitted marketing on that basis. In the UK that is an MHRA marketing authorisation; in the US, FDA approval.
• Withdrawn or refused. Assessed and then rejected, or permitted and later pulled. This is a finding.
• Investigational. In clinical trials, with an application in progress. Not yet approved, and the outcome unknown.
• Never assessed. No dossier was ever filed, so no regulator has formed any view at all.

The fourth state is where most of this field sits, and it is the one that gets misread hardest. "Not FDA approved" and "FDA found a problem" are very different statements, and so are "not approved" and "approved for something else".

The corollary matters too: approval is per indication. A compound can be licensed for one condition and entirely unlicensed for every other use anyone puts it to.

Compound by compound

BPC-157 — never assessed by the FDA or the MHRA for any indication. No licensed product exists anywhere. The FDA placed it in a category of substances it considered raised safety concerns for compounding in 2023, which is a statement about pharmacy compounding rather than an evaluation of a marketing application. The World Anti-Doping Agency prohibits it.

TB-500 — a synthetic fragment related to thymosin beta-4. Never assessed for approval. Thymosin beta-4 itself has been through clinical trials for other purposes without reaching approval. Prohibited by WADA.

GHK-Cu — a copper-binding tripeptide with a long history in cosmetic formulation. Topical cosmetic use is regulated as a cosmetic ingredient, not as a medicine, and is not "approval" in the sense people mean. There is no licensed medicinal product.

MOTS-C — a mitochondrial-derived peptide identified in 2015. Research-stage throughout. No approval, no licence, no application.

CJC-1295 DAC — a GHRH analogue that entered clinical development and did not reach approval. This is the "investigational, discontinued" state rather than the never-assessed one.

KPV — a three-amino-acid fragment of alpha-MSH. Never assessed for approval anywhere.

Tesamorelin — the exception. It holds a US approval, granted in 2010, for one specific indication in one specific population, marketed there under a brand name. It has no UK marketing authorisation. A US approval is not a UK licence, and an approval for one indication says nothing about any other.

Tirzepatide and semaglutide — both are licensed medicines in the UK, which makes them prescription-only. That is the tightest status on this page and the consequences run the other way from what people expect: a licence does not make a compound freely available, it makes advertising it to the public a criminal matter under the Human Medicines Regulations 2012. Our article on the legal position in the UK sets that out.

Retatrutide — investigational, in late-stage clinical trials, approved and licensed nowhere in the world.

What this does and does not tell you

It tells you who has looked. It does not tell you what would be found if they did.

A compound with no approval has no regulator-reviewed safety dossier, no agreed indication, no authorised labelling and no post-marketing surveillance. That is a genuine information gap and not a technicality. Anyone claiming otherwise is selling something.

Equally, "never assessed" is not a verdict. Most of these compounds have never had a sponsor willing to fund a dossier, which is an economic fact about who owns the molecule rather than a scientific one about the molecule.

What you can establish about a specific vial is narrower and more useful: what it is, how pure it is, and how much of it is there. That is what an independent laboratory report answers, and it is the only question in this field with a checkable answer — see what a Janoshik report actually proves and how to get a peptide independently tested in the UK.

Anti-doping status is a separate rulebook again, and usually a stricter one — which peptides are on the WADA prohibited list goes through the categories.

Why we will not fill the gap for you

You will notice this article says nothing about what any of these compounds does. That is deliberate and it is not evasion — an unlicensed product may not be advertised with a medicinal claim, and a licensed prescription-only one may not be advertised to the public at all. Both are law rather than policy, and we set out the reasoning in why there is no dosing guide.

The research peptides hub covers what we do publish: format, provenance, and the report for the batch you would actually receive.