Why these compounds are not EMA-authorised

What a marketing authorisation is

In the EU's centralised procedure, the European Medicines Agency (EMA) carries out the scientific assessment of a medicine's quality, safety and efficacy, and the European Commission then takes the legally binding decision. Once granted, a centralised marketing authorisation is valid in every EU member state plus Iceland, Norway and Liechtenstein.

The decision attaches to a specific medicinal product: a named product from a named marketing authorisation holder, at defined strengths, in defined pharmaceutical forms, for defined indications. The Union Register entry for Mounjaro, for example, records the holder (Eli Lilly Nederland B.V.), the active substance (tirzepatide) and the exact wording of the type 2 diabetes and weight-management indications. It is not a statement that tirzepatide, as a molecule, is authorised wherever it appears. Our TIRZEPATIDE 60 pen is a different product from Mounjaro and is not covered by that authorisation.

Authorisation follows a completed clinical trial programme, which is the expensive part. That is why regulatory status tracks commercial development rather than scientific interest: a compound can be well characterised in the literature and still unauthorised because no company has funded and submitted a full dossier.

Two axes: regulatory status and evidence status

"Unapproved" is a poor label because it flattens two separate questions. The first is regulatory status: has a regulator assessed a product containing this compound and granted an authorisation? The second is evidence status: what has actually been demonstrated in humans, and at what scale? A compound can score high on one axis and low on the other, and the combinations matter more than either answer alone.

The last column is the important one. Absence of authorisation is an absence of regulatory assessment. It is not a finding of harm, and it is equally not a finding of safety. The evidence axis is what tells you how much is actually known, and it has to be read compound by compound.

Where the compounds in our range sit

Tirzepatide and semaglutide are the two molecules here that have authorised medicines behind them. The Commission granted Mounjaro's authorisation on 15 September 2022 (EU/1/22/1685) and Wegovy's on 6 January 2022 (EU/1/21/1608); both entries are marked active in the Union Register and both have a European public assessment report (EPAR) on the EMA website.

Retatrutide is investigational. Eli Lilly's TRIUMPH programme includes several Phase 3 trials registered on ClinicalTrials.gov, among them TRIUMPH-1 (NCT05929066), a placebo-controlled study in adults with obesity or overweight without type 2 diabetes that reached primary completion in April 2026. No product containing retatrutide appears in the Union Register or among EMA's authorised medicines. Our retatrutide overview and the retatrutide vs tirzepatide comparison cover the published trial figures.

CJC-1295 has published human pharmacokinetic and pharmacodynamic data: Teichman and colleagues (2006) reported prolonged growth hormone and IGF-1 responses after single and repeated doses in healthy adults. That is real evidence, but it is early-phase evidence, and no Phase 3 programme has followed. Melanotan II, BPC-157, GHK-Cu and MOTS-c have no centrally authorised EU medicine, and no Phase 3 programme is registered on ClinicalTrials.gov for any of them. Their regulatory position is the same; how much human evidence sits behind each one is not, and that is the question worth asking compound by compound.

What authorisation provides that a certificate cannot

An authorised medicine comes with infrastructure. There is a summary of product characteristics with an approved dose, a public assessment report explaining why the benefit-risk balance was judged positive, mandatory pharmacovigilance collecting adverse events after launch, and GMP inspection of the manufacturing site. None of that infrastructure exists for a compound that has not been through the procedure, which is why an unreported side effect is not evidence of no side effect.

A certificate of analysis answers a narrower question. Every batch we sell is tested by an independent laboratory for identity by mass spectrometry, purity by HPLC and sterility, and the certificate is published at our COA index and reachable from the QR code on each pen. That tells you what is in a specific batch. It does not tell you that the compound is authorised, indicated for any condition, or interchangeable with an authorised medicine. How to read a COA explains what each line of the certificate covers.

The two records are complementary, not substitutes. Authorisation speaks to the product's regulatory and clinical standing; the certificate speaks to a single lot. A compound with no authorisation and a clean certificate is exactly that: an unassessed compound whose batch has been tested.

Where to check current status

Regulatory positions change. A compound that is investigational today may be authorised next year, and an authorised product can have its indications extended or its authorisation withdrawn. The official records are public and free to search, so the current position is always checkable.

Search by product name in the Union Register and by active substance on the EMA site. If a compound returns nothing on either, no centrally authorised medicine contains it. For an investigational compound, the trial registries show the phase and status of the programme, which is the most useful indicator of where it stands short of a decision.