A molecule is not simply “legal” or “approved” everywhere. Status depends on the jurisdiction, exact product/formulation and authorised indication. WhichPeps therefore avoids one global badge when the underlying regulatory facts differ.
Five questions behind any “approved” label
1. Which active ingredient or molecule?
The same active name can appear in authorised medicines, investigational programmes and unverified research-market materials.
2. Which named product and formulation?
Approval attaches to a defined medicinal product and presentation; it does not automatically transfer to another vial, salt, concentration, route or formulation.
3. Which indication and population?
Authorisation is for specified uses and populations. Evidence or approval in one setting should not be silently generalised to another.
4. Which jurisdiction?
FDA, MHRA and EU/EMA status can differ. WhichPeps therefore avoids treating one country’s authorisation as a global status.
5. At what date?
Development and regulatory status can change. A dated primary regulator or sponsor record is more useful than an undated badge.
Core status terms
Approved medicine
A named product authorised by a regulator for one or more specific indications/conditions. The authorisation does not automatically apply to unverified products using the same active-ingredient name.
Approved indication
The exact use authorised for that product. An approved medicine can still be used outside its authorised indication in some clinical contexts; that is a different question from whether the product itself is authorised.
Off-label use
Use of an authorised medicine outside its approved indication or conditions. In UK professional guidance, this is distinct from use of an unlicensed medicine.
Investigational
Under study. Late-stage or positive human evidence does not itself create marketing authorisation.
Unlicensed medicine / product
A product without the relevant marketing authorisation in the jurisdiction being discussed. UK rules allow limited professional routes for unlicensed medicines, but this is not public product approval.
Research-only / preclinical
A research descriptor, not a therapeutic approval. Evidence may be laboratory/animal only, and human safety/efficacy may be unknown.
UK: MHRA and medicine supply status
The UK uses legal supply classifications including prescription-only medicine (POM), pharmacy medicine (P) and general sale list (GSL). Public advertising of POMs is prohibited, and unlicensed medicines cannot be advertised as if they were licensed medicines. WhichPeps therefore keeps public evidence pages separate from medicine sales and supplier promotion.
European Union: EMA and marketing authorisation
EMA pages describe centrally assessed product authorisations and authorised indications. For example, Mounjaro contains tirzepatide and has EU-authorised type 2 diabetes and adult weight-management indications; Wegovy contains semaglutide and has EU-authorised weight-management indications. Those product records do not validate unverified “research” products that merely use the same active name.
United States: FDA
FDA approval is product- and indication-specific. FDA states that compounded drugs are not FDA-approved. FDA also states that retatrutide has not been found safe and effective for any condition and cannot be used in compounding under federal law. By contrast, Forzinity (elamipretide) received accelerated approval in 2025 for a narrow Barth syndrome indication in patients meeting the labelled weight criterion.
Why jurisdiction can change the answer
Tesamorelin
FDA approved Egrifta for reducing excess abdominal fat in HIV-infected patients with lipodystrophy. The EMA marketing-authorisation application for Egrifta was withdrawn in 2012 after unresolved benefit-risk concerns. A single “approved” badge without jurisdiction would therefore be incomplete.
Retatrutide
Phase III evidence exists, including a peer-reviewed diabetes trial, but the compound remains investigational and unapproved as of this review.
Elamipretide / SS-31
A named authorised US product exists for a narrow rare-disease context. Generic research-market SS-31 is not automatically equivalent to that approved product.
How WhichPeps displays status
Profiles should state the jurisdiction, regulator, product/formulation and date/source where known. “Approved”, “investigational”, “unlicensed” and “research-only” are never treated as interchangeable evidence grades.