Tesamorelin UK legal status
Tesamorelin (Egrifta) is an FDA-approved medicine for one narrow indication: visceral-fat reduction in HIV-associated lipodystrophy. It has no UK or EU marketing authorisation. ‘Research-grade tesamorelin’ marketed for general body composition is unlicensed-medicine supply with no UK clinical-need basis.
Current UK regulatory framing
Tesamorelin is a synthetic GHRH analogue. It has FDA approval (as Egrifta / Egrifta SV) for reducing excess abdominal fat in HIV patients with lipodystrophy. It does not have a UK or EU marketing authorisation for any indication.
The FDA indication is narrow and clinically specific. The consumer-market positioning of tesamorelin as a “visceral-fat-reduction peptide” for the general population extrapolates well beyond it.
The ‘specials’ question
UK law allows a prescriber to source an unlicensed medicine via the “specials” framework where a UK-licensed product isn’t suitable. For tesamorelin, this might in principle apply to an HIV patient stabilised on the FDA-approved product abroad and continuing treatment in the UK. It does not extend to a fitness-population prescription for “belly fat” or body recomposition.
See compounded peptides in the UK for the framework details.
Sport — WADA S2
As a GHRH analogue, tesamorelin falls under S2 of the WADA Prohibited List. Strict liability applies. The FDA-approved status does not produce a TUE pathway for general use.
What this means in practice
For sellers
Marketing tesamorelin for visceral-fat reduction in the general population is unlicensed-medicine advertising that extrapolates from a narrow specialist indication. MHRA and ASA jurisdiction.
For clinics
A UK clinic offering tesamorelin to a non-HIV patient for aesthetic body-composition reasons is outside any plausible ‘specials’ justification. The CQC-registered clinic question becomes acute: which clinical guideline supports this?
For athletes
Direct S2 exposure. The FDA-approved status of tesamorelin makes no difference to WADA classification.
Red-flag claims
If you see wording like this on a seller, clinic, or social-media advert, treat it as a warning sign rather than a benefit.
“Tesamorelin — FDA-approved visceral fat reduction”
True only for the narrow HIV-lipodystrophy indication. Implying general-population approval misrepresents the licence.
“Egrifta — get the same active ingredient at half the price”
Egrifta is not UK-licensed. ‘Same active ingredient’ from a research-chemical supplier is not the same as the FDA-approved product through a regulated supply chain.
“GHRH therapy for over-40s body composition”
Off-label / off-licence use of a non-UK-licensed medicine for a non-clinical indication. Hard to fit inside any lawful prescribing route.
“Compounded tesamorelin — UK pharmacy”
‘Specials’ framework is narrow. Body-composition use does not meet the clinical-need test required to compound an unlicensed medicine.
Sources & further reading
- MHRA — gov.uk
- Human Medicines Regulations 2012 — legislation.gov.uk
- WADA Prohibited List (S2) — wada-ama.org
- Global DRO — globaldro.com
Frequently asked questions
- Is tesamorelin licensed in the UK?
- No. Tesamorelin (brand name Egrifta) is licensed in the US by the FDA for HIV-associated lipodystrophy. It is not licensed by the MHRA or EMA. There is no UK marketing authorisation.
- Can a UK clinician prescribe tesamorelin?
- There is no UK-licensed tesamorelin product to prescribe. The UK ‘specials’ framework could in principle support importation under narrow clinical-need circumstances (e.g. a specific HIV-related indication where a patient has been stabilised on it abroad), but it doesn't extend to general body-composition use.
- Is tesamorelin prohibited in sport?
- Yes. As a GHRH analogue, tesamorelin falls under S2 of the WADA Prohibited List. Strict liability.
- What's the difference between tesamorelin and CJC-1295?
- Both are GHRH analogues. Tesamorelin actually completed pharmaceutical development and is FDA-approved for a narrow indication; CJC-1295 was never approved. From a UK regulatory perspective the difference is meaningful in principle but small in practice — neither has a UK MA.
- Why is tesamorelin marketed as ‘visceral fat reduction’?
- Its FDA indication is reducing excess abdominal fat in HIV-associated lipodystrophy. Marketing then extrapolates this to general-population body composition, which is well beyond the licensed indication and not supported by trial evidence in non-HIV populations.