Encyclopedia entry

Tesamorelin

Evidence: Human RCT

Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)

Last updated 2026-06-04

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AI-friendly summary · Tesamorelin

Tesamorelin is a synthetic growth-hormone-releasing-hormone (GHRH) analogue. It is the only peptide covered on PeptideClear that holds a currently active FDA marketing authorisation. EGRIFTA and EGRIFTA WR (Theratechnologies) are licensed in the US for HIV-associated lipodystrophy. There is no UK or EMA marketing authorisation. The NHS does not prescribe tesamorelin for any indication. UK availability outside clinical trials is via research-peptide retailers only.

Mechanism of action

How Tesamorelin works

Tesamorelin is a stabilised analogue of growth-hormone-releasing hormone (GHRH 1-44) modified at the N-terminus to resist enzymatic degradation. It binds the GHRH receptor on anterior pituitary somatotrophs, stimulating pulsatile growth hormone (GH) release in the natural physiological pattern. The downstream IGF-1 elevation drives the visceral adipose tissue reduction observed in HIV-associated lipodystrophy Phase III trials. Because the compound acts upstream of GH itself, negative feedback by IGF-1 and somatostatin remains intact, in contrast to direct exogenous GH administration.

Source: Falutz J et al. NEJM Phase III HIV-associated lipodystrophy programme

Pharmaceutical history

Tesamorelin sits in a different regulatory zone than the other peptides on this encyclopedia because it has an active FDA-approved indication. The Phase III trial programme reported visceral adipose tissue reduction in HIV-positive patient populations sufficient to support the 2010 FDA approval. EGRIFTA WR (2023) reformulated the product for improved stability.

· Developed by Theratechnologies (Montreal, Canada).
· FDA approved as EGRIFTA in 2010 for HIV-associated lipodystrophy.
· Reformulated as EGRIFTA WR in 2023 for improved stability and reduced injection volume.
· Phase III data on visceral adipose tissue reduction supported the original approval (Falutz et al., NEJM).
· Off-label discussion in longevity and biohacker communities focuses on visceral fat reduction in non-HIV populations. There is no UK-licensed pathway for this off-label use.
· On the WADA prohibited list (S2 peptide hormones class). Use by competing athletes is sanctionable.

Adjacent compounds in the GHRH-analogue class include Sermorelin (formerly licensed as Geref, withdrawn 2008) and CJC-1295 (longer-acting analogue, no licensed indication). See Sermorelin and CJC-1295 encyclopedia entries.

UK regulatory status

Tesamorelin holds no UK marketing authorisation and no EMA authorisation. The US FDA approval of EGRIFTA and EGRIFTA WR does not transfer to the UK. The NHS does not prescribe tesamorelin for any indication. Anyone wanting tesamorelin for a non-HIV indication in the UK is in research-chemical territory, with no clinical supervision and no UK licensing route.

· No UK marketing authorisation. NHS does not prescribe.
· Not a controlled drug under the Misuse of Drugs Act 1971.
· Not scheduled under the Psychoactive Substances Act 2016.
· Sold by UK research-peptide retailers under "research use only" framing.
· The US FDA approval of EGRIFTA and EGRIFTA WR does not confer UK licensed-medicine status.
· Becomes an unlicensed medicinal product the moment a retailer or commentator makes therapeutic claims about it.
· On the WADA prohibited list (S2 peptide hormones class).

Risks and unknowns

What the literature does not yet show about Tesamorelin

Known concerns

FDA label includes warnings on glucose intolerance, fluid retention, and potential growth of malignancy in HIV-positive patient populations. These pharmacological properties are present in the molecule regardless of jurisdiction.
Off-label use in non-HIV populations has no licensed evidence base for safety or efficacy.
WADA prohibited list inclusion (S2 class). Competing athletes face sanctions for detected use.
Purity of UK research-peptide supply varies and is not connected to Theratechnologies pharmaceutical-grade manufacturing.

Open questions in the literature

Long-term safety beyond the duration of the Theratechnologies Phase III trial programme in non-HIV populations is not characterised.
Whether the visceral fat reduction effect translates from HIV-associated lipodystrophy to general visceral adiposity is not established by RCT evidence.
Effects in patients with subclinical pituitary adenomas or other pituitary pathology are not characterised.
Interactions with currently-licensed adult GH replacement therapies and metabolic medications have not been formally studied outside the HIV-associated lipodystrophy population.

Regulatory note

No UK marketing authorisation. Not a controlled drug under the Misuse of Drugs Act 1971. FDA approval of EGRIFTA/EGRIFTA WR does not transfer to the UK. On the WADA prohibited list (S2 peptide hormones). Becomes an unlicensed medicinal product the moment a retailer or commentator makes therapeutic claims about it.

Important: PeptideClear publishes encyclopedia commentary only and does not recommend human use. Speak to a UK-registered prescriber before any medical decision.

Editorial

Baseline panels to track

If you are working with a UK private doctor or NHS prescriber on a peptide protocol, these are the blood panels typically ordered at baseline for Tesamorelin. Not a recommendation for self-administered testing.

IGF-1. Tesamorelin is US-licensed as EGRIFTA and EGRIFTA WR for HIV-associated lipodystrophy. The FDA-label monitoring schedule centres on IGF-1 as the downstream growth hormone marker. Baseline plus post-administration tracking is standard prescriber practice.
HbA1c. The FDA label flags glucose intolerance as a warning. HbA1c gives a 90-day glucose average and is the canonical metabolic-monitoring panel for any GH-axis intervention.
Lipid panel. Tesamorelin acts on visceral adipose tissue and the resulting IGF-1 elevation influences lipid metabolism. Baseline lipid panel allows tracking of cardiovascular markers across the treatment window.

Order a UK lab panel

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Where to learn more

· PubMed search: Tesamorelin returns the Theratechnologies Phase III HIV-lipodystrophy programme.
· FDA Drugs@FDA database for EGRIFTA and EGRIFTA WR prescribing information.
· WADA prohibited list (S2 peptide hormones class).
· Adjacent compound: Sermorelin encyclopedia entry (the formerly-licensed GHRH analogue).
· UK retailer purity comparison: research peptides UK retailers.
· Ranked retailers: best UK Tesamorelin retailers.

Frequently asked questions

Is Tesamorelin legal in the UK?

Tesamorelin is not a controlled drug under the Misuse of Drugs Act 1971 and is not scheduled under the Psychoactive Substances Act 2016. It is sold by UK research peptide retailers under "research use only" framing. It holds no UK marketing authorisation as a medicine and is on the WADA prohibited list (S2 peptide hormones).

What does the human evidence show for Tesamorelin?

Tesamorelin has substantial Phase III RCT data supporting the FDA-approved indication for HIV-associated lipodystrophy. Multiple peer-reviewed publications report visceral adipose tissue reduction in HIV-positive patient populations. Off-label use in non-HIV populations has no equivalent RCT evidence base.

What is the regulatory status of Tesamorelin in the UK?

Tesamorelin has no UK marketing authorisation and no EMA authorisation. The FDA approval of EGRIFTA and EGRIFTA WR (Theratechnologies) for HIV-associated lipodystrophy does not transfer to the UK. The NHS does not prescribe tesamorelin for any indication. Sold as a research chemical when marketed without health claims, but becomes an unlicensed medicinal product the moment therapeutic claims are made.

What forms is Tesamorelin available in?

The FDA-approved EGRIFTA and EGRIFTA WR products are subcutaneous injections supplied via US specialty pharmacy channels. UK research peptide retailers list Tesamorelin most commonly as lyophilised powder in 1mg, 2mg, or 5mg vials for reconstitution. PeptideClear publishes no dosing or human-use instructions.

Where can I learn more about Tesamorelin?

A PubMed search for "Tesamorelin" returns the Theratechnologies Phase III data on visceral adipose tissue reduction in HIV-associated lipodystrophy. The FDA prescribing information for EGRIFTA and EGRIFTA WR is publicly available via the FDA label database. The "Where to learn more" section links to the primary sources.

Compare UK retailers stocking Tesamorelin

Side-by-side comparison across UK research peptide retailers. Trust Index ranking. Research use only.

Compare UK retailers

Clinical evidence record

Read the clinical evidence record for Tesamorelin

Top peer-reviewed citations, mechanism of action, structured UK regulatory status. Machine-readable companion to this encyclopedia entry.

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