Skip to main content
    Fact-checked by the Peptide Authority Editorial Board · Last reviewed:
    Share:X PostLinkedIn
    Hormonal & Endocrine•Updated 2026-02-01•5 min read

    What Is Tesamorelin? Benefits, Research & Safety

    An FDA-approved growth hormone releasing hormone analogue used to reduce excess abdominal fat in HIV patients with lipodystrophy.

    Share:X PostLinkedIn
    Also known as:
    Egrifta
    TH9507
    Growth Hormone Releasing Factor
    BModerate human evidenceUK: Unlicensed (UK)WADA: Prohibited in sport

    UK summary: FDA-approved in the US (Egrifta) for HIV-associated lipodystrophy with reasonable human evidence base for that specific indication. Not currently a UK-licensed medicine. Prohibited at all times under WADA S2 for athletes.

    Quick Facts

    Category
    Hormonal & Endocrine
    Half-Life
    26-38 minutes (as GHRH analogue)
    UK Status
    Not approved. Not available on NHS. May be accessible through specialist channels.
    EU Status
    Not approved by EMA. Application was withdrawn.

    Overview

    Tesamorelin is a synthetic analogue of growth hormone releasing hormone (GHRH, also known as growth hormone releasing factor or GRF). It consists of the 44-amino acid sequence of human GHRH with an added trans-3-hexenoic acid group to improve stability. Tesamorelin was developed by Theratechnologies and is marketed under the brand name Egrifta. It received FDA approval in 2010 for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, a metabolic complication associated with HIV infection and its treatment. Unlike direct growth hormone administration, tesamorelin stimulates the body's own pituitary gland to produce and secrete growth hormone. This maintains the physiological pulsatile pattern of GH release and may have advantages in terms of the body's normal feedback mechanisms. Tesamorelin has attracted interest beyond its approved indication for its potential anti-ageing and body composition effects. However, use outside approved indications carries risks and lacks the same level of evidence for safety and efficacy. The medication is administered by daily subcutaneous injection and requires ongoing treatment to maintain effects. Upon discontinuation, fat typically returns to baseline levels.
    Evidence standards summary

    Tesamorelin — evidence and risk at a glance

    Twenty standard modules scored against the Peptide Authority evidence grading methodology. Missing modules indicate the field has not yet been characterised editorially — treat absences as uncertainty rather than reassurance.

    01Evidence snapshot

    FDA-approved in the US (Egrifta) for HIV-associated lipodystrophy with reasonable human evidence base for that specific indication. Not currently a UK-licensed medicine. Prohibited at all times under WADA S2 for athletes.

    02Human evidence grade

    BModerate human evidenceStrength of evidence from published human trials.

    03Preclinical evidence grade

    BModerate human evidenceAnimal-model and in-vitro evidence quality.

    04Regulatory status

    • UK: Not approved. Not available on NHS. May be accessible through specialist channels.
    • EU: Not approved by EMA. Application was withdrawn.
    • Notes: Tesamorelin (Egrifta) is FDA-approved in the US for HIV lipodystrophy. Not approved in UK or EU. Off-label use for anti-ageing or body composition is not supported by approved labeling.

    05Approved medical uses

    • HIV-associated lipodystrophy (FDA-approved as Egrifta in the US; not MHRA-licensed in the UK).

    06Unapproved / promotional claims

    • Targeted visceral-fat reduction for healthy adults.
    • Anti-ageing growth-hormone restoration.
    • Cognitive-decline reversal in older adults.
    • Body-recomposition enhancement for bodybuilders.

    07Common internet claims

    • Marketed as an off-label fat-loss injection for cosmetic visceral-fat reduction.
    • Sold by private 'anti-ageing' clinics as a GHRH analogue alternative to HGH.
    • Promoted in bodybuilding stacks alongside testosterone, HGH, and insulin.

    08Claim vs evidence

    ClaimEvidenceHuman evidence?Regulatory concernSafer wording
    “Approved for HIV lipodystrophy”BYesModerateEgrifta is FDA-approved for HIV-associated visceral lipodystrophy; this is not the same as UK MHRA approval, and it is not on the NHS.
    “Targets visceral fat in healthy adults”CLimitedHighOutcome data are largely from the HIV-lipodystrophy population; generalising to healthy adults is not supported.
    “Permitted in sport since it's a 'GHRH analogue'”ENoHighProhibited at all times under WADA S2.
    “Safer alternative to growth hormone”ENoHighComparative-safety claims need comparative trials in the relevant population.

    09Safety uncertainty score

    High

    Limited human safety data; meaningful uncertainty about rare or long-term effects.

    10Known adverse signals

    • Hyperglycaemia and worsened insulin resistance with sustained use.
    • Joint pain, peripheral oedema, carpal tunnel symptoms (GH-axis side effects).
    • Injection-site reactions.
    • Theoretical oncologic risk from sustained IGF-1 elevation.

    11Drug-interaction uncertainty

    High

    Interaction picture sparse; meaningful uncertainty when combined with other medicines.

    12Anti-doping status

    WADA: Prohibited in sportWADA strict-liability framing applies.

    13UK legal position

    UK: Unlicensed (UK)

    Not approved. Not available on NHS. May be accessible through specialist channels.

    Read the full UK legal guide → Peptides and athletes (UK)

    14EU legal position

    Not approved by EMA. Application was withdrawn.

    15What this page cannot tell you

    • Whether a UK-purchased compounded tesamorelin contains the labelled peptide at the labelled concentration.
    • Whether off-label cosmetic-fat-loss use carries the same safety profile as the licensed HIV-lipodystrophy indication.
    • Long-term oncologic risk in healthy adults with no diagnosed deficiency.
    • What the WADA in-competition exposure looks like — GH secretagogues are class-prohibited (S2).

    16Last reviewed

    Last reviewed:

    Next review due:

    Spotted an error or something out of date? Send a correction.

    17Citation quality score

    BModerate human evidenceQuality of the sources we cite, graded against the evidence grading methodology.

    18Research gaps

    • No Phase 3 trials in non-HIV populations for cosmetic visceral-fat loss.
    • Long-term oncologic surveillance in non-HIV populations absent.
    • Body-composition outcome data in healthy adults limited.
    • Combination-stack safety with HGH or insulin uncharacterised.

    19Safer alternatives / established care pathways

    • Licensed Wegovy (semaglutide) or Mounjaro (tirzepatide) via NHS or GMC-registered prescriber for clinically relevant weight reduction.
    • GP and endocrinologist review for adult GH deficiency with formal testing.
    • Resistance training plus structured aerobic exercise — the only evidence-based body-recomposition stack.

    Related Safety Centre page → Athlete anti-doping risks

    20Doctor discussion prompts

    Questions to ask a qualified clinician

    These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.

    • Is Tesamorelin a licensed UK medicine?
    • If I have HIV-associated lipodystrophy, what UK access routes exist?
    • If I'm an athlete, what is the WADA position?
    • What licensed alternatives exist for the underlying issue I'm asking about?

    Discovery & History

    Tesamorelin was developed by Theratechnologies, a Canadian biopharmaceutical company, in the early 2000s. The peptide was designed as a stabilised analogue of naturally occurring GHRH with improved pharmacokinetic properties. The development focus was on HIV-associated lipodystrophy, a syndrome characterised by abnormal fat distribution—particularly visceral fat accumulation—seen in many HIV-positive patients, often associated with antiretroviral therapy. Clinical development included multiple Phase III trials demonstrating significant reductions in trunk fat with tesamorelin treatment compared to placebo. Studies showed meaningful reductions in visceral adipose tissue measured by CT scan. In November 2010, the FDA approved tesamorelin (Egrifta) for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. This approval made it the first medication specifically approved for this indication. The EMA did not approve tesamorelin, citing concerns about the clinical benefit-risk balance for the EU population. Research continues into potential applications in other conditions including cognitive decline in older adults and broader metabolic indications.

    Mechanism of Action

    Tesamorelin works through specific activation of GHRH receptors on pituitary somatotroph cells: **GHRH Receptor Activation** Tesamorelin binds to GHRH receptors (GHRH-R) on the anterior pituitary gland: - Stimulates synthesis and secretion of growth hormone - Maintains pulsatile GH release pattern (more physiological than exogenous GH) - Effect is dependent on functioning pituitary somatotrophs - Subject to normal feedback regulation by IGF-1 and somatostatin **Growth Hormone Effects on Fat Metabolism** Increased GH leads to metabolic changes affecting adipose tissue: - Stimulation of lipolysis (fat breakdown) - Preferential reduction of visceral adipose tissue - Enhanced fatty acid oxidation - Effects on lipid profiles **IGF-1 Elevation** GH stimulation leads to increased IGF-1 production: - Contributes to metabolic effects - May have anabolic effects on lean tissue - Involved in GH feedback regulation **Stabilisation Chemistry** The trans-3-hexenoic acid modification: - Protects against enzymatic degradation - Improves binding affinity to albumin - Extends biological activity

    Researched Benefits

    Based on preclinical and clinical research findings:

    • 1
      Significant reduction in visceral adipose tissue (trunk fat)
    • 2
      Modest improvements in trunk fat to limb fat ratio
    • 3
      Improvements in some cardiovascular risk biomarkers
    • 4
      Potential improvement in body image and quality of life
    • 5
      Maintains physiological pulsatile GH release
    • 6
      Research ongoing into cognitive benefits in older adults

    Claim vs Evidence

    How popular claims about Tesamorelin stack up against the current research, graded using our public evidence grading methodology.

    ClaimEvidenceHuman evidence?Regulatory concernSafer wording
    “Approved for HIV lipodystrophy”BYesModerateEgrifta is FDA-approved for HIV-associated visceral lipodystrophy; this is not the same as UK MHRA approval, and it is not on the NHS.
    “Targets visceral fat in healthy adults”CLimitedHighOutcome data are largely from the HIV-lipodystrophy population; generalising to healthy adults is not supported.
    “Permitted in sport since it's a 'GHRH analogue'”ENoHighProhibited at all times under WADA S2.
    “Safer alternative to growth hormone”ENoHighComparative-safety claims need comparative trials in the relevant population.

    Theoretical Dosing & Protocols

    ⚠️ Educational Only: The following information is derived from research literature and is not a prescription or recommendation. No standardised human dosing exists. Always consult a qualified healthcare professional.
    Theoretical Dosage2 mg subcutaneous injection daily (approved dose)
    FrequencyOnce daily
    DurationOngoing treatment required; effects reverse upon discontinuation
    NotesTesamorelin (Egrifta) is FDA-approved only for HIV lipodystrophy. Off-label use lacks the same evidence base. Treatment requires ongoing administration. Should be prescribed and monitored by a physician.

    Administration Routes

    Routes studied in research settings (educational only):

    • Subcutaneous injection (approved route)
    Half-LifeStability
    26-38 minutes (as GHRH analogue)Commercial product has defined stability; requires refrigeration

    Safety Profile & Known Risks

    Commonly Reported Side Effects

    • Injection site reactions (most common)
    • Arthralgia (joint pain)
    • Peripheral oedema
    • Myalgia (muscle pain)
    • Pruritus (itching)
    • Paraesthesia

    Rare Risks & Concerns

    • Fluid retention syndromes
    • Glucose intolerance or worsening diabetes
    • Hypersensitivity reactions
    • Potential effects on tumour growth (theoretical)
    • Carpal tunnel syndrome

    Contraindications

    • Active malignancy
    • Pregnancy and breastfeeding (Category X)
    • Hypersensitivity to tesamorelin or mannitol
    • Disruption of hypothalamic-pituitary axis (head trauma, surgery, etc.)
    • Pituitary tumour or pituitary surgery

    UK & EU Regulatory Context

    🇬🇧 United Kingdom

    Not approved. Not available on NHS. May be accessible through specialist channels.

    🇪🇺 European Union

    Not approved by EMA. Application was withdrawn.

    Tesamorelin (Egrifta) is FDA-approved in the US for HIV lipodystrophy. Not approved in UK or EU. Off-label use for anti-ageing or body composition is not supported by approved labeling.

    Clinical Studies Summary

    Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials.

    Tesamorelin improves body composition, hepatic fat, lean body mass, and IGF-1 levels in HIV-associated lipodystrophy, without serious side effects or perturbation of glucose.

    Obes Res Clin Pract. 2026View on PubMed

    Growth hormone axis treatments for HIV-associated lipodystrophy: a systematic review of placebo-controlled trials.

    Our review indicates that, based on the findings of the 10 included studies, GH axis treatments are effective in reducing VAT and increasing LBM in patients with HIV-associated lipodystrophy. However, clinicians must decide whether the attributed benefits are clinically significant, considering the costs and potential risks of GH axis treatments.

    HIV Med. 2011View on PubMed

    Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.

    While tesamorelin reduced WC, the cognitive benefits did not significantly differ between groups. Recognizing the limitations of insufficient power and no placebo arm, this study suggests no clear benefit of short-term AO reduction with tesamorelin on NCI. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints.

    J Infect Dis. 2025View on PubMed

    Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors.

    The current analysis provides the first dedicated data on the efficacy and safety of tesamorelin among PWH on INSTI-based regimens. Despite the association of INSTI use with weight gain and adipose tissue dysfunction, tesamorelin had beneficial effects on body composition with no exacerbation of glycemic control.

    AIDS. 2024View on PubMed

    Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD.

    The Massachusetts General Hospital has a royalty and license agreement with Theratechnologies for tesamorelin. SKG is the inventor on a pending patent, GHRH or Analogues Thereof For Use in Treatment of Hepatic Disease (application 16832128).

    JCI Insight. 2020View on PubMed

    Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.

    Tesamorelin might be beneficial in people with HIV and NAFLD. Further studies are needed to determine the long-term effects of tesamorelin on liver histology.

    Lancet HIV. 2019View on PubMed

    Registered Trials & Regulatory Status

    Registered trials
    20
    Currently recruiting
    3
    Furthest phase
    Phase 4
    Approved product
    Yes
    EGRIFTA SV, EGRIFTA WR

    4 of 10 completed trials have never posted results. Unreported trials are not neutral: results that go unpublished are more often negative ones.

    Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)

    PHASE2

    Status: Recruiting · 120 participants · Hudson Biotech

    Conditions: Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis

    No results postedNCT07481734

    Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

    PHASE2

    Status: Recruiting · 100 participants · Massachusetts General Hospital

    Conditions: HIV-1-infection, Frailty, Impaired Physical Function

    No results postedNCT06554717

    Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk

    PHASE2

    Status: Completed · 51 participants · Massachusetts General Hospital

    Conditions: Non-Alcoholic Fatty Liver Disease, Obesity, Obesity, Abdominal

    Results postedNCT03375788

    Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

    PHASE2

    Status: Recruiting · 36 participants · Johns Hopkins University

    Conditions: Peripheral Nerve Injuries

    No results postedNCT03150511

    Body Composition and Adipose Tissue in HIV

    PHASE4

    Status: Terminated · 6 participants · Columbia University

    Conditions: HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition

    Results postedNCT03226821

    Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

    PHASE2

    Status: Completed · 73 participants · University of California, San Diego

    Conditions: Mild Cognitive Impairment

    Results postedNCT02572323

    Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

    PHASE2

    Status: Withdrawn · National Institute of Nursing Research (NINR)

    Conditions: Sleep Disorder, Traumatic Brain Injury

    No results postedNCT02931474

    Tesamorelin Effects on Liver Fat and Histology in HIV

    NA

    Status: Completed · 61 participants · Massachusetts General Hospital

    Conditions: Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)

    Results postedNCT02196831

    Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue

    NA

    Status: Withdrawn · Massachusetts General Hospital

    Conditions: Abdominal Obesity

    No results postedNCT01632592

    Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®

    N/A

    Status: Terminated · 391 participants · Theratechnologies

    Conditions: HIV

    No results postedNCT01579695

    Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

    PHASE4

    Status: Terminated · 129 participants · Theratechnologies

    Conditions: Diabetic Retinopathy, HIV

    No results postedNCT01591902

    Egrifta Replacement and Sleep Disordered Breathing

    N/A

    Status: Withdrawn · Johns Hopkins University

    Conditions: Lipodystrophy

    No results postedNCT01788462

    Adverse event reports (FDA FAERS)

    • depression3
    • anxiety2
    • lipodystrophy acquired2
    • weight decreased2
    • acute kidney injury1
    • angiopathy1
    • anhedonia1
    • asthenia1
    • basal cell carcinoma1
    • chronic gastritis1

    FDA FAERS spontaneous reports. A report is not proof the substance caused the event, and an absence of reports is not evidence of safety.

    Source: ClinicalTrials.gov and openFDA. Updated automatically.

    Looking for Tesamorelin?

    Source research-grade Tesamorelin from a trusted UK supplier — third-party tested with certificate of analysis.

    View at Supplier

    Frequently Asked Questions

    Questions to ask a qualified clinician about Tesamorelin

    These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.

    • Is Tesamorelin a licensed UK medicine?
    • If I have HIV-associated lipodystrophy, what UK access routes exist?
    • If I'm an athlete, what is the WADA position?
    • What licensed alternatives exist for the underlying issue I'm asking about?

    UK regulatory & safety context

    Related Research Guides

    Peptide Comparisons

    Related Peptides

    Explore More Peptides

    Browse our comprehensive database of research-backed peptide profiles.