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Tesamorelin

Tesamorelin Acetate (trans-3-hexenoic acid–GHRH(1-44))

The only currently FDA-approved GHRH analog. Approved for HIV-associated lipodystrophy with emerging evidence for NAFLD and cognitive function.

Reviewed March 2026·18 min read·13 citations·FDA-approvedHIV lipodystrophy
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At a glance

Tesamorelin (brand name Egrifta) is the only GHRH analog that is currently FDA-approved. It was approved in November 2010 for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy — and it remains on the market today. Unlike sermorelin (FDA-approved then withdrawn) or CJC-1295 (never approved), tesamorelin has an active, current FDA approval with an updated prescribing label. Its evidence base is substantially stronger than other GH peptides: two large Phase 3 RCTs (n=806 combined), a meta-analysis confirming efficacy, and additional RCTs for cognitive function and liver disease.

Animal studiesStrongExtensive preclinical data

Well-characterized mechanism via GHRH receptor on pituitary somatotrophs. Preclinical pharmacology and toxicology studies supported NDA filing. Dose-dependent GH release confirmed across models.

Human evidenceStrongFDA approval + multiple RCTs

FDA-approved for HIV lipodystrophy based on two Phase 3 RCTs (n=806). Additional RCTs for cognition (n=152) and NAFLD (n=61). One non-HIV obesity RCT (n=60). The strongest evidence base of any GHRH analog.

Safety dataStrongFDA prescribing information

Comprehensive safety data from Phase 3 trials with 52-week extension. FDA-approved prescribing information documents all adverse events. Key concern: increased diabetes risk (HR 3.3). Antibodies in ~50% (mostly non-neutralizing).

How are these scores calculated?

Tesamorelin stands apart from other GH peptides: it has an active FDA approval and the strongest clinical evidence base in this category. For its approved indication (HIV lipodystrophy), the evidence is robust. For off-label uses — anti-aging, body composition in non-HIV adults, cognitive enhancement — the evidence is more limited and mostly extrapolated from HIV-population studies.

New research, delivered clearly

When new studies publish or clinical trials report results, we'll break them down in plain language.

Quick facts

Molecular weight
5,135.9 Da
Amino acids
44 (modified GHRH analog)
CAS Number
218949-48-5
Brand name
Egrifta / Egrifta WR
FDA status
Approved (November 2010)
WADA status
Prohibited (Section S2.2.4)

Amino acid sequence

Hex-Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-Gln-Gln-Gly-Glu-Ser-Asn-Gln-Glu-Arg-Gly-Ala-Arg-Ala-Arg-Leu-NH2

What is tesamorelin?

Tesamorelin is a synthetic peptide consisting of all 44 amino acids of human growth hormone-releasing hormone (GHRH), with one key modification: a trans-3-hexenoic acid group attached to the tyrosine at position 1. This modification increases metabolic stability and extends the peptide's half-life compared to native GHRH and the shorter sermorelin fragment (GRF 1-29).[8]

Developed by Theratechnologies Inc. (initially as TH9507), tesamorelin was approved by the FDA in November 2010 under the brand name Egrifta for a specific indication: reducing excess abdominal fat (visceral adipose tissue) in HIV-infected patients with lipodystrophy.[1] It was reformulated as Egrifta SV in 2019 (a single-vial preparation), and most recently as Egrifta WR in March 2025, which allows weekly reconstitution instead of daily — reducing patient burden.

Why this matters in the peptide landscape. Tesamorelin is the only GHRH analog that is currently FDA-approved for any indication. Sermorelin was FDA-approved in 1997 but voluntarily withdrawn in 2008. CJC-1295 was never FDA-approved and had its clinical program discontinued. This gives tesamorelin a uniquely strong regulatory position — not just historical approval, but an active, maintained market presence with a current prescribing label.

The HIV lipodystrophy context: HIV-associated lipodystrophy is a metabolic syndrome where antiretroviral therapy causes abnormal fat redistribution — particularly accumulation of visceral (deep abdominal) fat. This is not cosmetic; excess visceral fat in HIV patients is associated with cardiovascular disease, insulin resistance, and metabolic syndrome. Tesamorelin was developed specifically for this medical need.

How it works

Tesamorelin works the same way as sermorelin and native GHRH: it binds to the GHRH receptor on pituitary somatotroph cells and triggers the release of endogenous growth hormone. The GH release it stimulates is subject to normal somatostatin feedback — your body's built-in brake — so it is very difficult to produce supraphysiological GH levels with tesamorelin.[11]

The practical difference from sermorelin is the trans-3-hexenoic acid modification, which makes tesamorelin more resistant to enzymatic degradation. Native GHRH and sermorelin have half-lives of roughly 10-20 minutes; tesamorelin has a modestly longer duration of action, though it is still administered daily by subcutaneous injection.

Detailed mechanism (for advanced readers)

Tesamorelin's mechanism of action is identical to native GHRH at the receptor level:

  • Primary target: GHRH receptor (GHRHR) on anterior pituitary somatotroph cells
  • Signaling cascade: Gs-coupled activation of adenylyl cyclase, increasing intracellular cAMP, activating PKA. This drives both GH gene transcription and vesicle exocytosis (immediate GH release).
  • Feedback regulation: GH release is subject to normal negative feedback via somatostatin (hypothalamic) and IGF-1 (hepatic). This prevents supraphysiological GH levels — the core safety feature of all GHRH-pathway compounds.
  • Modification advantage: The trans-3-hexenoic acid group at position 1 protects the N-terminus from dipeptidyl peptidase-IV (DPP-IV) cleavage, extending metabolic stability without altering receptor binding.
  • Pulsatility: Tesamorelin preserves the natural pulsatile pattern of GH secretion, unlike exogenous GH injection.[6]

How it compares to related compounds:

  • vs. Sermorelin (GRF 1-29): Both are GHRH-pathway. Sermorelin is 29 amino acids (minimal active fragment); tesamorelin is the full 44 amino acids with an N-terminal modification. Tesamorelin has an active FDA approval; sermorelin's was withdrawn.
  • vs. CJC-1295: CJC-1295 uses Drug Affinity Complex (DAC) technology to bind to albumin for a half-life of days. Never FDA-approved. Had a participant death during development.
  • vs. Ipamorelin: Works on a completely different receptor (GHS-R1a, the ghrelin receptor). Complementary pathway to tesamorelin/sermorelin.
  • vs. Exogenous GH (somatropin): Tesamorelin stimulates endogenous GH production with feedback regulation; exogenous GH bypasses all regulation.

What the research says

Tesamorelin has the strongest clinical evidence base of any GHRH analog — including two large Phase 3 RCTs, a meta-analysis, and an active FDA approval. For HIV lipodystrophy, the evidence is robust. For NAFLD and cognitive function, early trial data is promising but limited. For general anti-aging use in non-HIV adults, the data is thin.

Peptide Garden evidence assessment, March 2026

Research timeline

Tesamorelin's development was driven by the medical need for treating HIV-associated lipodystrophy:

  1. 2003Preclinical

    Tesamorelin (TH9507) enters clinical development

    Theratechnologies Inc. begins clinical trials of TH9507, a modified 44-amino-acid GHRH analog with a trans-3-hexenoic acid modification, targeting HIV-associated lipodystrophy.

  2. 2007Human study

    First Phase 3 trial published in NEJM

    Falutz et al. publish the first pivotal Phase 3 RCT (n=412) in the New England Journal of Medicine. Tesamorelin reduces visceral fat by 15.2% vs placebo with improved triglycerides.

  3. 2008Human study

    Confirmatory Phase 3 trial completed

    A second Phase 3 trial (n=404) confirms the results of the first. Combined data from both trials (n=806) forms the basis for the FDA approval submission.

  4. 2010Regulatory

    FDA approval — Egrifta

    FDA approves tesamorelin (Egrifta) in November 2010 for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It is the first and only drug approved for this indication.

  5. 2012Human study

    Cognitive function trial — positive results

    Baker et al. publish a 20-week RCT (n=152) showing tesamorelin improves executive function in healthy older adults and those with mild cognitive impairment. Opens a new research avenue.

  6. 2012Human study

    Non-HIV obesity trial

    Makimura et al. publish a 12-month RCT (n=60) in non-HIV obese adults showing tesamorelin reduces VAT and improves cardiovascular markers. First evidence outside HIV population.

  7. 2019Regulatory

    Egrifta SV reformulation approved

    FDA approves a single-vial formulation (Egrifta SV) reducing preparation complexity. Muscle composition analysis from Phase 3 data also published.

  8. 2020Human study

    NAFLD trial — significant liver fat reduction

    Fourman et al. publish a 12-month RCT (n=61) in Lancet HIV showing 37% relative reduction in liver fat, with 35% resolving NAFLD entirely. Fibrosis progression also reduced.

  9. 2025Regulatory

    Egrifta WR approved; new cognitive data

    FDA approves Egrifta WR (F8 formulation) for weekly reconstitution. Ellis et al. publish Phase 2 cognitive trial — trend toward improvement but not significant between groups.

  10. 2026Milestone

    Meta-analysis confirms efficacy

    A meta-analysis of 5 RCTs confirms VAT reduction of -27.71 cm2 (P<0.001). Tesamorelin's evidence base continues to be the strongest of any GHRH analog.

Human clinical trials

Tesamorelin's human evidence base is centered on its Phase 3 HIV lipodystrophy program, but extends into cognition, NAFLD, and non-HIV body composition:

2007·Randomized, double-blind, placebo-controlled, 26 weeks·n=412High quality

First pivotal Phase 3 trial — NEJM (Falutz 2007)

HIV-associated lipodystrophy with excess abdominal fat

VAT decreased 15.2% with tesamorelin vs 5.0% increase with placebo. Triglycerides decreased by 50 mg/dL. No clinically meaningful changes in glucose parameters. Published in the New England Journal of Medicine.

2010·Pooled analysis of two Phase 3 RCTs, 52-week follow-up·n=806High quality

Pooled Phase 3 analysis with 52-week safety extension (Falutz 2010)

HIV-associated lipodystrophy with excess abdominal fat

VAT decreased -24 cm2 vs +2 cm2 placebo at 26 weeks (P<0.001). 15.4% treatment effect on VAT. Reduction maintained through 52 weeks. Improved triglycerides and cholesterol/HDL ratio. Generally well tolerated.

2012·Randomized, double-blind, placebo-controlled, 20 weeks·n=152High quality

Cognitive function in aging and MCI (Baker 2012)

Healthy older adults (55-87 years) and adults with mild cognitive impairment

Favorable effect on cognition (P=0.03). Improved executive function (P=0.005) with trend for verbal memory (P=0.08). IGF-1 increased 117% in MCI group. Body fat reduced 7.4%.

2020·Randomized, double-blind, placebo-controlled, 12 months·n=61High quality

NAFLD liver fat reduction in HIV (Fourman 2020)

Non-alcoholic fatty liver disease in HIV-infected adults

Hepatic fat reduced 37% relative to placebo (P=0.02). 35% resolved NAFLD entirely (below 5% liver fat) vs 4% placebo. Only 2 tesamorelin patients had fibrosis progression vs 9 on placebo.

2012·Randomized, double-blind, placebo-controlled, 12 months·n=60Moderate quality

Non-HIV obesity — body composition and metabolic effects (Makimura 2012)

Abdominally obese non-HIV adults with reduced GH secretion

Reduced VAT, improved carotid intima-media thickness, decreased CRP and triglycerides. This is the key evidence for tesamorelin's effects outside the HIV population.

The quality and scale of tesamorelin's evidence base is notably different from other GH peptides. The Phase 3 program alone enrolled 806 patients across two multicenter international trials — larger than the entire combined clinical dataset for sermorelin, CJC-1295, and ipamorelin in adult populations.

The NAFLD data

The Fourman 2020 trial deserves special attention because NAFLD (non-alcoholic fatty liver disease) is one of the most common liver conditions globally, and pharmacological treatments are limited.[4]

In 61 HIV-infected adults with NAFLD (liver fat >= 5%), tesamorelin 2 mg daily for 12 months produced:

  • 37% relative reduction in hepatic fat fraction vs placebo (P=0.02)
  • 35% of tesamorelin patients resolved NAFLD entirely (liver fat below 5%) vs only 4% on placebo
  • Fibrosis protection: only 2 tesamorelin patients experienced fibrosis onset or worsening, compared to 9 in the placebo group

A Phase 2 trial (NCT03375788) exploring tesamorelin for NASH (non-alcoholic steatohepatitis) more broadly is underway. If these results replicate and extend to non-HIV populations, it would represent a significant expansion of tesamorelin's clinical utility.

Important caveat: The NAFLD trial was conducted entirely in HIV-infected patients. HIV infection itself contributes to liver inflammation, so the degree to which these results translate to the much larger non-HIV NAFLD population is unknown. The Phase 2 NASH trial may help answer this question.

The cognition data

The cognitive function data tells a more nuanced story. The Baker 2012 trial (n=152) in healthy older adults and those with MCI showed statistically significant improvement in executive function, with tesamorelin increasing IGF-1 by 117% — and IGF-1 is known to promote brain angiogenesis, neurite outgrowth, and synaptogenesis.[3]

However, the more recent Ellis 2025 trial, which specifically examined cognition in HIV patients with abdominal obesity, found only a non-significant trend toward improvement. The between-group difference was not statistically significant (P=0.673), though the tesamorelin group did show a greater reduction in waist circumference.[7]

This mixed picture suggests that cognitive benefits may be real but modest, potentially population-dependent, and not yet ready to be considered a primary reason for using tesamorelin.

What the evidence shows

People encounter tesamorelin through different lenses — HIV treatment, off-label fat loss, cognitive enhancement, or liver health. Here's what the published research actually supports:

Does tesamorelin reduce visceral abdominal fat in HIV lipodystrophy?

This is tesamorelin's FDA-approved indication and the most robustly supported claim. Two Phase 3 RCTs (n=806 combined) demonstrated a 15.4% reduction in visceral adipose tissue vs placebo, with improvements maintained through 52 weeks. A 2026 meta-analysis of 5 RCTs confirmed VAT reduction of -27.71 cm2. The effect is specific to visceral fat — subcutaneous fat is preserved.

Well-supported

Can tesamorelin reduce liver fat in NAFLD?

A well-designed RCT (n=61) in HIV patients with NAFLD showed a 37% relative reduction in liver fat vs placebo over 12 months. 35% resolved their NAFLD entirely compared to 4% on placebo, and fibrosis progression was significantly reduced. Results are clinically meaningful but from a single moderate-sized trial in HIV-infected patients specifically.

Well-supported

Does tesamorelin improve cognitive function?

A 20-week RCT (n=152) in healthy older adults and those with MCI found tesamorelin improved executive function (P=0.005). However, a more recent Phase 2 trial in HIV patients with abdominal obesity found only a non-significant trend. The cognitive benefits may be population-dependent and modest in magnitude.

Some supporting evidence

Is tesamorelin effective for body composition in non-HIV adults?

One 12-month RCT (n=60) in non-HIV obese adults with reduced GH secretion showed tesamorelin reduced VAT and improved cardiovascular markers. This is encouraging but represents a single small trial. All large trials and the FDA approval are in the HIV population specifically.

Some supporting evidence

Is tesamorelin safer than exogenous growth hormone for fat reduction?

Tesamorelin works through the GHRH receptor and is subject to somatostatin feedback, making supraphysiological GH levels unlikely. Phase 3 data showed generally acceptable safety at 52 weeks, though diabetes risk was elevated (HR 3.3). No head-to-head trial vs exogenous GH exists, but the feedback-regulated mechanism is a genuine safety advantage.

Some supporting evidence

Safety & side effects

What the Phase 3 data shows

Tesamorelin has the most comprehensive safety dataset of any GHRH analog, documented in its FDA-approved prescribing information from Phase 3 trials (n=806) with 52-week follow-up:[12]

Common adverse events (from prescribing information):

  • Injection-site reactions: erythema, pruritus, pain, irritation (~24.5% in first 26 weeks, declining to ~6.1% in second 26 weeks)
  • Arthralgia (joint pain)
  • Peripheral edema (fluid retention)
  • Myalgia (muscle pain)
  • Paresthesia (tingling or numbness)
  • Carpal tunnel syndrome (related to GH effects on tissue turgor)

The glucose and diabetes concern

This is the most clinically significant safety issue. From the Phase 3 data:[2]

  • Patients receiving tesamorelin had an increased risk of developing diabetes (HbA1c >= 6.5%) compared with placebo: 5% vs 1%, hazard ratio of 3.3
  • Fasting glucose increases were observed, though mean changes were modest
  • The prescribing information recommends evaluating HbA1c before and during treatment

About the diabetes risk: A hazard ratio of 3.3 sounds alarming, but context matters. The absolute risk increase was 4 percentage points (5% vs 1%) over 26-52 weeks, in a population (HIV on ART) that already has elevated metabolic risk. However, this is a real signal that requires monitoring — particularly for off-label use in patients who may already have pre-diabetes or metabolic syndrome.

Antibody formation

Anti-tesamorelin IgG antibodies were detected in approximately 49.5% of patients treated for 26 weeks and 47.4% at 52 weeks. In most cases, these antibodies are non-neutralizing and do not affect efficacy. However, in the Phase 3 trials, some patients with anti-tesamorelin antibodies did show reduced treatment response. This is similar to the antibody formation seen with sermorelin.[12]

Treatment discontinuation

The safety profile supports long-term use for most patients: discontinuation due to adverse events was 9.6% for tesamorelin vs 6.8% for placebo in the first 26 weeks — a modest difference indicating that most adverse events are manageable.

Contraindications and interactions

Contraindications (from prescribing information):

  • Active malignancy (GH can stimulate tumor growth). Tesamorelin should be discontinued if a malignancy is diagnosed.
  • Disruption of the hypothalamic-pituitary axis due to conditions including hypophysectomy, pituitary tumor/surgery, head irradiation, or trauma
  • Pregnancy (Category X — potential fetal harm)
  • Known hypersensitivity to tesamorelin or mannitol

Key precautions:

  • Monitor glucose and HbA1c before and during treatment
  • Fluid retention (edema, carpal tunnel) — typically resolves with dose adjustment or discontinuation
  • GH may alter thyroid hormone metabolism — monitor thyroid function
  • Potential interaction with glucocorticoids (may blunt GH response)

How people use it

Tesamorelin exists in two distinct usage contexts: its FDA-approved indication and off-label use.

FDA-approved use

For HIV-associated lipodystrophy, tesamorelin (Egrifta / Egrifta WR) is prescribed at 2 mg subcutaneously once daily, injected into the abdomen. The newest formulation (Egrifta WR, approved March 2025) allows weekly reconstitution of a multi-dose vial, reducing the preparation burden from daily to weekly.

Treatment is ongoing — the prescribing label notes that fat accumulation returns when treatment is discontinued, so this is a maintenance therapy, not a cure.

Off-label context

Tesamorelin is increasingly prescribed off-label through anti-aging clinics and telehealth providers for:

  • General visceral fat reduction (non-HIV)
  • Body composition optimization
  • NAFLD/fatty liver (emerging indication)
  • Cognitive support (limited evidence)

About off-label dosing: Off-label dosing for non-HIV use has not been standardized in clinical trials. The FDA-approved dose is 2 mg daily for HIV lipodystrophy. If you're considering tesamorelin, the right first step is a conversation with a healthcare provider who can assess your specific situation and monitor appropriately.

Common stacking context

In clinical practice, tesamorelin is sometimes discussed alongside other GH-related compounds:

  • Tesamorelin alone — most common for the approved indication. The Phase 3 data is for tesamorelin monotherapy.
  • Tesamorelin + Ipamorelin — complementary GHRH + ghrelin receptor pathways. No controlled trials of this combination exist.
  • Tesamorelin vs. Sermorelin — same GHRH pathway, but tesamorelin has an active FDA approval, a longer half-life, and a much larger evidence base. Higher cost.

All combination protocols are based on clinical practice and mechanistic reasoning, not controlled studies.

If you plan to reconstitute peptides, see our reconstitution guide for safety-first preparation instructions.

As of March 2026:

FDA status

Tesamorelin is currently FDA-approved as Egrifta / Egrifta WR for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It is the only GHRH analog with an active FDA approval — a critical distinction from sermorelin (withdrawn 2008) and CJC-1295 (never approved).[12]

The approval history:

  1. November 2010: Original Egrifta approval (NDA 022505)
  2. 2019: Egrifta SV (single-vial reformulation)
  3. March 2025: Egrifta WR (tesamorelin F8, weekly reconstitution formulation)

Tesamorelin is available both as the branded product (Egrifta WR) through specialty pharmacies and through compounding pharmacies with a valid prescription. Off-label use for non-HIV indications is at physician discretion.

What the active FDA approval means: Unlike peptides that exist only in the compounding space, tesamorelin has a current NDA holder (Theratechnologies), a maintained prescribing label, ongoing pharmacovigilance, and FDA oversight. This provides a level of quality assurance and safety monitoring that compounded-only peptides lack.

WADA / USADA status

Tesamorelin is prohibited at all times under WADA Section S2.2.4 (Growth Hormone Releasing Factors) as a GHRH analog. This applies to all athletes subject to anti-doping testing. A Therapeutic Use Exemption is technically possible but unlikely, as alternative treatments for GH-related conditions exist.[13]

International status

Tesamorelin is FDA-approved in the United States. It is available through some international clinics and compounding pharmacies. It is not approved for non-HIV indications in any country.

How tesamorelin compares

Tesamorelin exists in a landscape of GHRH-pathway peptides. Here's how it compares to the most relevant alternatives:

Tesamorelin

FDA-approved (current) · Egrifta WR

Animal evidence70%
Human evidence75%
Safety data70%

FDA history

Approved 2010

Status

Active approval

Amino acids

44

Key trial

n=806 (Phase 3)

Sermorelin

Previously FDA-approved · Legal to compound

Animal evidence65%
Human evidence40%
Safety data45%

FDA history

Approved 1997

Status

Withdrawn 2008

Amino acids

29

Largest trial

n=19 (adults)

The comparison illustrates why tesamorelin's evidence base matters. Both are GHRH analogs working through the same receptor, but tesamorelin has an active FDA approval, Phase 3 trials with 806 patients, a maintained prescribing label, and ongoing post-market safety surveillance. Sermorelin's adult evidence rests on trials with 11-19 participants and a pediatric approval that was withdrawn for commercial reasons.

For someone choosing between GHRH-pathway peptides, tesamorelin has the stronger evidence — but it is also significantly more expensive and its off-label access may be more limited. Sermorelin is more widely available through compounding pharmacies at lower cost, with a longer track record in the anti-aging clinic space.

Common exaggerations to watch for

Tesamorelin is sometimes marketed with claims that go beyond the evidence. Here are the most common ones:

  • "FDA-approved for weight loss / anti-aging" — False. The FDA approval is specifically for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It is not approved for general weight loss, anti-aging, or body composition in non-HIV adults.
  • "Proven to reverse fatty liver disease" — Overstated. One RCT (n=61) showed significant liver fat reduction in HIV patients with NAFLD. Promising, but not yet proven in the broader NAFLD population and not an approved indication.
  • "Boosts brain function and prevents cognitive decline" — Overstated. One trial showed modest executive function improvement. A more recent trial in HIV patients showed only a non-significant trend. The cognitive story is incomplete.
  • "No side effects — completely natural" — False. Phase 3 data documents injection-site reactions (~25%), arthralgia, edema, and a 3.3x increased risk of diabetes. These are manageable for most patients but real.
  • "Works for everyone who wants to lose belly fat" — The evidence is strongest in HIV patients with lipodystrophy and in non-HIV adults with documented reduced GH secretion. Whether tesamorelin meaningfully reduces visceral fat in healthy adults with normal GH levels is not established.

Related content

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Guide

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A clear, safety-first guide to preparing lyophilized peptides. Essential reading if you're working with injectable peptides.

News

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Tesamorelin's unique position as an FDA-approved growth hormone secretagogue.

Tool

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Calculate exact syringe units for tesamorelin reconstitution.

References

  1. [1]
    Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, et al.. “Metabolic effects of a growth hormone-releasing factor in patients with HIV.” N Engl J Med. 2007. 357(23):2359-2370 DOI PubMedRCT

    First pivotal Phase 3 RCT. n=412, 26-week placebo-controlled. Published in NEJM. High-quality evidence for HIV lipodystrophy indication.

  2. [2]
    Falutz J, Allas S, Kotler D, Thompson M, Koutkia P, Albu J, et al.. “Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two phase 3 trials with safety extension data.” J Clin Endocrinol Metab. 2010. 95(9):4291-4304 DOI PubMedRCT

    Pooled analysis of both pivotal trials. n=806 total, 52-week extension. Definitive efficacy and safety dataset for FDA approval.

  3. [3]
    Baker LD, Barsness SM, Borber S, Trittschuh EH, Espeland MA, Claxton A, et al.. “Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial.” Arch Neurol. 2012. 69(11):1420-1429 DOI PubMedRCT

    Well-designed RCT, n=152, 20 weeks. Positive results for executive function. Largest cognitive trial with a GHRH analog.

  4. [4]
    Fourman LT, Billingsley JM, Engelman T, Rodriguez-Guilarte L, Corey KE, Bredella MA, et al.. “Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.” Lancet HIV. 2020. 6(12):e821-e830 DOI PubMedRCT

    RCT, n=61, 12 months. Well-designed but moderate sample size. Published in Lancet HIV. Clinically significant endpoints (NAFLD resolution, fibrosis prevention).

  5. [5]
    Makimura H, Feldpausch MN, Stanley TL, Sun N, Grinspoon SK. “The growth hormone releasing hormone analogue, tesamorelin, decreases muscle fat and increases muscle area in adults with HIV.” J Clin Endocrinol Metab. 2019. 104(11):5070-5080 DOI PubMedRCT

    Secondary analysis from Phase 3 trials. Demonstrates muscle composition improvements beyond visceral fat reduction.

  6. [6]
    Makimura H, Stanley TL, Sun N, Feldpausch MN, Grinspoon SK. “Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial.” J Clin Endocrinol Metab. 2012. 97(12):4769-4779 DOI PubMedRCT

    RCT, n=60, 12 months. Only published RCT in non-HIV obese adults. Important for extrapolating beyond HIV indication.

  7. [7]
    Ellis RJ, Marquine MJ, Engstrom A, et al.. “Effects of tesamorelin on neurocognitive impairment in persons with HIV and abdominal obesity.” J Infect Dis. 2025. 231(5):1230-1240 DOI PubMedRCT

    Phase 2, open-label. Trend toward cognitive improvement but between-group difference not significant. Open-label design limits interpretation.

  8. [8]
    Spooner LM, Olin JL. “Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy.” Ann Pharmacother. 2012. 46(2):240-247 DOI PubMedReview

    Comprehensive clinical review covering mechanism, pharmacokinetics, efficacy, and safety. Good overview reference.

  9. [9]
    Falutz J. “Growth hormone and tesamorelin in the management of HIV-associated lipodystrophy.” HIV Ther. 2011. 5(2):209-225 PubMedReview

    Expert review by lead Phase 3 trialist. Covers GH and tesamorelin in the context of HIV lipodystrophy management.

  10. [10]
    Meta-analysis authors. “Body composition, hepatic fat, metabolic, and safety outcomes of tesamorelin in HIV-associated lipodystrophy: a meta-analysis of randomized controlled trials.” Obes Res Clin Pract. 2026. PubMedSystematic review

    Most recent meta-analysis (5 RCTs, searched through July 2025). Confirms VAT reduction -27.71 cm2 (95% CI -38.37, -17.06).

  11. [11]
    Ishida J, Saitoh M, Ebner N, Springer J, Anker SD, von Haehling S. “Growth hormone secretagogues: history, mechanism of action, and clinical development.” JCSM Rapid Commun. 2020. 3(1):25-37 DOIReview

    Comprehensive review of all GH secretagogues including GHRH analogs. Provides pharmacological context.

  12. [12]
    Theratechnologies Inc. (prescribing information). “EGRIFTA WR (tesamorelin for injection) — Full Prescribing Information.” 2025. Link

    Current FDA-approved prescribing label. Definitive source for safety data, dosing, contraindications, and adverse event rates.

  13. [13]
    World Anti-Doping Agency. “The World Anti-Doping Code International Standard — Prohibited List 2026.” 2026. Link

Medical disclaimer

Peptide Garden is an educational resource, not a medical provider. The information on this page is compiled from published research and is intended for informational purposes only. It does not constitute medical advice, diagnosis, or treatment recommendations. Tesamorelin (Egrifta) is FDA-approved only for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. All other uses discussed on this page are off-label. Always consult a qualified healthcare provider before making decisions about peptide therapy.