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Tesamorelin

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Tesamorelin is a synthetic peptide analog of growth hormone-releasing hormone (GHRH), consisting of 44 amino acids with enhanced stability and potency. It is studied for its ability to stimulate endogenous growth hormone (GH) release by binding to GHRH receptors in the anterior pituitary. Research applications include investigations into GH pulsatility, IGF-1 regulation, and metabolic pathways involving lipid turnover and insulin sensitivity.

Weight .06 kg
Size

5 mg, 10 mg
Shelf Life

24 months
Storage

Lyophilized: refrigerate at 2–8 °C (35.6–46.4 °F)
Reconstituted: refrigerate at 2–8 °C (35.6–46.4 °F); use within 4-6 weeks.
Molecular Formula

C221H366N72O67S
PubChem CID

16137828 http://www.pubchem.ncbi.nlm.nih.gov/compound/16137828
Disclaimer

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. For research purposes only. Not for human consumption.

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Research Compound Profile

Tesamorlin

Also known as:Egrifta · TH9507 · GHRH Analog Category:Growth Hormone Releasing Peptide Clinical Status:FDA Approved — HIV Lipodystrophy FDA Status:Approved · Egrifta® (2010)

A synthetic 44-amino acid analog of growth hormone-releasing hormone (GHRH) that stimulates pituitary GH secretion. FDA-approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. All data presented reflects published clinical trial and research findings.

Explore the Research ↓
🧬Peptide Type

Synthetic GHRH Analog (44 amino acids)

📊Primary Indication

Visceral fat reduction in HIV lipodystrophy

🔬Mechanism

Stimulates pituitary GH release via GHRH receptor

🧪Regulatory Status

FDA Approved (Egrifta®) · 2010

What Is Tesamorlin?

🧠 Simple Explanation

Tesamorlin is a lab-made version of a natural brain hormone called GHRH (growth hormone-releasing hormone). It tells your pituitary gland — a small gland at the base of the brain — to produce more growth hormone. In clinical trials, this extra growth hormone helped reduce excess belly fat, particularly the deep visceral fat that wraps around internal organs.

It is FDA-approved under the brand name Egrifta® specifically for HIV-infected patients who have developed lipodystrophy — an abnormal redistribution of body fat caused by antiretroviral therapy.

🔬 Advanced Context

Tesamorlin (TH9507) is a stabilized synthetic analog of human GHRH(1-44) with a trans-3-hexenoic acid modification at the N-terminus that increases its half-life and resistance to enzymatic degradation. It binds to GHRH receptors on pituitary somatotrophs, stimulating pulsatile growth hormone release that preserves physiological feedback mechanisms and circadian rhythms.

FDA approval was based on two pivotal Phase 3 trials (LIPO-010 and CTR-1011) involving 816 HIV-infected patients with lipodystrophy. At 26 weeks, Tesamorlin reduced visceral adipose tissue (VAT) by approximately 15.4% vs. a 5% increase in the placebo group, as measured by CT scan. Effects were maintained at 52 weeks (-17.5%).

Beyond lipodystrophy, research is ongoing in NAFLD (37% hepatic fat reduction in RCT) and cognitive function (executive function P=0.005 in older adults and those with mild cognitive impairment).

How It Works

Mechanism of action based on clinical trial evidence

STEP 01→

GHRH Receptor Binding

Tesamorlin binds to GHRH receptors on pituitary somatotroph cells, stimulating pulsatile growth hormone (GH) release that maintains physiological feedback mechanisms and circadian rhythms.

💡 Simple Translation

The peptide attaches to receptors on the pituitary gland and signals it to release growth hormone in natural pulses, just like your body normally would.

STEP 02→

GH & IGF-1 Elevation

Elevated GH stimulates hepatic production of insulin-like growth factor 1 (IGF-1), which mediates many of GH's downstream effects including lipolysis, protein synthesis, and metabolic regulation.

💡 Simple Translation

The released growth hormone travels to the liver, triggering IGF-1 production — a signaling molecule that tells fat cells to break down stored fat and helps muscles maintain their mass.

STEP 03→

Selective Visceral Lipolysis

IGF-1-mediated lipolysis preferentially targets visceral adipose tissue (VAT) while preserving subcutaneous fat and lean muscle mass. This selectivity is unique among GH-related therapies.

💡 Simple Translation

This process specifically targets dangerous deep belly fat around your organs — linked to heart disease and diabetes — while leaving healthy fat and muscle untouched.

STEP 04

Clinical Outcomes

In Phase 3 trials (n=816), Tesamorlin reduced VAT by 15.4% at 26 weeks and 17.5% at 52 weeks. Secondary outcomes included reduced triglycerides, improved body image scores, and preserved muscle mass.

💡 Simple Translation

In large clinical trials, patients lost significant dangerous belly fat over 6–12 months, saw blood fat improvements, and maintained muscle mass throughout treatment.

Clinical Development Status

Current position in the regulatory pipeline

✓
Preclinical

Laboratory and animal studies conducted before testing in humans. Evaluates basic safety, biological activity, and dosing ranges.

✓
Phase 1

First-in-human trials focused primarily on safety, tolerability, and pharmacokinetics in a small group of healthy volunteers.

✓
Phase 2

Larger trials evaluating effectiveness and side effects in patients with the target condition. Establishes optimal dosing.

✓
Phase 3

Large-scale trials (LIPO-010 & CTR-1011, n=816) comparing Tesamorlin against placebo in HIV lipodystrophy patients. Required for regulatory approval.

✓
Phase 4

Post-approval surveillance studies monitoring long-term safety and effectiveness. Ongoing research in NAFLD and cognitive function.

✓
FDA Approved

Full regulatory approval granted by the U.S. FDA in 2010 for HIV-infected patients with lipodystrophy. Marketed as Egrifta®.

FDA approved in 2010 as Egrifta® for HIV-associated lipodystrophy. Based on Phase 3 trials LIPO-010 & CTR-1011 (n=816). Ongoing research in NAFLD and cognitive function.

What Does the Research Show?

Summary of findings from FDA-approved clinical trials and ongoing research

📊Key Findings
  • 18.2% average visceral fat reduction at 26 weeks in Phase 3 trials
  • 73% of participants achieved >8% VAT reduction (primary responders)
  • 117% increase in IGF-1 levels from baseline
  • 37% reduction in hepatic fat in NAFLD randomized trial
📈Clinical Milestones
  • FDA approved in 2010 as Egrifta® (Theratechnologies Inc.)
  • Phase 3 trials enrolled 816 HIV-infected patients with lipodystrophy
  • NAFLD trial demonstrated 35% complete fatty liver resolution
  • Cognitive benefits shown in controlled trial (P=0.005 executive function)
🔬Metabolic Effects
  • Selective visceral lipolysis while preserving subcutaneous fat and muscle mass
  • Triglyceride reduction of 20–50 mg/dL in VAT responders
  • Improved muscle density (+4.86 HU) and psoas area (+0.46 cm²)
  • No significant adverse effects on glucose homeostasis
🧪Safety Profile
  • 91.2% of participants well-tolerated and completed treatment
  • Most common AE: injection site reactions (25%), arthralgia (13.3%)
  • Anti-Tesamorlin antibodies detected but no impact on efficacy
  • Serious adverse events in <4% of participants

Published Findings

Peer-reviewed studies and regulatory documents with linked sources

StudyModelKey FindingYearSource
Phase 3 pooled analysis (LIPO-010 & CTR-1011)Human (n=816)15.4% VAT reduction at 26 weeks, 17.5% at 52 weeks; preserved muscle mass and improved body image2010J Clin Endocrinol Metab ↗
NAFLD randomized trial in HIVHuman (RCT)37% reduction in hepatic fat (MRI-PDFF); improved fibrosis scores and gene expression2019Lancet HIV ↗
Cognitive function in older adults & MCIHuman (Controlled)Significant improvements in executive function (P=0.005) and response inhibition (P=0.009) at 1 mg daily2012Archives of Neurology ↗
Muscle fat & area in HIVHuman (Clinical)Decreased muscle fat, increased muscle density (+4.86 HU) and psoas area (+0.46 cm²)2019J Clin Endocrinol Metab ↗
Hepatic transcriptomic signaturesHuman (Molecular)Favorable gene expression changes related to NAFLD pathways; reduced NASH risk markers2020JCI Insight ↗
Lipid profile improvementsHuman (Clinical)Triglyceride reduction of 20–50 mg/dL in VAT responders; total cholesterol ↓9 mg/dL2012J Clin Endocrinol Metab ↗
Long-term efficacy & safetyHuman (Extension)Effects maintained at 52 weeks with continued treatment; 91.2% well-tolerated2010J Clin Endocrinol Metab ↗
FDA prescribing information updateRegulatoryUpdated safety and efficacy data; contraindicated in active malignancy; monitor IGF-12025FDA Label ↗

⚠️ Tesamorlin is FDA-approved for HIV-associated lipodystrophy only. Research in NAFLD and cognitive function is ongoing and not yet approved for those indications.

Research Timeline

Key milestones in Tesamorlin development and investigation

1999

Early Development

Tesamorlin (TH9507) developed as a stabilized GHRH analog with trans-3-hexenoic acid modification for improved half-life

2004

Phase 2 Trials

Initial efficacy studies demonstrate significant visceral fat reduction in HIV-infected patients with lipodystrophy

2007

Phase 3 Trials Begin

LIPO-010 and CTR-1011 pivotal trials enroll 816 HIV-infected patients across multiple centers

2010

FDA Approval

Tesamorlin approved as Egrifta® by the U.S. FDA for reduction of excess abdominal fat in HIV lipodystrophy

2012

Cognitive Function Study

Controlled trial demonstrates significant executive function improvements (P=0.005) in older adults at 1 mg daily

2019

NAFLD Trial Published

Randomized trial in Lancet HIV shows 37% hepatic fat reduction and improved fibrosis scores in HIV patients

2020

Hepatic Transcriptomics

JCI Insight publishes favorable gene expression changes related to NAFLD pathways with Tesamorlin treatment

2025

Updated FDA Label

Revised prescribing information for Egrifta® with updated safety and efficacy data from post-marketing surveillance

Delivery Methods & Administration

FDA-approved administration protocol and clinical dosing

Subcutaneous Injection

FDA-approved route; injected into the abdomen. Primary administration method in all clinical trials

Once Daily Dosing

2 mg daily is the FDA-approved dose for HIV-associated lipodystrophy

Before Bed (Fasted)

Optimal timing on empty stomach, aligned with natural GH release during sleep

Lyophilized Reconstitution

Supplied as lyophilized powder; reconstituted with sterile water before injection

Abdominal Administration

Injection site rotated within the abdominal area to minimize site reactions

FDA-Approved Dosing

The FDA-approved dose of Tesamorlin is 2 mg administered once daily via subcutaneous injection in the abdomen. In clinical trials, doses ranged from 1–2 mg daily. The cognitive function trial used 1 mg daily. IGF-1 levels should be monitored regularly during treatment.

⚠️ Tesamorlin is FDA-approved only for HIV-associated lipodystrophy. It is contraindicated in patients with active malignancy, disruption of the hypothalamic-pituitary axis, or known hypersensitivity. Effects are not sustained after discontinuation.

Molecular Profile

Physicochemical characteristics and regulatory parameters

Molecular Weight

~5,135.9 g/mol

Structure Type

Synthetic GHRH(1-44) Analog

Brand Name

Egrifta® / Egrifta SV®

Amino Acid Length

44 residues

N-Terminal Modification

Trans-3-hexenoic acid

Administration

Subcutaneous injection (abdomen)

FDA-Approved Dose

2 mg once daily

Storage

Refrigerated 2–8°C

Reference: FDA Prescribing Information (Egrifta®)

Research Applications

Approved indications and areas of active clinical investigation

FDA-approved for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

Investigated in non-alcoholic fatty liver disease (NAFLD) with 37% hepatic fat reduction in RCT

Studied for cognitive benefits in older adults and mild cognitive impairment (executive function P=0.005)

Evaluated for metabolic improvements including triglyceride reduction and adiponectin elevation

Researched for muscle quality enhancement including density and lean mass preservation

Explored for hepatic transcriptomic changes favorable to NASH risk reduction

Assessed for body image and patient-reported outcome improvements in lipodystrophy

Investigated in combination with lifestyle interventions for metabolic syndrome markers

Formulation & Preparation

Understanding Tesamorlin's pharmaceutical formulation

❄️

Lyophilized Formulation

Tesamorlin is supplied as a sterile lyophilized (freeze-dried) powder. This removes water content, significantly reducing chemical degradation and preserving the peptide's structural integrity during storage and transport.

💉

Reconstitution Protocol

Before injection, the lyophilized powder is reconstituted with sterile water for injection. The solution should be gently swirled (not shaken) and administered immediately or refrigerated for use within 24 hours.

🛡️

Stability & Storage

Unreconstituted vials should be refrigerated at 2–8°C and protected from light. The N-terminal trans-3-hexenoic acid modification provides enhanced stability compared to native GHRH, extending the compound's half-life.

🔬

Pharmaceutical Grade

As an FDA-approved product (Egrifta®), Tesamorlin is manufactured under cGMP conditions with rigorous quality control, identity testing, potency verification, and sterility assurance for each production batch.

✅

Administration Standards

Subcutaneous injection in the abdominal area with rotation of injection sites to minimize reactions. Proper aseptic technique is essential. Patients are trained on self-injection by healthcare providers.

Transparency & Quality Verification

Analytical standards applied to research-grade peptide materials

🧪

Third-Party Analytical Testing

Independent laboratories perform comprehensive analysis on each production batch, ensuring unbiased verification of compound identity and purity.

📊

Purity Verification (HPLC)

High-Performance Liquid Chromatography confirms peptide purity levels, typically targeting ≥98% for research-grade material.

🔬

Identity Confirmation (Mass Spectrometry)

Mass spectrometry validates molecular weight and structural identity, confirming the compound matches its expected profile.

📋

Batch-Specific Certificates of Analysis

Each lot is accompanied by a unique COA detailing purity percentage, lot number, test date, labeled vs. actual content, and testing laboratory.

📁

Documentation Transparency

All analytical results, testing methodologies, and laboratory credentials are made available for researcher review and institutional compliance.

🌡️

Storage Verification Standards

Cold-chain integrity monitoring ensures proper temperature maintenance from production through delivery, preserving compound stability.

Frequently Asked Questions

Clinical and investigational context for common inquiries

Tesamorlin is a synthetic 44-amino acid analog of human growth hormone-releasing hormone (GHRH). Developed by Theratechnologies Inc. with an N-terminal trans-3-hexenoic acid modification that increases resistance to enzymatic degradation and extends its half-life compared to native GHRH. Marketed under the brand name Egrifta®.
Tesamorlin is FDA-approved specifically for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy — an abnormal redistribution of body fat caused by antiretroviral therapy. It is NOT approved for general weight loss, bodybuilding, or anti-aging purposes.
In Phase 3 clinical trials (LIPO-010 & CTR-1011) involving 816 HIV-infected patients, Tesamorlin reduced visceral adipose tissue by approximately 15.4% at 26 weeks and 17.5% at 52 weeks, compared to a 5% increase in the placebo group. 73% of participants achieved >8% VAT reduction.
Tesamorlin is administered as a once-daily subcutaneous injection in the abdomen at a dose of 2 mg. It is supplied as a lyophilized powder that must be reconstituted with sterile water before injection. Best taken on an empty stomach before bed to align with natural GH release during sleep.
The most common adverse effects include injection site reactions (25%), arthralgia/joint pain (13.3%), peripheral edema (7.5%), myalgia/muscle pain (5.7%), and paresthesia (5.1%). Serious adverse events occurred in <4% of participants.
Tesamorlin is contraindicated in patients with active malignancy (due to IGF-1 elevation), disruption of the hypothalamic-pituitary axis (e.g., from surgery, radiation, or trauma), and known hypersensitivity to the drug. It may cause glucose intolerance (5% developed HbA1c ≥6.5%).
Effects are not sustained after discontinuation. Clinical studies show visceral fat returns to near baseline levels within 26 weeks of stopping treatment. Continuous therapy is necessary to maintain benefits.
No. Tesamorlin stimulates your body's own growth hormone production through GHRH receptor activation, preserving natural GH pulsatility and feedback mechanisms. This is physiologically different from exogenous HGH, which delivers GH directly and can disrupt natural patterns.
IGF-1 levels typically increase within 2–4 weeks of starting treatment. Visible reduction in abdominal fat generally begins around 8–12 weeks, with maximal effects observed at 26 weeks. The Phase 3 trials showed 15–18% visceral fat reduction at 6 months.
Regular monitoring includes: IGF-1 levels (should remain within physiological range), glucose tolerance and HbA1c (especially in patients with diabetes or pre-diabetes), injection site reactions, and periodic assessment of treatment response.
Research shows promising cognitive benefits. A controlled trial in Archives of Neurology demonstrated significant improvements in executive function (P=0.005) and response inhibition (P=0.009) in both healthy older adults and those with mild cognitive impairment, using 1 mg daily. Not currently approved for cognitive indications.
Tesamorlin is a GHRH analog that stimulates natural GH release, similar in mechanism to Sermorelin and CJC-1295. Unlike GH secretagogues (Ipamorelin, GHRP-6, MK-677), it acts specifically on GHRH receptors rather than ghrelin receptors. Tesamorlin is the only one in this class with full FDA approval for a specific clinical indication.
A randomized, double-blind trial in Lancet HIV (2019) showed that Tesamorlin reduced hepatic fat by 37% as measured by MRI-PDFF, with 35% of patients achieving complete NAFLD resolution. Favorable gene expression changes were also reported. However, it is not FDA-approved for NAFLD treatment.

Sources & References

Peer-reviewed publications, regulatory documents, and reference materials cited on this page

Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials ↗

Falutz J, Allas S, Blot K, et al. · Journal of Clinical Endocrinology & Metabolism (2010) · PMID: 20554713

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

Stanley TL, Fourman LT, Zheng I, et al. · Lancet HIV (2019) · PMID: 31611038

Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults ↗

Baker LD, Barsness SM, Borber S, et al. · Archives of Neurology (2012) · PMID: 22869065

The Growth Hormone Releasing Hormone Analogue, Tesamorlin, Decreases Muscle Fat and Increases Muscle Area in Adults with HIV ↗

Adrian S, Scherzinger A, Engelman D, et al. · Journal of Clinical Endocrinology & Metabolism (2019) · PMID: 31050749

Effects of tesamorlin on hepatic transcriptomic signatures in HIV-associated NAFLD ↗

Fourman LT, Bilber BE, Engelman D, et al. · JCI Insight (2020) · PMID: 32780726

A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with fat accumulation ↗

Falutz J, Allas S, Kotler D, et al. · Journal of Clinical Endocrinology & Metabolism (2012) · PMID: 22495074

Tesamorlin: a review of its use in the management of HIV-associated lipodystrophy ↗

Dhillon S · Drugs (2011) · PMID: 22298602

EGRIFTA (tesamorelin) Prescribing Information ↗

Theratechnologies Inc. · FDA (2025)

⚠️ Important Notice

For educational and research reference purposes only. This information is not intended to diagnose, treat, cure, or prevent any disease.

All information presented on this page is derived from peer-reviewed clinical trials, FDA prescribing information, and published research. Nothing on this page constitutes medical advice, personal recommendations, or encouragement of any kind. Tesamorlin (Egrifta®) is a prescription medication — consult a qualified healthcare provider for medical decisions.

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Tesamorelin
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