Tesamorelin (TH9507)
Synthetic Growth Hormone-Releasing Factor (GRF 1-44) analogue with an N-terminal trans-3-hexenoyl modification. Marketed as EGRIFTA and EGRIFTA SV. FDA-approved exclusively for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Off-label use for bodybuilding, athletics, or general weight loss is not approved and is prohibited in sports by WADA.
60-Second Scientific Briefing
Tesamorelin (Egrifta) is an FDA-approved synthetic 44-amino-acid GHRH analogue indicated exclusively for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It is NOT approved for cosmetic fat reduction, general obesity, or athletic performance enhancement.
What is Tesamorelin?
Pharmacological Classification & Molecular IdentitySynthetic human growth hormone-releasing factor analogue comprising the 44-amino acid sequence of human GHRH with a trans-hexenoyl fatty acid moiety.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Binds GHRH receptors on pituitary somatotropes, stimulating endogenous production and pulsatile release of growth hormone (GH) and downstream hepatic IGF-1.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsFDA Approved exclusively for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy (Egrifta NDA 022505). NOT approved for general obesity or bodybuilding.
Tesamorelin has received regulatory approval for specific medical indications. Commercial distribution and medical usage require appropriate prescription and adherence to approved labeling.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesRandomized, placebo-controlled Phase 3 clinical trials published in NEJM (2007) demonstrating approximately 15-18% reduction in visceral adipose tissue (VAT).
Clinical Evidence
Randomized, placebo-controlled Phase 3 clinical trials published in NEJM (2007) demonstrating approximately 15-18% reduction in visceral adipose tissue (VAT).
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesArthralgia, injection site erythema/pruritus, peripheral edema, myalgia, and glucose intolerance. May increase risk of neoplasm; contraindicated in active malignancy.
Visceral fat returns toward baseline upon drug discontinuation; sustained benefits require ongoing medical management.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesFDA-approved clinical dosage for indicated adult HIV patients: 2 mg once daily subcutaneous injection (or 1.4 mg for Egrifta SV formulation).
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic human growth hormone-releasing factor analogue comprising the 44-amino acid sequence of human GHRH with a trans-hexenoyl fatty acid moiety.
- Targets & Selectivity: Binds GHRH receptors on pituitary somatotropes, stimulating endogenous production and pulsatile release of growth hormone (GH) and downstream hepatic IGF-1.
- Randomized, placebo-controlled Phase 3 clinical trials published in NEJM (2007) demonstrating approximately 15-18% reduction in visceral adipose tissue (VAT).
- Safety considerations: Arthralgia, injection site erythema/pruritus, peripheral edema, myalgia, and glucose intolerance. May increase risk of neoplasm; contraindicated in active malignancy.
? Unknown / Under Ongoing Investigation
- Visceral fat returns toward baseline upon drug discontinuation; sustained benefits require ongoing medical management.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysTesamorelin is classified as a Growth Hormone-Releasing Factor (GHRF) Analogue. Molecular structure: Synthetic human growth hormone-releasing factor analogue comprising the 44-amino acid sequence of human GHRH with a trans-hexenoyl fatty acid moiety..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Tesamorelin exerts biological activity via Binds GHRH receptors on pituitary somatotropes, stimulating endogenous production and pulsatile release of growth hormone (GH) and downstream hepatic IGF-1..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
- Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV (New England Journal of Medicine, 2007-12-06)
Regulatory status: FDA Approved exclusively for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy (Egrifta NDA 022505). NOT approved for general obesity or bodybuilding.
Prescription use requires a verified medical diagnosis and adherence to approved labeling.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Clinical evaluation status: Randomized, placebo-controlled Phase 3 clinical trials published in NEJM (2007) demonstrating approximately 15-18% reduction in visceral adipose tissue (VAT).
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
- Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV (New England Journal of Medicine, 2007-12-06)
Reported safety profile: Arthralgia, injection site erythema/pruritus, peripheral edema, myalgia, and glucose intolerance. May increase risk of neoplasm; contraindicated in active malignancy.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Key scientific uncertainties: Visceral fat returns toward baseline upon drug discontinuation; sustained benefits require ongoing medical management.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV (New England Journal of Medicine, 2007-12-06)
FDA-approved clinical dosage for indicated adult HIV patients: 2 mg once daily subcutaneous injection (or 1.4 mg for Egrifta SV formulation).
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Storage status: Store original lyophilized vials at 2°C to 8°C (36°F to 46°F) protected from light. Reconstitute immediately before injection and discard unused portion.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Athletic status depends on WADA category classification; peptide hormones, growth factor mimetics, and related substances are prohibited under WADA Section S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- FDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2010-11-10)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesFDA Drugs@FDA Database: EGRIFTA / EGRIFTA SV (Tesamorelin) Approval History and Prescribing Information ↗
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV ↗
https://www.nejm.org/doi/10.1056/NEJMoa072375