Is tesamorelin FDA-approved?

Yes. Tesamorelin (Egrifta) received initial US approval in 2010 for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. Its label states that long-term cardiovascular safety has not been established and that it is not indicated for weight loss management.

What did the tesamorelin Phase 3 trials show?

In the 412-patient 2007 NEJM trial, 26 weeks of 2 mg daily reduced visceral adipose tissue by 15.2% versus a 5.0% increase with placebo. A pooled analysis of two Phase 3 trials (806 patients) reported a 15.4% treatment effect on visceral fat at 26 weeks.

What is tesamorelin's half-life?

Current FDA labels report a mean elimination half-life of 8 minutes (EGRIFTA SV, 1.4 mg) and 11 minutes (EGRIFTA WR, 1.28 mg) after a single subcutaneous dose in healthy subjects.

Tesamorelin

aka Egrifta · TH9507

CAS 218949-48-5C221H366N72O67S5135.9 Da

strong evidenceFDA-Approved

Tesamorelin in brief

Tesamorelin (Egrifta, TH9507) is a synthetic growth hormone-releasing factor analog: the 44-amino-acid human GRF sequence with a hexenoyl group on its N-terminal tyrosine. The FDA approved it in 2010 to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. In a 412-patient Phase 3 trial, visceral fat fell 15.2% versus a 5.0% rise with placebo.

Tesamorelin: the FDA-approved GHRH analog

Open any panel for the full data

Third-party creator videos and discussion, surfaced for research context. Amino Axiom does not endorse creator claims.

Long-form breakdowns

5 videos

Short-form clips

9 clips

Trial evidence

Three published randomized trials carry most of tesamorelin's human evidence. All used 2 mg once daily by subcutaneous injection against placebo in people with HIV.

Trial	Design	Reported results
Falutz et al., N Engl J Med 2007 (PMID 18057338; NCT00123253)	412 patients with abdominal fat accumulation, 26 weeks	Visceral adipose tissue -15.2% vs +5.0% with placebo; triglycerides -50 vs +9 mg/dL; IGF-I +81.0% vs -5.0%
Falutz et al., J Clin Endocrinol Metab 2010 (PMID 20554713)	Pooled analysis of two Phase 3 trials, 806 patients randomized 2:1, 26 weeks plus a 26-week extension	Visceral fat -24 vs +2 cm² at week 26 (treatment effect -15.4%); in the group continued on tesamorelin, visceral fat was -17.5% from baseline at week 52
Stanley et al., Lancet HIV 2019 (PMID 31611038; NCT02196831)	61 enrolled with liver fat fraction of 5% or more, 12 months	Liver fat fraction -4.1% absolute vs placebo (-37% relative); 35% vs 4% ended below 5% liver fat

None of the three trials found clinically meaningful differences in glucose measures between groups. The 2007 trial reported more withdrawals for adverse events in the tesamorelin group, and the 2019 trial reported more injection-site complaints.

Current FDA labeling notes two limits: long-term cardiovascular safety has not been established, and the product is not indicated for weight loss management.

Sources

Pharmacokinetics and identifiers

Current FDA labels report a short elimination half-life after a single subcutaneous dose in healthy subjects: a mean of 8 minutes for 1.4 mg of EGRIFTA SV and 11 minutes for 1.28 mg of EGRIFTA WR.

Property	Value
Structure	44 amino acids of human GRF plus an N-terminal hexenoyl moiety
Molecular weight (free base)	5,135.9 Da
CAS	218949-48-5
FDA UNII	MQG94M5EEO
Initial US approval	2010

Sources

Common questions

Is tesamorelin FDA-approved?: Yes. Tesamorelin (Egrifta) received initial US approval in 2010 for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. Its label states that long-term cardiovascular safety has not been established and that it is not indicated for weight loss management.
What did the tesamorelin Phase 3 trials show?: In the 412-patient 2007 NEJM trial, 26 weeks of 2 mg daily reduced visceral adipose tissue by 15.2% versus a 5.0% increase with placebo. A pooled analysis of two Phase 3 trials (806 patients) reported a 15.4% treatment effect on visceral fat at 26 weeks.
What is tesamorelin's half-life?: Current FDA labels report a mean elimination half-life of 8 minutes (EGRIFTA SV, 1.4 mg) and 11 minutes (EGRIFTA WR, 1.28 mg) after a single subcutaneous dose in healthy subjects.

Full Research Data

Overview

Tesamorelin is a synthetic analog of GHRH approved by the FDA in 2010 specifically for reducing excess abdominal fat in HIV-infected patients with lipodystrophy. Unlike general GH stimulation, it was developed specifically for this indication with extensive safety data in immunocompromised populations.

PubMed results: 85 · Human studies: 68 · Animal studies: 68

Dosing Ranges

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

FDA-approved dosing for HIV-associated lipodystrophy

Subcutaneous Injection — standard range 2 mg, Once daily

Half-Life

8-11 minutes (high confidence)

Mean elimination half-life after a single subcutaneous dose in healthy subjects: 8 minutes for 1.4 mg EGRIFTA SV and 11 minutes for 1.28 mg EGRIFTA WR, per current FDA labeling.

Observed Benefits

Reduction of excess visceral abdominal fat in HIV lipodystrophy (Strong clinical): Pivotal randomized trials in HIV-associated lipodystrophy demonstrated significant reductions in visceral adipose tissue with this synthetic GHRH analog, supporting its FDA-approved indication for excess abdominal fat in this population.
Stimulation of endogenous GH axis (Strong clinical): Tesamorelin acts as a GHRH analog, increasing pulsatile growth hormone secretion and IGF-1, with extensive safety characterization in immunocompromised clinical cohorts.
Metabolic research interest in NAFLD (Moderate clinical): Investigational work has explored effects on hepatic fat and metabolic parameters in HIV and related populations, consistent with GH-axis modulation of lipid and glucose metabolism.

Side Effects

Arthralgia and myalgia — Mild, Common. Joint and muscle pain are among the more frequently reported adverse events in HIV lipodystrophy trial programs, consistent with GH-axis stimulation.
Injection site reactions — Mild, Common. Subcutaneous dosing has been associated with erythema, pruritus, and local discomfort at injection sites in clinical studies.
Glucose intolerance / hyperglycemia risk — Moderate, Uncommon. GH-mediated insulin antagonism can worsen glycemic control; clinical monitoring of glucose is emphasized, particularly in patients with diabetes or impaired glucose tolerance.

Contraindications

Active malignancy (Established): GH and IGF-1 stimulation raise theoretical and labeling-based concern about promoting neoplastic growth; active cancer is a standard exclusion for GHRH-based therapy.
Disruption of the hypothalamic-pituitary axis (Established): Efficacy depends on an intact pituitary GH secretory capacity; hypothalamic-pituitary disruption or hypophysectomy precludes the intended pharmacologic response.

Storage

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), Use promptly after reconstitution per product labeling. Solvent: Bacteriostatic water

Clinical Trials

NCT00850564 — Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men (NA), status: COMPLETED. Indications: Healthy Volunteers
NCT00123253 — TH9507 in Patients With HIV-Associated Lipodystrophy (PHASE3), status: COMPLETED. Indications: HIV Infections, Lipodystrophy
NCT00608023 — TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy (PHASE3), status: COMPLETED. Indications: Lipodystrophy, HIV Infections
NCT01264497 — Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes (PHASE2), status: COMPLETED. Indications: Type 2 Diabetes
NCT01591902 — Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA® (PHASE4), status: TERMINATED. Indications: Diabetic Retinopathy, HIV
NCT02196831 — Tesamorelin Effects on Liver Fat and Histology in HIV (NA), status: COMPLETED. Indications: Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
NCT01632592 — Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue (NA), status: WITHDRAWN. Indications: Abdominal Obesity
NCT03226821 — Body Composition and Adipose Tissue in HIV (PHASE4), status: COMPLETED. Indications: HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition
NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (PHASE2), status: RECRUITING. Indications: HIV-1-infection, Frailty, Impaired Physical Function, Abdominal Obesity, Aging
NCT07481734 — Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (PHASE2), status: RECRUITING. Indications: Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis
NCT00795210 — Effects of Short-term Growth Hormone in HIV-infected Patients (NA), status: COMPLETED. Indications: HIV Lipodystrophy
NCT02012556 — Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients (PHASE1), status: COMPLETED. Indications: HIV
NCT00675506 — Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese (PHASE2), status: COMPLETED. Indications: Abdominal Obesity, Growth Hormone Deficiency
NCT00257712 — SMART: Somatotrophics, Memory, and Aging Research Trial (PHASE2), status: COMPLETED. Indications: Aging, Mild Cognitive Impairment
NCT01388920 — Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting (PHASE2), status: TERMINATED. Indications: Chronic Obstructive Pulmonary Disease (COPD)
NCT01263717 — Effects of Growth Hormone Releasing Hormone in HIV (NA), status: COMPLETED. Indications: HIV, HIV Lipodystrophy
NCT02931474 — 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. Indications: Sleep Disorder, Traumatic Brain Injury
NCT02553603 — The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment (PHASE1), status: COMPLETED. Indications: Mild Cognitive Impairment
NCT03375788 — Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (PHASE2), status: COMPLETED. Indications: Non-Alcoholic Fatty Liver Disease, Obesity, Obesity, Abdominal, Liver Fat, Fatty Liver
NCT03826160 — Growth Hormone Dynamics and Cardiac Steatosis in HIV, status: COMPLETED. Indications: Human Immunodeficiency Virus, Lipodystrophy, Cardiac Disease