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Tesamorelin

Growth Hormone

Also known as: Egrifta, TH9507, Theratechnologies GRF analog

Half-life: ~26 minutes

Muscle GrowthFat LossAnti AgingCognitive

Overview

Tesamorelin is a synthetic analog of growth hormone releasing hormone (GHRH) consisting of the full 44-amino-acid GHRH sequence with a trans-3-hexenoic acid modification at the N-terminus that improves metabolic stability. Developed by Theratechnologies Inc. of Montreal, Canada, it is one of the few GH-stimulating peptides to achieve actual FDA approval. Tesamorelin was approved in November 2010 under the brand name Egrifta for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, a condition characterized by abnormal fat redistribution.

Clinical trials involving over 800 HIV patients demonstrated that tesamorelin significantly reduces visceral adipose tissue (VAT) without adversely affecting glucose homeostasis at approved doses. The peptide acts by stimulating the pituitary gland to release growth hormone in a pulsatile, physiological manner, which distinguishes it from exogenous GH administration. This pulsatile release pattern is important because it allows the body's normal feedback mechanisms to remain functional, reducing the risk of GH-related side effects compared to direct GH supplementation.

Beyond its approved indication, tesamorelin has generated interest for potential cognitive benefits. A Phase 2 clinical trial published in Archives of Neurology (2012) showed improvements in executive function and verbal memory in cognitively normal older adults treated with tesamorelin. Theratechnologies has also investigated its effects on non-alcoholic fatty liver disease (NAFLD), where studies have shown reductions in hepatic fat alongside visceral fat. These findings position tesamorelin as a multifaceted GH-releasing peptide with therapeutic potential extending beyond lipodystrophy.

History

Developed by Theratechnologies Inc. in Montreal during the 2000s. Based on the native 44-amino-acid GHRH sequence with an N-terminal trans-3-hexenoic acid group to improve stability. Phase 3 trials demonstrated significant reduction in trunk fat in HIV patients with lipodystrophy. FDA approved in November 2010. Theratechnologies also investigated it for non-alcoholic fatty liver disease (NAFLD) and cognitive function in aging. The cognitive study published in Archives of Neurology (2012) showed intriguing improvements in executive function. The drug is manufactured and distributed in the US through specialty pharmacies.

Effects

  • FDA-proven reduction of visceral adipose tissue
  • Stimulates physiological pulsatile GH release
  • Improves body composition by reducing trunk fat
  • May enhance cognitive function in older adults
  • Increases IGF-1 levels
  • Does not significantly affect glucose homeostasis at approved doses

Side Effects

  • Injection site reactions (erythema, pruritus, pain)
  • Arthralgia (joint pain)
  • Peripheral edema
  • Myalgia (muscle pain)
  • Hypersensitivity reactions (rare)
  • Potential increase in IGF-1 above normal range

Tolerability

Tesamorelin has been evaluated in large clinical trials with over 800 HIV patients, providing robust tolerability data. The most common side effects are injection site reactions (occurring in about 8-13% of patients) and arthralgia. Discontinuation due to adverse events was low in clinical trials (approximately 5%). The peptide does not significantly impair glucose tolerance, which was an important finding given that GH can worsen insulin sensitivity. However, IGF-1 levels should be monitored, as elevations above the normal range occurred in some patients. Overall, its safety profile was sufficient for FDA approval.

Dosing Ranges

HIV lipodystrophy (FDA approved)

Dose Range

2000 mcg

Frequency

Once daily (SubQ)

Duration

Ongoing as prescribed

Body composition / anti-aging (off-label)

Dose Range

1000-2000 mcg

Frequency

Once daily

Duration

8-12 weeks

Dosing information is for educational purposes only. Consult a healthcare professional before using any peptide.

Reconstitution

Preparation Details

Typical Vial Size

2 mg

Water Type

Sterile water (included with Egrifta) or bacteriostatic water

Mixing Volume

2 mL

Half-Life

~26 minutes

Molecular Weight

5135.9 Da

Egrifta SV comes as lyophilized powder with diluent. Reconstituted solution should be used immediately. Research-grade tesamorelin reconstituted with BAC water may be stored refrigerated for up to 28 days.

Regulatory Status

FDA Status

FDA approved. Egrifta (tesamorelin) approved November 2010 for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Egrifta SV (reformulated single-vial) approved 2019.

Legal Status

Prescription medication in the United States. Available through specialty pharmacies. Also available as a research chemical.

USA

Approved

FDA approved 2010 as Egrifta for HIV-associated lipodystrophy.

Canada

Approved

Health Canada approved for HIV lipodystrophy. Developed by Canadian company Theratechnologies.

EU

Not approved

EMA has not authorized tesamorelin.

UK

Not approved

Not licensed for use in the UK.

Australia

Not approved

TGA has not approved tesamorelin.

Cited Studies

Effects of tesamorelin on body composition and visceral fat in HIV-infected patients with abdominal fat accumulation

Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S

Journal of Clinical Endocrinology & Metabolism (2007)

Phase 2/3 trial demonstrating that tesamorelin significantly reduces visceral adipose tissue and improves body composition in HIV patients with lipodystrophy.

View Study →

Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation

Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK

Journal of Acquired Immune Deficiency Syndromes (2014)

Demonstrated that tesamorelin reduces both visceral and hepatic fat in HIV patients, suggesting benefits for NAFLD in this population.

View Study →

Growth hormone-releasing hormone effects on brain γ-aminobutyric acid levels in mild cognitive impairment and healthy aging

Baker LD, Barsness SM, Borber S, Callaghan JP, Craft S, Mehta PD, Reger MA, Thal LJ, Vitiello MV, Plymate SR

Archives of Neurology (2012)

Phase 2 trial showing tesamorelin improved executive function and verbal memory in cognitively normal older adults, suggesting neuroprotective potential.

View Study →

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