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Tesamorelin vs Sermorelin: Two GHRH Analogs With Very Different Evidence

Both copy the hormone that tells the pituitary to release growth hormone. One has FDA-approved trials in more than 800 people; the other has two small studies in older men.

Article type
Evidence
Sources
12
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7 min
By Craig PalmerPublished

Tesamorelin and sermorelin are often sold as two strengths of the same idea, and at the receptor they are. Both copy the hormone the hypothalamus uses to tell the pituitary to release growth hormone. Where they part company is the evidence, which differs in size, in the people studied and in what was measured.

This page compares the two molecules and their records. Each has its own page on what the trials found: tesamorelin’s Egrifta trials and whether sermorelin works. The sleep question, for readers arriving from the sleep goal, is covered on the sermorelin page.

Two copies of one hormone

Natural growth-hormone-releasing hormone is 44 amino acids long. Sermorelin is its first 29, which a 1999 review describes as the shortest synthetic peptide with the full biological activity of the natural hormone [3]. It acts on the pituitary to release growth hormone, which the liver answers with IGF-1.

Tesamorelin keeps all 44 amino acids and adds a hexenoyl group, a six-carbon chain, to the first one [1]. The label states that it binds the human receptor with potency similar to the natural hormone. Researchers describe it as a stabilized analog [7]. Even so, the label gives its half-life after an injection under the skin as about 11 minutes [1].

Both act on the same receptor, so both need a working pituitary to do anything. The tesamorelin label rules it out in people whose pituitary axis has been disrupted [1], and one of sermorelin’s approvals was a test of whether the pituitary could respond at all [2].

Two very different regulatory histories

Tesamorelin was approved by the FDA in November 2010 [4]. Its label covers one use: reducing excess abdominal fat in adults with HIV-associated lipodystrophy [1]. It remains on the market as Egrifta.

On March 23, 2020, Egrifta’s approval was deemed a biologics license [11]. The FDA states that products in that transition are not eligible for the exemptions that allow pharmacies to compound drugs [12]. Tesamorelin is available lawfully only as the brand product.

Sermorelin was approved twice under the name GEREF. One approval, from 1990, was a diagnostic test of the pituitary; the other, from 1997, treated growth hormone deficiency in children [2]. The maker discontinued both in 2008, and the approvals were withdrawn in 2009.

In 2013 the FDA determined that GEREF had not been withdrawn for reasons of safety or effectiveness [2]. That finding is what lets pharmacies compound sermorelin now, for adults and for uses the approval never covered.

What each has been tested in

The human trials behind each molecule, by population
TesamorelinSermorelin
Largest controlled trials2 phase 3 trials, 806 adults with HIV, 26 weeksNone in adults
Adults without HIV60 adults with abdominal obesity, 12 months; 152 older adults, 20 weeks10 older men, 2 weeks; 11 older men, 6 weeks
ChildrenNot established, per the label110 children with growth hormone deficiency, open-label, 1 year
Placebo group in adult trialsYesNo
FDA statusApproved 2010; a licensed biologic since 2020Approvals withdrawn 2009; not for safety
Can a pharmacy compound it?NoYes, under the 2013 determination
The human trials behind each molecule, by population Egrifta WR label; Federal Register 78 FR 14095; the trials cited below.

Tesamorelin’s results

In the two phase 3 trials, 806 adults with HIV received 2 mg daily or placebo for 26 weeks [5]. Visceral fat fell with a treatment effect of −15.4%, and IGF-1 rose by a mean of 108 ng/mL. Glucose measures did not change in a clinically meaningful way.

Two trials went beyond HIV. In 60 adults with abdominal obesity and low growth hormone, 12 months of 2 mg daily cut visceral fat by 35 cm² more than placebo, with a 95% CI of −58 to −12 [6]. In 152 adults aged 55 to 87, 20 weeks of 1 mg nightly raised IGF-1 by 117% and lowered percent body fat by 7.4% [7].

Sermorelin’s results

The sermorelin record in adults rests on two studies of older men, neither with a placebo group running alongside it. In 10 men with a mean age of 68, 1 mg twice daily for 14 days raised 24-hour growth hormone and IGF-1 to the levels of young men; 0.5 mg twice daily did not [8].

In 11 men aged 64 to 76, 2 mg injected nightly for 6 weeks raised nighttime growth hormone but did not change IGF-1 [9]. Weight, muscle and fat measured by DEXA scan did not change either, and the authors concluded that a single nightly dose was less effective than several a day.

Sermorelin’s largest study is in children, the use GEREF was approved for. In 110 children with growth hormone deficiency, nightly injections raised mean height velocity from 4.1 to 8.0 cm a year after 6 months, in a trial with no control group [10].

How each was dosed

The tesamorelin trials used 2 mg once daily of the original formulation, and the current labels state 1.28 mg or 1.4 mg depending on the product [1]. The detail is in tesamorelin dosage.

Sermorelin’s only approved treatment regimen was for children, at 30 micrograms per kilogram under the skin at bedtime [3]. The adult studies above used 0.5 mg to 2 mg, once or twice a day, and none of those doses was ever approved. They are laid out in sermorelin dosage.

What the comparison means for a patient

If the question is which molecule has been tested more thoroughly, the answer is tesamorelin, by a wide margin, but only in people with HIV, obesity with low growth hormone, or memory complaints in later life. If the question is which one a pharmacy may lawfully compound, the answer is sermorelin, and only sermorelin.

None of the studies here measured sleep, and none tested either drug for building muscle in healthy younger adults, the use both are often sold for. For how sermorelin compares with a peptide that works on a different receptor, see sermorelin vs ipamorelin.

Frequently asked questions

What is the difference between tesamorelin and sermorelin?
Both copy growth-hormone-releasing hormone. Sermorelin is its first 29 amino acids. Tesamorelin keeps all 44 and adds a hexenoyl group to the first one. Tesamorelin is FDA-approved; sermorelin's approvals were withdrawn in 2009.
Is tesamorelin stronger than sermorelin?
No trial has compared them directly. Tesamorelin has far more and larger placebo-controlled trials, but they measured different outcomes in different people from sermorelin's small studies in older men.
Why can sermorelin be compounded?
In 2013 the FDA determined that GEREF, the approved sermorelin product, was not withdrawn from sale for reasons of safety or effectiveness. That determination is the basis for compounding it. Tesamorelin has no such route: its approval was deemed a biologics license in 2020, and the FDA states such products are not eligible for the compounding exemptions.
What is tesamorelin approved for?
Reducing excess abdominal fat in adults with HIV-associated lipodystrophy. Its label states it is not indicated for weight loss because it has a weight neutral effect.

Sources

12 cited
  1. 1Theratechnologies Inc. (2025). EGRIFTA WR (tesamorelin) for injection, for subcutaneous use: prescribing information (revised 03/2025) DailyMed, U.S. National Library of Medicine. Source
  2. 2Food and Drug Administration (2013). Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Federal Register 78 FR 14095 (March 4, 2013). Source
  3. 3Prakash A, Goa KL (1999). Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency BioDrugs. PMID 18031173
  4. 4Spooner LM, Olin JL (2012). Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy Annals of Pharmacotherapy. PMID 22298602
  5. 5Falutz J, Mamputu JC, Potvin D, et al. (2010). Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data Journal of Clinical Endocrinology and Metabolism. PMID 20554713
  6. 6Makimura H, Feldpausch MN, Rope AM, et al. (2012). Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial Journal of Clinical Endocrinology and Metabolism. PMID 23015655
  7. 7Baker LD, Barsness SM, Borson S, et al. (2012). Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial Archives of Neurology. PMID 22869065
  8. 8Corpas E, Harman SM, Piñeyro MA, et al. (1992). Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men Journal of Clinical Endocrinology and Metabolism. PMID 1379256
  9. 9Vittone J, Blackman MR, Busby-Whitehead J, et al. (1997). Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men Metabolism. PMID 9005976
  10. 10Thorner M, Rochiccioli P, Colle M, et al. (1996). Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group Journal of Clinical Endocrinology and Metabolism. PMID 8772599
  11. 11U.S. Food and Drug Administration (2020). List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 FDA. Source
  12. 12U.S. Food and Drug Administration (2020). Notice to Compounders: Changes that affect compounding as of March 23, 2020 FDA, Human Drug Compounding (content current as of March 5, 2020). Source

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