Comparison
Sermorelin vs Tesamorelin: FDA status and research
Sermorelin vs tesamorelin: two GHRH analogs. One was approved and discontinued, one is FDA approved today. Studies, half-life, compounding and WADA.
| Sermorelin | Tesamorelin | |
|---|---|---|
| FDA status | Once approved as Geref (1990, 1997). Discontinued in 2008 and approvals withdrawn in 2009, not for safety or effectiveness reasons [1, 2] | FDA approved since 2010. Sold as Egrifta SV and Egrifta WR [7, 9] |
| Studied for | Growth hormone deficiency in children, and as a test of pituitary function [3, 4] | Labeled to reduce excess belly fat in adults with HIV and lipodystrophy. Also studied for liver fat in HIV [7, 11] |
| Route | IV for the diagnostic test; under the skin for daily use [3] | Under the skin once daily [7] |
| Key trials | Geref study in 110 children; a small study in 11 older men [4, 6] | Phase 3 trial in 412 adults with HIV; liver fat trial in 61 adults [10, 11] |
| What it is | The first 29 amino acids of human GHRH [3] | All 44 amino acids of human GHRH plus a hexenoyl group [7] |
| Half-life | About 4.3 minutes after IV infusion of GHRH 1-29 (10 healthy men) [5] | 8 minutes (Egrifta SV) to 11 minutes (Egrifta WR) in healthy adults (label) [8, 7] |
| Compounding | Sermorelin acetate is in 503B category 1 and is not in any 503A category [13, 14] | Regulated as a biologic since March 23, 2020, so not eligible for 503A or 503B compounding [9, 15] |
| WADA | Banned at all times under S2.2.4 [12] | Banned at all times under S2.2.4 [12] |
Sermorelin and tesamorelin are both lab-made versions of growth hormone-releasing hormone (GHRH). Both signal the pituitary gland to release the body's own growth hormone [3, 7]. The key difference is status. Tesamorelin is FDA approved today as Egrifta SV and Egrifta WR [7, 8]. Sermorelin was approved as Geref, but the products were discontinued in 2008 and no FDA-approved sermorelin is sold now [1, 2].
Size and how long they last
Sermorelin matches the first 29 amino acids of human GHRH. It is the shortest synthetic piece with the full activity of GHRH [3]. Tesamorelin has all 44 amino acids of human GHRH, plus a small fatty acid group on the first amino acid [7].
Both leave the blood fast. In 10 healthy men given an IV infusion of GHRH 1-29, the half-time was about 4.3 minutes [5]. The tesamorelin labels list a mean half-life of 8 minutes for Egrifta SV and 11 minutes for Egrifta WR [8, 7]. Both were given once daily in studies [4, 10].
What each was studied for
Sermorelin was studied for growth hormone deficiency in children. In the Geref study, 110 children got 30 mcg/kg under the skin at bedtime for up to a year. Mean growth rose from 4.1 cm per year to 7.2 cm per year at 12 months [4]. In 11 healthy men aged 64 to 76, nightly doses for 6 weeks raised growth hormone release at night [6]. A single IV dose was also used as a test of pituitary function [3].
Tesamorelin was studied in adults with HIV and extra belly fat. In a phase 3 trial of 412 adults, fat deep in the belly fell 15.2% on tesamorelin 2 mg daily and rose 5.0% on placebo over 26 weeks [10]. It was also studied for fatty liver in HIV. In a 12-month trial of 61 adults, liver fat fell more than with placebo [11]. Fatty liver is not an approved use, and the label says it is not for weight loss [7]. See the sermorelin and tesamorelin pages for full details.
Safety
In the Geref data, brief facial flushing and injection site pain were the most common side effects [3]. In 2013, FDA found that neither Geref product was withdrawn from sale for safety or effectiveness reasons [1].
The tesamorelin label has no boxed warning. It must not be used by people with a disrupted pituitary axis, active cancer, or in pregnancy. Warnings include raised IGF-1, fluid retention, and glucose intolerance or diabetes [7].
Compounding and sport
FDA's 503B list, updated March 21, 2025, places sermorelin acetate in category 1 and marks it as a component of an FDA-approved drug [13]. Sermorelin is not in any 503A category on FDA's list updated May 14, 2026 [14].
Tesamorelin has been regulated as a biologic since March 23, 2020 [9]. FDA says biological products that moved over on that date are not eligible for the 503A and 503B compounding exemptions [15]. See the FDA Peptide Status Tracker for updates.
WADA names both under S2.2.4, growth hormone releasing factors, banned in and out of competition [12].
Frequently asked questions
Is sermorelin the same as tesamorelin?
No. Both are GHRH analogs. Sermorelin has 29 amino acids [3]. Tesamorelin has 44 amino acids plus a hexenoyl group [7].
Is sermorelin FDA approved?
Not today. Geref was approved in 1990 and 1997, discontinued in 2008, and its approvals were withdrawn in 2009 [1].
Is tesamorelin FDA approved?
Yes. It was approved in 2010 and is sold as Egrifta SV and Egrifta WR [9, 7].
Is tesamorelin approved for weight loss?
No. The label says it is not for weight loss because it has a weight neutral effect [7].
Can sermorelin or tesamorelin be compounded?
Sermorelin acetate is in 503B category 1 [13]. Tesamorelin is a biologic and is not eligible for 503A or 503B compounding [15, 9].
Are sermorelin and tesamorelin banned in sports?
Yes. WADA lists both under S2.2.4, banned at all times [12].
Sources
- Federal Register 2013-04827: Geref not withdrawn for safety or effectiveness (FDA)
- Drugs@FDA: NDA 020443 (Geref 0.5 mg and 1 mg vials)
- Prakash and Goa 1999, BioDrugs, sermorelin review (PubMed)
- Thorner et al. 1996, J Clin Endocrinol Metab (PubMed)
- Soule et al. 1994, J Clin Endocrinol Metab (PubMed)
- Vittone et al. 1997, Metabolism (PubMed)
- DailyMed: Egrifta WR (tesamorelin) label
- DailyMed: Egrifta SV (tesamorelin) label
- Drugs@FDA: BLA 022505 (Egrifta)
- Falutz et al. 2007, N Engl J Med (PubMed)
- Stanley et al. 2019, Lancet HIV (PubMed)
- WADA: 2026 Prohibited List
- FDA: Bulk drug substances nominated under section 503B (categories, updated March 21, 2025)
- FDA: Bulk drug substances nominated under section 503A (categories, updated May 14, 2026)
- FDA: Notice to Compounders, changes as of March 23, 2020