Sermorelin: The Complete Guide, From Geref to the Compounding Pharmacy

What sermorelin is

Growth hormone-releasing hormone (GHRH) is a 44-amino-acid hormone from the hypothalamus that tells the anterior pituitary to release growth hormone. Its activity sits in the first 29 amino acids, and sermorelin is that fragment with an amide at the end: GHRH(1-29)-NH2. A 1999 review describes it as the shortest synthetic peptide with the full biological activity of the natural hormone, and notes that given into a vein or under the skin it specifically stimulates growth hormone secretion ¹.

That distinguishes it from growth hormone itself. Sermorelin supplies no hormone; it asks the pituitary for some, so the response depends on a pituitary that can answer. Two later drugs start from the same place: CJC-1295 modifies the same 29-amino-acid sequence to make it last for days, and tesamorelin modifies the full 44-amino-acid hormone and is approved in the US for HIV-associated abdominal fat.

Approved twice, then discontinued

Sermorelin reached the US market twice under the brand name Geref, both times from EMD Serono. FDA approved a 0.05 mg ampoule for testing the pituitary's growth hormone reserve on December 28, 1990 (NDA 019863), and 0.5 mg and 1.0 mg vials on September 26, 1997 (NDA 020443) ². The vials were used as a nightly injection for prepubertal children with idiopathic growth hormone deficiency ¹. Drugs@FDA lists both applications as discontinued.

Why they were discontinued is not in the sources we hold, and the often-repeated line that manufacturing stopped "in 2008 for business reasons" has no citation we could find. What is on record is FDA's decision of March 4, 2013: Geref was not withdrawn from sale for reasons of safety or effectiveness ³. That determination matters legally, because it lets a company file an abbreviated application that refers to Geref. None has been approved, as far as we could find.

The evidence in children

As a test. In the 1999 review, an intravenous dose of 1 µg/kg was a rapid and relatively specific test for growth hormone deficiency, with fewer false positives in children without deficiency than other provocative tests. A normal response could not rule out deficiency caused by the hypothalamus, so other tests were needed to confirm those cases ¹. A 1994 study extended the idea: sixteen short children who had failed a first GHRH test received GHRH(1-29)-NH2, 5 µg/kg under the skin, for six days. In eight the growth hormone response to a repeat test rose from 6.0 to 18.0 ng/mL; in the other eight priming did not raise it. The test separated children whose pituitary cells were under-stimulated from those with a pituitary deficiency ⁴.

As a treatment. Limited data in the review showed that once-daily injections of 30 µg/kg at bedtime raised height velocity in some prepubertal children with idiopathic growth hormone deficiency, sustained over 12 months of treatment, with data in a few children suggesting the effect lasted 36 months. Its effect on final adult height had not been determined ¹.

Other routes. In 1986, five healthy prepubertal children with short stature received 100 µg/kg as a nasal spray. Growth hormone rose promptly in all five, peaking at 15 minutes, and one child had a burning nose ⁵. No nasal product was approved.

What has been studied in adults

Adult use is a different matter from the evidence above. The adult studies in our set are small and physiological:

• Seventeen healthy young adults given 150 µg into a vein recalled more words from a list two hours later than six given placebo (14.8 against 11.8), with growth hormone peaking 15 to 45 minutes after the injection. The groups were small and different people, not the same people tested twice ⁶.
• In eight people with acromegaly, blocking muscarinic receptors did not change the growth hormone response to 1 µg/kg, unlike in healthy people, which the authors read as tumours disconnected from hypothalamic control ⁷.
• A 2006 commentary asked whether sermorelin was a better approach to adult-onset growth hormone insufficiency; it has no abstract, and it reports no trial ⁸.

None of these studies tested sermorelin for body composition, muscle, fat loss, sleep, ageing or wellbeing, the purposes for which it is marketed to adults today, and none followed adults for months. The pediatric results cannot be transferred: they were in children with a diagnosed deficiency, at weight-based doses, under specialist care.

A peptide that is hard to deliver

Sermorelin is not an easy molecule to keep in solution. In laboratory tests it precipitated in salt solutions and in plasma, where it formed complexes with albumin, transferrin, haptoglobin and immunoglobulin G. Loaded into biodegradable pellets implanted under the skin of rats, it was released slowly despite this, but only a very small part of the dose reached the blood ⁹. No pharmacokinetic study in people is in our evidence set, and the Geref labels were withdrawn with the product, so figures for its half-life that circulate online have no source here.

Safety

The studies above report few problems, but they were short and small: a burning nose in one of five children given a nasal dose ⁵, nothing notable in single intravenous doses in adults ^{6 7}. The pediatric program ran for years under specialist care, and the review describes nightly treatment of children for up to 36 months in a few cases ¹; the full Geref safety labeling is no longer published. There are no long-term safety data in healthy adults in our evidence set, and none for compounded products, whose quality depends on the pharmacy that makes them.

Claims you will see, checked

• "It is an FDA-approved anti-aging peptide." It was approved as Geref for diagnosing and treating growth hormone deficiency in children, and both products are discontinued ². No approval covered adults or ageing.
• "It has decades of safety data." Its data are pediatric and diagnostic ¹. We found no long-term study in healthy adults.
• "It is safer than growth hormone because it keeps your natural feedback." It works through the pituitary, which is real ¹, but no study compares its safety or benefit with growth hormone in adults.
• "It was pulled for business reasons, not safety." FDA determined in 2013 that Geref was not withdrawn for safety or effectiveness ³. The reason and the date of discontinuation are not in that notice, and the "2008" date has no source we could find.
• "It won't show up on a drug test." WADA names it under S2.2.4 ¹⁰.

Dosing: what was studied and what circulates

The studied doses were weight-based and given to children or as single tests. Adult clinic schedules are fixed doses with no outcome trial behind them. If you are checking the arithmetic of a vial, the calculator below converts milligrams to syringe units; it cannot tell you whether a dose works.

Legal status in the US and in sport

United States. Sermorelin was approved as Geref and both products are discontinued; FDA's 2013 determination that Geref was not withdrawn for safety or effectiveness allows abbreviated applications, and none has been approved as far as we could find ^{2 3}. Sermorelin is not on FDA's 503A category lists (updated May 14, 2026) and is not in 503B Category 2 ¹¹. It is sold today through compounding pharmacies on prescription.

Sport. WADA's 2026 Prohibited List names sermorelin under S2.2.4, among the growth hormone-releasing factors prohibited at all times, and the 2027 List keeps it there ^{10 12}.

How it compares with other growth hormone peptides

Of the GHRH-type peptides, only tesamorelin holds a current US approval, for a specific condition in people with HIV. Sermorelin's approvals were for children and are no longer active.

Frequently asked questions

Is sermorelin FDA-approved?

It was: as Geref, a diagnostic ampoule approved on December 28, 1990 and treatment vials approved on September 26, 1997, for children with growth hormone deficiency. Both are discontinued. In 2013 FDA determined Geref was not withdrawn for reasons of safety or effectiveness.

Does sermorelin work in adults?

It raises growth hormone in adults, but no study in our evidence set tested it for body composition, ageing or wellbeing. Its treatment evidence comes from prepubertal children with diagnosed deficiency.

What was the approved dose?

In children, 30 µg/kg under the skin at bedtime for treatment, and 1 µg/kg into a vein as a single diagnostic test, according to the 1999 review. No dose was approved for adults.

Can a pharmacy compound sermorelin?

Sermorelin is not on FDA's 503A category lists and is not in 503B Category 2, and compounding pharmacies sell it on prescription (as of September 28, 2026).

Is sermorelin banned in sport?

Yes. WADA's 2026 and 2027 Prohibited Lists name sermorelin under S2.2.4, prohibited at all times.

Related on Grey Peptides

• Sermorelin encyclopedia entry
• CJC-1295 encyclopedia entry
• Tesamorelin encyclopedia entry
• CJC-1295: the complete guide
• Regulatory tracker
• Reconstitution calculator

Sources

1. Prakash, A. & Goa, K. L. (1999). Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs, 12(2), 139-57. PMID: 18031173
2. U.S. Food and Drug Administration. Drugs@FDA: Geref (sermorelin acetate), NDA 019863 (0.05 mg ampoule, approved December 28, 1990) and NDA 020443 (0.5 mg and 1 mg vials, approved September 26, 1997), EMD Serono; both discontinued (read September 28, 2026).
3. U.S. Food and Drug Administration. Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness. Federal Register 78:14096, March 4, 2013 (Docket FDA-2012-P-1071). Federal Register notice
4. Bueno, G. et al. (1994). Priming with GHRH (1-29) NH2: an aid in differential diagnosis between hypothalamic and pituitary deficiencies. J Pediatr Endocrinol, 7(4), 309-16. PMID: 7735368
5. Borkenstein, M. (1986). The effects of intranasal insufflation of growth hormone releasing factor analogue GRF 1-29 NH2 on growth hormone secretion in children with short stature. Acta Endocrinol Suppl (Copenh), 279, 135-8. PMID: 2877535
6. Alvarez, X. A. & Cacabelos, R. (1990). Effects of GRF (1-29) NH2 on short-term memory: neuroendocrine and neuropsychological assessment in healthy young subjects. Methods Find Exp Clin Pharmacol, 12(7), 493-9. PMID: 2087150
7. Jordan, V. et al. (1986). Lack of effect of muscarinic cholinergic blockade on the GH responses to GRF 1-29 and TRH in acromegalic subjects. Clin Endocrinol (Oxf), 24(4), 415-20. PMID: 2874906
8. Walker, R. F. (2006). Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging, 1(4), 307-8. PMID: 18046908
9. Mariette, B. et al. (2005). Interactions of GRF(1-29)NH2 with plasma proteins and their effects on the release of the peptide from a PLAGA matrix. J Control Release, 106(3), 253-62. PMID: 15987661
10. World Anti-Doping Agency. The 2026 Prohibited List, section S2.2.4 (read September 27, 2026). WADA 2026 List
11. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (current as of April 22, 2026), and Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated May 14, 2026). FDA Category 2 page
12. World Anti-Doping Agency. The 2027 Prohibited List, in force January 1, 2027 (read September 27, 2026). WADA 2027 List

This article is for education. It is not medical or legal advice, and it is not a guide to buying or using any peptide. Sermorelin's US approvals are discontinued, and it is prohibited in sport.