No approved product on the marketGeref, the only FDA-approved sermorelin, has not been sold since 2008 and its approvals were withdrawn in 2009 at the company's request.[2] The FDA later determined it was not withdrawn for safety or effectiveness reasons.[3] Any sermorelin sold today is not Geref. The calculator does arithmetic only.
What is sermorelin?
Sermorelin is a synthetic copy of the first 29 amino acids of human growth-hormone-releasing hormone (GHRH), the signal that tells the pituitary gland to release growth hormone. It is a peptide, not growth hormone itself.[7][1]
- Sequence
- GHRH(1-29)-NH2: YADAIFTNSYRKVLGQLSARKLLQDIMSR[7]
- Formula and weight
- C149H246N44O42S, 3,357.9 g/mol
- Forms and names
- Sermorelin acetate (the salt used in Geref); Geref was the brand
- What it acts on
- The pituitary gland. Geref's first approval was as a test of "the ability of the somatotroph of the pituitary gland to secrete growth hormone"[1]
- Class
- A GHRH analogue, the class WADA lists in S2.2.4[12]
Because the sermorelin peptide works through the body's own pituitary, its effect depends on a pituitary that can respond. The FDA quoted one line of the Geref label in 2024: "children who do not adequately respond (i.e., peak GH level < 2 ng/mL) should be excluded from Geref therapy".[8]
The Geref story: approved, then discontinued
Sermorelin was approved twice, as a diagnostic in 1990 and as a pediatric treatment in 1997, and both approvals ended in 2009 at the company's request.
| Date | Event |
|---|---|
| Dec 28, 1990[1] | Geref 0.05 mg ampule approved (NDA 19-863) as a diagnostic test of pituitary growth hormone secretion |
| Sept 26, 1997 | Geref 0.5 mg and 1.0 mg vials approved (NDA 20-443) to treat idiopathic growth hormone deficiency in children with growth failure |
| 2008[2] | EMD Serono discontinues both products and asks the FDA to withdraw the applications |
| June 18, 2009 | FDA withdrawal of approval takes effect |
| Mar 4, 2013[3] | FDA determines Geref "not withdrawn from sale for reasons of safety or effectiveness", which allows generic (ANDA) applications |
That 2013 determination is often misread. It means a generic company could apply to make an approved copy of Geref. It does not approve any product, and as of November 2026 none is on the market. The FDA noted in 2024 that, among growth-hormone secretagogues such as CJC-1295, only sermorelin was ever approved, for short stature from growth hormone deficiency in children.[8] The original label is not available on the FDA's site.[1]
Does sermorelin work? What the trials measured
In the largest published study, sermorelin roughly doubled the growth rate of children with growth hormone deficiency over six months. In older men, the two small studies found raised growth hormone but mixed results for IGF-I and strength.
| Study | Who | Amount and route studied | Before → after |
|---|---|---|---|
| Thorner 1996[4] | 110 prepubertal children with GH deficiency (86 evaluable), open-label | 30 µg/kg under the skin at bedtime, daily, up to 1 year | Growth rate 4.1 → 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months; 74% "good" responders at 6 months |
| Corpas 1992[5] | 10 healthy men, average age 68 | 0.5 mg and 1 mg under the skin twice daily, 14 days each | Only the 1 mg dose significantly raised 24-hour GH and IGF-I; no change in glucose or blood pressure |
| Vittone 1997[6] | 11 men aged 64–76 | 2 mg under the skin nightly for 6 weeks | Night-time GH rose; IGF-I did not change; 2 of 6 strength measures improved |
What "before and after" cannot show here. None of these studies reported photographs or body-composition results, the adult studies lasted 2 to 6 weeks in 10 or 11 men, and none of the three was placebo-controlled. Claims about sermorelin and appearance, fat loss or muscle are not supported by the published studies listed above. The 30 µg/kg figure is the pediatric trial's, not a label quotation, and it means micrograms per kilogram of body weight, not a fixed amount.[4]
Sermorelin side effects: what the studies reported
The published studies described sermorelin as well tolerated, but they were small, and the Geref label, which would list side effects, is not available from the FDA.[1]
- Children, up to 1 year (n = 110): "well tolerated", with no adverse biochemical changes.[4]
- Older men, 2 × 14 days (n = 10): no effect on glucose or blood pressure.[5]
- Older men, 6 weeks (n = 11): "No significant adverse effects".[6]
These results describe Geref-era sermorelin given under study conditions. They say nothing about the purity of products sold today as "research use only", which the FDA has called unapproved drugs.[11] See are peptides safe?
Sermorelin vs tesamorelin
Both copy GHRH, but tesamorelin is the full 44-amino-acid hormone and the only one with a current FDA approval, as Egrifta for HIV-associated abdominal fat.[15][13][14] The full comparison, with dates, evidence and side effects, is on sermorelin vs tesamorelin; ipamorelin and CJC-1295 are compared on the HGH peptides page.
Compounding and enforcement
Sermorelin is absent from the FDA's 503A category lists, and the FDA has warned at least one research-use seller of it.
- Compounding lists. Sermorelin is not on the FDA's 503A category lists.[9] The 503B list for outsourcing facilities marks sermorelin acetate as a component of an FDA-approved drug.[10] We found no FDA statement addressing sermorelin under 503A specifically.
- Research-use sellers. In December 2024 the FDA warned a seller that marketed sermorelin "for research use only" while claiming it helped weight loss, calling it an unapproved new drug.[11]
- Sport. WADA 2026 S2.2.4 names sermorelin; it is prohibited at all times.[12]
Sermorelin dosage calculator: the arithmetic
The sermorelin dosage calculator above converts any amount you enter into syringe units; this chart shows what one unit holds at each mix. The vial sizes below include Geref's historic 0.5 mg and 1.0 mg strengths. Nanomoles use 3,357.9 g/mol: 100 mcg is 29.8 nmol.
| Vial + liquid | mg/mL | mcg per unit | nmol per unit | Units per 100 mcg |
|---|---|---|---|---|
| 0.5 mg + 0.5 mL | 1 | 10 | 2.98 | 10 |
| 0.5 mg + 1 mL | 0.5 | 5 | 1.49 | 20 |
| 0.5 mg + 2 mL | 0.25 | 2.5 | 0.74 | 40 |
| 1 mg + 0.5 mL | 2 | 20 | 5.96 | 5 |
| 1 mg + 1 mL | 1 | 10 | 2.98 | 10 |
| 1 mg + 2 mL | 0.5 | 5 | 1.49 | 20 |
| 2 mg + 0.5 mL | 4 | 40 | 11.91 | 2.5 |
| 2 mg + 1 mL | 2 | 20 | 5.96 | 5 |
| 2 mg + 2 mL | 1 | 10 | 2.98 | 10 |
Example arithmetic: 1 mg in 1 mL holds 10 mcg per unit, so 100 mcg is 10 units. Because sermorelin vials are small, a 0.3 mL (30-unit) syringe fills quickly at weak dilutions; check the "largest amount each syringe holds" table on the peptide dosage chart page.
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
- CJC-1295 / ipamorelinNot approved Two growth-hormone secretagogues, often sold together. Both rejected for compounding in 2024.
- AOD-9604Not approved Growth hormone fragment. Obesity trials failed; committee voted 0–12.
- GHRP-6Not approved Growth hormone-releasing hexapeptide. On FDA 503B Category 2.
- HexarelinNot approved GHRP-6 plus one methyl group. Studied in the 1990s, never approved.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
Frequently asked questions
What is sermorelin?
Does sermorelin work?
Is sermorelin safe?
What is sermorelin acetate?
The acetate salt of sermorelin, the form used in Geref, the discontinued FDA-approved product.[3]
Is sermorelin FDA-approved?
It was, as Geref, from 1990 (diagnostic) and 1997 (treatment). The approvals were withdrawn in 2009 at the company's request, and no approved sermorelin product is on the market now.[2]
Why was Geref discontinued?
EMD Serono discontinued it in 2008. In 2013 the FDA determined it was not withdrawn for reasons of safety or effectiveness.[3] The FDA notice does not give the company's business reasons.
How many units is 100 mcg of sermorelin?
It depends on the mix. From a 1 mg vial with 1 mL, 100 mcg is 10 units; with 2 mL it is 20 units. This is arithmetic, not a suggested amount.
Sources
- Drugs@FDA: Geref (sermorelin acetate), NDA 020443
- Withdrawal of approval of 92 new drug applications, including Geref (74 FR 23407)
- Determination that Geref (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (78 FR 14095)
- Thorner M et al. Sermorelin in prepubertal children with growth hormone deficiency (JCEM 1996;81:1189–96)
- Corpas E et al. GHRH(1-29) twice daily in older men (JCEM 1992;75:530–5)
- Vittone J et al. Nightly GHRH(1-29) in healthy older men (Metabolism 1997;46:89–96)
- PubChem CID 16132413: sermorelin
- FDA briefing document: CJC-1295-related bulk drug substances
- Bulk drug substances nominated for use in compounding under section 503A (category lists)
- Bulk drug substances nominated for use in compounding under section 503B (category lists)
- Warning letter: Xcel Research LLC
- World Anti-Doping Code: Prohibited List 2026
- Drugs@FDA: Egrifta (tesamorelin), BLA 022505
- Egrifta SV (tesamorelin) prescribing information
- PubChem CID 16137828: tesamorelin