Sermorelin

Sermorelin is a synthetic peptide representing the first 29 amino acids of human growth hormone-releasing hormone (GHRH), the smallest fragment shown to retain full biological activity. It was FDA-approved, sold as Geref (diagnostic use in 1990, treatment in 1997), for diagnosing and treating growth hormone deficiency in children, but the products were discontinued, and in 2013 FDA determined they were not withdrawn from sale for reasons of safety or effectiveness. It is no longer FDA-approved for any use, though compounded versions are sold by pharmacies and clinics, most commonly used off-label in adults for age-related growth hormone decline.

Research snapshot

Category	Current information
Peptide category	Growth hormone-releasing hormone (GHRH) analog, secretagogue
Primary research interest	Stimulating endogenous growth hormone release; historically studied for pediatric growth hormone deficiency
Highest available evidence	Published pediatric clinical trials, mostly open label, plus the original FDA approval (since discontinued for commercial reasons)
Human research available	Yes – pediatric GHD trials supporting the original approval; limited adult data
Development status	Formerly FDA-approved (Geref, 1997); discontinued, and FDA found in 2013 it was not withdrawn for safety or effectiveness reasons; compounded versions are sold by pharmacies and clinics
Regulatory status	Not currently an FDA-approved product; historical approval was withdrawn from the market by its sponsor

Technical identity

Technical property	Information
Primary name	Sermorelin
Alternative names	GRF(1-29), GRF 1-29 NH2, GHRH(1-29), Sermorelin acetate, Geref (brand name, discontinued)
Peptide sequence	H-Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-NH2
Amino-acid length	29 residues
Molecular formula	C149H246N44O42S
Molecular weight	3357.93 g/mol
CAS Registry Number	86168-78-7
PubChem CID	16132413
Chemical modifications	C-terminal amidation; corresponds to the biologically active N-terminal 1-29 fragment of native 44-residue human GHRH
Peptide class	Growth hormone-releasing hormone (GHRH) analog
Primary biological target	Growth hormone-releasing hormone receptor (GHRHR) on pituitary somatotrophs
Developer or originator	Originally developed as Geref by Serono (later Merck Serono)
Development status	Formerly FDA-approved; discontinued; now compounded

What it is

Sermorelin (GRF 1-29, or GHRH 1-29) is a synthetic 29 amino acid peptide corresponding to the biologically active N-terminal fragment of human growth hormone-releasing hormone, the hypothalamic hormone that signals the pituitary gland to release growth hormone. Serono Laboratories developed it and the FDA approved it, sold as Geref (diagnostic use in 1990, treatment in 1997), for two pediatric uses: as a diagnostic test for growth hormone deficiency and as a treatment for children with idiopathic growth hormone deficiency or growth failure. Geref is no longer marketed, and in 2013 FDA determined it was not withdrawn from sale for reasons of safety or effectiveness. Sermorelin is not currently FDA-approved for any indication, though compounded versions are sold by pharmacies and clinics.

How does it work?

Plain-English explanation

The pituitary gland releases growth hormone in natural pulses, prompted by GHRH from the hypothalamus. Sermorelin mimics that natural signal, telling the pituitary to release its own growth hormone rather than supplying growth hormone directly, the way injectable recombinant human growth hormone does. Because it works through the body’s own feedback system, the pituitary’s natural braking mechanisms stay intact.

Technical explanation

Sermorelin binds the growth hormone-releasing hormone receptor on pituitary somatotrophs, stimulating pulsatile GH secretion that remains subject to somatostatin-mediated negative feedback, in contrast to exogenous recombinant human growth hormone, which bypasses the pituitary and hypothalamic feedback loop entirely. This pulsatile, feedback-regulated release is the basis for the claim that sermorelin carries a lower risk of the tachyphylaxis and dysregulated GH/IGF-1 signaling associated with direct rhGH administration, though this comparative claim is theoretical and mechanism-based rather than demonstrated in a head-to-head outcomes trial.

Potential benefits and research applications

Growth hormone deficiency and growth failure in children (the FDA-approved historical use)

What is being investigated: this is not currently under investigation; it describes sermorelin’s original, now-lapsed approval. How the effect might occur: GHRH receptor stimulation restoring or supplementing endogenous GH pulses in children whose own GHRH signaling is insufficient. Evidence: sermorelin (Geref) was FDA-approved in 1997 for diagnosing growth hormone deficiency and treating idiopathic GHD or growth failure in children, based on the trial data supporting that approval. Strength: was shown sufficient for FDA approval at the time. Limitation: the drug is no longer FDA-approved or commercially manufactured for this use; Geref is no longer marketed (FDA found in 2013 it was not withdrawn for safety or effectiveness reasons), and pediatric GHD is now treated with recombinant human growth hormone as standard of care.

Off-label growth hormone support in adults with age-related GH decline

What is being investigated: whether stimulating a person’s own GH release can address age-related decline in growth hormone and IGF-1 levels. How the effect might occur: the same GHRH receptor mechanism used in the pediatric approval, applied to a different population and goal. Evidence: sermorelin is prescribed off-label for this purpose by compounding-pharmacy-affiliated anti-aging and hormone clinics, and its mechanism is well described, but this site did not identify a modern, placebo-controlled, published human trial specifically evaluating sermorelin for anti-aging or age-related GH decline outcomes such as body composition, strength, or quality of life. Strength: the underlying GHRH-receptor mechanism is well established from the pediatric drug development era. Limitation: has not been established for adult anti-aging use in a dedicated modern trial; this is a widely practiced off-label use built on mechanistic plausibility and the drug’s original approval for a different population and purpose, not on new controlled human data for this specific application.

General claims made for sermorelin (muscle, fat loss, cognition, sleep, skin, immunity, longevity)

What is being investigated: whether raised endogenous GH and IGF-1 from sermorelin use produces the wide range of benefits commonly claimed for it. How the effect might occur: downstream effects of growth hormone and IGF-1 signaling, which are broadly plausible in general terms since GH does affect metabolism, body composition, and tissue repair. Evidence: no established or reliably sourced human clinical evidence was identified for sermorelin specifically producing improved cognition, sleep quality, skin appearance, immune function, or extended lifespan; a source document supplied as background for this entry made all of these claims but supported every one of them only with unsourced references to “lab animals,” without citing a single named study. Strength: has been reported anecdotally, in marketing material, and by prescribing clinics, not in peer-reviewed human trials for these specific outcomes. Limitation: this is a wide list of benefits attached to a single mechanism with essentially no cited primary evidence behind most of the individual claims.

Figures in this table summarize amounts described in the original FDA-approved prescribing information for pediatric growth hormone deficiency, and amounts reported by compounding pharmacies and practitioners for off-label adult use. Their inclusion documents what is reported and does not establish that a regimen is verified, safe, effective, or appropriate for any individual.

Reported use or research objective	Route reported	Amount reported	Frequency reported	Reported duration	Evidence or source category
Pediatric growth hormone deficiency (original FDA-approved indication)	Subcutaneous	Weight-based dosing per the original approved label (not reproduced here; a licensed prescriber’s dosing decision)	Once daily, at bedtime	Ongoing, per physician monitoring	FDA-approved prescribing information (discontinued product)
Off-label adult GH support (age-related decline)	Subcutaneous	Commonly reported in the range of ~200-300 mcg	Once daily, at bedtime	Weeks to months, cycled per practitioner	Practitioner / compounding-pharmacy reported – not traced to a controlled clinical trial

What dosage information circulates?

Figures in this section summarize amounts and schedules reported in published research or circulating online. Their inclusion documents what is reported and does not establish that a regimen is verified, safe, effective, or appropriate.

Sermorelin’s only FDA-reviewed dosing was for its lapsed pediatric indication. Its current, far more common use, off-label in adults through compounding pharmacies, is not FDA-reviewed, and this site did not identify a controlled clinical trial establishing a specific adult dose.

Amounts studied in human research

Research objective	Amount studied	Frequency	Duration	Route	Study population	Source
Diagnosing growth hormone deficiency	1 microgram/kg, single dose	One time	Single test	Intravenous	Children with suspected GH deficiency	Prakash and Goa 1999 (review)
Treating childhood GH deficiency (the Geref regimen)	30 micrograms/kg per day	Once daily at bedtime	Up to 1 year	Subcutaneous	110 prepubertal GH-deficient children (86 evaluable), open label, no control group	Thorner 1996
Dose comparison in hypothalamic GH deficiency	30 or 60 micrograms/kg per day, versus GH 0.1 IU/kg per day	Three divided doses daily	6 months	Subcutaneous	43 prepubertal children, randomized	Neyzi 1993
Radiation-induced GH deficiency	15 micrograms/kg	Twice daily	1 year	Subcutaneous	9 children, uncontrolled	Ogilvy-Stuart 1997
Idiopathic short stature	20 micrograms/kg	Twice daily	12 months	Subcutaneous	18 short prepubertal children (one withdrew), uncontrolled	Kirk 1994
Absorption and GH release in healthy men	0.25 to 2 micrograms/kg intravenous; up to about 50 micrograms/kg intranasal	Single doses; one arm repeated intranasal dosing three times in a day	Single sessions	Intravenous and intranasal	30 healthy men aged 19 to 43	Wilton 1993
Adults aged 55 to 71 (a modified analog, not sermorelin itself)	10 micrograms/kg of [Nle27]GHRH(1-29)-NH2	Nightly, about 9 pm	16 weeks, after 4 weeks of placebo	Subcutaneous	19 adults, single blind, placebo-controlled	Khorram 1997

In plain English: in children with diagnosed growth hormone deficiency, sermorelin at 30 micrograms/kg a day roughly doubled growth speed in the first six months of an open-label study, from 4.1 to 8.0 cm a year, and 7.2 cm a year at 12 months (Thorner 1996). In a randomized comparison the 30 micrograms/kg arm grew slowest of three, while 60 micrograms/kg and daily growth hormone were about equal (Neyzi 1993). A review of the program notes the gains were smaller than those seen in children given daily growth hormone, although the two were not compared directly in the label trials (Prakash and Goa 1999). These are weight-based pediatric regimens for a diagnosed deficiency, a different situation from an adult using it for general anti-aging purposes.

Adult evidence is thin. The one randomized, placebo-controlled adult trial this site found used a modified analog, [Nle27]GHRH(1-29)-NH2, not sermorelin itself, in 19 people for 16 weeks. Nightly injections raised overnight growth hormone and IGF-I within two weeks, although IGF-I drifted back toward baseline by week 16; skin thickness rose in both sexes, lean mass rose in men only, and the one adverse effect reported was transient high blood lipids (Khorram 1997). It is a small, short trial of a different molecule, so it does not validate any adult sermorelin amount.

For scale only: 30 micrograms/kg is about 2,100 micrograms for a 70 kg person, roughly seven to ten times the 200 to 300 microgram figure that circulates for adults. No trial this site found tested whether a flat 200 to 300 microgram nightly amount changes growth hormone or IGF-I in adults, so the clinic figure is not a scaled-down version of anything published. This arithmetic is an illustration, not a suggested amount.

Practitioner and community-reported protocols

Widely repeated online: adult anti-aging and hormone-optimization clinics commonly describe sermorelin dosed in the range of roughly 200 to 300 micrograms by subcutaneous injection at bedtime, timed to coincide with the body’s largest natural nightly GH pulse. This figure is widely repeated across compounding-pharmacy and clinic websites, but this site did not trace it to a specific, controlled, published human trial establishing it as an optimal or validated adult dose; it should be treated as a practitioner-reported convention rather than an established clinical finding.

Side effects, risks, and limitations

Reported side effects for sermorelin include injection site reactions, flushing, headache, and dizziness; because it stimulates the body’s own GH release rather than supplying GH directly, it is generally described as carrying a different, and possibly more limited, risk profile than direct rhGH regarding GH/IGF-1 overshoot, though this comparative safety claim has not been established through a dedicated head-to-head trial. As a peptide no longer subject to FDA post-marketing surveillance for a current indication, and typically obtained through compounding pharmacies, the consistency of compounded product quality is a separate practical consideration from the drug’s own pharmacological safety profile.

Regulatory and developmental status

Sermorelin has no FDA-approved product on the market today. Per FDA records, Geref was approved in two steps: a 0.05 mg ampule as a diagnostic (NDA 19-863, 28 December 1990) and 0.5 mg and 1 mg vials for treating childhood growth hormone deficiency (NDA 20-443, 26 September 1997), both held by EMD Serono and now discontinued. In a notice dated 26 February 2013 (published 4 March 2013), FDA determined that these products were not withdrawn from sale for reasons of safety or effectiveness, which allows FDA to approve generic applications that refer to them if other requirements are met.

Compounded sermorelin is sold by pharmacies and clinics. This page did not find an FDA document that places sermorelin on a 503A bulk drug substances list, and it does not appear on the FDA page listing Category 2 substances that may present significant safety risks (read 8 October 2026). It was also not among the seven substances the FDA advisory committee voted on in July 2026 (BPC-157, KPV, TB-500, MOTS-c, epitalon, semax and emideltide), according to a law-firm summary. Whether a given pharmacy can lawfully compound it depends on the pathway that pharmacy relies on, which this page has not verified, and the landscape can shift as FDA acts on the July votes.

Frequently asked questions

What is sermorelin?

A synthetic 29 amino acid fragment of human growth hormone-releasing hormone (GHRH), formerly FDA-approved (as Geref) for pediatric growth hormone deficiency, now used off-label in adults and obtained through compounding pharmacies.

Is sermorelin FDA approved?

It was, from 1997 as Geref for a pediatric indication, but the product is discontinued, and FDA found in 2013 it was not withdrawn for safety or effectiveness reasons. It is not FDA-approved for any use today.

How does it work?

It stimulates the pituitary gland to release its own growth hormone, rather than supplying growth hormone directly the way injectable recombinant human growth hormone does.

What dosage has been studied?

In children with growth hormone deficiency: 30 micrograms/kg once daily at bedtime (the Geref regimen, tested in a 110-child open-label study), and in other trials 15 to 20 micrograms/kg twice daily or 30 to 60 micrograms/kg per day in three doses. For diagnosis, a single 1 microgram/kg intravenous dose. No adult trial of sermorelin itself was found; one 19-person adult trial used a modified analog at 10 micrograms/kg nightly.

What dosage commonly circulates online?

A nightly subcutaneous dose of roughly 200 to 300 micrograms is widely repeated across compounding-pharmacy and anti-aging clinic sources, but this site could not trace that figure to a specific, controlled, published human trial; it functions as a practitioner convention rather than an established finding.

Has it been studied in humans?

Yes. Sermorelin was tested in children with growth hormone deficiency, idiopathic short stature and radiation-induced deficiency, mostly in open-label studies of up to a year, plus small pharmacokinetic studies in healthy men. Adult data are thin: a 19-person randomized, placebo-controlled trial used a modified analog rather than sermorelin itself.

Does it help with muscle, fat loss, sleep, skin, or longevity?

No established or reliably sourced human clinical evidence was identified for these specific claims. They are commonly made by clinics and marketing material, sometimes citing only unspecified animal research without naming a study.

Is it available legally?

It can be obtained through 503A compounding pharmacies under an individual prescription, though it is not FDA-approved for any current indication and its regulatory status for routine compounding has been under ongoing review.

What remains unknown?

Whether the wide range of anti-aging and wellness claims made for adult sermorelin use hold up in controlled human trials, and what an optimal, validated adult dose actually is, since no such trial was identified.

Bottom line

Sermorelin has a genuine history as an FDA-approved drug (Geref, 1997) for pediatric growth hormone deficiency, discontinued, and FDA determined in 2013 it was not withdrawn for reasons of safety or effectiveness. Its mechanism, stimulating the body’s own GH release through the GHRH receptor, is well established from that era. Its much more common present-day use, off-label in adults through compounding pharmacies, rests on that older mechanistic foundation rather than on a body of new, controlled human trials for anti-aging or wellness outcomes, and the wide list of benefits often attached to it (cognition, sleep, skin, immunity, longevity) is supported mainly by marketing material and unsourced animal claims rather than named, citable human studies.