Sermorelin

A synthetic copy of the first 29 amino acids of the body's own growth-hormone-releasing hormone — the whole of that hormone's working end — with the chain capped by an amide group. It was an American medicine sold as Geref: first as a test of whether the pituitary gland can release growth hormone (approved 28 December 1990), then as a treatment for growth failure in children who cannot make enough growth hormone (approved 26 September 1997). Both approvals were withdrawn effective 18 June 2009 after the manufacturer stopped making it. It is now sold as a compounded injection by anti-ageing and hormone clinics, and online under research labelling.

Sold as

Injection under the skin as it is sold; injection into a vein for the diagnostic test it was approved for.

Legal status in the EU

Not approved as a medicine in the EU, Sweden or anywhere else. A review prepared for the FDA in December 2020 searched the medicines registers of 13 countries and regions, including the EU, the UK and Ireland, and found no approved sermorelin product in any of them; its only approvals were the two American ones, both withdrawn in 2009. In the United States a pharmacy may compound from a raw substance only if that substance has a US Pharmacopeia entry, is a component of an approved medicine, or appears on the FDA's 503A list — sermorelin is none of the three, and it does not appear on the FDA's category 2 list of substances flagged for significant safety risks either. Named on the WADA 2026 Prohibited List, section S2.2.4, growth hormone releasing factors, alongside CJC-1293, CJC-1295 and tesamorelin.

It binds the GHRH receptor on the pituitary gland and makes the gland release growth hormone, which in turn raises IGF-1 in the blood. Because it pushes a gland rather than replacing a hormone, it can do nothing in someone whose pituitary cannot make growth hormone at all, and the body's own feedback still applies. The chain YADAIFTNSYRKVLGQLSARKLLQDIMSR matches residues 32–60 of the human GHRH precursor in UniProt P01286 letter for letter; every residue is a standard L-amino acid, and the only chemical difference from that stretch of the natural hormone is the amide cap at the far end, which is why the one-letter code can honestly be printed here.

Part of the bodyWhat happensHow it is knownKind of evidence

The pituitary gland, at the base of the brain

Sermorelin is the working end of the body's own growth-hormone-releasing hormone, copied and made in a factory. It latches onto the pea-sized gland under the brain and tells it to release growth hormone. The release is a burst, not a flood: growth hormone climbs within minutes and stays above where it started for about three hours, even though sermorelin itself is cleared from the blood quickly. Because it works by pushing a gland rather than replacing a hormone, it can do nothing at all in someone whose pituitary gland cannot make growth hormone in the first place.

Measured in 30 healthy men aged 19 to 43 given it into a vein or up the nose. The smallest amount tested into a vein, 0.25 micrograms per kilogram of body weight, already produced a measurable release; the biggest response came at 1 to 2 micrograms per kilogram. Through the nose, only 3 to 5 per cent of the dose got into the blood.

Measured in people

Source [05]Source [08]

Height, in children whose own signal is missing

Children who cannot make enough growth hormone because the signal from the brain is missing do grow faster on sermorelin — and less fast than they would on growth hormone itself. In the head-to-head study, children on sermorelin grew 9.2 and 9.3 centimetres a year on the two amounts tested, and children on growth hormone grew 14.6. In a second study the higher amount of sermorelin matched growth hormone for speed of growth, but only the growth-hormone group gained height relative to the maturity of their bones, which is what decides how tall someone ends up. Nobody has ever followed these children to their adult height.

Measured in two randomised studies over 6 months, one in 60 children split into three equal groups and one in 43 children aged 4.3 to 18.9. Both had a growth-hormone comparison group. Randomised means the children were put into their groups by chance, not by choice.

Measured in people

Source [03]Source [05]Source [09]

The immune system's reaction to the drug itself

The body learns to recognise it. In the six-month children's study, 20 of 20 on the higher amount and 19 of 20 on the lower amount made antibodies against the hormone. Antibodies are the immune system's tags for something it treats as foreign, and because sermorelin is a copy of a hormone the body already makes, those tags can in principle stick to the natural version too. In this study the tags had almost disappeared nine months after treatment stopped, and how much of them a child made had nothing to do with how much they grew. Nobody has looked for these antibodies in an adult taking it.

Measured in 39 of the 40 children who received sermorelin in a randomised 6-month study, and followed for 9 months after treatment ended.

Measured in people

Source [03]

Working out whether someone is short of growth hormone

This was one of its two approved jobs, and it is the job the evidence is strongest for. A single injection into a vein makes a healthy pituitary gland release growth hormone; a gland that cannot, does not. Given together with the amino acid arginine it becomes more reliable still, and was regarded as the better alternative to the old test, which works by deliberately dropping a person's blood sugar and needs close supervision. It has one built-in blind spot: a normal result does not rule out a deficiency that comes from the brain rather than the gland, because the injection supplies exactly the brain signal that is missing.

Measured in 279 people who received sermorelin across the only two studies that met the inclusion rules of a US-government-funded review — 435 participants in total, given 1 microgram per kilogram of body weight into a vein, once or twice, with arginine in 168 of the test arms and with a different helper drug in 127. That review excluded 47 further studies for the sole reason that they used the branded product. The blind spot is described in a review of the paediatric evidence.

Measured in people

Source [02]Source [05]

The growth signal in the blood (IGF-1)

Growth hormone works mostly by making the liver release IGF-1, and it is IGF-1 that reaches muscle and bone. Here the studies do not agree. Ten men aged around 68, injecting twice a day for two weeks, raised IGF-1 significantly on the larger of the two amounts — far enough that they no longer differed from men in their twenties. Eleven men aged 64 to 76, injecting once a night for six weeks, raised growth hormone but did not move IGF-1 at all. In children treated for six months, IGF-1 rose at first and then drifted back down to where it had been before treatment. What all three have in common is that the effect on IGF-1 depends on how often it is injected, not just how much.

Measured in 10 healthy older men over two 14-day courses with a 14-day gap between them, in 11 healthy older men over 6 weeks, and in 60 children over 6 months. None of the three adult courses lasted longer than six weeks.

Studies in people disagree

Source [03]Source [04]Source [10]

Blood sugar and insulin

The two age groups gave different answers. In 17 short children injecting twice a day for a year, fasting blood sugar and fasting insulin both rose over the course of treatment. In 11 older men injecting nightly for six weeks, blood sugar, insulin and the response to a sugar drink were all unchanged, and in 10 older men injecting twice daily for two weeks, fasting blood sugar was unchanged as well. Growth hormone held high over long periods is known to push blood sugar up; the longest anyone has been watched here is one year, and that is the study where it happened.

Measured in 17 children over 12 months, in 11 older men over 6 weeks and in 10 older men over two 14-day courses.

Studies in people disagree

Source [04]Source [10]Source [11]

Muscle and body fat

This is the reason most people buy it, and the one time anyone weighed it, nothing moved. Eleven healthy men aged 64 to 76 injected 2 milligrams every night for six weeks. Their body weight, their body mass index, their waist-to-hip ratio, the muscle and fat measured by a body scan, and a sample of muscle looked at under a microscope were all unchanged at the end. Two of six strength tests improved — an upright row and a shoulder press — along with one test of endurance. There was no dummy-injection group, so those three results cannot be told apart from the effect of doing the tests a second time.

Measured once, in 11 healthy non-obese men aged 64 to 76 with low starting IGF-1, over 6 weeks, each man compared with himself before treatment. No published study has weighed muscle or fat in anyone taking sermorelin for longer than six weeks.

One small study

Source [04]

Thinking, in healthy older adults

One trial found a real effect and nobody has repeated it with this compound. Eighty-nine healthy adults averaging 68 years old took a daily injection of sermorelin or a dummy injection for six months. The sermorelin group did better on a general problem-solving score, on a test of arranging pictures into a story, on two tests of mental speed and on a test of switching between two tasks at once. Tests of stored knowledge, such as vocabulary, did not change. The effect did not depend on whether the person was a man or a woman or on how well they scored at the start.

Measured once, in 89 healthy older adults over 6 months, with a dummy-injection group and neither the participants nor the staff knowing who had which. The much larger follow-up trial that is usually cited beside it, in 152 adults, used tesamorelin — a different molecule — and says nothing about sermorelin.

One small study

Source [12]Source [13]Source [14]

Graded as limited human data rather than as an approved medicine because the approvals no longer exist and there is no product information sheet anyone can open: Drugs@FDA holds only approval letters and chemistry reviews. NDA 19-863 and NDA 20-443, both held by EMD Serono, were withdrawn effective 18 June 2009 at the company's own request, and the FDA determined on 4 March 2013 that neither was withdrawn for reasons of safety or effectiveness. The real human evidence is narrow. A randomised 6-month head-to-head in 60 children with growth hormone deficiency of hypothalamic origin gave height velocities of 9.2 and 9.3 cm/year on the two sermorelin amounts against 14.6 cm/year on growth hormone itself, and 39 of the 40 children on sermorelin developed antibodies against the hormone. A randomised, placebo-controlled 6-month trial in 89 healthy older adults reported better problem-solving and mental speed. For what it is sold for now, one study weighed it: 11 men aged 64–76 injecting 2 mg nightly for six weeks showed no change in body weight, body mass index, waist-to-hip ratio, DEXA muscle or fat, or muscle histology. No trial of sermorelin is currently registered. The widely repeated claim that six months raised lean mass and cut visceral fat traces through a review to Merriam et al., Today's Therapeutic Trends 2000;18:335-54 — a journal with no PubMed record at all — and could not be opened.

Growth hormone rises within minutes of an injection into a vein and stays above where it started for about three hours, even though sermorelin itself clears from the blood quickly. IGF-1, the signal that actually reaches tissue, is slower and depends on how often it is injected: twice a day for two weeks moved it in older men, once a night for six weeks did not move it at all, and in children treated for six months it rose and then drifted back to where it began. Height in children was measured over 6 and 12 months, and the gain reversed within three months of stopping. Antibodies against the hormone appeared within six months and had almost gone nine months after treatment ended. The longest published course in which anything beyond growth was measured is 12 months, and that was 17 children.

What was measuredWhat happenedIn whomHow it is known

How fast children grew, against growth hormone itself

9.2 centimetres a year on the lower amount of sermorelin and 9.3 on the higher, against 14.6 centimetres a year on growth hormone. The difference in favour of growth hormone was statistically clear. The two sermorelin amounts did not differ from each other.

60 children with confirmed growth hormone deficiency coming from the brain rather than the gland, split by chance into three equal groups of 20, treated for 6 months.

Measured in people

Source [03]

Height relative to how mature the bones were

Improved only in the growth-hormone group. In this second study the higher amount of sermorelin matched growth hormone for how fast the children grew, and all but two of the 43 children increased their growth rate by at least 2 centimetres a year — but the measure that tracks whether a child is catching up rather than simply growing on schedule moved only for growth hormone.

43 children before puberty, aged 4.3 to 18.9, split by chance into a lower-amount sermorelin group of 15, a higher-amount group of 12 and a growth-hormone group of 16, treated for 6 months.

Measured in people

Source [09]

Growth hormone and IGF-1 in older men, against men in their twenties

On the larger of the two amounts, average growth hormone over 24 hours, the size of the bursts and IGF-1 all rose enough that the older men no longer differed from the younger men measured alongside them. The smaller amount did not achieve this. Blood pressure, fasting blood sugar and routine blood counts were unchanged; blood phosphate rose.

10 healthy non-obese men averaging 68 years old, injecting 0.5 milligrams and then 1 milligram twice a day for 14 days each in random order, with a 14-day gap between the two courses, compared against 9 men averaging 26.

Measured in people

Source [10]

Antibodies against the hormone

39 of the 40 children given sermorelin made them within six months — every one of the 20 on the higher amount and 19 of the 20 on the lower. They had almost gone nine months after treatment stopped, and how many a child made had no relationship to how much they grew. No antibodies against growth hormone itself appeared.

The 40 children who received sermorelin in the randomised 6-month comparison against growth hormone, followed for 9 months afterwards.

Measured in people

Source [03]

Body weight, body fat, muscle mass and muscle tissue in older men

No change in any of them after six weeks: not body weight, not body mass index, not the waist-to-hip ratio, not the muscle and fat measured by a whole-body scan, and not the muscle itself looked at under a microscope. Blood fats, blood sugar and insulin were unchanged too. Two of six strength tests and one endurance test improved, but there was no dummy-injection group to compare those against.

11 healthy non-obese men aged 64 to 76 with low starting IGF-1, injecting 2 milligrams every night at home for 6 weeks, each compared with himself beforehand.

One small study

Source [04]

Thinking and problem-solving in healthy older adults

Better than the dummy injection on a general problem-solving score, on arranging pictures into a story, on two tests of mental speed and on doing two tasks at once. Tests of stored knowledge such as vocabulary did not change.

89 healthy adults averaging 68 years old, randomly assigned to a daily injection of sermorelin or a dummy injection for 6 months.

One small study

Source [12]

How fast short children grew when they were not short of growth hormone

From 4.8 centimetres a year before treatment to 7.2 centimetres a year after twelve months, and the gain held all year. Predicted adult height went up by 3.4 centimetres on average. Then it reversed: in the first three months after stopping, growth slowed to 3.89 centimetres a year — below where it started — and by six and twelve months off treatment it was back to the pre-treatment rate. There was no comparison group.

18 short children before puberty, 17 of them boys, who had passed a growth hormone test normally, injecting twice a day for 12 months; one dropped out.

One small study

Source [11]

The trials reported short-lived facial flushing and injection-site pain as the two commonest effects and no serious harms — but the longest course in which anything beyond height was measured is 12 months in 17 children and 6 months in 89 adults, and although a review reports that a few children stayed on it for 36 months, growth was the only thing followed that far, so late or rare harm has not been looked for. Nearly every child treated for six months made antibodies against the hormone; they faded within nine months of stopping and nobody has looked for them in an adult injecting for years. Fasting blood sugar and insulin rose over 12 months in children. The FDA's public side-effect file holds 58 reports naming sermorelin, 35 of them flagged serious, including four describing a severe whole-body allergic reaction; those reports are unchecked and almost all name other products alongside it. What is in an unapproved compounded or online vial is verified by nobody.

EffectWhat it feels likeHow often

Severe allergic reactionsSerious

These are voluntary reports, not a count of how often it happens, and nothing in them is checked by anyone. Almost every one names several other products alongside sermorelin, so none of them establishes that sermorelin caused anything. What they do establish is that reactions of this severity have been reported. Milder allergic signs are the commonest thing in the file: itching in 7 reports, hives, rash and hypersensitivity in several more.

Four reports of anaphylaxis — the whole-body allergic reaction that closes the airway — among the 58 side-effect reports naming sermorelin in the US regulator's public file, filed between 2009 and 2026: three recorded as an anaphylactic reaction and one as anaphylactic shock.

Source [15]

Going red and warm in the face

It is described as short-lived. This is what a compound that widens blood vessels does, and the same effect is the commonest complaint reported for the related compound CJC-1295. One of the 58 reports in the US side-effect file describes flushing, widened blood vessels and a rise in blood pressure together.

Named as one of the two commonest effects across the published paediatric evidence, but without a number. The product information sheet that would have carried the frequencies is no longer published: the approvals were withdrawn in 2009, and the regulator's drug database now holds only the approval letters and chemistry reviews, not the label.

Source [05]Source [15]Source [16]

Pain and irritation where the needle goes in

Described as mild in the trial that counted it. Nobody has published what daily injections do to adult skin over months, which is how it is used by the people buying it now.

3 of the 40 children in the six-month randomised study reported mild irritation at the injection site. Named alongside facial flushing as one of the two commonest effects in the review of the paediatric evidence. Hives, itching and swelling at the injection site appear repeatedly in the US side-effect file.

Source [03]Source [05]

The immune system making antibodies against it

Because sermorelin is a copy of a hormone the body already makes, tags the immune system creates against it could in principle stick to the natural version. In the one study that measured it, the tags faded almost completely within nine months of stopping and had no relationship to how well the children grew. What happens with years of continuous use, which is how it is sold, has never been studied.

39 of the 40 children who received it for six months. Never looked for in an adult.

Source [03]

Fasting blood sugar and insulin creeping up

Growth hormone kept high is known to make the body respond less well to insulin. The only study long enough to look — a year — is the one where it happened. Nobody has run a study of that length in an adult.

Seen over 12 months in 17 short children injecting twice a day. Not seen in older men over 6 weeks or 2 weeks.

Source [04]Source [11]

Anything that takes more than a year to appear

The US regulator determined in 2013 that the two sermorelin products were not withdrawn for reasons of safety or effectiveness, which is a statement about what was known when they were pulled — not a finding that long-term use is safe. Nobody was studying long-term use, because the medicine was for a test and for children.

Not measured. The longest published course in which anything beyond growth was measured is 12 months, in 17 children; a review reports a few children continuing to 36 months with only their growth reported. In adults it is 6 months, in 89 people.

Source [01]Source [02]Source [05]

These are the amounts the studies below gave their participants, and they are here as facts about those studies. They are not a recommendation, not a starting point and not a range to pick from. What a person should take, if anything, is a question for a doctor who knows them.

The approved diagnostic test — checking whether the pituitary gland can release growth hormone, in the only two studies that met the inclusion rules of a US-government-funded review

1 microgram per kilogram of body weight, injected into a vein.

A single injection, or two; given together with the amino acid arginine in 168 of the test arms and with a different helper drug in 127.

Source [02]

The approved children's treatment, as summarised in the review of the paediatric evidence — growth failure in children who cannot make enough growth hormone

30 micrograms per kilogram of body weight per day, injected under the skin at bedtime.

12 months in the studies with sustained results; a small number of children were followed to 36 months.

Source [05]

The head-to-head trial against growth hormone in 60 children with a deficiency coming from the brain

30 or 60 micrograms per kilogram of body weight per day under the skin, against growth hormone at 0.1 international units per kilogram per day.

6 months.

Source [03]

Vittone and colleagues 1997 — the only study that weighed muscle and fat, in 11 healthy men aged 64 to 76

2 milligrams, injected under the skin by the men themselves every night at home.

6 weeks.

Source [04]

Corpas and colleagues 1992 — whether hormone levels in older men can be brought back to those of younger men

0.5 milligrams and then 1 milligram, injected under the skin twice a day, in random order.

14 days on each amount, with a 14-day gap between them.

Source [10]

Vitiello and colleagues 2006 — thinking and memory in 89 healthy older adults, against a dummy injection

A daily injection. The published abstract does not state the amount given, and the full paper is not free to read, so no figure is printed here.

6 months.

Source [12]

What people report

• Whether it builds muscle in an adult: the one study that measured it, in 11 men over 6 weeks, found no change.
• Whether it reduces body fat in an adult: the same study measured that too, and found no change.
• Whether the widely repeated six-month result showing more lean mass and less belly fat is real — it was published in a trade journal with no entry in the medical literature database and could not be opened.
• Whether it improves sleep: the only trial that looked reported no improvement and possibly the opposite, in a source that cannot be checked.
• Whether it helps any injury or tendon heal — never measured, in any study.
• Whether it does anything for energy, mood or libido.
• What the children in the approval trials ended up as adults: nobody followed them to their final height.
• What it does past 12 months, which is as long as any published course has measured anything beyond growth, and past 6 months in an adult.
• Whether the antibodies nearly every treated child made matter at all in someone injecting daily for years — never looked for in an adult.
• What happens when it is injected together with GHRP-2 and GHRP-6, or with ipamorelin, as compounded kits combine them: no published study has given a person that combination.
• Whether steering the amount by IGF-1 in the blood, as clinics describe doing, changes anything a person would notice.
• Whether women respond differently: the adult studies were almost entirely in men, and the one trial that included both did not report results separately.
• Whether it does anything at all in someone whose pituitary gland cannot make growth hormone — mechanically it cannot, and it has never been tested in that group.
• What is in the vials sold online or mixed by a compounding pharmacy: nobody has published an analysis of what customers actually receive.
• Whether the computer study that ranked sermorelin as the most promising drug for recurrent brain tumours means anything: it screened gene-activity data, not patients, and no person with a glioma has been given it in a published study.
• How many people are using it: the most serious attempt to find out, a survey sent to US professional medical associations in 2020, received no replies at all.

Is sermorelin FDA approved?

Not any more. It was approved twice, both times under the brand name Geref: the small ampoule on 28 December 1990, for testing whether the pituitary gland can release growth hormone, and the vial on 26 September 1997, for growth failure in children who cannot make enough growth hormone. The manufacturer, EMD Serono, told the regulator in July and December 2008 that it was stopping both products, and both approvals were formally withdrawn effective 18 June 2009. There is no approved sermorelin product anywhere in the world today.

Source [01]Source [02]

Why was sermorelin taken off the market — was it dangerous?

No. The US regulator examined exactly this question and published its answer on 4 March 2013: both Geref products "were not withdrawn from sale for reasons of safety or effectiveness". It reviewed its own files and independently checked the published literature and post-marketing side-effect reports before saying so. The company simply stopped making it. An endocrinologist interviewed for a later government review guessed at the reason — Serono also made growth hormone, and would have been competing with itself — but said so as a guess. The practical effect is that a business decision became a medical one.

Source [01]Source [02]

Does sermorelin work?

It depends entirely on what you mean by work. It reliably makes the pituitary gland release growth hormone — that has been measured many times and is not in dispute. It worked well enough as a test for growth hormone deficiency to be an approved diagnostic for eighteen years. As a treatment for growth failure in children it did increase growth, but growth hormone itself increased it a lot more: 14.6 centimetres a year against 9.2 and 9.3 in the head-to-head study. For what it is actually sold for now — muscle, fat loss, energy, recovery — the honest answer is that almost none of it has been measured, and the one study that weighed body fat and muscle in older men found no change.

Source [03]Source [04]Source [05]

Does sermorelin build muscle or burn fat?

Nobody has shown that it does. One published study weighed it: eleven healthy men aged 64 to 76 injected 2 milligrams every night for six weeks, and their weight, body mass index, waist-to-hip ratio, and the muscle and fat measured by a whole-body scan were all unchanged at the end. Two of six strength tests improved, but with no dummy-injection group those cannot be told apart from simply doing the test twice. A widely repeated claim that six months of sermorelin raised lean mass and cut belly fat traces to an article in a trade journal that has no entry in the medical literature database at all and could not be opened, so it is not treated as evidence here.

Source [04]Source [13]

Does sermorelin help you sleep?

The evidence points the wrong way, and it is thin. A standard endocrinology reference describes a six-month trial of sermorelin in healthy older adults which found that it failed to improve deep sleep and may even have made it worse, despite raising growth hormone and IGF-1. That result appeared in a trade journal with no entry in the medical literature database, so the underlying numbers cannot be checked. A separate registered trial of this hormone for age-related sleep problems ran at the University of Washington until July 2007 and never posted a result. No published study supports better sleep.

Source [13]Source [17]

Is sermorelin legal?

It is not an approved medicine anywhere, so nothing sold as sermorelin is a licensed product. In the United States a pharmacy may only compound a medicine from a raw substance if that substance has a US Pharmacopeia entry, is a component of an approved medicine, or appears on a list the regulator keeps. Sermorelin is none of the three: the government-funded review confirmed there is no US Pharmacopeia entry, the approvals that would have made it a component of an approved medicine were withdrawn in 2009, and it does not appear on the regulator's 503A list. It is also not on the regulator's list of substances flagged as presenting significant safety risks, which is a separate thing from being permitted.

Source [02]Source [18]Source [19]

Can you buy sermorelin?

It is widely sold, mostly by anti-ageing and hormone clinics in the United States that have it mixed up by a compounding pharmacy, and by online sellers labelling it for research. The government-funded review found that compounding is the only remaining route to it, and recorded one outsourcing facility that had stopped making it because it is not on the permitted list. This register does not name sellers or link to them. What is in an unapproved vial is not checked by anyone: the side-effect file contains reports of dispensing errors, the wrong product being given, and product quality problems for sermorelin specifically.

Source [02]Source [15]

Sermorelin vs ipamorelin — what is the difference?

They push the same gland through two different doors. Sermorelin copies the brain's own growth-hormone-releasing hormone and works on that receptor; ipamorelin works on the ghrelin receptor, the one the hunger hormone uses. Sermorelin has by far the longer track record in people: it was an approved medicine for eighteen years and has randomised trials in children and older adults. They are sold mixed together, or with CJC-1295, and no published study has given a person any of those combinations.

Source [02]Source [05]Source [19]

Is sermorelin banned in sport?

Yes, at all times, in and out of competition. The 2026 Prohibited List names it directly, under section S2.2.4, growth hormone releasing factors, alongside CJC-1293, CJC-1295 and tesamorelin. Testing is harder than banning: as of a 2021 study of detection methods, accredited anti-doping laboratories had not actually found these compounds in samples despite evidence of use, because the amounts that reach urine are tiny. That same study went on to build a method for detecting sermorelin and its breakdown products in urine.

Source [07]Source [20]

What are sermorelin's side effects?

In the trials, the two commonest were short-lived facial flushing and pain or irritation where the needle went in; three of the forty children in the six-month study reported the latter. Nearly every child in that study also made antibodies against the hormone, which faded after treatment stopped. In the US regulator's public file of voluntary reports there are 58 naming sermorelin, including four of anaphylaxis — a severe whole-body allergic reaction — and a good many of itching, hives and rash. Those reports are unchecked and almost all list other products alongside it, so they show what has been reported, not how often anything happens.

Source [03]Source [05]Source [15]

Each letter represents one amino acid.

1. [01]Determination That GEREF (Sermorelin Acetate) Injection, 0.5 mg Base/Vial and 1.0 mg Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 mg Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Federal Register 78 FR 14095, 4 March 2013) — gives NDA numbers, approval dates of 28 December 1990 and 26 September 1997, and withdrawal effective 18 June 2009 (2013)
2. [02]Sermorelin acetate: Summary Report, prepared for the FDA by the University of Maryland Center of Excellence in Regulatory Science and Innovation, December 2020 — no approved product in 13 national registers, no USP monograph, 2 included studies of 435 patients, clinician interviews (2020)
3. [03]A comparative study of growth hormone (GH) and GH-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency (Acta Paediatr Suppl, 60 children, 6 months; 9.2 and 9.3 vs 14.6 cm/year; GHRH antibodies in 39 of 40) (1993)
4. [04]Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men (Metabolism, 11 men, 6 weeks; no change in DEXA muscle or fat, weight, BMI, glucose, insulin or lipids) (1997)
5. [05]Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (BioDrugs) — 1 µg/kg IV for diagnosis, 30 µg/kg/day at bedtime for treatment, flushing and injection-site pain as commonest adverse events (1999)
6. [06]UniProt P01286 (SLIB_HUMAN, somatoliberin) — FASTA sequence; residues 32–60 read YADAIFTNSYRKVLGQLSARKLLQDIMSR
7. [07]WADA International Standard Prohibited List 2026, section S2.2.4 — growth hormone releasing hormone and its analogues, sermorelin named (2026)
8. [08]Pharmacokinetics of GHRH(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration (Acta Paediatr Suppl, 30 healthy men) (1993)
9. [09]Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone (Acta Paediatr Suppl, 43 children, 6 months) (1993)
10. [10]Growth hormone-releasing hormone-(1-29) twice daily reverses the decreased GH and IGF-I levels in old men (J Clin Endocrinol Metab) (1992)
11. [11]Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity (Clin Endocrinol, 18 children, 12 months) (1994)
12. [12]Vitiello and colleagues, growth hormone releasing hormone improves the cognition of healthy older adults (Neurobiology of Aging, 89 adults, 6 months) (2006)
13. [13]Growth Hormone and Aging (Endotext, NCBI Bookshelf) — identifies the compound in the 2006 cognition trial as sermorelin acetate and separates it from the tesamorelin trials
14. [14]Baker and colleagues, effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults (Archives of Neurology) — the 152-person trial, which used tesamorelin (2012)
15. [15]Side-effect reports naming sermorelin in the FDA adverse event database (openFDA query, 58 reports)
16. [16]Drugs@FDA entry for GEREF, NDA 020443 — the record holds no product information sheet
17. [17]Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances (NCT00000380, completed July 2007, no results posted) (2007)
18. [18]Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (FDA) — the three conditions a substance must meet
19. [19]Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (FDA, category 2 list) — sermorelin does not appear on it
20. [20]Advances in the detection of growth hormone releasing hormone synthetic analogs (Drug Testing and Analysis) (2021)