Evidence review
Does sermorelin produce the effects attributed to growth hormone therapy?
The answer
Not on this record. Sermorelin reliably raises growth hormone, but the adult trials that measured what a reader cares about are three studies from the 1990s that disagree with each other, and no clinical trial of the molecule has been published since 2005.
Sermorelin is the first 29 amino acids of growth hormone-releasing hormone, the shortest fragment that keeps the full hormone's activity at the pituitary gland. It does not supply growth hormone. It instructs the gland to release its own, which leaves the body's feedback control intact, and that mechanism is genuine, well described, and the reason the molecule is interesting at all.
The mechanism is also the whole of what most sellers are describing when they compare the compound to growth hormone therapy. A stimulus that raises a hormone is not the same claim as a treatment that changes an outcome, and the distance between those two sentences is what this review measures. The monograph records the regulatory position with the date it was verified; this page concerns the evidence.
Searched across the five names the compound is indexed under in August 2026, the literature runs to 562 records, of which 334 carry the Humans subject heading. Under the clinical-trial publication type the same union returns 71, and under the stricter randomized-controlled-trial type it returns 39; 52 of the 71 carry the adult subject heading and 19 the child heading [4].
The number that reframes all the others is the year. Of those 71 trials, 9 were published before 1990, 57 during the 1990s, 5 between 2000 and 2009, and none at all from 2010 onward. The five records from the 2000s were read individually rather than counted, and the most recent of them was published in 2005 [4].
A publication-type filter that has quietly stopped matching returns zero for every substance in the database, so the same run put a control term with a large and undisputed trial literature through the identical filter: it returned 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag that this index has been burned by once returned 0 for that same control term, and a deliberately invalid record identifier errored in the same session [4]. The instrument was answering, and the most recent answer it returned was published in 2005.
That gap is the finding a reader should carry away first. Sermorelin is marketed in 2026 as a modern intervention for body composition, sleep, recovery, and aging. Its clinical trial record belongs to the decade of its approval, and nothing has been added to it in the years since the market for it grew.
Three of the 71 are indexed under body composition. All three were read, and they do not agree with one another, which is a more useful fact than any single one of them.
The largest is a 16-week single-blind randomized placebo-controlled study in 19 adults aged 55 to 71, who injected the analogue nightly after four weeks of placebo. Nocturnal growth hormone rose in both sexes, serum IGF-1 rose within two weeks, and skin thickness increased in both. Lean body mass increased in the men only. No other measure of body composition changed in either sex, bone mineral density did not move, body weight did not move, and sleep quality was unaffected [1].
The second is a six-week study in 11 healthy men aged 64 to 76 with low baseline IGF-1, injecting 2 mg nightly at home. Nocturnal growth hormone release rose. IGF-1 did not, nor did IGF binding protein 3 or growth hormone binding protein, and the dual-energy x-ray absorptiometry measures of muscle and fat did not change. Two of six strength measures improved [2]. The authors' own reading was that a single nightly dose is less effective than multiple daily doses at producing the downstream effects.
The third is a 14-day study in 10 men of mean age 68, comparing two doses against their own baseline and against young men. Growth hormone and IGF-1 rose to the levels measured in the young comparison group, but only at the higher dose, and the study measured hormones rather than body composition [3].
Put side by side, the three establish something narrow and defensible: sermorelin raises growth hormone, dose-dependently and reproducibly. Whether that translates into IGF-1 depends on the dose and schedule, since one trial found the rise and another did not. Whether it translates into a body a person would notice is a question that has been asked three times — in 19 subjects, in 11, and in 10 — and answered inconsistently.
An outcome is what the patient experiences. A biomarker is a number measured on the way there, and the two part company often enough that regulators treat them as different categories of evidence. Growth hormone and IGF-1 are biomarkers. Lean mass, strength, sleep, and fat are closer to outcomes, and they are the terms in which the compound is sold.
This is not a hypothetical distinction here, because the trials above contain the split in a single study. The six-week trial raised growth hormone and left IGF-1, muscle, and fat exactly where it found them [2]. A page that reported only the hormone result from that trial would be reporting a true number and describing a false effect.
The same discipline applies to the comparison the question asks about. Injected growth hormone and a secretagogue are not two grades of one product; they are different interventions with different evidence and different risk arguments, and the argument that favors the secretagogue is a safety argument about preserved feedback control, not an efficacy argument about equivalent results. Tesamorelin, the approved drug in the same GH secretagogues class, shows what a completed registrational file for this mechanism looks like, and what it was and was not allowed to claim.
It is one of the few molecules in this index with a lawful route. Licensed 503A pharmacies compound sermorelin against a valid prescription, and the compoundable page records what that permits and what it does not. That position is unusual and it is durable, because the molecule was once the active ingredient of an approved drug rather than a substance that arrived through the research-chemical market.
The withdrawal record is public and dated. Geref was the subject of two applications, approved December 28, 1990 and September 26, 1997. The sponsor wrote to the FDA on December 2, 2008 to say the product was being discontinued and to ask that the application be withdrawn; the agency published the withdrawal of approval on May 19, 2009, effective the following month; and in a determination published March 4, 2013 the agency found that the Geref presentations had not been withdrawn from sale for reasons of safety or effectiveness [5].
That last sentence is the one worth quoting when a reader meets the phrase discontinued drug and hears a safety verdict in it. The agency addressed the question directly, in a document written for the purpose, and answered it the other way. What that record does not do is supply the modern outcome evidence the previous sections looked for and did not find. A drug can leave the market for commercial reasons and still have a thin file, and this one does.
For the neighboring cases, CJC-1295 shows the same class with a withdrawn nomination and no lawful route at all, and ipamorelin shows what happens when a compound's single controlled trial is run and reported honestly. The approved peptides table sets out the small set of peptides that cleared the full path.
Monographs
Reference tables
Every source below is inherited from a monograph in this index, where it was verified at writing time; this review introduces none of its own. The pointer beside each entry names the monograph and the reference number it came from.