Sermorelin: evidências, dosagem, segurança e interações
GRF(1-29)-NH2 (a truncated analog of human GHRH)
This helps your body release its own growth hormone, rather than giving you growth hormone directly. It used to be an approved medicine for two decades; today it's mostly made by compounding pharmacies rather than sold as the original approved drug.
- What it is
- A GHRH fragment that prompts the pituitary to release its own growth hormone. Formerly the FDA-approved drug Geref; now supplied by compounding pharmacies.
- Evidence
- Its GH-stimulating pharmacology is well established across multiple controlled human trials. Its anti-aging use case rests on one small 1997 RCT in 19 healthy older adults, unreplicated at that scale since.
- Studied dose
- 1–2 mcg/kg intravenously for diagnostic GH-reserve testing; 10 mcg/kg subcutaneously nightly in the one aging trial. The lower doses typically prescribed off-label for anti-aging (commonly 200–500 mcg nightly) have not themselves been tested in a controlled trial.
- Safety
- Well tolerated in the trials reviewed here, with transient hyperlipidemia the only adverse effect reported in the aging study. Today's supply is compounded material, not an FDA-approved product, since the branded drug was discontinued.
O que os estudos em humanos realmente mostram
Apenas ensaios randomizados e controlados por placebo em humanos. Dados em animais nunca aparecem nesta seção — não podem elevar uma classificação e são indicados separadamente mais abaixo.
- 01The Journal of Clinical Endocrinology & Metabolism1997— Endocrine and metabolic effects in age-advanced adults
- Desenho
- Single-blind, randomized, placebo-controlled trial
- Dose
- 10 mcg/kg subcutaneous nightly for 16 weeks, after 4 weeks of placebo
- Duração
- 20 weeks total (4 placebo + 16 treatment)
19 healthy adults aged 55–71 (10 women, 9 men)
Significantly increased nocturnal GH and IGF-1 in both sexes. Lean body mass and insulin sensitivity increased in men only; skin thickness increased in both sexes; general well-being and libido improved in men only, with no change in women. The only adverse effect was transient hyperlipidemia that resolved by study end.
doi:10.1210/jcem.82.5.3943 - 02The Journal of Clinical Endocrinology & Metabolism1997— Immune-system effects in the same age-advanced cohort
- Desenho
- Single-blind, randomized, placebo-controlled trial (same 19 subjects as above)
- Dose
- 10 mcg/kg subcutaneous nightly for 16 weeks, after 4 weeks of placebo
- Duração
- 20 weeks total
19 healthy adults aged 55–71 (10 women, 9 men)
GH analog administration increased B- and T-cell counts and function (mitogen responsiveness, IL-2 receptor expression) in both sexes, with no reported adverse effects. This is immune-cell activation, not a demonstrated clinical benefit such as fewer infections.
doi:10.1210/jcem.82.11.4363 - 03European Journal of Endocrinology2000— GHRH dose-response in confirmed GH insufficiency
- Desenho
- Randomized controlled pharmacology study
- Dose
- Ascending IV bolus doses of GHRH(1-29)NH2: 0.05, 0.15, and 1.0 mcg/kg
- Duração
- Single-day pharmacology study
5 adult survivors of childhood brain tumors with post-radiation GH insufficiency, plus 5 matched controls
Confirms the diagnostic mechanism sermorelin was approved for: a dose-dependent GH release that is measurably blunted in patients with genuine hypothalamic GH insufficiency versus controls, supporting its historic use as a GH-reserve stimulation test.
doi:10.1530/eje.0.1420359 - 04Clinical Endocrinology1999— GH pulse generation mechanism
- Desenho
- Randomized controlled physiology study
- Dose
- Continuous subcutaneous GHRH(1-29)NH2 infusion (60 ng/kg/min) combined with intermittent somatostatin withdrawal
- Duração
- 24-hour profiling sessions
12 adult and 6 pediatric survivors of childhood brain tumors, with matched controls
Confirms that GHRH amplifies pulsatile GH release in healthy adults and can partially, but not fully, restore GH pulsatility in those with radiation-induced hypothalamic damage — mechanistic evidence for how sermorelin works, not an efficacy trial for any marketed claim.
doi:10.1046/j.1365-2265.1999.00839.x - 05Acta Paediatrica (Supplement)1993— Pharmacokinetics and dose-response in healthy adults
- Desenho
- Randomized, double-blind, dose-ranging trial
- Dose
- IV doses from 0.25–2 mcg/kg, and intranasal doses up to 50 mcg/kg
- Duração
- Single-dose pharmacology sessions
30 healthy men aged 19–43
Established the basic human dose-response curve: IV doses of 1–2 mcg/kg produced maximal GH release (peaks around 90 mU/L), with GH elevated for about 3 hours despite the peptide itself clearing from plasma within minutes. This is the pharmacokinetic basis for sermorelin's diagnostic use.
doi:10.1111/j.1651-2227.1993.tb12827.x
The trial that anti-aging sermorelin use actually rests on is one study, from one research group, of 19 people, published in 1997 — and it was never repeated at scale. Its positive functional findings (lean mass, insulin sensitivity, libido, well-being) held only in men; women in the same trial saw none of those benefits despite comparable GH and IGF-1 increases, a discrepancy nobody has since explained. No trial has measured a hard outcome — fracture risk, frailty, cognitive function, mortality — for sermorelin in aging adults, in either sex. And no controlled trial has tested the actual doses compounding pharmacies dispense today (commonly 200–500 mcg nightly), which are far below the 10 mcg/kg (roughly 700–800 mcg for a typical adult) used in the one positive aging trial. Separately, because no FDA-approved sermorelin product is currently marketed, nobody outside a compounding pharmacy is verifying the purity or potency of what patients actually inject.
Grade B — promissor. Sermorelin reliably provokes a real, dose-dependent growth hormone pulse in controlled human trials — that pharmacology is well established and is exactly what earned it two FDA approvals decades ago. But the specific claim sold at longevity clinics today — that nightly sermorelin meaningfully slows or reverses aging in otherwise healthy adults — rests on one small placebo-controlled trial of 19 people (10 women, 9 men) published in 1997, which found real but modest, sex-asymmetric effects (lean mass and libido improved in men only, not women) and no data on fracture, frailty, function, or mortality. That is a materially better evidence position than most peptides on this page, and still a long way from proof of an anti-aging benefit. Como classificamos as evidências.
Efeitos colaterais e segurança
- Reported in trials
- Generally well tolerated across the studies reviewed here. The 16-week aging trial reported only transient hyperlipidemia, which resolved by the end of the study; injection-site reactions are commonly reported anecdotally with any subcutaneous GHRH analog.
- Class effects of raising GH/IGF-1
- Water retention, joint or muscle aches, and mild insulin resistance are recognized effects of stimulating the GH axis generally (seen more clearly with higher-dose GH therapy and with tesamorelin), and are plausible with sermorelin at higher doses even though the small trials here did not report them.
- Product risk
- Because no FDA-approved sermorelin product is currently marketed in the US, what patients receive is compounded material from a 503A pharmacy — legal under a prescription, but not independently verified for potency or sterility the way an approved drug is.
Interações com medicamentos
A seção que a maioria dos sites de longevidade ignora. Se você toma medicamento sob prescrição, leia isto antes de qualquer outra coisa nesta página.
Raising growth hormone can reduce insulin sensitivity. Anyone on diabetes medication should have blood glucose monitored after starting sermorelin.
Glucocorticoids can blunt the pituitary's GH response to GHRH analogs, and chronic steroid use independently suppresses growth in children — the original approved pediatric population. Discuss any steroid use with the prescriber.
Growth hormone secretagogues, sermorelin included, are prohibited under the World Anti-Doping Agency's list (class S2). A tested athlete risks sanction regardless of the prescription's legality.
Sermorelin é legal onde você vive?
O estatuto regulatório é acompanhado por mercado e revisto na data indicada. Quando um composto não está autorizado, este site não remete a vendedores.
Sermorelin was FDA-approved as Geref in 1990 (diagnostic) and 1997 (treatment of pediatric growth failure), then voluntarily discontinued by the manufacturer in 2008 for commercial reasons. The FDA's own 2013 determination confirms it was not withdrawn for safety or effectiveness. No FDA-approved sermorelin product is currently marketed; all US supply comes from 503A compounding pharmacies under a patient-specific prescription. Anti-aging use in adults is off-label.
Fonte: US Food and Drug Administration
No sermorelin product holds a UK marketing authorisation. It is not sold as a supplement. Access would require an unlicensed 'special' prescribed and imported under a doctor's direct responsibility, which is a narrow route, not routine availability.
Fonte: MHRA
No centralised or national marketing authorisation exists for sermorelin in the EU. There is no lawful over-the-counter route of supply.
Fonte: European Medicines Agency
Aucune autorisation de mise sur le marché n'existe pour la sermoréline dans l'UE. Aucune voie légale de vente libre n'existe.
Fonte: ANSM / European Medicines Agency
No existe autorización de comercialización para la sermorelina en la UE. No hay una vía legal de venta libre.
Fonte: AEMPS / European Medicines Agency
Für Sermorelin besteht keine Zulassung in der EU. Es gibt keinen legalen freiverkäuflichen Bezugsweg.
Fonte: BfArM / European Medicines Agency
We found no evidence of a MOHAP- or DHA-registered sermorelin product. Where it is used at all, it would be through a licensed anti-aging/wellness clinic under physician supervision, not over the counter; we could not independently verify a specific MOHAP position.
Fonte: UAE Ministry of Health and Prevention (MOHAP)
We found no evidence of an SFDA-registered sermorelin product. No legitimate consumer or over-the-counter route to the compound was identified.
Fonte: Saudi Food and Drug Authority (SFDA)
Non esiste alcuna autorizzazione all'immissione in commercio per la sermorelina nell'UE, e non è disponibile come integratore alimentare legale.
Fonte: Ministero della Salute / European Medicines Agency
Er bestaat geen markttoelating voor sermoreline in de EU en er is geen legale vrij verkrijgbare route.
Fonte: CBG-MEB / Europese Commissie
Não identificamos registro da sermorelina na Anvisa em nenhuma categoria (medicamento ou suplemento). A Anvisa já alertou publicamente sobre a venda irregular de peptídeos injetáveis não registrados nas redes sociais, um alerta que se aplicaria igualmente aqui.
Fonte: Agência Nacional de Vigilância Sanitária (ANVISA)
Dosagem e horário
The dose that produced maximal GH release in the pharmacokinetic trials behind the original Geref approval — used to test whether the pituitary can still respond to GHRH stimulation.
The dose used in the one placebo-controlled aging trial (roughly 700–800 mcg for a typical adult) — considerably higher than what most compounding-pharmacy protocols currently prescribe.
The range commonly dispensed by longevity clinics and compounding pharmacies today. This specific dose has not itself been tested in a published controlled trial — it is extrapolated downward from the higher doses used in older pharmacology studies.
Perguntas que as pessoas realmente fazem
Is sermorelin FDA-approved?
It was — twice. The FDA approved sermorelin (as Geref) in 1990 for diagnosing growth hormone deficiency, and again in 1997 for treating growth failure in children with GH deficiency. The manufacturer discontinued the branded product in 2008 for commercial, not safety, reasons, and the FDA confirmed that determination in 2013. No FDA-approved sermorelin product is marketed today; what is sold now is compounded. Anti-aging use in healthy adults was never an approved indication.
Does sermorelin actually increase growth hormone in humans?
Yes, reliably — this is the best-established part of the sermorelin story. Multiple controlled human trials, going back to the 1990s, show a consistent, dose-dependent GH pulse after sermorelin administration. What is far less established is whether that pulse translates into a meaningful anti-aging benefit at the doses typically prescribed off-label.
Is sermorelin legal?
In the US it is legal by prescription, dispensed by a compounding pharmacy under Section 503A — the FDA has not moved to restrict it the way it has BPC-157. It is not legally sold as a supplement, and it is not an FDA-approved drug product in its current form, since Geref was discontinued. Regulatory status elsewhere varies; see the market notes below.
What's the difference between sermorelin and CJC-1295 or ipamorelin?
All three raise GH by acting on the GHRH or ghrelin-receptor pathways, but sermorelin is the only one of the three that was ever an FDA-approved drug. CJC-1295 and ipamorelin are unapproved research chemicals with a thinner and different human evidence base — see their own pages for specifics.
Why was the brand-name sermorelin product discontinued if it worked?
Not for safety. The FDA's own 2013 determination states plainly that Geref was not withdrawn for reasons of safety or effectiveness — the manufacturer pulled it in 2008 because recombinant human growth hormone had become the standard of care for pediatric GH deficiency, and demand for a GHRH-analog diagnostic and treatment collapsed.