Reader’s guide · First edition · September 2026 · Revised September 23, 2026
Sermorelin
A guide to the clinic classic: a drug approved for children and then withdrawn, a molecule pharmacies may still compound, and thirty-year-old trials that measured hormones rather than outcomes
Sermorelin is the first 29 amino acids of growth hormone-releasing hormone, the shortest fragment that still does the whole job. It was an approved drug from 1990 to 2008, first as a diagnostic test and then as a treatment for children who were not growing, and it left the market because growth hormone itself worked better. What kept it alive is a quirk of compounding law: because it was withdrawn for commercial reasons rather than safety, pharmacies may still make it, which makes sermorelin the one growth hormone releaser an anti-aging clinic can prescribe without breaking a rule. This guide covers what it is, what the adult trials actually measured, how it is dosed as sold, and why the legal position is better than the evidence.
Who this is for
Written for adults who are using, or being offered, sermorelin for sleep, recovery, body composition, or anti-aging. It summarizes the historical label, the published trials, and the regulatory position as of the edition date. It is not medical advice.
Growth hormone-releasing hormone (GHRH) is a 44-amino-acid signal from the hypothalamus that tells the pituitary to release growth hormone. In the 1980s researchers found that the first 29 amino acids carried all of the activity, and that fragment, made synthetically, became sermorelin. It is the parent of the whole class: tesamorelin is the full 44-residue hormone with a stabilizing group, and the "no DAC" CJC-1295 in blend vials is sermorelin with four substitutions.
- Class
- Growth hormone-releasing hormone analog; GHRH(1-29) amide
- Brand history
- Geref Diagnostic, approved December 1990 as a test of pituitary function; Geref, approved September 1997 to treat children with idiopathic growth hormone deficiency. Both withdrawn by the manufacturer in 2008 for commercial reasons. FDA determined in 2013 that the withdrawal was not for safety or effectiveness.
- Approved for
- Nothing, today. No FDA-approved sermorelin product exists. The historical approval was for children.
- Forms in use
- Compounded vials from 503A pharmacies on a prescription, commonly 5 to 15 mg of powder; research-chemical vials of 5 or 10 mg, which are unapproved drugs; blends with ipamorelin or GHRP-2 from research vendors
- Anti-doping
- Prohibited by WADA at all times under section S2, growth hormone-releasing factors
Approved once, for children, and then outcompeted
Geref raised growth velocity in children with growth hormone deficiency, but less reliably than injecting growth hormone itself, and by 2008 the market had moved on. The adult wellness use sold today never had a label, a trial program, or a manufacturer behind it. What it has is a legal opening.
Sermorelin binds the GHRH receptor on pituitary cells and triggers a pulse of growth hormone, which raises IGF-1 over the following day. It lasts minutes in the blood, so one injection produces one pulse, which is why it is given at bedtime to ride the natural nocturnal peak. Because it works through the pituitary rather than replacing growth hormone, the body's own feedback still applies: the pulse is capped by what the gland can make, and a suppressed gland gives a small response.
| What blunts the response | Why it matters |
|---|---|
| Age | The pituitary's response to GHRH declines with age; the older adults in the trials responded, but less than young ones |
| Glucocorticoids | Steroid medicines suppress the response; the historical label warned of it |
| Hypothyroidism | Low thyroid function blunts growth hormone release; the label called for thyroid testing before and during treatment |
| Obesity | Growth hormone secretion is suppressed in abdominal obesity, the very state most buyers hope to treat |
| A damaged pituitary | Sermorelin cannot make a gland release what it cannot make; the label excluded deficiency from intracranial lesions |
None of these is a reason the peptide is dangerous. They are reasons the response is unpredictable without measuring it.
Total adults studied across those trials
Trials measuring strength, function, sleep quality, recovery, or any outcome a buyer is paying for
Adult trials published since 1997
| Year | Study | Result | What it supports |
|---|---|---|---|
| 1992 | Healthy men aged 70 to 85, sermorelin twice daily for 14 days | Growth hormone pulses and IGF-1 rose toward young-adult levels | The pituitary still responds in old age; nothing about benefit |
| 1997 | Healthy elderly men, one nightly injection at three doses for 4 weeks | Dose-dependent rise in overnight growth hormone and IGF-1 | Bedtime dosing raises the hormones; nothing about benefit |
| 1997 | 19 men and women aged 55 to 71, a close analog of sermorelin nightly for 16 weeks | Men gained about 1.3 kg of lean mass and reported better well-being; women did not gain lean mass; skin thickness rose in both | The only body-composition result, small, in men only, with a modified molecule |
The 16-week trial used a norleucine-substituted analog, not sermorelin itself. It is the study every clinic brochure is quoting, usually without that detail.
What would count as evidence
A randomized trial of sermorelin against placebo in adults, lasting six months or more, measuring body composition by scan, strength or function, sleep by polysomnography, and IGF-1 and glucose for safety. None exists, none is registered, and no company has a reason to run one for a molecule it cannot patent. The nearest evidence is for growth hormone itself in healthy older adults: small lean-mass gains, no gain in strength or function, and more swelling, joint pain, and glucose problems.
The historical label dosed children by body weight, once a day at bedtime. Clinics kept the bedtime and dropped the weighing: adult protocols use a flat dose chosen by custom and by the size of the vial the pharmacy dispenses.
| Form | Instruction | What is known |
|---|---|---|
| Geref (historical label) | 30 mcg per kilogram once daily at bedtime, subcutaneous, in children with growth hormone deficiency | The approved regimen; about 2 mg a day for a 70 kg adult, which no clinic uses |
| Clinic, compounded | 200 to 500 mcg at bedtime, five nights on and two off, for three to six months, then a break | Custom. The 1990s trials used 1 to 2 mg nightly or 10 mcg per kilogram; clinic doses are a fraction of that |
| Research vial | As above, from a 5 or 10 mg vial reconstituted by the buyer | An unapproved drug; identity and strength unverified |
| Blends | Sermorelin with ipamorelin or GHRP-2 in one vial | No study of any combination; the ipamorelin half may not lawfully be compounded |
What the next table is, and is not
It expresses the common clinic protocol for a 5 mg vial, so the arithmetic can be checked. Compounding pharmacies dispense other sizes, often 9 or 15 mg with their own diluent volume; the pharmacy label governs and the concentration must be recomputed for it. A research-chemical vial's identity and strength are unverified.
- Vial
- 5 mg, as sold by research vendors and some pharmacies; identity and quantity unverified unless a pharmacy dispensed it
- Water added
- 2 mL bacteriostatic water. A 10 mg vial takes 4 mL for the same concentration.
- Concentration
- 2,500 mcg/mL. One concentration for the whole course.
- Syringe
- 0.3 mL insulin syringe with half-unit marks; every draw in the table is under 30 units
| Weeks | Nightly dose | Draw | Units | Used per 4 weeks |
|---|---|---|---|---|
| 1–4 | 200 mcg | 0.08 mL | 8 | 4 mg (about 1 vial) |
| 5–12 | 300 mcg | 0.12 mL | 12 | 6 mg (about 1.2 vials) |
| Higher clinic dose | 500 mcg | 0.2 mL | 20 | 10 mg (2 vials) |
| After 12 | Measure IGF-1; stop if nothing measurable changed |
Twenty injection nights per 4 weeks at five on, two off. The 1990s trials dosed every night and used more; the clinic ramp and rest days are custom.
What each draw looks like · 0.5 mL (50-unit) U-100 insulin syringe
The plunger tip sits on the line for the dose. Units are marks on a U-100 syringe: 100 units is 1 mL. The picture assumes the concentration in the table above; a different amount of water changes every line.
- Bedtime on an empty stomach is the one piece of the protocol with physiology behind it: the natural pulse comes in early deep sleep, and a carbohydrate meal blunts it.
- Three-to-six-month courses with breaks are convention, not pharmacology. No study has tested whether the response fades or whether breaks restore it.
- The historical label's monitoring, thyroid function before and during treatment, is the part clinics most often skip.
Sermorelin's legal position is the most favorable of any growth hormone releaser, and it rests on a technicality worth understanding. Section 503A lets a pharmacy compound from a bulk substance that is a component of an FDA-approved drug. Geref was approved, and when FDA reviewed the 2008 withdrawal it found the reasons were commercial, not safety. So sermorelin stays eligible even though no approved product exists, and because nothing is on the market, the rule against compounding copies of available drugs does not apply either.
| Route | Legal position | What the buyer gets |
|---|---|---|
| Compounded by a 503A pharmacy on a prescription | Lawful. The bulk substance is a component of a formerly approved drug withdrawn for non-safety reasons | A pharmacy-made vial with a label, a beyond-use date, and a pharmacist; no FDA review of the product itself |
| Made in bulk by a 503B outsourcing facility | Unsettled. Sermorelin is nominated for the 503B list and FDA had not decided as of the edition; facilities have used it under FDA's interim policy meanwhile | Office-stock vials at clinics; the same molecule under a different set of rules |
| Research-chemical vial | An unapproved new drug, whatever the label says | Unverified identity and strength, no pharmacy, no prescriber. Sermorelin is also the molecule most often sold as tesamorelin |
| Date | Event |
|---|---|
| Dec 1990 | Geref Diagnostic approved as a test of pituitary growth hormone reserve |
| Sep 1997 | Geref approved to treat idiopathic growth hormone deficiency in children |
| 2008 | Both products withdrawn by the manufacturer for commercial reasons |
| Mar 2013 | FDA determines the withdrawal was not for safety or effectiveness, keeping sermorelin eligible for compounding |
| Sep 2023 | FDA places CJC-1295 and ipamorelin in Category 2. Sermorelin is not touched, and clinics begin substituting it |
| Oct 2024 | Advisory committee votes against adding ipamorelin and ibutamoren to the 503A list; sermorelin is not on the agenda because it does not need to be |
| May 2026 | FDA's notice on the 503B list proposes excluding semaglutide, tirzepatide, and liraglutide; sermorelin's nomination remains undecided |
Legal is not the same as tested
Everything a clinic says about sermorelin's legality is true. The compounded vial is lawful, the prescription is lawful, and the pharmacist is real. None of that is evidence that it does anything for an adult, and FDA has never reviewed a sermorelin product for that use. "FDA-approved" in a clinic's marketing refers to a children's drug that left the market in 2008.
- Insurance does not cover compounded sermorelin for wellness use; the cash price is the price.
- A telehealth prescription is lawful when a licensed prescriber evaluates the patient. A questionnaire and a credit card are the version to be wary of.
- The substitution problem runs the other way too: cheap sermorelin relabeled as tesamorelin is a known research-market fraud. A certificate of analysis should confirm identity by mass spectrometry; sermorelin is about 3.4 kilodaltons, tesamorelin about 5.1.
Reading a vial: the microgram arithmetic2
Sermorelin doses are in micrograms and vials are labeled in milligrams, and pharmacies dispense several vial sizes. The same 300 mcg dose is a different number of units on every one of them, which is the most common way a patient ends up injecting the wrong amount after a refill.
units = (dose mcg ÷ concentration mcg/mL) × 100
A 5 mg vial (5,000 mcg) reconstituted with 2 mL of bacteriostatic water is 2,500 mcg/mL. A 300 mcg dose is 0.12 mL, which is 12 units on a U-100 insulin syringe. A 9 mg pharmacy vial with 3 mL is 3,000 mcg/mL, and the same dose is 10 units.
| Water added | Concentration | 200 mcg | 300 mcg | 500 mcg |
|---|---|---|---|---|
| 1 mL | 5,000 mcg/mL | 4 units | 6 units | 10 units |
| 2 mL | 2,500 mcg/mL | 8 units | 12 units | 20 units |
| 3 mL | 1,667 mcg/mL | 12 units | 18 units | 30 units |
Four units is too small to measure reliably. Reconstituted sermorelin is a multi-dose vial; a pharmacy sets its beyond-use date, a research vendor does not.
Sermorelin's safety record comes from pediatric trials in the 1990s and from three small adult studies of a few months. Since the 2008 withdrawal there has been no manufacturer, no post-marketing surveillance, and no requirement that anyone report what happens to the adults now using it.
- Common
- Injection-site pain, redness, and swelling in about one patient in six in the pediatric trials. Headache, flushing, difficulty swallowing, dizziness, hyperactivity, sleepiness, and hives, each in under 1%.
- Antibodies
- A large share of children developed antibodies to the peptide during treatment, without an apparent effect on growth. What antibodies to a fragment of your own hypothalamic hormone mean over years of adult use has not been studied.
- Thyroid
- Hypothyroidism appeared in 6.5% of treated children. The label called for thyroid testing before and during treatment, because low thyroid also blunts the response.
- Metabolic
- IGF-1 rises by design. The 16-week adult trial reported improved insulin sensitivity in men; growth hormone excess over longer periods does the opposite. No adult data beyond four months.
- Theoretical
- IGF-1 is a growth signal, and long-term growth hormone excess is associated with tumor growth, joint enlargement, and carpal tunnel syndrome. No study has examined sermorelin in people with cancer or a cancer history.
- Do not use
- In pregnancy (the label was Category C, and compounders exclude it); with an active cancer; with growth hormone deficiency from a pituitary or brain lesion; with a known hypersensitivity. Glucocorticoids blunt the response.
- Unknown
- Everything past four months in adults, including whether the response persists, whether antibodies matter, and whether raised IGF-1 for years carries the risks seen with growth hormone.
- Athletes
- A positive test at any time; detection methods for GHRH fragments are in routine use.
- Is this a pharmacy-compounded vial on a prescription, or a research vial? Which pharmacy, and is the beyond-use date on the label?
- What were my IGF-1 and thyroid results before starting, and when are they rechecked?
- What is the concentration on this vial, and does the units figure match the dose the clinic told me? Ask again after every refill.
- Do I have a cancer history, a pituitary condition, or diabetes? Am I taking a steroid medicine? Am I pregnant or planning to be?
- What is being measured to decide whether it works, and by when?
- Am I subject to anti-doping rules, at work or in sport?
- If nothing measurable changes in twelve weeks, what is the plan?
What does have evidence for the goals on the brochure
For body composition: resistance training and adequate protein, which outperform growth hormone itself in healthy adults. For sleep: sleep timing, light, and alcohol, with controlled trials behind each. For a diagnosed growth hormone deficiency: growth hormone, from an endocrinologist, with monitoring, which is the treatment that replaced Geref.
Latest
Developments since this edition, newest first. Items here are dated and sourced; they update the guide without re-editing it.
Hims & Hers to sell compounded sermorelin by year-end
The telehealth company told investors it will offer peptides that are already compoundable, sermorelin among them, through its own pharmacy by the end of 2026. Analysts expect little revenue effect this year.
Telehealth entry starts with the peptides already legal to compound
Hims & Hers plans to begin with substances such as sermorelin while FDA rulemaking on the committee-backed peptides is pending. Expect sermorelin's compounded price to move as a large seller enters.
Sermorelin was not part of the July committee review; status unchanged
The seven peptides reviewed in July did not include sermorelin, which remains compoundable on the basis of the withdrawn Geref approval.
References
- 1.U.S. Food and Drug Administration. Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness. Federal Register, March 4, 2013. https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
- 2.Geref (sermorelin acetate for injection) prescribing information, historical. EMD Serono, 1997 (NDA 020443).
- 3.Corpas E, et al. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and IGF-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530-535. https://academic.oup.com/jcem/article-abstract/75/2/530/2649366
- 4.Vittone J, et al. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism. 1997;46(1):89-96. https://pubmed.ncbi.nlm.nih.gov/9005976/
- 5.Khorram O, Laughlin GA, Yen SSC. Endocrine and metabolic effects of long-term administration of [Nle27]GHRH-(1-29)-NH2 in age-advanced men and women. J Clin Endocrinol Metab. 1997;82(5):1472-1479. https://academic.oup.com/jcem/article-abstract/82/5/1472/2823341
- 6.U.S. Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A (Category 2 placements, September 2023; update April 2026). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-federal-food-drug-and-cosmetic-act
- 7.U.S. Food and Drug Administration. Meeting of the Pharmacy Compounding Advisory Committee, October 29, 2024 (ipamorelin, ibutamoren, kisspeptin-10, L-theanine). https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-29-2024-meeting-pharmacy-compounding-advisory-committee-10292024
- 8.U.S. Food and Drug Administration. List of bulk drug substances for which there is a clinical need under section 503B. Federal Register, May 1, 2026; comment period extended June 26, 2026. https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
- 9.Sigalos JT, Pastuszak AW. The safety and efficacy of growth hormone secretagogues. Sex Med Rev. 2018;6(1):45-53. https://pmc.ncbi.nlm.nih.gov/articles/PMC5632578/
- 10.World Anti-Doping Agency. The Prohibited List 2026: S2, growth hormone-releasing factors, including sermorelin. https://www.wada-ama.org/en/prohibited-list
- 11.Liu H, et al. Systematic review: the safety and efficacy of growth hormone in the healthy elderly. Ann Intern Med. 2007;146(2):104-115. https://pubmed.ncbi.nlm.nih.gov/17227934/