Sermorelin Dosage: What the FDA Label and Studies Say

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The only FDA-approved sermorelin dosage for treatment was a children’s dose: the product Geref was given as 30 micrograms per kilogram of body weight once a day at bedtime, by injection under the skin, to children with idiopathic growth hormone deficiency, according to a reprint of the Geref label. No FDA-approved sermorelin treatment dose for adults exists. The adult doses in studies and on clinic websites come from small trials in men and from company pages, and they do not match. This page lays out what each source reports so you can ask better questions. It is not a dosing guide, and I am not a clinician. For the bigger picture, start with my sermorelin therapy overview.

Table of Contents

What is the FDA-approved sermorelin dosage?

The Geref label says the product is indicated for idiopathic growth hormone deficiency in children with growth failure. Its Dosage and Administration section recommends 0.03 mg (30 mcg) per kg of body weight once daily at bedtime by subcutaneous injection, with injection sites rotated, and says treatment should stop when the growth plates are fused. The dose was weight based, not one number for everyone.

The FDA’s Drugs@FDA page for this application says the label is not available on its site (read October 26, 2026), so the text above comes from a reprint dated December 30, 2005, which may differ from the last version FDA held. A 1999 review in BioDrugs reports the same dose and calls the data limited.

What did the Geref label’s trial measure?

Height growth, not weight. In the label’s open-label study of 110 prepubertal children, 56 were evaluable at 12 months, and their average height velocity rose from 4.1 cm a year to 7.2 cm a year. Twenty children left because they did not meet the efficacy criteria at 6 months. The BioDrugs review says the effect on final adult height was not known. This was a pediatric trial and says nothing about adult weight loss.

Is there an FDA-approved sermorelin treatment dose for adults?

No. A 2013 FDA notice in the Federal Register lists the two Geref products. The vials were approved on September 26, 1997 for children with growth failure. The ampule was approved on December 28, 1990 for evaluating whether the pituitary can secrete growth hormone. Neither carried an adult treatment dose.

The same notice says the maker, EMD Serono, told FDA in 2008 that both products were discontinued and asked FDA to withdraw the applications, and approval was withdrawn effective June 18, 2009. In 2013 FDA determined neither was withdrawn for reasons of safety or effectiveness. The notice does not say why the maker discontinued the products, only that safety and effectiveness were not the reason. The diagnostic use is separate: the BioDrugs review describes a single intravenous 1 mcg per kg dose as a test for growth hormone deficiency, not a treatment dose.

What sermorelin doses have studies in adults used?

Very few, and the two adult papers cited here are small. This table shows what the label and those papers report.

Source	Who was studied	Dose and schedule	What was measured	What it reported
Geref label reprint	110 prepubertal children with growth hormone deficiency	30 mcg per kg once daily at bedtime, subcutaneous	Height velocity	4.1 to 7.2 cm a year at 12 months in 56 evaluable children; open label
Corpas and colleagues, 1992	10 healthy, nonobese men, average age 68; 9 young men for comparison	0.5 mg or 1 mg of GHRH 1-29 twice daily for 14 days each, with a 14 day break	24 hour growth hormone and IGF-I	Only the 1 mg dose raised both significantly; afterward no significant difference from young men
Vittone and colleagues, 1997	11 healthy, nonobese men aged 64 to 76 with low IGF-I	2 mg of GHRH 1-29 once nightly for 6 weeks	Growth hormone, IGF-I, strength, body composition	Night time growth hormone release rose; IGF-I, weight and body fat did not change

Both papers name the peptide GHRH 1-29, the same 29 amino acid segment of growth hormone-releasing hormone that the Geref label describes as sermorelin. Notice who is missing: both adult studies enrolled only men, for 14 days and 6 weeks.

Why did two adult studies get different results?

The two studies differ in schedule, total daily dose and what they measured. In the Vittone study, one 2 mg injection each night did not change IGF-I, body mass index or DEXA measures of fat and muscle, and it improved 2 of 6 strength measures plus an abdominal crunch endurance test. No significant adverse effects were observed. The authors concluded that single nightly doses look less effective than multiple daily doses. In Corpas, twice daily 1 mg doses raised IGF-I in old men until it no longer differed significantly from young men.

A 2008 review by Hersch and Merriam is cautious. The authors say functional changes from growth hormone in healthy older adults were inconsistent, older adults were more sensitive to side effects, and the balance of benefits and risks in normal aging remained uncertain.

What do companies say about sermorelin dosage today?

Compounding pharmacies and online providers publish their own ranges. Three are below, as they read on October 26, 2026. These are company pages, not trials or labels, and they show how much the numbers vary.

Company page	Dose it states	Timing and monitoring it states
Olympia Pharmaceuticals, a compounding pharmacy	300 mcg once nightly for its 0.9 mg per mL product, subcutaneous or intramuscular per the prescriber	60 to 90 minutes after the last meal
Sermorelin.com, an online provider	200 to 500 mcg once daily at bedtime; most start at 200 to 300 mcg	Fasting at least 90 minutes, 2 hours preferred; IGF-1 labs at 4 to 6 weeks, then every 3 to 6 months
Eden, an online provider	Starting dose of 200 to 300 mcg; typical range 200 to 500 mcg daily	At least 1 hour after a meal; mentions 5 days on, 2 days off

They disagree on meal timing (1 hour to 2 hours), route (one allows intramuscular) and frequency. The FDA’s compounding questions and answers page says compounded drugs are not FDA-approved and that FDA does not verify their safety, effectiveness or quality before they are marketed.

Why does sermorelin dosage vary between prescribers?

Four reasons show up in the sources. No adult dose was ever approved, so each prescriber starts from studies or company ranges. The label dose is weight based and was set for children, while the adult papers used fixed milligram doses on different schedules. Sermorelin.com says its dose is individualized by age, body weight, baseline IGF-1 and treatment goals. And Olympia lists a 0.9 mg per mL product, so strength depends on what a pharmacy prepares. The label also reports about 6 percent absolute bioavailability after subcutaneous injection and a half-life of 11 to 12 minutes.

Which tests do prescribers use to monitor sermorelin?

An IGF-1 blood test is the one these sources keep returning to. MedlinePlus explains that growth hormone levels swing through the day while IGF-1 is more stable, and that the test is used to detect and monitor growth hormone disorders. It adds that IGF-1 testing is not common in adults, since other disorders are far more likely to cause the same symptoms. The Geref label says IGF-1, growth hormone, phosphorus and alkaline phosphatase may rise with therapy, and that thyroid hormone should be checked before and during treatment, since hypothyroidism occurred in 6.5 percent of its clinical-study patients.

A prescriber decides whether treatment is appropriate at all, which product and route to use, the dose, the lab schedule and when to stop. Those decisions rest on your health history, which no web page can see.

Is there a sermorelin dosage for weight loss?

No label or trial cited here sets one. The Geref label studied children’s height, and the Vittone trial found no change in weight, body mass index or DEXA fat and muscle. Sermorelin.com has a weight management row on its dosage page (read October 26, 2026), and says its ranges are typical ranges observed in clinical practice, not prescriptive recommendations. If weight loss is your goal, my best peptides for weight loss guide looks at the evidence for peptides, and my GLP-1 weight loss guide covers medicines tested with weight as the main outcome.

What side effects were reported at studied sermorelin doses?

The label reports that the most common treatment-related event, in about 1 patient in 6, was a local injection reaction with pain, swelling or redness. Of 350 patients exposed in trials, three stopped for that reason. Other events occurred in under 1 percent and included headache, flushing and dizziness. The label rates sermorelin pregnancy category C and says it should not be used by anyone with a known sensitivity. The BioDrugs review lists transient facial flushing and injection site pain as most common. For more, see my sermorelin side effects page.

Is compounded sermorelin the same as Geref?

No. Geref was an FDA-approved product with a label, and its maker discontinued it in 2008. Compounded sermorelin is made by a pharmacy from a prescription and, per the FDA page above, is not FDA-approved. For the steps to find a licensed prescriber and pharmacy, read how to get sermorelin.

Please talk with your prescriber or pharmacist before you start, change or stop any hormone-related medicine, especially with a pituitary or thyroid condition, during pregnancy, or if you take steroid medicine. I am not a medical professional, and this page reports sources. It does not tell you what to take.

Frequently Asked Questions

Were women included in the sermorelin dosing studies?

Not in the two adult studies above. Corpas studied old and young men, and Vittone studied men aged 64 to 76. The Geref label says clearance of sermorelin in normal men and women is similar, but that is a pharmacology finding, not a dosing study in women.

How long did the studies give sermorelin?

The adult studies ran 14 days (Corpas) and 6 weeks (Vittone). The pediatric label study followed children for 12 months, and the BioDrugs review says data in a few children suggest the effect held through 36 months.

Does a higher sermorelin dose work better?

In one trial of 10 older men, only 1 mg twice daily, not 0.5 mg, raised growth hormone and IGF-I significantly. In another, 2 mg once nightly did not raise IGF-I. The Vittone authors concluded that single nightly doses looked less effective than multiple daily doses. Both studies were small, at 10 and 11 men.

Why is sermorelin dosed at bedtime?

The Geref label specifies bedtime and the Vittone trial dosed nightly, but neither explains why. Olympia’s page says bedtime is meant to line up with the body’s night time growth hormone pulses. That is a company statement, not a trial result.

Does sermorelin dosage depend on body weight?

On the Geref label it did: 30 mcg per kg. Sermorelin.com says its dose is individualized by age, body weight and baseline IGF-1, yet the examples on the three company pages are fixed microgram amounts, and the two adult trials used fixed milligram doses.

Who decides my sermorelin dose?

A licensed prescriber. The Geref label says therapy should be carried out under the regular guidance of a physician experienced in the diagnosis and management of growth disorders. FDA says it does not verify the safety, effectiveness or quality of compounded drugs before they are marketed, so your prescriber’s instructions and the pharmacy label are what apply to you.

Sources

Sermorelin Dosage: What the Old FDA Label and Studies Report