Is sermorelin FDA approved?

Not anymore. Sermorelin was FDA approved as Geref (a 1990 diagnostic and a 1997 pediatric growth-hormone-deficiency treatment), but the manufacturer discontinued it in 2008 for commercial reasons and the approvals were withdrawn in 2009. The FDA's own determination was that it was not withdrawn for safety or effectiveness. It is now available only through compounding pharmacies.

What sermorelin dose do compounded protocols use?

Adult compounded and clinic protocols commonly use roughly 200–500 mcg by subcutaneous injection once nightly, typically at bedtime on an empty stomach, in time-limited courses. These are not FDA-labeled doses — they reflect compounding practice and should be set and supervised by a prescriber.

Why is it dosed at night?

Sermorelin stimulates the body's own pulsatile growth-hormone release, which is naturally concentrated during slow-wave sleep. Bedtime dosing is intended to align with that rhythm, though the practice is convention rather than a labeled requirement.

Dosage Guide · Formerly approved · now compounded

Sermorelin Dosage: Compounded Protocols & FDA History

Last updated May 19, 2026 · Reviewed by Grey Peptides Editorial Board · ✓ Primary-sourced

← Sermorelin encyclopedia entry · See also: Tesamorelin dosage · Ipamorelin dosage

📋 Key takeaways

Sermorelin occupies an unusual middle ground: it was once an FDA-approved drug (Geref) but the manufacturer discontinued it in 2008 for commercial reasons — not safety or effectiveness — and the approval was withdrawn. Today it is available only through compounding pharmacies, prescribed off-label for adult growth-hormone optimization.

Because there is no longer an active label, "dosing" comes from compounding practice: commonly around 200–500 mcg subcutaneously once nightly, in courses, set by a prescriber.

This page documents those ranges for education and explains the regulatory history so the numbers are read in context. It is not a recommendation, and any use should be clinician-supervised.

The short version

Sermorelin is GHRH(1-29) — the first 29 amino acids of growth-hormone-releasing hormone, the shortest fragment that retains full activity. Like tesamorelin, it prompts the pituitary to secrete growth hormone in natural pulses rather than supplying the hormone directly. Its history is the key to understanding its dosing: it is a formerly approved drug that now lives in the compounding world, so the schedules in circulation come from clinics and compounders, not a current FDA label.

🔎 Regulatory history (why there's no current label)

The FDA approved Geref Diagnostic in 1990 (a growth-hormone stimulation test) and Geref in 1997 (treatment of pediatric growth-hormone deficiency). In 2008, manufacturer EMD Serono notified the FDA it was discontinuing the product and requested withdrawal of the approvals, which took effect in 2009. The FDA later formally determined the product was not withdrawn for reasons of safety or effectiveness — it was a business decision. That is why sermorelin can still be compounded today.

Compounded / clinic dosing ranges

Adult protocols from clinics and compounding pharmacies most commonly report the following pattern. These are descriptive of practice, not labeled doses, and individual prescribers vary.

Parameter	Commonly reported
Amount	~200–500 mcg per dose
Frequency	Once daily (often nightly)
Timing	At bedtime, empty stomach
Route	Subcutaneous
Course	Time-limited; re-evaluated periodically

A practical safety note often cited is that because sermorelin works through the pituitary and remains subject to somatostatin negative feedback, it is harder to drive growth hormone to supraphysiologic levels than with injected HGH. That feedback loop is a feature, not a license to dose casually.

Reconstitution and administration

Compounded sermorelin is typically supplied as a powder requiring reconstitution with bacteriostatic water, then a small nightly subcutaneous injection. The microgram amounts make the dilution math worth doing carefully: our Reconstitution Calculator turns vial strength and diluent volume into an exact syringe draw, and the Mixing & Administration Guide covers technique and storage. With a compounded product, the pharmacy's specific instructions take precedence.

Frequently asked questions

Is sermorelin legal to obtain?

Losing FDA approval did not make it illegal; it is dispensed through compounding pharmacies with a prescription. It simply no longer exists as a commercially marketed, FDA-approved product.

How does it compare to tesamorelin?

Both are GHRH analogs, but tesamorelin (Egrifta) is a currently FDA-approved 44–amino-acid analog with a specific indication, whereas sermorelin is the shorter 29–amino-acid fragment now used via compounding. See the tesamorelin dosage page for that side.

Is it cycled?

Compounded courses are usually time-limited with periodic reassessment, but there is no labeled schedule, so practice varies by prescriber.

Sources

FDA, Federal Register — determination that Geref (sermorelin acetate) was not withdrawn for reasons of safety or effectiveness (2013); withdrawal of NDAs 19-863 and 20-443 (2009).
Geref (sermorelin acetate) historical U.S. Prescribing Information — EMD Serono.
Walker RF. "Sermorelin: a better approach to management of adult-onset growth hormone insufficiency?" Clin Interv Aging. 2006;1:307–308.

Medical disclaimer: Education only, not medical advice. Sermorelin is no longer an FDA-approved product; compounded use is off-label. Dosing figures reflect compounding practice, not a recommendation. Consult a licensed clinician.