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Is Sermorelin FDA Approved? Not Since 2009

Creator: Julian Reyes, Health Writer
Published: 2026-09-07

Geref, the only sermorelin product the United States ever approved, left the market in 2008 and its approvals were withdrawn in 2009 — not over safety. Here is what that means for a prescription today.

Julian Reyes, Health Writer September 7, 2026 7 min read

A man in his fifties sits on a linen sofa in a quiet living room, a plain mug in both hands, facing the camera

The short version

There is no FDA-approved sermorelin product on the U.S. market. Geref, the only one there has ever been, had its approvals withdrawn effective June 18, 2009.
Geref was not pulled over a safety problem. FDA published a formal determination on March 4, 2013 that neither Geref product was withdrawn from sale for reasons of safety or effectiveness.
The 1997 label covered children with idiopathic growth hormone deficiency and growth failure — not adults, and nothing about body composition, sleep or aging.
Sermorelin appears nowhere on FDA's record of bulk substances nominated for 503A compounding, in any of its three categories, as of the May 14, 2026 update.
The pivotal trial ran in 110 children: growth rate rose from about 4 cm a year to about 8 cm at six months, and roughly three in four were counted as good responders. Adult data is far thinner — one six-week study in eleven men raised overnight growth hormone but moved neither IGF-1 nor body composition.
Sermorelin prescribed today is compounded, which is different from an FDA-approved product: the compounded formulation is not FDA-approved. A licensed provider may still prescribe it where they judge it appropriate.

Is sermorelin FDA approved? Not today, and not since June 2009.

There was an approved sermorelin product once. It was called Geref, it went to children who weren't growing properly, and the company that made it stopped making it. The agency formally withdrew the approvals in 2009, and nothing has taken its place.

So the sermorelin a doctor writes a prescription for now is compounded — prepared for one named patient by a licensed pharmacy. That is different from an FDA-approved product: the compounded formulation is not FDA-approved. It is still a real prescription medicine from a real pharmacy, ordered by a clinician who has read your history. It just has not been through the agency's premarket review.

Is sermorelin FDA approved? Not since June 18, 2009

Two different Geref products existed, and the dates are worth having straight — the internet garbles them constantly.

Date	What happened
December 28, 1990	The first Geref clears — a 0.05 mg ampoule used to test whether a pituitary gland can release growth hormone. A diagnostic, not a treatment.
September 26, 1997	The second Geref arrives — vials for treating idiopathic growth hormone deficiency in children with growth failure.
July and December 2008	EMD Serono writes to the agency to say both products are being discontinued, and asks for the applications to be withdrawn.
June 18, 2009	The withdrawal takes effect. There has been no approved sermorelin product on the U.S. market since.
March 4, 2013	The agency publishes a determination that neither Geref was withdrawn for reasons of safety or effectiveness.

The whole sequence is recited in the 2013 Federal Register determination; the 2009 notice is the one that closed the file.

It was discontinued, not taken away

This is the part people get wrong, and it matters if you are nervous about it.

The agency did not pull Geref. The company stopped selling it and asked for the paperwork to be closed. The 2009 notice says so in as many words: the application holders told FDA the products were no longer marketed and requested the withdrawal themselves.

Four years later, somebody made the agency say it on the record. A lawyer petitioned FDA in October 2012 to determine whether Geref had left the market for reasons of safety or effectiveness. The agency went back through its own files, independently reviewed the published literature and the post-marketing adverse-event reports for both products, and answered in March 2013: neither one was withdrawn for those reasons. Both stayed in the Orange Book's Discontinued Drug Product List, which covers drugs discontinued for reasons other than safety or effectiveness.

That answer did one more thing. It cleared the path for a copy: any company can now file an abbreviated application pointing back at Geref and, if it meets every other legal requirement, sell a generic sermorelin injection. Thirteen years on, none has — FDA's drug database still shows exactly two sermorelin applications, both flagged discontinued.

What the 1997 label actually covered

Children. That is the whole answer.

It covered kids whose bodies were not making enough growth hormone and who were not growing at a normal rate. It said nothing about adults, sleep, body composition or aging — which is what most people are asking about when they land on a page like this one.

The trial behind it enrolled 110 children who had never been treated before, 86 of whom had usable results after up to a year of a nightly injection. Their growth rate went from about 4 cm a year to about 8 cm at six months, settling near 7 cm at twelve. Roughly three in four counted as good responders at six months, and the investigators reported no troubling changes in blood chemistry (Thorner et al., Journal of Clinical Endocrinology & Metabolism, 1996). That is a real result in a specific group of people, and it is also the strongest evidence sermorelin has.

The adult picture is much thinner, and you are better off hearing that here than finding it out later. In one study, eleven healthy men aged 64 to 76 injected the same molecule nightly for six weeks. Their overnight growth hormone output rose. Their IGF-1 — the downstream blood marker clinicians actually track — did not budge. Neither did their weight, or the muscle and fat on a body-composition scan. Two of six strength tests improved (Vittone et al., Metabolism, 1997). Eleven men, six weeks, a mixed picture. Does sermorelin work walks through that literature properly, and sermorelin versus HGH explains why the two are not interchangeable.

Where sermorelin sits on FDA's compounding lists

A compounding pharmacy cannot start from any powder it likes. Section 503A — the part of federal drug law covering a pharmacy that prepares a medicine for one named patient — lets it use a bulk substance in one of three situations: there is a published USP or NF quality standard for it, or it is a component of a drug the agency has approved, or it sits on a particular list the agency maintains.

The agency also keeps a running record of substances people have nominated for that list, sorted into three groups: under evaluation, raising significant safety concerns, and nominated without enough supporting information. As of that record's most recent update on May 14, 2026, sermorelin is in none of the three.

Those two things get conflated constantly. Being absent from that record is different from being flagged on it — the record catalogues what somebody asked the agency to look at.

CJC-1295 with ipamorelin, the other growth-hormone pairing people ask about, has its own history — it never had a U.S. approval to lose in the first place. Same prescription route today, a different paper trail behind it. Why an approval isn't inherited covers those 503A routes in more detail, and are peptides legal takes the lawfulness question on its own.

None of this decides anything for you. Regulatory status is one input into a prescribing decision, not the whole of it, and a licensed provider may still prescribe a compounded formulation where they judge it appropriate — that decision is between you and your doctor.

What the newest research says, as of September 2026

As of September 6, 2026, the day this article was written, the most recent published work to look hard at sermorelin is a review in Frontiers in Endocrinology, posted on June 18, 2026 by an endocrinology group at Poznan University of Medical Sciences in Poland. It is not a trial. It is a field guide for doctors who keep meeting patients already using growth-hormone peptides bought online, and it does one genuinely useful thing: it sorts each compound into one of four tiers by how much human evidence sits behind it.

Sermorelin gets a starred category of its own — a compound that once held a regulatory approval and has early-phase human studies behind it in endocrine testing, but nothing of the kind for the body-composition goals it now gets sought out for. At the far end of the same table sit compounds with no peer-reviewed human studies at all. That spread, inside one product category, is the thing worth taking away.

The authors' concern is not really the molecules. It is the supply. When nobody can say what is in the vial, at what strength, or what else is going in alongside it, the effects they catalogue across this family of peptides — fluid retention, joint and muscle aches, shifts in blood sugar and hormone levels, injection-site reactions — become close to impossible to read (Dominikowski et al., Frontiers in Endocrinology, 2026). That, more than any list, is the practical case for a prescription over a website that ships to anyone.

What going through a doctor actually changes

Seeing a clinician does not get you an approved product. It gets you three other things: someone accountable who has read your medical history, a pharmacy licensed and inspected by a state board, and a preparation made under those rules rather than shipped by a seller you cannot name.

At Promise, sermorelin has its own intake questionnaire, because the clinical questions for a growth-hormone peptide are not the questions for anything else. A licensed provider reviews every request, and not everyone qualifies. If they decline, that is the process working, not failing.

Common questions

Is sermorelin FDA approved?

Not currently. A sermorelin product called Geref was cleared for sale twice — a pituitary-test version in December 1990 and a children's treatment in September 1997 — and both approvals were withdrawn effective June 18, 2009 after the manufacturer discontinued them. No approved sermorelin product has been marketed in the United States since, and the compounded sermorelin prescribed today is not FDA-approved.

Why was Geref taken off the market?

Its maker stopped selling it. EMD Serono wrote to FDA in July and December 2008 to say both Geref products were being discontinued and to ask for the applications to be withdrawn. In March 2013, after reviewing its own files and the published safety literature, FDA published a formal determination that neither product was withdrawn for reasons of safety or effectiveness.

Is compounded sermorelin legal?

Yes. Compounding — a licensed pharmacy preparing a medicine for one named patient against a prescription — is a lawful, regulated activity under section 503A of the federal drug law. What it is not is a second approval pathway. The finished preparation never goes through premarket review, so it is not FDA-approved, and a legitimate service will tell you that plainly.

Is sermorelin on FDA's list of substances that raise safety concerns?

No. Sermorelin appears nowhere on FDA's record of bulk substances nominated for use in 503A compounding — not among those under evaluation, not among those raising significant safety concerns, and not among those nominated without adequate support. That record was last updated May 14, 2026. Being absent from it is a different thing from being flagged on it.

Can a doctor still prescribe sermorelin?

Yes, where they judge it appropriate. A licensed provider reads your medical history, weighs it against what sermorelin does, and decides — and they can decline. Regulatory status is one input into that decision rather than the whole of it, and the choice sits with you and your prescriber, not with a website.

Could a generic sermorelin be approved?

It could. FDA's 2013 determination specifically cleared the way for abbreviated applications referencing Geref, meaning a company can seek clearance to sell a generic sermorelin injection if it meets every other requirement. Thirteen years later nobody has: as of September 2026, FDA's drug database lists only the two original Geref applications, both marked discontinued.