Peptide LexiconAll compounds

Sermorelin: The Approved Drug That Was Withdrawn for Business Reasons, Not Safety

Sermorelin was a licensed American medicine sold as GEREF. It was discontinued in the 2000s, and FDA recorded that the withdrawal was not for safety or effectiveness reasons. What it is, what it was approved to do, and what that history does and does not mean.

Was approved (US)DiscontinuedNot currently marketed

Caroline S · Published 2026-09-07

Length

29 amino acids

Sequence

GHRH(1-29), the N-terminal fragment of human growth hormone releasing hormone

Origin

Fragment of a natural human hormone

Last reviewed

2026-09-07

What is it good for?

It was approved to diagnose and to treat growth hormone deficiency — testing whether a pituitary gland can release growth hormone, and treating growth failure in children who lack it. It is now marketed informally for adult body composition, sleep and ageing, none of which were approved uses or the subject of its trial record.

Illustration: A clear glass ampule with faint residue on a white surface, subtle green reflection.
Illustration

What it is

Sermorelin is a 29-amino-acid fragment of growth hormone releasing hormone, the signal the hypothalamus sends down to the pituitary gland when it wants growth hormone released.

The natural hormone is 44 amino acids long. Researchers found that the first 29 of them carry essentially all of the activity at the receptor, and that the remaining 15 can be left off without losing the effect. Sermorelin is that shortened version — the working end of a human hormone, made synthetically.

The distinction that matters most for a beginner: sermorelin is not growth hormone, and it does not supply any. It asks the pituitary gland to release its own. If the pituitary cannot respond — because it is damaged, or absent — sermorelin does nothing. That property is exactly why its first approved use was diagnostic.

What it is said to be good for

Two very different answers, and the gap between them is the whole story of this compound.

What it was approved for was growth hormone deficiency: as a test of whether a pituitary gland can release growth hormone when properly asked, and as a treatment for growth failure in children who lack the hormone. It was a pediatric endocrinology and diagnostic drug.

What it is marketed for now — in clinics and by research-chemical sellers — is adult body composition, sleep quality, recovery and ageing. Those were not approved uses, and they are not what its large clinical literature was built to answer.

What the research shows

Sermorelin has the largest human research record of any compound in this library that is not currently sold as a medicine. Searching PubMed on 2026-09-07 returns 445 records, of which 243 are tagged as human research and 20 are randomized controlled trials.

That is a genuinely substantial body of work, and it is important to be precise about what it is work on. The great majority of it concerns pituitary function: whether the gland responds, how much it releases, how the response changes with age and sex, and how the compound performs as a diagnostic provocation agent. It is a literature about a test, and about a deficiency, built by the people who used the drug for those things.

A large literature answering one question is not evidence about a different question. The reader who sees "445 studies" on a vendor page and concludes that adult body-composition use is well studied has made the substitution the page invited.

The same substitution runs the other way on AOD-9604, where a research file of twenty-two papers is presented as a body of fat-loss evidence and most of it is anti-doping detection chemistry.

Its regulatory history, which is unusual and often misdescribed

Sermorelin was an approved American medicine. Marketed as GEREF by EMD Serono, it holds two entries in FDA's Drugs@FDA database: NDA 019863, for a 0.05 mg ampoule, and NDA 020443, for 0.5 mg and 1 mg vials, whose original approval is dated 1997-09-26.

Both are now listed as Discontinued. And both carry a specific annotation, which we read directly from FDA's own database through its openFDA interface on 2026-09-07:

Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons.

That sentence is FDA's formal notation for a product that left the market for commercial reasons — the sponsor stopped making it — rather than because a regulator found a problem. It is a real and meaningful fact about this compound, and it is one of the few things vendors say about sermorelin that is true.

It is also routinely over-read. The determination records why the product left the market. It does not say the drug works for anything it was not approved for, it does not extend to material made by someone else, and it does not make an unapproved product legal. A drug that was approved for diagnosing pituitary function in the 1990s and left the market for business reasons is still, today, a drug with no marketed approved form.

Where it stands

Approved as a medicine: it was, in the United States, and is not now. No approved sermorelin product is currently marketed there.

Reason recorded for withdrawal: not for safety or effectiveness reasons, per the Federal Register determination noted against both applications.

Available as: compounded preparations from pharmacies, and as a research chemical. Neither is the approved product, and neither carries what an approval carries — a label, a manufacturer of record, a batch history and a regulator behind it.

Related entries in this library: tesamorelin is the analogue of the same hormone that is still an approved medicine, for one narrow use. The ghrelin-mimicking hexapeptide licensed in Japan is the other compound here with an approval behind it, and like this one it was approved partly for testing a pituitary rather than for treating a body. Ipamorelin reaches the same axis through a different receptor, with a far smaller evidence base.

Last checked

2026-09-07. FDA's Drugs@FDA records for NDA 019863 and NDA 020443 were queried through the openFDA API on that date, and the PubMed and ClinicalTrials.gov counts were run the same day.

What the research shows

Provoking growth hormone release from the pituitary

Human; the basis of its approved diagnostic use

Growth failure in children with growth hormone deficiency

Human; the basis of its approved treatment use

Body composition or anti-ageing effects in healthy adults

Not an approved use; not what the trial record addresses

Bars show how much of the evidence is in humans, not how well anything works.

Where it stands

Was approved as a medicine

United States, as GEREF, under NDA 019863 and NDA 020443 (the latter approved 1997-09-26), sponsor EMD Serono.

Current status

Both applications listed Discontinued in Drugs@FDA. No approved sermorelin product is marketed in the US today.

Reason recorded for withdrawal

Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons.

Available as

Compounded preparations and research chemicals, neither of which is the approved product.

Frequently asked questions

What is sermorelin?

A 29-amino-acid fragment of growth hormone releasing hormone — the signal the hypothalamus sends to the pituitary gland telling it to release growth hormone. The natural hormone is 44 amino acids long; the first 29 do essentially all of the work at the receptor, and sermorelin is those 29. It does not supply growth hormone. It asks the pituitary for some.

Was sermorelin ever an approved drug?

Yes, in the United States. It was marketed as GEREF by EMD Serono under two FDA applications, NDA 019863 and NDA 020443, the second approved on 1997-09-26. Both are now listed as Discontinued. That makes sermorelin unusual in this library: most compounds here were never approved anywhere, while this one was approved and then left the market.

Was sermorelin withdrawn because it was dangerous?

FDA's own record says no. Both discontinued GEREF applications carry the annotation that there was a Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons — the formal notation FDA uses when a product leaves the market for commercial reasons rather than because something was found wrong with it. That is a meaningful distinction, and it is also frequently over-read. It records why the product left; it does not certify any use it was never approved for.

What was sermorelin approved to treat?

Its approved uses were in growth hormone deficiency — both as a diagnostic agent, to test whether a pituitary gland can release growth hormone when properly asked, and in the treatment of growth failure in children with growth hormone deficiency. It was a pediatric endocrinology and diagnostic drug. The uses it is marketed for today, in adults, for body composition, sleep or ageing, were not what it was licensed for.

How much human research is there on sermorelin?

More than for almost anything else in this library. PubMed indexes 445 records, 243 of them tagged as human and 20 as randomized controlled trials, as of 2026-09-07. That literature is largely about pituitary function testing and growth hormone deficiency, because that is what the drug was used for. A large literature on one question is not evidence about a different question.

Is sermorelin the same as ipamorelin or CJC-1295?

No, though all three end up raising growth hormone. Sermorelin is a fragment of the natural releasing hormone and acts at that hormone's receptor. Ipamorelin acts at a different receptor, the one ghrelin uses. CJC-1295 is a modified releasing-hormone analogue built to last far longer in the body than sermorelin's few minutes. Same broad axis, three different molecules with three different evidence bases.