Sermorelin is a lab-made copy of the first 29 amino acids of growth hormone-releasing hormone. It signals the pituitary to release its own growth hormone rather than supplying the hormone directly. The US brand was discontinued, and compounded sermorelin is not FDA-approved.
Sermorelin is a synthetic peptide that copies the active portion of growth hormone-releasing hormone (GHRH), the signal your brain sends to the pituitary gland to release growth hormone. That is the core difference: growth hormone medications supply the hormone itself, while sermorelin asks your pituitary to release its own. Sermorelin was once sold in the US as an FDA-approved brand, but that product was discontinued, and the compounded sermorelin prescribed today is not FDA-approved.
A 1999 review in BioDrugs by Prakash and Goa describes sermorelin as a 29 amino acid analog of human GHRH and "the shortest synthetic peptide with full biological activity of GHRH." Given intravenously or under the skin, it specifically stimulates growth hormone secretion from the anterior pituitary.
Historically, sermorelin had two medical uses. As a single intravenous dose, it served as a test of whether the pituitary could release growth hormone. As a nightly injection, limited data showed it could increase growth rates in some prepubertal children with idiopathic growth hormone deficiency, although increases in growth velocity were smaller than those seen in children receiving daily growth hormone in the comparisons the review describes.
Growth hormone is released by the pituitary in pulses. A 2023 Endocrine Society scientific statement notes that growth hormone secretion peaks around mid-puberty and then declines by about 50 percent every 7 to 10 years, mainly because the pulses get smaller rather than less frequent.
| Growth hormone (somatropin) | Sermorelin | |
|---|---|---|
| What it is | The hormone itself, made by recombinant technology | A copy of the hypothalamic signal (GHRH) that triggers release |
| Where it acts | Directly on tissues throughout the body | On the pituitary, which then releases its own growth hormone |
| Depends on pituitary function | No | Yes |
| Current US status | FDA-approved for specific conditions | Brand discontinued; compounded versions are not FDA-approved |
A 2018 review in Sexual Medicine Reviews by Sigalos and Pastuszak explains why this distinction matters. Agents that stimulate the body's own growth hormone release produce pulsatile secretion that stays subject to the body's negative feedback, which may prevent supratherapeutic growth hormone levels. The same review notes that some drawbacks of giving growth hormone directly are thought to come partly from bypassing that feedback. "May" is the important word: the review also stresses that few long-term, rigorously controlled studies exist.
According to the Endocrine Society statement, recombinant growth hormone is approved for children with growth failure or short stature and for adults with growth hormone deficiency or HIV-related wasting. Sermorelin is not an approved substitute for any of those uses today.
The FDA's 2013 Federal Register notice lays out the history. The brand product, Geref, was first approved in December 1990 as a diagnostic test of pituitary function, and a treatment version was approved in September 1997 for idiopathic growth hormone deficiency in children with growth failure. In 2008 the manufacturer told the FDA it was discontinuing both products and asked the agency to withdraw their approvals, which the FDA did effective June 18, 2009.
In 2013, after reviewing its records, the literature and postmarketing adverse event data, the FDA determined that both products "were not withdrawn for reasons of safety or effectiveness." The notice does not give the manufacturer's business reasons for stopping production. The notice keeps both products on the FDA's list of discontinued drug products.
Interest in sermorelin for adults grew out of studies on age-related decline in growth hormone. One example is a 1997 randomized, placebo-controlled study by Khorram and colleagues in 19 adults aged 55 to 71 who used a closely related GHRH analog for 16 weeks. The analog increased nighttime growth hormone in both men and women and raised IGF-1 (a marker of growth hormone activity), which then drifted back toward baseline by 16 weeks. Skin thickness increased in both sexes, while lean body mass, insulin sensitivity, general well-being and libido improved in men only. Body weight, blood pressure and bone density did not change. The authors called for further studies.
Studies like this are small and short. The Endocrine Society statement concludes that GHRH and growth hormone secretagogues exist but are not approved for use as anti-aging agents, and that studies of growth hormone and secretagogues in older people have not shown benefits that outweigh risks. Any use of sermorelin in adults is off-label.
With the brand's approval withdrawn, the sermorelin available through NewDay Wellness is prepared by a compounding pharmacy. The FDA states that compounded drugs are not FDA-approved and that the agency does not review their safety, effectiveness or quality before they are marketed. Dosing, if sermorelin is prescribed, is set by your prescriber.
It can help to know that a different GHRH analog, tesamorelin, is FDA-approved for one specific use: reducing excess abdominal fat in adults with HIV and lipodystrophy. Its label states it is not indicated for weight loss management and that its long-term cardiovascular safety has not been established. Tesamorelin is a different molecule, but its label shows how narrowly regulators define the approved uses of this drug class. For a closer look at risks, see sermorelin side effects and safety considerations.
No. Sermorelin is a copy of the signal that tells the pituitary to release growth hormone. Growth hormone medications supply the hormone itself, while sermorelin relies on the pituitary to respond.
The manufacturer discontinued the brand products in 2008 and asked the FDA to withdraw approval. In 2013 the FDA determined the products were not withdrawn for reasons of safety or effectiveness. The FDA notice does not describe the company's business reasons.
No. Compounded sermorelin is not FDA-approved for any use, and the Endocrine Society notes that no therapy to increase growth hormone secretion is approved as an anti-aging intervention.
In small studies, GHRH and its analogs raised IGF-1 on average, but responses differ from person to person. In one 1997 study, IGF-1 rose early and then drifted back toward baseline by 16 weeks. A prescriber may decide whether lab monitoring is appropriate for you.
A licensed provider can review your symptoms, medical history and goals, explain the limited evidence for sermorelin in adults, and discuss whether a compounded product is reasonable for you or whether an evaluation for a diagnosable condition makes more sense. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
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