Is Sermorelin legal in the US?
No. The original drug was approved for children's growth tests but is no longer made, and anti-ageing use was never approved.
Sermorelin was FDA-approved as Geref for diagnosing growth hormone deficiency and for treating growth failure in children with idiopathic growth hormone deficiency. EMD Serono discontinued Geref in 2008, and in 2013 the FDA determined it was not withdrawn for reasons of safety or effectiveness, which allows the agency to approve generic versions, though none has been approved. There is no FDA-approved sermorelin product on the market; what clinics prescribe is compounded, and the anti-aging and body composition uses it is prescribed for were never approved.
As Geref, it was used to diagnose and treat growth hormone deficiency in children. EMD Serono discontinued Geref in 2008. In 2013 the FDA ruled that it was not withdrawn for safety or effectiveness. That allows the agency to approve generic versions, though none has been approved. No approved product exists now. Clinics prescribe compounded sermorelin for uses that were never approved. 10
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Citations
- Front Endocrinol 2026: performance-enhancing peptides modulating the GH-IGF-1 axis, review pubmed.ncbi.nlm.nih.gov
- Falutz 2007, N Engl J Med: metabolic effects of tesamorelin in patients with HIV pubmed.ncbi.nlm.nih.gov
- Falutz 2010, J Clin Endocrinol Metab: pooled analysis of two phase 3 tesamorelin trials pubmed.ncbi.nlm.nih.gov
- Makimura 2012, J Clin Endocrinol Metab: tesamorelin in obese subjects with reduced GH secretion pubmed.ncbi.nlm.nih.gov
- Iovino 1989, J Clin Endocrinol Metab: repetitive GHRH restores the GH response in normal aging pubmed.ncbi.nlm.nih.gov
- Sigalos 2017, Am J Mens Health: GH secretagogue treatment raises IGF-1 in hypogonadal men pubmed.ncbi.nlm.nih.gov
- Steiger 1992, Neuroendocrinology: GHRH and somatostatin effects on sleep EEG and nocturnal hormones pubmed.ncbi.nlm.nih.gov
- Kerkhofs 1993, Am J Physiol: sleep-promoting effects of GHRH in normal men pubmed.ncbi.nlm.nih.gov
- Guldner 1997, Neurobiol Aging: reduced efficacy of GHRH on sleep in the elderly pubmed.ncbi.nlm.nih.gov
- Federal Register 2013: determination that Geref (sermorelin acetate) was not withdrawn for safety or effectiveness federalregister.gov
- Adrian 2019, J Frailty Aging: tesamorelin decreases muscle fat and increases muscle area in adults with HIV pubmed.ncbi.nlm.nih.gov
- Obes Res Clin Pract 2026: meta-analysis of tesamorelin RCTs in HIV-associated lipodystrophy pubmed.ncbi.nlm.nih.gov
- Clin Geriatr Med 1997: the somatopause, should GH deficiency in older people be treated pubmed.ncbi.nlm.nih.gov
- Russell-Aulet 1999, J Clin Endocrinol Metab: evidence for relative GHRH deficiency in aging pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Sermorelin article, fact-checked against the cited sources. No dosing anywhere on this site.