Sermorelin

Approval status

FDA approved sermorelin acetate (Geref) in 1990 as a diagnostic test and in 1997 to treat children with growth hormone deficiency. The maker discontinued it in 2008 and approval was withdrawn in 2009; in 2013 FDA determined this was not for reasons of safety or effectiveness. No sermorelin product is FDA-approved today; it is not on FDA's 503A nomination lists, and for outsourcing facilities sermorelin acetate is in 503B Category 1 (under evaluation), not Category 2.^3458910

What it’s used or studied for

• Approved use

  Diagnostic test of whether the pituitary can release growth hormone (FDA-approved as Geref until 2009).³²

• Approved use

  Treatment of idiopathic growth hormone deficiency in children with growth failure (FDA-approved as Geref until 2009).³²

• Human studies

  In a small 6-week study of healthy older men, sermorelin raised night-time growth hormone but did not change IGF-1 or body composition.⁶

Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.

Side effects

Geref's original label is not available on FDA's website, so these effects come from published studies and reviews, which describe it as well tolerated.²⁴⁷

Cautions

• Products sold today are not the discontinued Geref. A 2026 review notes quality-control uncertainty and variable composition in unregulated peptide supply.⁷
• The same review says benefits in healthy adults are uncertain because the human evidence is limited and largely indirect.⁷