Sermorelin: FDA History, Legal Status, and Evidence

Sermorelin is a synthetic version of the first 29 amino acids of human growth hormone-releasing hormone (GHRH). This is the shortest portion of the hormone that keeps full receptor activity. It is also written GRF(1-29)NH2 or GHRH(1-29).

FDA first approved sermorelin acetate as Geref in December 1990, and approved a new dosage form of Geref in 1997. Drugs@FDA lists both Geref applications as discontinued and notes a Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons. Drugs@FDA does not post the Geref label.

Sermorelin binds the GHRH receptor on growth hormone-producing cells in the anterior pituitary. The receptor raises cyclic AMP and promotes release of the body's stored growth hormone, which then increases IGF-1 production in the liver and other tissues.

Because sermorelin acts upstream of the pituitary, its effect depends on a working hypothalamic-pituitary axis and remains subject to feedback from IGF-1 and somatostatin. Receptor-binding evidence comes from rat pituitary tissue, which is preclinical. Laboratory formulation studies show that binding to plasma proteins and rapid breakdown of the peptide complicate delivery.

The human record in the library is small and old. A 1986 study used GRF(1-29)NH2 as a diagnostic test of pituitary response in children and adolescents evaluated for growth hormone deficiency. A diagnostic response shows that the pituitary can respond; it is not evidence of a therapeutic benefit.

A 2006 editorial proposed sermorelin for adult-onset growth hormone insufficiency, but it is an opinion piece, not a trial. A 2003 review by authors at the drug company Serono covers ways to extend the action of GHRH analogs and is indirect for sermorelin itself. It notes that sermorelin lasts only minutes in human blood. No modern randomized trial establishes recovery, muscle, sleep, or healthy-aging benefits. Claims about body composition or performance are extrapolated from the broader growth hormone and IGF-1 axis.

The cited sources do not include a modern safety trial, and the original Geref label is not posted on Drugs@FDA. The 1986 diagnostic study described the test as a safe and convenient way to diagnose growth hormone deficiency, which says little about repeated use over months.

Questions that apply to any stimulation of the growth hormone and IGF-1 axis, such as effects on glucose regulation and on tissue growth, have not been studied for sermorelin in long-term human trials. Product quality outside an approved channel is a separate unknown.

No current FDA- or Health Canada-approved sermorelin product was found as of 2026-10-27. Health Canada's Drug Product Database lists no product containing sermorelin. WADA prohibits sermorelin in and out of competition as a growth hormone-releasing factor.