Safety
Compounded sermorelin isn’t FDA-reviewed for safety, effectiveness or quality, and its old Geref labeling covered children, not adults using it for aging. The small trials above reported no significant adverse effects over 6 to 16 weeks. Clinics list pain, redness or swelling where you inject, nausea, headache, dizziness and fatigue. Tell your prescriber about every condition and medicine you have, since sermorelin raises growth hormone and IGF-1.
Legal status
Prescription only; the ingredient has an FDA-approved form, but compounded versions are not FDA-approved. Sermorelin is prepared by a compounding pharmacy for an individual prescription. Compounded products are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality. Sermorelin was the active ingredient of an FDA-approved drug (Geref) discontinued for reasons other than safety, so a 503A pharmacy may compound it for an individual prescription. No approved sermorelin is on the market, its use for aging is off-label, and it is not a controlled substance.
What sermorelin is
FDA determined in 2013 that Geref was not withdrawn from sale for reasons of safety or effectiveness. Prescribing sermorelin to adults for aging is off-label.
What the FDA has approved
- Geref injection was approved in 1997 to treat idiopathic growth hormone deficiency in children with growth failure, and in 1990 to test how well the pituitary releases growth hormone
- Both Geref products were discontinued in 2008; no approved sermorelin is sold today
Dosing
Usually a nightly injection; your prescriber sets the schedule. Products we checked include 9 mg and 12.5 mg vials at 2.5 mg/mL, 200 mcg nasal sprays and 300 to 1,000 mcg troches. Trials in older adults used 2 mg or 10 mcg/kg nightly.
How well it works
Trials are small and short. In 11 men aged 64 to 76, 2 mg nightly for 6 weeks raised growth hormone release and improved 2 of 6 strength measures but did not change IGF-1, muscle or fat (Vittone 1997). In 19 adults aged 55 to 71, 16 weeks of a nightly sermorelin analogue raised growth hormone and IGF-1 (Khorram 1997). No trial has tested sermorelin for aging outcomes or lifespan. Individual results vary.
Sermorelin cost
Prices vary by clinic. For a full breakdown, read How much does sermorelin cost?.