Source notebook
Separate the old approval from the evidence for the result you want today.
Evidence note
The body makes growth hormone as a chemical messenger.
In December 1990, the FDA, the US medicine agency, approved sermorelin (Geref) for a test of whether the body can release growth hormone.
It approved sermorelin for children’s growth failure caused by a growth hormone shortage in September 1997.
Neither approval covered adults’ energy, body shape, sleep or ageing.
Read the FDA history noticeEvidence note
Both Geref approvals ended on June 18, 2009, after the maker asked for their withdrawal.
What else to know
As of September 28, 2026, no FDA-approved sermorelin medicine is sold in the US.
Evidence note
In March 2013, the FDA determined that Geref had not been withdrawn for safety or effectiveness reasons.
What else to know
That finding addresses why Geref stopped being sold; it gives no approval to a medicine a pharmacy prepares for an order today.
Evidence note
Thorner’s 1996 study treated 110 children who made too little growth hormone, but only 86 met its rules for counting growth results.
The study summary does not explain why the other children did not count in that result.
Before treatment, average yearly growth was about 4 centimetres (cm), roughly 1½ inches.
In the first treatment year, the average reached 7–8 cm, about 3 inches.
What else to know
There was no group receiving a different treatment or no treatment to compare growth; all the children received sermorelin, and the study included no adults.
A rise in a hormone level is a test result; ask whether the study also measured the change you care about.
Evidence note
These older-adult studies were published in 1992 and 1997; each included 10–19 people and lasted at most 16 weeks.
Sermorelin and a slightly changed version both raised growth hormone; body fat did not change in the two studies that measured it.
What else to know
Khorram’s 1997 study used a changed version of sermorelin, rather than sermorelin itself.
Evidence note
Khorram’s 1997 study used that same changed version, given by nightly injections under the skin, and found no better sleep after 16 weeks.
What else to know
The sleep-lab studies gave growth hormone-releasing hormone (GHRH), a signal that tells the body to release growth hormone, into a vein.
The summaries do not say which version of GHRH was used; those results do not prove a benefit from sermorelin offered today.
Ask how your proposed medicine would be given and whether its studies used that same method.
Compounding is the preparation of a medicine for an order; in “sermorelin acetate”, acetate identifies the particular version of the ingredient used in the old medicine Geref.
Evidence note
As of September 28, 2026, federal rules may let a state-licensed pharmacy make sermorelin acetate because it was an ingredient in an approved medicine.
This requires a valid prescription naming the patient, as well as compliance with ingredient quality rules and state pharmacy rules.
The ingredient used as the starting material must have laboratory test results documented and must come from a manufacturer listed with the FDA.
The pharmacy must follow any official ingredient quality standard that applies, along with its state’s pharmacy rules.
The ingredient in Geref was sermorelin acetate; a different version of sermorelin does not automatically meet the same pharmacy rules.
What else to know
No FDA document found specifically confirms this rule for sermorelin in an ordinary pharmacy, so permission for a particular prescription cannot be assumed.
Evidence note
For medicines prepared to order, the FDA does not assess safety, benefit or quality before sale, as of September 26, 2026.
Read the FDA compounding explanationTake the link or paper to the visit. Ask the doctor what the study found and what it still cannot tell you about your care.