Synthetic gonadotropin-releasing hormone, formerly approved as Factrel. Its 503A status is unsettled.
Key takeaway
Gonadorelin is identical to natural GnRH, the hypothalamic hormone that signals the pituitary to release LH and FSH.
At a glance
| FDA status | Formerly in an approved drug (discontinued) |
|---|---|
| 503A compounding | Eligible for 503A compounding (component of an approved drug) |
| Body areas | Hormones & pituitary, Sexual & reproductive health |
| Through ScriptMates | Information only |
| Open questions | 1 noted below |
What is gonadorelin?
Gonadorelin is identical to natural GnRH, the hypothalamic hormone that signals the pituitary to release LH and FSH.
It was the active ingredient of the FDA-approved diagnostic Factrel, which is now discontinued. We found no published FDA determination on whether it was withdrawn for safety or effectiveness reasons.
Dosage forms
Historical FDA-approved form: Factrel injection. Factrel is discontinued; a more specific preparation or route was not confirmed from this FDA record.
Is gonadorelin FDA-approved?
Active ingredient of Factrel (discontinued). Not in any 503A category.
Can it be prescribed through ScriptMates?
Eligible for 503A compounding (component of an approved drug). A partner pharmacy lists it, but its 503A status is unsettled, so it is shown for information only.
What we could not confirm
- It is unclear whether a component of a discontinued approved drug qualifies under section 503A, and we found no FDA safety-or-effectiveness determination for Factrel. We show gonadorelin as information only until that is confirmed.
Sources
- Drugs@FDA: Factrel (gonadorelin)
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.