Track ganirelix in Peptimes™
Ganirelix is a synthetic peptide of 10 amino acids, derived from native gonadotropin-releasing hormone (GnRH), that acts against GnRH. It is the active ingredient in FDA-approved prescription injections. (Source: DailyMed label.)
Is ganirelix FDA-approved?
Yes, as specific products: Ganirelix Acetate Injection, Fyremadel and other generic ganirelix injections are FDA-approved for the use in their labels, and they're prescription only.
Ganirelix
Also: ganirelix acetate, Fyremadel, Orgalutran, Antagon, Org 37462
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- Subcutaneous
- Updated
- 1 Nov 2026
US regulatory status
FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Ganirelix Acetate Injection (Organon)
Subcutaneous
"The inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation".
Source: DailyMed label, checked 1 Nov 2026
Fyremadel (ganirelix acetate) injection
Subcutaneous
The same use as above, as stated on its label (approved through an abbreviated new drug application, ANDA).
Source: DailyMed label, checked 1 Nov 2026
Generic ganirelix acetate injection, from several manufacturers
Subcutaneous
As stated on each product's label (approved through ANDAs, with Organon's product as the reference).
Source: Drugs@FDA, checked 1 Nov 2026
Prescription
Prescription only. Drugs@FDA lists each product above as "Prescription".
Source: Drugs@FDA, checked 1 Nov 2026
Investigational
No, for the products and uses above.
Source: Drugs@FDA, checked 1 Nov 2026
How to track it in Peptimes
Add ganirelix in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.
- Logging: the amount you took and how you feel.
- Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell ganirelix or any other compound.
More sources
- FDA, Drugs@FDA: NDA 021057 (Ganirelix Acetate, Organon) and ANDA 204246 (Fyremadel), checked 1 Nov 2026: product, route and marketing status.
- FDA, Global Substance Registration System, Ganirelix, checked 1 Nov 2026: the name Orgalutran.
Related pages
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