Track leuprolide in Peptimes™
Leuprolide (leuprorelin) is a synthetic peptide of 9 amino acids, an analog of the natural gonadotropin-releasing hormone (GnRH). It is the active ingredient in several FDA-approved prescription injections. (Source: DailyMed label.)
Is leuprolide FDA-approved?
Yes, as specific products: Lupron Depot, Lupron Depot-PED, Eligard, Fensolvi, Camcevi and other leuprolide injections are FDA-approved for the uses in their labels, and they're prescription only.
Leuprolide
Also: leuprorelin, leuprolide acetate, Lupron Depot, Lupron Depot-PED, Eligard, Fensolvi, Camcevi, Vabrinty, Lutrate Depot, Lupron, Prostap, Enantone, Lucrin, TAP-144
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- IntramuscularSubcutaneous
- 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.
Lupron Depot (leuprolide acetate for depot suspension), the formulations labelled for prostate cancer
Intramuscular
Advanced prostate cancer.
Source: DailyMed label, checked 1 Nov 2026
Lupron Depot (leuprolide acetate for depot suspension), the formulations labelled for endometriosis and fibroids
Intramuscular
Management of endometriosis, including pain relief and reduction of endometriotic lesions, and the other uses in its label.
Source: DailyMed label, checked 1 Nov 2026
Lupron Depot-PED (leuprolide acetate for depot suspension)
Intramuscular
Central precocious puberty in children.
Source: DailyMed label, checked 1 Nov 2026
Eligard (leuprolide acetate) injectable suspension
Subcutaneous
Advanced prostate cancer.
Source: DailyMed label, checked 1 Nov 2026
Vabrinty (leuprolide acetate) injectable suspension
Subcutaneous
Advanced prostate cancer.
Source: DailyMed label, checked 1 Nov 2026
Fensolvi (leuprolide acetate) injectable suspension
Subcutaneous
Central precocious puberty in children aged 2 and older.
Source: DailyMed label, checked 1 Nov 2026
Camcevi (leuprolide) injectable emulsion
Subcutaneous
Advanced prostate cancer in adults.
Source: DailyMed label, checked 1 Nov 2026
Leuprolide acetate for depot suspension, including Lutrate Depot
Intramuscular
Advanced prostate cancer.
Source: DailyMed label, checked 1 Nov 2026
Generic leuprolide acetate injection, from several manufacturers
Subcutaneous
Palliative treatment of advanced prostate cancer, as stated on each product's label (approved through abbreviated new drug applications, ANDAs).
Source: DailyMed label, 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 leuprolide 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.
- Routes: intramuscular or subcutaneous. Choose the one that matches each dose.
- Logging: the amount you took, the route 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 leuprolide or any other compound.
More sources
- FDA, Drugs@FDA, checked 1 Nov 2026: product, route and marketing status for NDA 019732 and NDA 020011 (Lupron Depot), NDA 020263 (Lupron Depot-PED), NDA 021343 (Eligard), NDA 213150 (Fensolvi), NDA 211488 (Camcevi) and NDA 205054 (leuprolide acetate for depot suspension).
- FDA, Global Substance Registration System, Leuprolide, checked 1 Nov 2026: the name leuprorelin.
Related pages
Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.