For clinicians
Leuprolide for prescribers: status, evidence and what FDA has said
A neutral reference. It reports Leuprolide's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | — |
| FDA approval | Approved (Lupron) |
| Compounding (503A) | Rx (FDA-approved as Lupron) |
| Outsourcing (503B) | No 503B status recorded |
| WADA 2026 List | Prohibited (S2.2.1) |
| WADA 2027 List | Prohibited (S2.2.1) |
| Evidence grade | High |
| Status reviewed | 2026-10-01 |
What FDA has said
Leuprolide is FDA-approved. The prescribing information is the authority on its dosing, monitoring and contraindications; below is what each label carries in its boxed warning and how its Warnings and Precautions section is organised, read from DailyMed on 2026-10-01.
Lupron Depot label version 1543, effective 2026-03-15
No boxed warning.
Its Warnings and Precautions section is organised under these headings:
- 5.1 Tumor Flare
- 5.2 Metabolic Syndrome
- 5.3 Cardiovascular Diseases
- 5.4 Effect on QT/QTc Interval
- 5.5 Convulsions
- 5.6 Severe Cutaneous Adverse Reactions
- 5. 7 Laboratory Tests
- 5. 8 Embryo-Fetal Toxicity
Read the full Lupron Depot prescribing information on DailyMed
Monitoring: what the literature does and does not say
For an approved drug, the prescribing information is where monitoring is set out — in its Warnings and Precautions section, whose headings are listed above for each label, and in its dosing and specific-populations sections. This page lists those headings so a prescriber can see what the label covers; it does not restate the label, and the label, not this page, is the authority.
Compounding: where it stands
Today's position for Leuprolide: Rx (FDA-approved as Lupron). An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
A synthetic nonapeptide GnRH agonist (GnRH with D-Leu at position 6 and an ethylamide in place of the tenth residue) that, given continuously, first stimulates and then suppresses pituitary gonadotropin release and downstream testosterone and oestrogen. Marketed as Lupron Depot (1- to 6-month intramuscular depots), Eligard (subcutaneous gel depot), Lupron Depot-Ped, Fensolvi, Camcevi, the daily Vobrig pen and generic injections.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID.
What this page leaves out
Doses, regimens and titration. For an approved drug those belong to the prescribing information, linked above; restating them here would create a second, unmaintained copy.
Sources
- Lupron Depot prescribing information, DailyMed SPL version 1543; read 2026-10-01. DailyMed
- Grey Peptides regulatory tracker, row for Leuprolide, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
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