GnRH agonist
Leuprolide dose
Answer
FDA label for leuprolide acetate: The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. Half-life on the label: approximately 3 hours. Trials with posted results tested 8 doses, most often 22.5 mg, 25 mg, 50 mg.
Not dosing advice.
FDA LABEL
What the approved labels state
leuprolide acetate ANDA215336 · label of 2026-05-28 Regulator
The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection.
Half-life: approximately 3 hours (section 12.3).
Lupron Depot NDA020517 · label of 2026-03-15 Regulator
The recommended dose of LUPRON DEPOT 30 mg for 4-month administration is one injection every 16 weeks.
Half-life: approximately 3 hours (section 12.3).
CAMCEVI NDA211488 · label of 2026-02-18 Regulator
The recommended dose of CAMCEVI is 42 mg administered subcutaneously once every 6 months. 2.2 Preparation and Administration CAMCEVI must be administered by a healthcare provider.
Half-life: approximately 3 hours (section 12.3).
Lupron Depot-PED NDA020263 · label of 2025-11-14 Regulator
Half-life: approximately 3 hours (section 12.3).
IN TRIALS
Doses tested in 172 trials with posted results
| Dose in the arm title | Trials | People on it | Phases |
|---|---|---|---|
| 22.5 mg | 3 | 538 | 3/4 |
| 25 mg | 1 | 144 | 3 |
| 50 mg | 1 | 137 | 3 |
| 7.5 mg | 1 | 135 | 3 |
| 30 mg | 2 | 80 | 3 |
| 11.25 mg | 2 | 76 | 3 |
| 80 mg | 1 | 69 | 3 |
| 160 mg | 1 | 66 | 3 |
Trial register Read from the titles of arms that received Leuprolide (n ≥ 20). An arm naming several doses counts under each; a schedule or escalation is on the trial record. All trials.
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