LUPRON DEPOT

Peak

leuprolide acetate

NDAINJECTIONINJECTABLE
Approved
Dec 1995
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
9

Mechanism of Action

acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation…

Clinical Trials (5)

NCT05341115Phase 4Completed

A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

Started Mar 2023
80 enrolled
Central Precocious Puberty
NCT04914195Phase 3Completed

Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer

Started Jul 2021
NCT03695237Phase 3Completed

A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

Started Oct 2018
45 enrolled
Central Precocious Puberty (CPP)
NCT02212197Phase 2Completed

Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

Started Sep 2014
NCT01746849Phase 2Active Not Recruiting

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

Started Dec 2012
82 enrolled
LeukemiaMultiple MyelomaMyelodysplastic Syndrome+1 more

Loss of Exclusivity

LOE Date
Feb 5, 2031
59 months away
Patent Expiry
Feb 5, 2031

Patent Records (2)

Patent #ExpiryTypeUse Code
9617303
Mar 22, 2028
U-4001
8921326
Feb 5, 2031
Product
U-1666