Drug · Other

Leuprolide

CI-DRUG-00000341Explore in graph →NCIt C62042 CHEMBL1201199 CIViC Approved

Regulatory

Approvals (52)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as LUPRON DEPOT (DIN 02562855) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 28, 2026	health-canada-dpd
CA

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	42	18	50	175	52	CA, EU, US	Jan 26, 1989	1989-07
Malignant Prostate Neoplasm	Approved	Phase 4	30	14	33	120	9	EU, US	Jan 26, 1989	1994-10
Malignant Breast Neoplasm	Phase3	Phase 3	4	2	6	16	0	—	—	1993-06
Malignant Uterine Corpus Neoplasm	Phase3	Phase 3	0	0	3	5

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
AR OVEREXPRESSION1
Bicalutamide + Leuprolide

Clinical trials

Trials with this intervention (186)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 186 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05827081	Phase IIIb Study of Ribociclib + ET in Early Breast Cancer(Adjuvant WIDER)	recruiting	Phase 3	1,400	Novartis PharmaceuticalsINDUSTRY	16	Sep 23, 2026	clinicaltrials
NCT07650240	Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial(SPARKLE)

Molecule

Record

Kind: Other
Mechanism: Gonadotropin-releasing hormone receptor agonist
Targets: 1 gene
UNII: 37JNS02E7V
Aliases: 6-D-Leucine-9-(N-ethyl-L-prolinamide)-10-deglycinamide Luteinizing Hormone-Releasing Factor (Pig), 6-D-Leucine-9-(N-ethyl-L-prolinamide)-1-9-luteinizing Hormone-releasing Factor (Pig), ABBOTT-43818 FREE BASE, CAMCEVI, CKD-841, ELIGARD, FENSOLVI, Leuporelin, Leuprolide, Leuprolide Acetate, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE DEPOT, Leuprolide Mesylate, Leuprorelin, Leuprorelina, Leuproreline, Leuprorelin slow release, LUPRON, LUPRON DEPOT, LUPRON DEPOT-PED, LUTRATE DEPOT, NSC-377526, TAP-144 FREE BASE, VABRINTY, ZEULIDE

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (38)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L02AE02	LEUPRORELIN
DIN (Health Canada)	00727695