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.
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-16T06:00
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260916-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Malignant Prostate Neoplasm | Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. | approved | May 24, 2022 | ema |
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 21 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.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 29211833
- Run
- ING-CIVIC-20260908-000001
| 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.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00937768 | Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy | terminated | Phase 2 | 16 | Mayo ClinicOTHER | 1 | Dec 27, 2019 | clinicaltrials |
| NCT03209518 | Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer" | completed |