Summary
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ovarian Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ovarian Cancer. ClinicalTrials.gov lists 3 registered trials linking Bicalutamide to Ovarian Cancer: 1 is currently recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00012090). The largest enrolment is 148 participants (NCT03458221). Registration activity spans 2000 to 2023. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2007. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Ovarian Cancer ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: No spontaneous remission; 5-year survival Stage I: 90%; Stage III/IV: 25-30%; most patients (75%) present at Stage III-IV.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 29.5 (trials 7.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 1 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AKT1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00012090 | Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum 2000 | completed | Phase 2 | — |
| NCT03458221 | Signal TrAnsduction Pathway Activity Analysis in OVarian cancER 2023 | recruiting | PHASE2, PHASE3 | 148 |
| NCT05647356 | The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (REFUEL PCOS) Study 2 2023 | status unknown | Not applicable | 16 |
Published literature
- Clinical trial publication A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remissionLevine D, Park K, Juretzka M et al. · Cancer · 2007 · PMID 17918264
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Bicalutamide approved for Ovarian Cancer?
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ovarian Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ovarian Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Bicalutamide in clinical trials for Ovarian Cancer?
ClinicalTrials.gov lists 3 registered trials linking Bicalutamide to Ovarian Cancer: 1 is currently recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00012090). The largest enrolment is 148 participants (NCT03458221). Registration activity spans 2000 to 2023.
What does the evidence show for Bicalutamide in Ovarian Cancer?
Bicalutamide has 1 completed trial and 1 linked publication for Ovarian Cancer. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.