Summary
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in PCOS (Polycystic Ovary Syndrome) would be drug repurposing rather than first-in-human development. This does not mean it is approved for PCOS (Polycystic Ovary Syndrome). ClinicalTrials.gov lists 2 registered trials linking Bicalutamide to PCOS (Polycystic Ovary Syndrome): 1 is currently recruiting; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 1 (NCT05979389). It plans or enrolled 50 participants. Registration activity spans 2023 to 2024. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2018. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Polycystic Ovary Syndrome ranks 177 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: PCOS is a lifelong endocrine disorder; complete spontaneous resolution rare; some phenotypic improvement with menopause; fertility returns in 50-70% with ovulation induction; metabolic features persist.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 26.5 (trials 4.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 1 recruiting, 0 active / not yet recruiting, 0 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 | ADCY5 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05979389 | Bicalutamide Therapy in Young Women With NAFLD and PCOS 2024 | recruiting | Phase 1 | 50 |
| 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 Combined Oral Contraception and Bicalutamide in Polycystic Ovary Syndrome and Severe Hirsutism: A Double-Blind Randomized Controlled TrialMoretti C, Guccione L, Di Giacinto P et al. · The Journal of clinical endocrinology and metabolism · 2018 · PMID 29211888
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 ADCY5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Bicalutamide approved for PCOS (Polycystic Ovary Syndrome)?
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in PCOS (Polycystic Ovary Syndrome) would be drug repurposing rather than first-in-human development. This does not mean it is approved for PCOS (Polycystic Ovary Syndrome). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Bicalutamide in clinical trials for PCOS (Polycystic Ovary Syndrome)?
ClinicalTrials.gov lists 2 registered trials linking Bicalutamide to PCOS (Polycystic Ovary Syndrome): 1 is currently recruiting; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 1 (NCT05979389). It plans or enrolled 50 participants. Registration activity spans 2023 to 2024.
What does the evidence show for Bicalutamide in PCOS (Polycystic Ovary Syndrome)?
Trials of Bicalutamide in PCOS (Polycystic Ovary Syndrome) are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. 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 ADCY5. 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 2026-07-05. Page built 2026-10-07.