Summary
Flumazenil has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. ClinicalTrials.gov lists 1 registered trial linking Flumazenil to Breast Cancer: 1 has completed. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 66 participants. Registered activity dates to 2022. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2024 to 2025. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Breast Cancer ranks 1462 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: Spontaneous regression documented but rare (<0.5%); 5-year survival stage I: ~99%; stage IV: ~28% overall, improving with modern therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 26.5 (trials 2.5, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 2 (2 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05435911 | Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol 2022 | completed | Not applicable | 66 |
Published literature
- Clinical trial publication Effects of remimazolam vs. an etomidate-propofol mixture on postoperative cognitive function in elderly female patients undergoing radical mastectomy for breast cancer: a randomized controlled trialShen W, Li L, Zhang Z et al. · Frontiers in medicine · 2025 · PMID 41657583
- Clinical trial publication Comparison of recovery profiles between total intravenous anaesthesia with propofol or remimazolam reversed with flumazenil in patients undergoing breast surgery: A randomised controlled trialLee J, Kim DH, Ju JW et al. · European journal of anaesthesiology · 2024 · PMID 38205822
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 Flumazenil approved for Breast Cancer?
Flumazenil has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Flumazenil in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 1 registered trial linking Flumazenil to Breast Cancer: 1 has completed. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 66 participants. Registered activity dates to 2022.
What does the evidence show for Flumazenil in Breast Cancer?
Flumazenil has 1 completed trial and 2 linked publications for Breast 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 2026-07-05. Page built 2026-10-07.