Summary
Epirubicin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Bladder Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Bladder Cancer. ClinicalTrials.gov lists 8 registered trials linking Epirubicin to Bladder Cancer: 1 is active or not yet recruiting; 1 has completed; 6 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04736394). It plans or enrolled 800 participants. Registration activity spans 2009 to 2024. No published literature item is linked to Epirubicin and Bladder Cancer in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Bladder 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: NMIBC: 50-70% recurrence within 5 years; MIBC: progression to metastatic in 50% without radical treatment; spontaneous remission essentially zero.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 39.5 (trials 19.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 1 completed, 6 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ALK |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01094964 | Hyperthermia and Mitomycin C, Bacillus Calmette-Guerin, or Standard Therapy as Second-Line Therapy in Treating Patients With Recurrent Bladder Cancer 2009 | status unknown | Phase 3 | 242 |
| NCT04736394 | A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients 2021 | status unknown | Phase 3 | 800 |
| NCT04490993 | Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients 2017 | status unknown | Phase 3 | 359 |
| NCT02438865 | Prophylactic Intravesical Chemotherapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Randomized Controlled Trial Between Single Postoperative Dose Versus Maintenance Therapy. 2015 | completed | Phase 2 | 74 |
| NCT06227065 | Precise Neoadjuvant Chemoresection of Low Grade NMIBC 2024 | not yet recruiting | Phase 2 | 28 |
| NCT05975151 | Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer 2023 | status unknown | Phase 2 | 63 |
| NCT02760953 | TURBt With Adjuvant Cryoablation to Treat Bladder Cancer 2017 | status unknown | Not applicable | 150 |
| NCT05547516 | Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients 2022 | status unknown | Not applicable | 140 |
Published literature
No publication is linked to this pair yet.
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 ALK. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Epirubicin approved for Bladder Cancer?
Epirubicin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Bladder Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Bladder Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Epirubicin in clinical trials for Bladder Cancer?
ClinicalTrials.gov lists 8 registered trials linking Epirubicin to Bladder Cancer: 1 is active or not yet recruiting; 1 has completed; 6 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04736394). It plans or enrolled 800 participants. Registration activity spans 2009 to 2024.
What does the evidence show for Epirubicin in Bladder Cancer?
Epirubicin has 1 completed registered trial for Bladder Cancer but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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 ALK. 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.