# A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy

> **NCT07342517** · PHASE3 · WITHDRAWN · sponsor: **Relmada Therapeutics, Inc.**

## Conditions studied

- Bladder (Urothelial, Transitional Cell) Cancer
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
- Urologic Cancer

## Interventions

- **DRUG:** NDV-01 (sustained-release gemcitabine-docetaxel)

## Key facts

- **NCT ID:** NCT07342517
- **Lead sponsor:** Relmada Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2026-06-30
- **Primary completion:** 2027-06-30
- **Final completion:** 2028-06-30
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** This study has been incorporated into the Relmada REL-NDV01-303 study.
- **Last updated:** 2026-03-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07342517

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07342517, "A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT07342517. Licensed CC0.

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