Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NDV-01 (sustained-release gemcitabine-docetaxel)
NDV-01 · 2 trials · 6 indications
Time from randomization to either time of the first recurrence or progression, or death due to any cause, whichever occurs first. It is hypothesized that sustained local delivery of GEM and DOCE (via NDV-01) in participants with IR-NMIBC will result in longer DFS than achieved with observation after TURBT. Under the exponential distribution assumption for DFS, this translates into testing the statistical hypothesis that the hazard ratio is significantly less than 1.0. Primary endpoint will be tested using a one-sided 2.5% level of significance.
Percentage of participants with CR at anytime based on cystoscopy, urine cytology, and biopsies. Protocol-driven mapping biopsies (as assessed by central pathology) will be performed at 12 months
Complete response is defined by at least one of the following criteria: Negative cystoscopy and negative or atypical urine cytology; and/or Positive cystoscopy with biopsy-confirmed benign or low-grade NMIBC, along with negative urine cytology.
Any new Change from Baseline to End of Study (EOS) in investigators assessment
| Arm | Type | Description |
|---|---|---|
| Intermediate Risk NMIBC, NDV-01 Treatment Group | EXPERIMENTAL | NDV-01 (sustained-release gemcitabine-docetaxel) |
| Intermediate Risk NMIBC, Observation Group | NO_INTERVENTION | Surveillance with Cystoscopy, Urine Cytology, and Biopsy (if indicated) |
| BCG-Unresponsive High-Risk NMIBC, NDV-01 Treatment Group | EXPERIMENTAL | NDV-01 (sustained-release gemcitabine-docetaxel) |
| NDV01 | EXPERIMENTAL | 1. Treatment phase: 6 biweekly instillations - six instillations on Days 1, 14, 28, 42, 56, and 70 2. Maintenance phase: monthly administration - maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340 A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule. |
| Name | Type | Description |
|---|---|---|
| NDV-01 (sustained-release gemcitabine-docetaxel) | DRUG | NDV-01 (sustained-release gemcitabine-docetaxel) |
| NDV01 intravesical controlled release formulation of gemcitabine and docetaxel | DRUG | NDV01 is administered intravesically using a catheter. |
Cohort 1 Inclusion Criteria: 1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent. 2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR N...
NDV-01 is an investigational intravesical controlled-release formulation of gemcitabine and docetaxel being developed for non-muscle invasive bladder cancer. It is a small molecule oncology asset that delivers both chemotherapy agents directly into the bladder as a sustained-release treatment. Relmada Therapeutics, Inc. (RLMD) is developing NDV-01, which is currently in Phase 3 clinical development.
NDV-01 is being developed for bladder (urothelial, transitional cell) cancer, specifically non-muscle invasive bladder cancer (NMIBC). It is an intravesical therapy intended to treat superficial or non-invasive urothelial carcinoma of the bladder, including recurrent disease. NDV-01 has not been approved for any indication and remains investigational.
NDV-01 is being developed by Relmada Therapeutics, Inc., which trades under the ticker RLMD. Relmada is the sponsor of the clinical program evaluating NDV-01 in non-muscle invasive bladder cancer. The asset is an intravesical controlled-release formulation of gemcitabine and docetaxel.
NDV-01 is in Phase 3 clinical development. The Phase 3 study is a randomized, no-treatment-controlled trial of NDV-01 in participants with non-muscle invasive bladder cancer. NDV-01 is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
NDV-01 is being evaluated in two registered clinical trials. The Phase 3 trial, NCT07464145, is a study of NDV-01 (sustained-release gemcitabine-docetaxel) in participants with non-muscle invasive bladder cancer and is not yet recruiting, with a planned enrollment of 393. The Phase 2 trial, NCT06663137, is recruiting in Israel with 70 participants.
Yes. NDV-01 is also known as NDV-01 (sustained-release gemcitabine-docetaxel) and as an NDV01 intravesical controlled-release formulation of gemcitabine and docetaxel. These names refer to the same investigational asset being developed by Relmada Therapeutics for non-muscle invasive bladder cancer.