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ndv-01

Generic: gemcitabine and docetaxel

ndv-01: developed by 1 company · 3 clinical trials tracked.

ndv-01 evidence translation

What we can confirm

What it means

Source-backed records connect ndv-01 to RLMD; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could ndv-01 → RLMD affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

Bladder (Urothelial, Transitional Cell) Cancer; Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Bladder (Urothelial, Transitional Cell) CancerUrologic Cancer

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
RELMADA THERAPEUTICS, INC. (RLMD)
Bladder (Urothelial, Transitional Cell) Cancer; Bladder (Uro…
Phase 3
Clinical Trials (3)

A Phase 3 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·Phase 3·RLMD
Withdrawn

Primary endpoint: To evaluate the efficacy of NDV-01 (determined by complete response [CR] anytime) administered by intravesical instillation in patients with BCG-unresponsive NMIBC who have recurred after first-line intravesical therapy (approved or in development).

Interventionalopen0 targetStarted 2026-06Completion 2028-06Relmada Therapeutics, Inc.

A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE)

NCT07464145·Phase 3·RLMD
Not yet recruiting

Primary endpoint: Disease Free Survival in participants with Intermediate Risk NMIBC

InterventionalRandomizedopen393 targetStarted 2026-06Completion 2032-09Relmada Therapeutics, Inc.

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)

NCT07313891·Phase 3·RLMD
Withdrawn

Primary endpoint: To compare DFS between study arms

InterventionalRandomizedopen0 targetStarted 2026-05Completion 2029-11Relmada Therapeutics, Inc.

Frequently asked questions

Who is developing ndv-01?

ndv-01 is being developed by RELMADA THERAPEUTICS, INC..

How many clinical trials involve ndv-01?

BioSniper tracks 3 clinical trials involving ndv-01.