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Study identifier: NCT06663137 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC

Condition: Non Muscle Invasive Bladder Cancer  ·  Sponsor: Relmada Therapeutics, Inc.

PhasePhase 2
Planned participants70
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.

This description comes directly from the study's public registry record.

Talk to the study team

Paul Greene  ·  +15129691739  ·  pgreene@relmada.com

Scott White  ·  +16464285264  ·  swhite@relmada.com

Always discuss trial participation with your own doctor first.

Locations (1)

Relmada SiteRaanana, IsraelRecruiting

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Source record: clinicaltrials.gov/study/NCT06663137