NDV-01 (sustained-release gemcitabine-docetaxel)

Phase 3Small molecule

NDV-01 (sustained-release gemcitabine-docetaxel) is one of 2 small molecule programs targeting Bladder (Urothelial, Transitional Cell) Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bladder (urothelial, Transitional Cell) CancerNot yet recruiting

Bladder (urothelial, Transitional Cell) CancerPhase 3

Not yet recruiting

Competition

Competitive Landscape

3 competitors in Bladder (urothelial, Transitional Cell) Cancer

#DrugCompanyPhaseTrials

TARA-002

PProtara Therapeutics

Phase 3

1 2

NDV-01 (sustained-release gemcitabine-docetaxel)

RRelmada Therapeutics, Inc.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2032

Phase 3Not yet recruiting

Bladder (urothelial, Transitional Cell) Cancer

NCT07464145

Clinical

Trials by Indication[1]

Gemcitabine1 trial

A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT

Withdrawn·RRelmada Therapeutics, Inc.·Phase 3·NCT07313891

Bladder Cancer1 trial

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

Withdrawn·RRelmada Therapeutics, Inc.·Phase 3·NCT07342517

Bladder (Urothelial, Transitional Cell) Cancer1 trial

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

Not yet recruiting·RRelmada Therapeutics, Inc.·Phase 3·NCT07464145·393 enrolled

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for NDV-01 (sustained-release gemcitabine-docetaxel). U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — NDV-01 (sustained-release gemcitabine-docetaxel) compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for NDV-01 (sustained-release gemcitabine-docetaxel). EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Relmada Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: RRelmada Therapeutics, Inc.

NDV-01 (sustained-release gemcitabine-docetaxel)

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2032

Trials by Indication[1]

Gemcitabine1 trial

Bladder Cancer1 trial

Bladder (Urothelial, Transitional Cell) Cancer1 trial

References

Drug Info

Quick Facts

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