Ndv-01
Urologic Cancer, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Bladder, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
Phase III
Not Yet Recruiting
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Mar 02, 2026
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Ndv-01
Urothelial Carcinoma Recurrent, Urothelial Carcinoma Bladder, Urologic Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
Phase III
Withdrawn
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
Jan 13, 2026
Ndv-01
Urologic Cancer, Urothelial Carcinoma Bladder, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
Phase III
Withdrawn
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
Dec 29, 2025
Ndv01 Intravesical Controlled Release Formulation Of Gemcitabine And Docetaxel
Non Muscle Invasive Bladder Cancer
Phase II
Recruiting
A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
Aug 08, 2024
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Rel-1017
Depression, Major Depressive Disorder
Phase III
Terminated
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
Aug 21, 2023
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Rel-1017
Major Depressive Disorder
Phase III
Completed
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
Oct 04, 2021
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Rel-1017
Depression, Major Depressive Disorder
Phase III
Terminated
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Apr 19, 2021
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Rel-1017
Major Depressive Disorder
Phase III
Completed
Safety of REL-1017 for Major Depressive Disorder
Apr 19, 2021
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Rel-1017
Major Depressive Disorder
Phase III
Completed
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Dec 07, 2020
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Rel-1017
Neuropathic Pain
Phase I
Completed
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)
Aug 10, 2018
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Relmada Therapeutics Inc (4E2) have in its pipeline
4E2 is currently developing the following drugs: Ndv-01, Ndv-01, Ndv-01. These drug candidates are in various stages of clinical development as the company works toward FDA approval.