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Relmada Therapeutics (RLMD)
NASDAQ:RLMD
Ndv-01 (Sustained-Release Gemcitabine-Docetaxel)
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 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
Jan 13, 2026
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Ndv-01 (Sustained-Release Gemcitabine-Docetaxel)
Urologic Cancer, Urothelial Carcinoma Bladder, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
Phase III
Not Yet Recruiting
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
Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade 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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Rel-1017
Neuropathic Pain
Phase I
Completed
Safety, Tolerability and Pharmacokinetics of Single 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 (RLMD) have in its pipeline
RLMD is currently developing the following drugs: Ndv-01 (Sustained-Release Gemcitabine-Docetaxel), Ndv-01 (Sustained-Release Gemcitabine-Docetaxel), Ndv01 Intravesical Controlled Release Formulation Of Gemcitabine And Docetaxel. These drug candidates are in various stages of clinical development as the company works toward FDA approval.