6 completed, 2 withdrawn, 1 not yet recruiting, 1 no longer available. 6 Phase 3, 2 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 3, Withdrawn 2, Not yet recruiting 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 1, Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer NDV-01 (sustained-release gemcitabine-docetaxel) - Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) | Phase 3 | Not yet recruiting | Relmada Therapeutics, Inc. | 393 | 2027-02-01 | 2026-09-02 |
| 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 NDV-01 (sustained-release gemcitabine-docetaxel) - Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) | Phase 3 | Withdrawn | Relmada Therapeutics, Inc. | 2026-06-30 | 2026-03-17 | |
| A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT NDV-01 (sustained-release gemcitabine-docetaxel) - Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer | Phase 3 | Withdrawn | Relmada Therapeutics, Inc. | 2026-05-01 | 2026-03-17 | |
| A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC NDV01 intravesical controlled release formulation of gemcitabine and docetaxel - Non Muscle Invasive Bladder Cancer | Phase 2 | Recruiting | Relmada Therapeutics, Inc. | 70 | 2024-08-01 | 2026-09-02 |
| A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD) REL-1017, Placebo - Major Depressive Disorder | Phase 3 | Completed | Relmada Therapeutics, Inc. | 232 | 2021-06-02 | 2024-03-26 |
| Safety of REL-1017 for Major Depressive Disorder REL-1017 - Major Depressive Disorder | Phase 3 | Completed | Relmada Therapeutics, Inc. | 627 | 2021-04-01 | 2025-02-11 |
| A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) REL-1017, Placebo - Major Depressive Disorder | Phase 3 | Completed | Relmada Therapeutics, Inc. | 227 | 2021-01-08 | 2024-08-27 |
| Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD REL-1017, Placebo - Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant | Phase 2 | Completed | Relmada Therapeutics, Inc. | 62 | 2018-05-11 | 2023-11-01 |
| Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone) REL-1017, Placebo - Neuropathic Pain | Phase 1 | Completed | Relmada Therapeutics, Inc. | 24 | 2015-08-31 | 2018-08-20 |
| Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone) REL-1017, Placebo - Neuropathic Pain | Phase 1 | Completed | Relmada Therapeutics, Inc. | 42 | 2014-12-04 | 2019-08-01 |
| Individual Patient Esmethadone (REL-1017) Expanded Access Program REL-1017 - Major Depressive Disorder, Depression | No longer available | Relmada Therapeutics, Inc. | 2026-08-12 |
Depressive Disorder, Major (5) · Neoplasms (3) · Non-Muscle Invasive Bladder Neoplasms (3) · Urologic Neoplasms (3) · Depression (2) · Neuralgia (2) · Urinary Bladder Neoplasms (2) · Depressive Disorder, Treatment-Resistant (1)
D-methadone (3) · Docetaxel (1) · Gemcitabine (1)
United States (4) · Israel (1)
Marco Pappagallo, MD (4) · Boris Chertin (1) · Maurizio Fava, MD (1) · Raj S Pruthi, MD MHA (1) · Raj S Pruthi, MD MHA FACS (1)
PMID 34933568, PMID 36821775, PMID 37468392, PMID 38265030, PMID 38767937, PMID 38917366, PMID 39999772, PMID 41749468