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Clinical trials
catalyst calendar across sponsors →Studies where RLMD is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
10 interventional · 1 expanded access · 4 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder CancerNCT07464145Disease Free Survival in participants with Intermediate Risk NMIBCRandomized · Open-label · Treatment | Phase 3 | Not yet recruiting | Drug: NDV-01 (sustained-release gemcitabine-docetaxel) | Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urologic Cancer | 393 | Sep 2029 | ≤ 1,138 d | 2026-03-11 |
| Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBCNCT06663137Number of Patients with Complete Response (CR) in High-Grade NMIBCOpen-label · Treatment | Phase 2 | Recruiting | Drug: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel | Non Muscle Invasive Bladder Cancer | 70 | Aug 2025 | — | 2025-06-13 |
| A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBTNCT07313891To compare DFS between study armsRandomized · Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: This study has been incorporated into the Relmada REL-NDV01-303 study. | Drug: NDV-01 (sustained-release gemcitabine-docetaxel) | Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer | 0 | 2029-09-01 | in 1,109 d | 2026-03-17 |
| A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line TherapyNCT07342517To evaluate the efficacy of NDV-01 (determined by complete response [CR] anytime) administered by intravesical instillation in patients with BCG-unresponsive NMIBC who have recurred after first-line intravesical therapy (approved or in development).Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: This study has been incorporated into the Relmada REL-NDV01-303 study. | Drug: NDV-01 (sustained-release gemcitabine-docetaxel) | Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urologic Cancer | 0 | 2027-06-30 | in 315 d | 2026-03-17 |
| Safety of REL-1017 for Major Depressive DisorderNCT04855760results2024-08-09Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: REL-1017 | Major Depressive Disorder | 627 | 2023-07-27actual | — | 2025-02-11 |
| A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)NCT04688164results2024-03-26Change in the MADRS10 Total Score From Baseline to Day 28Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: REL-1017, Placebo | Major Depressive Disorder | 227 | 2022-11-01actual | — | 2024-08-27 |
| A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)NCT05081167results2024-03-26Change in the MADRS10 Total Score From Baseline to Day 28Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: REL-1017, Placebo | Major Depressive Disorder | 232 | 2022-09-13actual | — | 2024-03-26 |
| Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDDNCT03051256results2021-03-17Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability]Randomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: REL-1017, Placebo | Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant | 62 | 2019-07-30actual | — | 2023-11-01 |
| Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)NCT03638869Adverse Events (AEs)Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: REL-1017, Placebo | Neuropathic Pain | 24 | 2015-11-16actual | — | 2018-08-20 |
| Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)NCT03637361Adverse Events (AEs)Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: REL-1017, Placebo | Neuropathic Pain | 42 | 2015-06-02actual | — | 2019-08-01 |
| Individual Patient Esmethadone (REL-1017) Expanded Access ProgramNCT06009003expanded access | — | No longer available | Drug: REL-1017 | Major Depressive Disorder, Depression | — | — | — | 2026-08-12 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19