RELMADA THERAPEUTICS, INC. (RLMD)
Relmada Therapeutics, Inc. operates as a clinical-stage biotechnology company in the United States. The company focuses on the development of NDV-01, a controlled-release intravesical formulation of gemcitabine and docetaxel, which is in Phase 2 clinical trial for patients with aggressive forms of non-muscle invasive bladder cancer; and Sepranolone, a neurosteroid epimer of allopregnanolone, which is Phase 2b-ready for the potential treatment of prader-willi syndrome, tourette syndrome, excessive tremor, and other diseases related to excessive GABAergic activity. The company has an agreement with Asarina Pharma AB and Trigone. Relmada Therapeutics, Inc. was founded in 2004 and is headquartered in Coral Gables, Florida.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Relmada Therapeutics, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
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
NCT04688164Enrollment227StartJan 2021Primary CompletionNov 2022CompletionNov 2022 - Phase 3Completed
Safety of REL-1017 for Major Depressive Disorder
REL-1017
Major Depressive Disorder
NCT04855760Enrollment627StartApr 2021Primary CompletionJul 2023CompletionJul 2023 - Phase 3Completed
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
REL-1017, Placebo
Major Depressive Disorder
NCT05081167Enrollment232StartJun 2021Primary CompletionSep 2022CompletionSep 2022 - Phase 3Withdrawn
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 +2
NCT07313891Enrollment0StartMay 2026est.Primary CompletionSep 2029est.CompletionNov 2029est. - Phase 3Withdrawn
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) +3
NCT07342517Enrollment0StartJun 2026est.Primary CompletionJun 2027est.CompletionJun 2028est. - Phase 3Not yet recruiting
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) +3
NCT07464145Enrollment393StartFeb 2027est.Primary CompletionDec 2029est.CompletionDec 2032est. - Phase 2Completed
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
NCT03051256Enrollment62StartMay 2018Primary CompletionJul 2019CompletionSep 2019 - Phase 2Recruiting
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
NCT06663137Enrollment70StartAug 2024Primary CompletionNov 2027est.CompletionDec 2027est. - Phase 1Completed
Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)
REL-1017, Placebo
Neuropathic Pain
NCT03637361Enrollment42StartDec 2014Primary CompletionJun 2015CompletionJun 2015 - Phase 1Completed
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)
REL-1017, Placebo
Neuropathic Pain
NCT03638869Enrollment24StartAug 2015Primary CompletionNov 2015CompletionNov 2015 - Expanded accessNo longer available
Individual Patient Esmethadone (REL-1017) Expanded Access Program
REL-1017
Major Depressive Disorder, Depression
NCT06009003Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | REL-1017, Placebo | NCT04688164 |
| Phase 3 | Completed | REL-1017 | NCT04855760 |
| Phase 3 | Completed | REL-1017, Placebo | NCT05081167 |
| Phase 3 | Withdrawn | NDV-01 (sustained-release gemcitabine-docetaxel) | NCT07313891 |
| Phase 3 | Withdrawn | NDV-01 (sustained-release gemcitabine-docetaxel) | NCT07342517 |
| Phase 3 | Not yet recruiting | NDV-01 (sustained-release gemcitabine-docetaxel) | NCT07464145 |
| Phase 2 | Completed | REL-1017, Placebo | NCT03051256 |
| Phase 2 | Recruiting | NDV01 intravesical controlled release formulation of gemcitabine and docetaxel | NCT06663137 |
| Phase 1 | Completed | REL-1017, Placebo | NCT03637361 |
| Phase 1 | Completed | REL-1017, Placebo | NCT03638869 |
| Expanded access | No longer available | REL-1017 | NCT06009003 |