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REL-1017

DRUG9 trials

Sponsors

Relmada Therapeutics, Inc., Levomecor Inc.

Conditions

DepressionDepressive Disorder, MajorDepressive Disorder, Treatment-ResistantMajor Depressive DisorderNeuropathic Pain

Phase 1

Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)
CompletedNCT03637361
Relmada Therapeutics, Inc.Neuropathic Pain
Start: 2014-12-04End: 2015-06-02Updated: 2019-08-01
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)
CompletedNCT03638869
Relmada Therapeutics, Inc.Neuropathic Pain
Start: 2015-08-31End: 2015-11-16Updated: 2018-08-20

Phase 2

Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
CompletedNCT03051256
Relmada Therapeutics, Inc.Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
Start: 2018-05-11End: 2019-09-30Updated: 2023-11-01

Phase 3

A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
CompletedNCT04688164
Relmada Therapeutics, Inc.Major Depressive Disorder
Start: 2021-01-08End: 2022-11-10Updated: 2024-08-27
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
TerminatedNCT04855747
Levomecor Inc.Depression, Major Depressive Disorder
Start: 2021-03-30End: 2025-01-14Updated: 2026-07-10
Safety of REL-1017 for Major Depressive Disorder
CompletedNCT04855760
Relmada Therapeutics, Inc.Major Depressive Disorder
Start: 2021-04-01End: 2023-07-27Updated: 2025-02-11
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
CompletedNCT05081167
Relmada Therapeutics, Inc.Major Depressive Disorder
Start: 2021-06-02End: 2022-09-14Updated: 2024-03-26
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
TerminatedNCT06011577
Levomecor Inc.Depression, Major Depressive Disorder
Start: 2023-08-17End: 2024-12-19Updated: 2026-07-10

Unknown Phase

Individual Patient Esmethadone (REL-1017) Expanded Access Program
NCT06009003
Relmada Therapeutics, Inc.Depression, Major Depressive Disorder
Updated: 2026-08-12

Related Papers

Long-Term Safety and Efficacy of Esmethadone in Patients With Major Depressive Disorder
The Journal of Clinical Psychiatry2025-02-165 citations
Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants
The Journal of Clinical Psychiatry2024-06-1712 citations
Effect of Time From Onset of Major Depressive Disorder on the Therapeutic Response to Esmethadone (REL-1017)
The Journal of Clinical Psychiatry2024-05-131 citations
Subanalysis of Subjective Cognitive Measures From a Phase 2, Double-Blind, Randomized Trial of REL-1017 in Patients With Major Depressive Disorder
The Primary Care Companion For CNS Disorders2023-02-134 citations