Drugs / Esmethadone
Esmethadone
also known as
REL-1017 · esmethadone HCl · (s)-methadone · D-methadone · D-methadone hydrochloride · Dextromethadone · Dextromethadone hydrochloride · Esmetadona · +3 more
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03638869 | Aug → Nov 2015 | neuropathy, painful | Relmada Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03637361 | Dec 2014 → Jun 2015 | neuropathy, painful | Relmada Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT03051256 | May 2018 → Jul 2019 | major depressive disorder | Relmada Therapeutics, Inc. | Completed | Met primary |
| Phase 36 trials · 3 missed | ||||||
| Phase 3 | NCT06735079 | Dec 2024 → Dec 2026 | major depressive disorder | MGGM LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06011577 | Aug 2023 → Dec 2024 | major depressive disorder | Levomecor Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05081167 | Jun 2021 → Sep 2022 | major depressive disorder | Relmada Therapeutics, Inc. | Completed | Missed primary |
| Phase 3 | NCT04855760 | Apr 2021 → Jul 2023 | major depressive disorder | Relmada Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04855747 | Mar 2021 → Dec 2024 | major depressive disorder | Levomecor Inc. | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT04688164 | Jan 2021 → Nov 2022 | major depressive disorder | Relmada Therapeutics, Inc. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT06009003 Background | — | major depressive disorder | Relmada Therapeutics, Inc. | Temporarily not available | No outcome recorded |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2024-12-09 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics to Discontinue the Reliance II and Relight Phase 3 Studies of REL-1017 relmada.com ↗
today announced that in light of the recent data monitoring committee (DMC) evaluation of the full dataset from the Reliance II Phase 3 study of the Company’s REL-1017 program, the Company will discontinue the Reliance II and Relight Phase 3 studies. |
| 2024-12-04 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Reports That Data Monitoring Committee (DMC) Assessment Indicates That the Phase 3 Reliance II Trial is Futile at its Interim Analysis and is Unlikely to Meet the Primary Efficacy Endpoint with Statistical Significance relmada.com ↗ |
| 2024-06-18 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announced Publication of Results from the Phase 3 Reliance I Study of REL-1017 in The Journal of Clinical Psychiatry relmada.com ↗
Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the publication of REL-1017 clinical data from the Reliance I Study in the peer-reviewed journal, The Journal of Clinical Psychiatry. |
| 2023-09-20 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Efficacy and Safety Results from the Phase 3 Long-Term Study of REL-1017 in Major Depressive Disorder relmada.com ↗
Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced efficacy results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from the Phase 3, long-term, open-label, registrational trial (Study 310) of REL-1017 in patients with Major Depressive Disorder (MDD). |
| 2022-12-07 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Top-line Results from Phase 3 RELIANCE I Trial for REL-1017 as an Adjunctive Treatment for Major Depressive Disorder relmada.com ↗
Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced results of the RELIANCE I study (REL-1017-301), evaluating REL-1017 as an adjunctive treatment for Major Depressive Disorder (MDD). |
| 2022-10-13 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Top-line Results from Phase 3 RELIANCE III Trial for REL-1017 as a Monotherapy for the Treatment of Major Depressive Disorder relmada.com ↗
In the study, the REL-1017 treatment arm showed a MADRS reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher than expected placebo response. |
| 2022-08-09 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Receives FDA Fast Track Designation for REL-1017 as a Monotherapy for the Treatment of Major Depressive Disorder relmada.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to REL-1017, the Company’s novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment major depressive disorder (MDD). |
| 2022-05-25 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics to Present Data at the American Society of Clinical Psychopharmacology 2022 Annual Meeting relmada.com ↗
No meaningful abuse potential in recreational ketamine users of REL-1017 (esmethadone hydrochloride), a new NMDAR antagonist and potential rapid-acting antidepressant |
| 2022-04-29 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Publication of REL-1017 Preclinical Data in Frontiers in Pharmacology relmada.com ↗ |
| 2022-02-23 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Ketamine for Abuse Potential relmada.com ↗
All doses of REL-1017, including the maximum tolerated dose, demonstrated a statistically significant difference in abuse potential vs. ketamine (p-values <0.05) |
| 2021-12-22 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Publication of REL-1017 Phase 2 Study Results in The American Journal of Psychiatry relmada.com ↗
These compelling data confirm the favorable safety and tolerability profile of REL-1017 without opioid, dissociative, or psychotomimetic effects |
| 2021-10-04 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Provides Regulatory and Development Updates on Ongoing Late-Stage Clinical Program for REL-1017 for Treatment of Major Depressive Disorder relmada.com ↗ |
| 2021-07-27 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Oxycodone for Abuse Potential relmada.com ↗ |
| 2020-06-23 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Announces Notice of Allowance for Patent in Canada Covering REL-1017 for Treatment of Psychiatric Symptoms relmada.com ↗
today announced the receipt of a Notice of Allowance from the Canadian Intellectual Property Office for Relmada’s patent application number, 2,893,238, titled, “d-Methadone for the Treatment of Psychiatric Symptoms.” |
| 2019-10-15 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Top-Line Results from REL-1017 Phase 2 Study in Individuals with Treatment Resistant Depression relmada.com ↗
Relmada Therapeutics, Inc. (NASDAQ: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today reported top-line data from REL-1017-202, a double-blind, placebo-controlled Phase 2 clinical study evaluating the safety, tolerability and efficacy of two doses of REL-1017 (dextromethadone), 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with treatment resistant depression. |
| 2019-05-31 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Presents Development Program of REL1017 for Treatment of Depression at the 2019 American Society of Clinical Psychopharmacology Meeting relmada.com ↗
The poster presentation entitled, “Development of the N-Methyl-D-Aspartate Receptor (NMDAR) Antagonist d-Methadone (REL 1017) for the Treatment of Depression and Other CNS Disorders”, reported previously announced results from multiple pre-clinical studies comparing the effects of d-methadone and ketamine in different behavioral animal models used to assess antidepressant activity. |
| 2019-04-16 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Publication of REL1017 Phase 1 Studies Results relmada.com ↗
Results from our Phase 1 studies indicate that REL1017 has the potential to offer a favorable safety and tolerability profile in the treatment of MDD as an oral NMDAR antagonist without the psychotomimetic and dissociative adverse events associated with ketamine and its recently approved stereoisomer esketamine. |
| 2018-12-12 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Presents Clinical Data on Increased BDNF Plasma Levels in Subjects Treated with REL-1017 relmada.com ↗
The study findings showed that the administration of REL-1017 significantly increased BDNF plasma levels in healthy subjects compared to placebo, ranging from twice to 17 times the pre-treatment BDNF levels. |
| 2018-10-02 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics to Present Clinical Data on the Effect of REL-1017 on BDNF Plasma Levels relmada.com ↗
Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, announced today that it will present clinical data demonstrating increased plasma levels of brain derived neurotrophic factor (BDNF) in healthy subjects treated with d-methadone (REL-1017). |
| 2017-10-27 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Announces Notice of Acceptance of Key Patent in Australia Covering NMDA Receptor Antagonist d-Methadone for Treatment of Psychiatric Symptoms relmada.com ↗
Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, announced today that IP Australia has issued a notice of acceptance for patent application number 2013323645 for “D-methadone for the treatment of psychiatric symptoms.” |
| 2017-04-13 | Relmada Therapeutics, Inc. | Regulatory Relmada Announces FDA Fast Track Designation for d-Methadone for Adjunctive Treatment of Major Depressive Disorder relmada.com ↗ |
| 2017-01-25 | Relmada Therapeutics, Inc. | Regulatory Relmada Announces FDA Acceptance of IND and Authorization to Commence Phase 2a Clinical Trial for d-Methadone relmada.com ↗
Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that the Investigational New Drug (IND) application for d-Methadone (REL-1017 dextromethadone), the company’s novel, N-methyl-D-aspartate (NMDA) receptor antagonist, has been cleared by the U.S. Food and Drug Administration (FDA). |
| 2016-06-07 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics’ d-Methadone Receives Orphan Drug Designation for Management of Postherpetic Neuralgia relmada.com ↗
Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, announced today that d-Methadone (dextromethadone, REL-1017), a N-methyl-d-aspartate (NMDA) receptor antagonist in development as a treatment for both depression and chronic neuropathic pain, has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia. |
| 2016-05-04 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Results of In Vivo Study Showing d-Methadone has Antidepressant-like Effects relmada.com ↗
Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced the results of an in vivo study showing that administration of d-Methadone (REL-1017), a N-methyl-d-aspartate (NMDA) receptor antagonist, results in antidepressant-like effects. |
| 2016-03-01 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Publication of Full Results from Phase I Study Showing Treatment with d-Methadone to be Safe and Well Tolerated relmada.com ↗
Results published in the Journal of Opioid Management[1] demonstrated that d-methadone appears to be safe and well tolerated. |
| 2016-01-04 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Successfully Completes Multiple Ascending Dose Study of d-Methadone for Neuropathic Pain relmada.com ↗ |
| 2015-08-17 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Receives Health Canada Clearance to Commence Multiple Ascending Dose Study with Promising NMDA Receptor Antagonist relmada.com ↗
it has received a No Objection Letter (NOL) from Health Canada to conduct a multiple ascending dose (MAD) clinical study with d-Methadone (REL-1017 dextromethadone) |
| 2015-07-27 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Announces Filing of Clinical Trial Application in Canada for Multiple Ascending Dose Study with Promising NMDA Receptor Antagonist d-Methadone relmada.com ↗ |
| 2015-06-10 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Successfully Completes Phase 1 Single Ascending Dose Study with Promising NMDA Receptor Antagonist d-Methadone relmada.com ↗
The study results indicate that d-Methadone was generally well tolerated and a maximum tolerated dose (MTD) was achieved. |
| 2015-04-16 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Receives Health Canada Clearance to Further Explore Promising NMDA Receptor Antagonist d-Methadone (REL-1017) relmada.com ↗ |
| 2015-03-17 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Reports Positive Phase 1 Results for NMDA Receptor Antagonist d-Methadone relmada.com ↗
In the Phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers not exposed to opioid therapy, d-Methadone demonstrated a good safety profile with no dose-limiting side effects after four cohorts were exposed to increasingly higher doses. |
| 2014-12-02 | Relmada Therapeutics, Inc. | Regulatory Relmada Therapeutics Receives Health Canada Clearance to Commence First Clinical Study of d-Methadone relmada.com ↗ |
| 2014-09-10 | Relmada Therapeutics, Inc. | Regulatory Relmada Announces The Filing Of Clinical Trial Application In Canada For d-methadone relmada.com ↗
Health Canada has accepted the application that is now under review. |
All press releases naming this drug 53 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Esmethadone | “REL-1017 (Esmethadone) as Adjunctive Treatment” PMID 34933568 ↗ Dec 2021 |
| Known as | (s)-methadone | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | D-methadone | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | D-methadone hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | Dextromethadone | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | Dextromethadone hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | Esmetadona | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | esmethadone HCI | “REL1017 (esmethadone HCI) (active drug)” NCT06735079 ↗ |
| Known as | esmethadone HCl | “REL-1017 (esmethadone HCl) is a novel N-methyl-d-aspartate receptor (NMDAR) channel blocker and a potentially rapidly acting antidepressant.” PMID 36821775 ↗ Feb 20231“an investigational drug called REL-1017 (esmethadone HCl).” NCT06735079 ↗ |
| Known as | ESMETHADONE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Known as | REL-1017 | “an investigational drug called REL-1017 (esmethadone HCl).” NCT06735079 ↗ |
| Known as | REL-1017 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL350719 ↗ |
| Action | Inhibit | “a novel N-methyl-d-aspartate receptor (NMDAR) channel blocker” PMID 34933568 ↗ Dec 2021 |
| Modality | Small molecule | — CHEMBL350719 ↗ |
| Route | Oral | “REL-1017 will be administered as an oral solution.” NCT03051256 ↗ |