Relmada Therapeutics, Inc.

Our research

and development programs

REL-1017

REL-1017 works as an NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive GluN2D channels. NMDARs are known to have a primary role in physiological neural plasticity, and their dysfunction has been associated with many CNS disorders, including MDD. The primary cause of MDD may be excessive activity of a subtype of NMDARs: the GluN1-GluN2D subtype. REL-1017 may regulate these receptors, while not interfering with the physiological activity of other NMDARs.

Blocking hyperactive NMDAR channels of the GluN2D subtype is a novel approach to rapidly treating depression with a mechanism that is different from standard serotoninergic antidepressants.
The data from our Phase 1 and Phase 2 trials support the advancement of REL-1017 to a larger Phase 3 registration program for the treatment for MDD.

Blocking hyperactive NMDAR channels of the GluN2D subtype is a novel approach to rapidly treating depression with a mechanism that is different from standard serotoninergic antidepressants.

The data from our Phase 1 and Phase 2 trials support the advancement of REL-1017 to a larger Phase 3 registration program for the treatment for MDD.

Phase 1

Phase 1

This trial showed the very favorable tolerability, safety, and pharmacokinetic profile of REL-1017.

Phase 2

Phase 2

This trial showed rapid, robust, and sustained antidepressant effects from REL-1017 in patients with inadequate response to standard treatment.

Phase 3

Phase 3

These trials are designed to evaluate the effectiveness of REL-1017 in a large number of people living with MDD.

Ongoing clinical research

Reliance, Relmada’s Phase 3 clinical development program for REL-1017, is designed to support FDA approval for the adjunctive treatment of MDD. Recent data from Reliance completed studies confirm potential efficacy in MDD and a very favorable safety profile with the lack of meaningful risk of abuse. New Phase 3 clinical trials in the Reliance program will endeavor to provide the necessary evidence to support a successful FDA submission for REL-1017, a new NMDA inhibitor as an effective and safe adjunctive treatment for MDD. You can learn more at reliancestudies.com.

Pipeline element below has 2 time periods, 1H 2023 and 2H 2023. There are 3 trials listed: Reliance II: 2nd pivotal adjunctive MDD trial (full length of both time periods), Reliance-OLS: long-term, open-label study in MDD (starting and ending in 1H 2023), and additional phase 3 trial in MDD (starts in middle of 1H 2023 and lasts full length of 2H 2023).

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1H 2023

2H 2023

Reliance II: 2nd pivotal adjunctive MDD trial
Reliance-OLS: long-term, open-label study in MDD
Additional phase 3 trial in MDD

Neuroplastogen® program

Relmada Therapeutics has obtained development and commercial rights to a novel Neuroplastogen® program from Arbormentis LLC. Neuroplastogen® drugs have the potential to restore impaired neural plasticity. Relmada will collaborate with Arbormentis on the development of new therapies without psychedelic effects targeting neurological and psychiatric disorders, leveraging its understanding of neural plasticity. While psilocybin in high doses is a psychedelic drug that can alter a person’s awareness of their thoughts, feelings, and surroundings, lower doses and improved formulations of psilocybin and its derivatives have the potential for enhancing neural plasticity without causing psychedelic effects. Neuroplastogen drugs have the potential to restore impaired neural plasticity without dissociative effects (Cooper 2023).