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 relmadastudies.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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H1 2023

H2 2023

H1 2024

H2 2024

H1 2025

Reliance OLS: open-label study in MDD
Reliance II (302): Phase 3 adjunctive MDD trial
Relight (304): Phase 3 adjunctive MDD trial
Expanded Access Program (EAP) for REL-1017

Other ongoing programs

NeuroplastogenTM program
We have obtained a novel NeuroplastogenTM program from Arbormetis LLC and have synthesized a series of novel esmethadone and psilocybin derivatives. NeuroplastogenTM drugs have the potential to restore impaired neural plasticity without dissociative effects (Cooper 2023). Leveraging our understanding of neural plasticity, we are in the process of selecting the most promising candidates targeting neurological and psychiatric disorders for clinical development. 

Metabolic program
We are developing a novel modified release psilocybin formulation that has shown promising activity in pre-clinical studies for the treatment of obesity and other metabolic diseases. A Phase 1 single ascending dose (SAD) clinical study will commence in 2024.