Results from Phase 1 and 2 studies fueled the progression of REL-1017 to registration trials for major depressive disorder (MDD).

Our lead program, REL-1017, an NCE and novel NMDAR channel blocker with a preference for hyperactive channels associated with MDD, has entered its Phase 3 registration program as an adjunctive treatment for MDD. Data from the Phase 2 trial with REL-1017 suggest rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. Safety and tolerability results in the Phase 2 study were also consistent with those reported in previously reported Phase 1 studies. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for REL-1017 as an adjunctive treatment of MDD.

Relmada has reached alignment with the FDA on the primary components of its Phase 3 program of REL-1017 for adjunctive treatment of MDD: Two pivotal, randomized, placebo-controlled studies, RELIANCE-I and RELIANCE-II, and a long-term, open-label study, RELIANCE-OLS.  RELIANCE-I, the first pivotal trial, was initiated in December 2020. Plans for a Phase 2 program for the clinical development of REL-1017 as a monotherapy agent are also underway.

product pipeline

We believe there is a real potential for REL-1017, as a once-daily, oral option, to treat major depressive disorder safely, effectively, and more quickly than is currently possible, potentially changing the current the standard of care.

The clinical program with REL-1017 suggests a potentially differentiated profile in terms of safety, efficacy, tolerability and onset of action. Visit our Data and publications page to learn more about REL-1017 and the clinical data to date.