ENX-104 / Engrail Therap - LARVOL DELTA

ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD) (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Engrail Therapeutics INC | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ENX-104: a selective and potent D2/D3 receptor antagonist enhances dopamine neurotransmission and reward responsiveness in translational rodent models. (PubMed, Neuropsychopharmacology) - "Predictably, higher doses (65-80% receptor occupancy) were associated with antipsychotic-like effects in the rat conditioned avoidance response assay, while extrapyramidal side effects, such as catalepsy, emerged only at much higher occupancies ( > 80% receptor occupancy). Our integrated pharmacokinetic-pharmacodynamic modeling suggests that a once-daily oral dosing regimen of ENX-104 could enable low D2/D3 receptor occupancies, potentially offering a novel therapeutic approach for the treatment of psychiatric conditions characterized by deficits in reward responsiveness."

Journal • Preclinical • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

A PET Study of ENX-104 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Engrail Therapeutics INC

New P1 trial

ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD) (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Engrail Therapeutics INC

New P1 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Engrail Therapeutics Initiates ENX-104 Clinical Program for the Treatment of Major Depressive Disorder Characterized by Anhedonia (GlobeNewswire) - "Engrail Therapeutics...announced initiation of a Phase 1 single ascending dose clinical study for ENX-104 in healthy volunteers....The lead indication for ENX-104 is the treatment of major depressive disorder (MDD) characterized by anhedonia (aMDD)....The ENX-104 Phase 1 study is a randomized, double-blind, placebo-controlled single ascending dose clinical study that is expected to enroll up to 48 healthy adult volunteers."

Trial status • CNS Disorders • Major Depressive Disorder