pregnenolone methyl ether (MAP4343) / Mapreg - LARVOL DELTA

RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode (clinicaltrials.gov) - P2 | N=126 | Completed | Sponsor: Mapreg | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: Mapreg | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Psychiatry

RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Mapreg | Trial completion date: Dec 2023 ➔ Mar 2025 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Chronic MAP4343 reverses escalated alcohol drinking in a mouse model of alcohol use disorder. (PubMed, Neuropsychopharmacology) - "Parallel analysis of tubulin post-translational modifications revealed lower α-tubulin acetylation in the medial prefrontal cortex of CIE-withdrawn mice. Altogether, these data support the relevance of microtubules as a therapeutic target for the treatment of AUD."

Journal • Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Psychiatry

RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Mapreg | Unknown status ➔ Recruiting | Trial completion date: Jun 2021 ➔ Dec 2023 | Trial primary completion date: Jun 2021 ➔ Sep 2023

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

MAP4343 Treatment for Alcohol Use Disorder (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: The Scripps Research Institute | N=50 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Addiction (Opioid and Alcohol)

MAP4343 Treatment for Alcohol Use Disorder (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: The Scripps Research Institute; Trial completion date: Jul 2022 ➔ Dec 2022; Initiation date: Jan 2020 ➔ Dec 2020; Trial primary completion date: Jul 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

New therapeutic avenues for neurosteroids in psychiatric diseases (PubMed, Biol Aujourdhui) - "On the other hand, their precursors and metabolites, such as pregnenolone (PREG), dehydroepiandrosterone (DHEA), their respective sulfate esters, pregnenolone sulfate (PREG-S) and DHEA sulfate (DHEA-S) and allopregnanolone (ALLOP), are defined as neurosteroids, but no corresponding nuclear receptors have been identified so far...It has been subsequently developed as Brexanolone and tested with success in phase III of clinical trials for the treatment of post-partum depression...An example of such innovative drugs is MAP4343, a synthetic derivative of PREG, which exhibits potent antidepressant-like efficacy in validated animal models. It is currently tested in depressed patients."

Journal

MAP4343 Treatment for Alcohol Use Disorder (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: The Scripps Research Institute

Clinical • New P2 trial

RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode (clinicaltrials.gov) - P2; N=110; Recruiting; Sponsor: Mapreg; Not yet recruiting ➔ Recruiting

Enrollment open