Brexanolone

Generic Name
Brexanolone
Brand Names
Zulresso
Drug Type
Small Molecule
Chemical Formula
C21H34O2
CAS Number
516-54-1
Unique Ingredient Identifier
S39XZ5QV8Y
Background

As of March 2019, brexanolone - developed and made available commercially by Sage Therapeutics Inc. as the brand name product Zulresso - is the first drug to have ever been approved by the US FDA specifically for the treatment of postpartum depression (PPD) in adult females . Since PPD, like various other types of depression, is characterized by feelings of sadness, worthlessness or guilt, cognitive impairment, and/or possibly suicidal ideation, it is considered a life-threatening condition . Studies have consequently found that PPD can genuinely have profound negative effects on the maternal-infant bond and later infant development . The development and availability of brexanolone for the treatment of PPD in adult females subsequently provides a new and promising therapy where few existed before .

In particular, the use of brexanolone in treating PPD is surrounded with promise because it acts in part as a synthetic supplement for possible deficiencies in endogenous brexanolone (allopregnanolone) in postpartum women susceptible to PPD whereas many commonly used anti-depressive medications elicit actions that may modulate the presence and activity of substances like serotonin, norepinephrine, and/or monoamine oxidase but do not mediate activities directly associated with PPD like natural fluctuations in the levels of endogenous neuroactive steroids like allopregnanolone .

And finally, although brexanolone may also be undergoing clinical trials to investigate its abilities to treat super-refractory status epilepticus, it appears that some such studies have failed to meet primary endpoints that compare success in the weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone vs. placebo when added to standard-of-care .

Indication

Brexanolone is a synthetic neuroactive steroid gamma-aminobutyric acid A (GABA(a)) receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adult women .

Associated Conditions
Postpartum Depression
Associated Therapies
-

Allopregnanolone As a Regenerative Treatment for Parkinson's Disease

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2024-02-16
Last Posted Date
2024-10-23
Lead Sponsor
Roberta Brinton
Target Recruit Count
10
Registration Number
NCT06263010
Locations
🇺🇸

The University of Arizona Clinical & Translational Science Research Center, Tucson, Arizona, United States

An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

Phase 2
Completed
Conditions
Interventions
First Posted Date
2022-12-09
Last Posted Date
2024-12-12
Lead Sponsor
Sage Therapeutics
Target Recruit Count
10
Registration Number
NCT05645432
Locations
🇺🇸

Sage Investigational Site, Iowa City, Iowa, United States

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

Completed
Conditions
First Posted Date
2022-09-16
Last Posted Date
2024-08-26
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
10
Registration Number
NCT05543746
Locations
🇺🇸

University of North Carolina, Chapel Hill, North Carolina, United States

Study on Allopregnanolone and Depression in Perimenopausal Women

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2022-04-15
Last Posted Date
2022-11-10
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
80
Registration Number
NCT05329779
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Effects Zulresso on Postpartum Psychosis

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-04-06
Last Posted Date
2024-08-26
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
10
Registration Number
NCT05314153
Locations
🇺🇸

UNC Hospitals, Chapel Hill, North Carolina, United States

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2022-02-04
Last Posted Date
2024-11-11
Lead Sponsor
Yale University
Target Recruit Count
25
Registration Number
NCT05223829
Locations
🇺🇸

Yale School of Medicine, New Haven, Connecticut, United States

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

First Posted Date
2021-04-09
Last Posted Date
2024-07-31
Lead Sponsor
University of Arizona
Target Recruit Count
200
Registration Number
NCT04838301
Locations
🇺🇸

Perseverance Research Center, Scottsdale, Arizona, United States

🇺🇸

ATP Clinical Research, Costa Mesa, California, United States

🇺🇸

Wake Research, Los Alamitos, California, United States

and more 7 locations

A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

First Posted Date
2020-09-03
Last Posted Date
2022-08-19
Lead Sponsor
Sage Therapeutics
Target Recruit Count
29
Registration Number
NCT04537806
Locations
🇺🇸

Sage Investigational Site, Seattle, Washington, United States

A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2020-02-18
Last Posted Date
2020-08-18
Lead Sponsor
Sage Therapeutics
Registration Number
NCT04273191
© Copyright 2024. All Rights Reserved by MedPath