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
-

Effect of Allopregnanolone on Stress-induced Craving

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-07-11
Last Posted Date
2024-03-18
Lead Sponsor
Yale University
Target Recruit Count
16
Registration Number
NCT04015869
Locations
🇺🇸

VA Connecticut Healtcase System, West Haven, Connecticut, United States

Allopregnanolone in Chronic Complex Traumatic Brain Injury

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2019-07-01
Last Posted Date
2024-06-17
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
132
Registration Number
NCT04003285
Locations
🇺🇸

Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-11-20
Last Posted Date
2023-04-25
Lead Sponsor
University of Arizona
Target Recruit Count
12
Registration Number
NCT03748303
Locations
🇺🇸

University of Southern California - Alzheimer Disease Research Center - Healthcare Consultation Center II, Los Angeles, California, United States

A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2018-09-11
Last Posted Date
2022-08-11
Lead Sponsor
Sage Therapeutics
Target Recruit Count
28
Registration Number
NCT03665038
Locations
🇺🇸

Sage Investigational Site, League City, Texas, United States

Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

First Posted Date
2015-11-13
Last Posted Date
2018-12-06
Lead Sponsor
Randi J. Hagerman, MD
Target Recruit Count
6
Registration Number
NCT02603926
Locations
🇺🇸

UC Davis MIND Institute, Sacramento, California, United States

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