You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR BREXANOLONE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Brexanolone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02603926 ↗ Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone Completed Randi J. Hagerman, MD Phase 2 2015-10-01 The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).
NCT02603926 ↗ Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone Completed University of California, Davis Phase 2 2015-10-01 The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).
NCT03665038 ↗ A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) Completed Sage Therapeutics Phase 3 2018-05-17 This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression.
NCT04273191 ↗ A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) Withdrawn Sage Therapeutics Phase 4 2020-02-01 In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters.
NCT04537806 ↗ A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19 Terminated Sage Therapeutics Phase 3 2020-12-18 The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Brexanolone

Condition Name

Condition Name for Brexanolone
Intervention Trials
Postpartum Depression 3
PTSD 1
Tinnitus 1
Acute Respiratory Distress Syndrome 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Brexanolone
Intervention Trials
Depression, Postpartum 4
Depressive Disorder 3
Depression 3
Stress Disorders, Post-Traumatic 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Brexanolone

Trials by Country

Trials by Country for Brexanolone
Location Trials
United States 23
Australia 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Brexanolone
Location Trials
California 3
North Carolina 3
Georgia 2
Mississippi 1
Kentucky 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Brexanolone

Clinical Trial Phase

Clinical Trial Phase for Brexanolone
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2 2
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Brexanolone
Clinical Trial Phase Trials
Not yet recruiting 6
Completed 2
Withdrawn 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Brexanolone

Sponsor Name

Sponsor Name for Brexanolone
Sponsor Trials
Sage Therapeutics 8
Randi J. Hagerman, MD 1
University of California, Davis 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Brexanolone
Sponsor Trials
Industry 9
Other 6
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Brexanolone: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Brexanolone, marketed as Zulresso, is a groundbreaking treatment for postpartum depression (PPD) that has garnered significant attention in the medical and pharmaceutical communities. This article provides an in-depth look at the clinical trials, market analysis, and future projections for brexanolone.

Clinical Trials Overview

Phase 3 Trials: The Hummingbird Program

The Hummingbird program, consisting of two Phase 3 multicenter, randomized, double-blind, placebo-controlled trials (Study 202B and Study 202C), was pivotal in establishing the efficacy and safety of brexanolone for PPD. These trials involved women with moderate and severe PPD, aged between 18 and 45 years, who were within six months postpartum. The primary endpoint was a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score at 60 hours compared to placebo. Both trials demonstrated statistically significant reductions in HAM-D scores, with brexanolone showing rapid and durable effects over 30 days[1].

Real-World Efficacy

In a real-world setting, brexanolone has continued to show promising results. A study tracking changes in depressive symptoms using the Edinburgh Postnatal Depression Scale (EPDS) found significant reductions in EPDS scores immediately post-infusion and sustained improvements up to three months post-treatment. This study also explored changes in functional connectivity (FC) using precision functional neuroimaging (pfMRI), indicating widespread changes in FC that correlated with symptom reduction[2].

Safety and Tolerability

Adverse Events

Clinical trials have shown that brexanolone is generally well-tolerated. The most common adverse events reported include headache, dizziness, and somnolence. Serious adverse events were rare, with no hospitalizations required in the trials. The safety profile of brexanolone is comparable to that of placebo, with similar rates of adverse events across all treatment groups[1].

Market Analysis

Regulatory Approval

Brexanolone was approved by the United States Food and Drug Administration (FDA) on March 19, 2019, for the treatment of PPD in adults. This approval marked a significant milestone, as brexanolone became the first FDA-approved treatment specifically for PPD[5].

Market Positioning

Brexanolone competes with another exogenous analog of allopregnanolone, zuranolone. Both drugs have shown efficacy in clinical trials, but they differ in administration and duration of treatment. Brexanolone is administered via infusion over 60 hours, while zuranolone is given orally for 14 days. The market positioning of brexanolone is strong due to its rapid onset of action and sustained efficacy, which are critical factors for treating PPD[3].

Clinical Efficacy Comparison with Zuranolone

Onset of Action

Brexanolone has been shown to have a rapid onset of action, with significant effects observed as early as 24 hours following the start of infusion. In contrast, zuranolone's effects are noticeable three days after initiating treatment. This rapid action can be a significant advantage in clinical settings where quick relief from depressive symptoms is crucial[3].

Response and Remission Rates

Brexanolone has demonstrated higher response and remission rates compared to placebo. For instance, brexanolone significantly increased the likelihood of achieving HAM-D 17 response and remission starting at 24 and 48 hours, respectively, and continuing through 72 hours. These results highlight the drug's effectiveness in rapidly restoring hormonal balance and alleviating depressive symptoms[3].

Market Projections

Growing Demand

The demand for effective treatments for PPD is increasing, driven by greater awareness of the condition and the need for targeted therapies. With its FDA approval and strong clinical trial data, brexanolone is well-positioned to capture a significant share of this growing market.

Expansion into New Markets

As awareness and diagnosis of PPD improve globally, the potential market for brexanolone is expected to expand beyond the United States. Regulatory approvals in other countries and regions will be crucial for the drug's global market penetration.

Postmarketing Studies and Commitments

The FDA has mandated several postmarketing studies, including an evaluation of the efficacy of a lower dose of brexanolone and the feasibility of outpatient daytime dosing. These studies will provide additional data on the drug's safety and efficacy, potentially expanding its use and further solidifying its market position[5].

Key Takeaways

  • Clinical Efficacy: Brexanolone has demonstrated significant reductions in depressive symptoms in clinical trials and real-world settings.
  • Safety Profile: The drug is generally well-tolerated with a favorable safety profile.
  • Market Positioning: Brexanolone is the first FDA-approved treatment specifically for PPD, offering a rapid onset of action and sustained efficacy.
  • Market Projections: Growing demand for PPD treatments and potential expansion into new markets suggest a strong future for brexanolone.
  • Postmarketing Studies: Ongoing and planned studies will continue to provide valuable data on the drug's safety and efficacy.

FAQs

Q: What is brexanolone, and how is it administered?

A: Brexanolone, marketed as Zulresso, is an infusion treatment for postpartum depression. It is administered over 60 hours in a clinical setting.

Q: How effective is brexanolone in treating PPD?

A: Brexanolone has shown statistically significant reductions in depressive symptoms in clinical trials, with rapid and durable effects observed over 30 days.

Q: What are the common adverse events associated with brexanolone?

A: The most common adverse events include headache, dizziness, and somnolence.

Q: How does brexanolone compare to zuranolone in treating PPD?

A: Brexanolone has a faster onset of action and is administered via infusion, while zuranolone is given orally over 14 days. Both drugs have shown efficacy, but brexanolone's rapid action is a notable advantage.

Q: What are the postmarketing commitments for brexanolone?

A: The FDA has required studies to evaluate the efficacy of a lower dose of brexanolone and the feasibility of outpatient daytime dosing, among other commitments.

Sources

  1. Sage Therapeutics Announces Brexanolone Achieves Primary Endpoints in Both Phase 3 Clinical Trials in Postpartum Depression. Investor.sagerx.com.
  2. Brexanolone Treatment in a Real-World Patient Population. PubMed.
  3. How do brexanolone and zuranolone compare in patients with postpartum depression?. Dig.pharmacy.uic.edu.
  4. ClinicalTrials.gov: Brexanolone. ClinicalTrials.gov.
  5. Approval Package for: Zulresso (brexanolone) injection 5 mg/ml. Accessdata.fda.gov.

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.