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SAGE-324

Alternative Names: sage-324, sage 324, sage324, BIIB124, BIIB-124, BIIB 124
Clinical Status: Active
Latest Update: 2025-05-16
Latest Update Note: Clinical Trial Update

Product Description

SAGE-324 is an investigational oral neuroactive steroid (NAS)GABAAreceptor positive allosteric modulator (PAM).

Mechanisms of Action: GABA Modulator

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Biogen
Company Location: CAMBRIDGE MA 02142
Company CEO: Michel Vounatsos
Additional Commercial Interests: Sage

Clinical Description

Map of Global Clinical Trials for SAGE-324

Countries in Clinic: United States

Active Clinical Trial Count: 1

Recent & Upcoming Milestones

  • Clinical Outcomes Reported - Sage announced they will present P0 Seizures results in 3Q25 for SAGE-324
  • Clinical Outcomes Reported - Sage presented P2 Essential Tremor results on 2024-07-24 for SAGE-324
  • Clinical Outcomes Reported - Sage announced they will present P2 Essential Tremor results in 3Q24 for SAGE-324

Highest Development Phases

Phase 2: Essential Tremor

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05173012

 324-ETD-202

P2

Completed

Essential Tremor

2024-05-02

50%

2025-05-17

Patient Enrollment|Primary Endpoints|Start Date|Treatments

Recent News Events

Date

Type

Title

05/12/2025

News Article

 PRISM MarketView Honors Mental Health Awareness Month with a Spotlight on Emerging Innovators

04/29/2025

News Article

 Sage Therapeutics Announces First Quarter 2025 Financial Results and Highlights Pipeline and Business Updates

04/22/2025

News Article

 Kuehn Law Encourages Investors of Sage Therapeutics, Inc. to Contact Law Firm

02/11/2025

News Article

 Sage Therapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Highlights Pipeline and Business Updates

04/01/2024

PubMed

 A Randomized Phase 2 KINETIC Trial Evaluating SAGE-324/BIIB124 in Individuals with Essential Tremor.

06/01/2022

PubMed

 GABAkines - Advances in the discovery, development, and commercialization of positive allosteric modulators of GABAA receptors.

02/01/2022

PubMed

 The imidazodiazepine, KRM-II-81: An example of a newly emerging generation of GABAkines for neurological and psychiatric disorders.

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