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Ganaxolone

Alternative Names: ganaxolone, ccd-1042, ztalmy
Latest Update: 2024-12-30
Latest Update Note: News Article

Product Description

Marinus is developing Ganaxolone as a treatment for seizure disorders. (Sourced from: https://marinuspharma.com/pipeline/science-pipeline/about-ganaxolone/)

Mechanisms of Action: GABA Modulator

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral,Intravenous

FDA Designation:
Orphan Drug - Lennox Gastaut Syndrome
Orphan Drug - Tuberous Sclerosis *

Approval Status: Approved

Approved Countries: United States

Approved Indications: Seizures

Known Adverse Events: Status Epilepticus | Suicidality | Drug Hypersensitivity | Environmental Hypersensitivity | Pregnancy Outcomes

Company: Marinus
Company Location: RADNOR PA 19087
Company CEO: Scott Braunstein
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Ganaxolone

Countries in Clinic: Australia, Belgium, Canada, China, France, Germany, Israel, Italy, Spain, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 4

Highest Development Phases

Phase 3: CDKL5-deficiency Disorder|Epilepsy|Status Epilepticus|Tuberous Sclerosis

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
TrustTSC OLE

P3

Enrolling by invitation

Tuberous Sclerosis|Epilepsy

2027-06-01

86%
1042-CDD-3002

P3

Not yet recruiting

CDKL5-deficiency Disorder

2026-12-01

RAISE

P3

Completed

Status Epilepticus

2024-03-30

CTR20231247

P3

Not yet recruiting

Epilepsy

None

Recent News Events

Date

Type

Title

12/30/2024

News Article

 Immedica to Acquire Biopharmaceutical Company Marinus Pharmaceuticals, Inc.

11/12/2024

News Article

 Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results

10/24/2024

News Article

 Marinus Pharmaceuticals Announces Topline Results From Phase 3 TrustTSC Trial of Oral Ganaxolone in Tuberous Sclerosis Complex and Commences Process to Explore Strategic Alternatives

10/15/2024

News Article

 Marinus Pharmaceuticals Further Strengthens Intellectual Property Estate with Method of Treatment Patent for ZTALMY® Titration Regimens

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