Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 35/100

Failure Rate

22.7%

5 terminated/withdrawn out of 22 trials

Success Rate

76.2%

-10.3% vs industry average

Late-Stage Pipeline

32%

7 trials in Phase 3/4

Results Transparency

119%

19 of 16 completed trials have results

Key Signals

19 with results

Enrollment Performance

Analytics

Phase 2
14(66.7%)
Phase 3
7(33.3%)
21Total
Phase 2(14)
Phase 3(7)

Activity Timeline

Global Presence

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Clinical Trials (22)

Showing 20 of 22 trials
NCT05604170Phase 3Terminated

Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

Role: lead

NCT05323734Phase 3Completed

Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

Role: lead

NCT04391569Phase 3Completed

Randomized Therapy In Status Epilepticus

Role: lead

NCT00442104Phase 2Terminated

Open-label Extension to Protocol 1042-0500

Role: lead

NCT05814523Phase 3Withdrawn

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Role: lead

NCT05757544Phase 2Withdrawn

Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)

Role: lead

NCT04678479Unknown

Ganaxolone Expanded Access Program Compassionate Use

Role: lead

NCT03460756Phase 2Completed

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

Role: lead

NCT03228394Phase 2Completed

A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

Role: lead

NCT02519439Phase 3Terminated

A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures

Role: lead

NCT03865732Phase 2Completed

Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)

Role: lead

NCT00441896Phase 2Completed

A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms

Role: lead

NCT03572933Phase 3Completed

Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder

Role: lead

NCT01725152Phase 2Completed

Ganaxolone Treatment in Children With Fragile X Syndrome

Role: lead

NCT04285346Phase 2Completed

Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)

Role: lead

NCT02358538Phase 2Completed

Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies

Role: lead

NCT00465517Phase 2Completed

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

Role: lead

NCT03350035Phase 2Completed

Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Role: lead

NCT01963208Phase 3Completed

Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

Role: lead

NCT00512317Phase 2Completed

Open-label Extension to Protocol 1042-0600

Role: lead