Fintepla

(Ganaxolone)

ApprovedSmall molecule

Ganaxolone is used to treat a rare type of epilepsy called CDKL5 deficiency disorder, which causes severe seizures starting in infancy. It works by helping to reduce the frequency and severity of these seizures.[2] Fintepla is currently approved and in use across 10 indications[4].[1]

Fintepla is one of 124 small molecule programs targeting CDKL5 disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

123

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

CDKL5 DisorderApproved

Post-Traumatic Stress DisorderApproved

Epilepsy SyndromeActive, not recruiting

Major Depressive DisorderActive, not recruiting

Tuberous SclerosisApproved

Focal Impaired Awareness SeizureApproved

Partial EpilepsyApproved

Complex Partial EpilepsyApproved

Dravet SyndromeRecruiting

CDKL5 Deficiency DisorderNot yet recruiting

CDKL5 DisorderApproved

Approved

Post-Traumatic Stress DisorderApproved

Approved

Epilepsy SyndromeApproved

Active, not recruiting

Major Depressive DisorderPreclinical

Active, not recruiting

Tuberous SclerosisApproved

Approved

Focal Impaired Awareness SeizureApproved

Approved

Partial EpilepsyApproved

Approved

Complex Partial EpilepsyApproved

Approved

Dravet SyndromeApproved

Recruiting

CDKL5 Deficiency DisorderPhase 3

Not yet recruiting

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Fintepla

IImmedica Pharma AB

Approved

25 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 7

Psilocybin

COMPASS Pathways

Phase 3

11 8

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 9

Aticaprant

Johnson & Johnson

Phase 3

4 10

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

ApprovedRecruiting

Dravet Syndrome

NCT07112365

Q4 2029

Phase 3Not yet recruiting

CDKL5 Deficiency Disorder

NCT05249556

Clinical

Trials by Indication[1]

Epilepsy4 trials

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

Terminated·MMarinus Pharmaceuticals·Phase 3·NCT05604170·117 enrolled

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

Completed·MMarinus Pharmaceuticals·Phase 3·NCT05323734·129 enrolled

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT03865732·29 enrolled

Show 1 more trial

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT02358538·30 enrolled

Seizure3 trials

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT00465517·147 enrolled

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

Completed·MMarinus Pharmaceuticals·Phase 3·NCT01963208·405 enrolled

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

Terminated·MMarinus Pharmaceuticals·Phase 3·NCT02519439·26 enrolled

Status Epilepticus2 trials

Randomized Therapy In Status Epilepticus

Completed·MMarinus Pharmaceuticals·Phase 3·NCT04391569·100 enrolled

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

Withdrawn·MMarinus Pharmaceuticals·Phase 3·NCT05814523

Postpartum Depression2 trials

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT03228394·91 enrolled

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

Completed·MMarinus Pharmaceuticals·Phase 2·NCT03460756·84 enrolled

CDKL5 Deficiency Disorder2 trials

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

Completed·MMarinus Pharmaceuticals·Phase 3·NCT03572933·101 enrolled

Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone in the Treatment of Seizures Associated With Genetically Confirmed Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) in Pediatric Patients From 6 Months to Less Than 2 Years of Age.

Not yet recruiting·IImmedica Pharma AB·Phase 3·NCT05249556·20 enrolled

9 more indications

Treatment2 trials

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT04285346·23 enrolled

A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

Completed·MMarinus Pharmaceuticals·Phase 2·NCT01002820·11 enrolled

Dravet syndrome2 trials

Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

Completed· UCB logo

UCB·Phase 3·NCT06118255·25 enrolled

The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.

Recruiting·TThe University of Texas Health Science Center, Houston·Approved·NCT07112365·25 enrolled

Treatment Resistant Depression1 trial

Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone

Completed·MMassachusetts General Hospital·N/A·NCT02900092·10 enrolled

Infantile Spasms1 trial

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT00441896·57 enrolled

GAN1 trial

Ganaxolone Expanded Access Program Compassionate Use

No longer available·MMarinus Pharmaceuticals··NCT04678479

Fragile X Syndrome1 trial

Ganaxolone Treatment in Children With Fragile X Syndrome

Completed·MMarinus Pharmaceuticals·Phase 2·NCT01725152·59 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

Ganaxolone in Posttraumatic Stress Disorder (PTSD)

Completed·MMarinus Pharmaceuticals·Phase 2·NCT01339689·112 enrolled

Smoking Cessation1 trial

Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

Completed·JJed E. Rose·Phase 2·NCT01857531·36 enrolled

Unspecified2 trials

Open-label Extension to Protocol 1042-0600

Completed·MMarinus Pharmaceuticals·Phase 2·NCT00512317·123 enrolled

Open-label Extension to Protocol 1042-0500

Terminated·MMarinus Pharmaceuticals·Phase 2·NCT00442104·54 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 1, 2022

ZTALMY

NDA NDA215904

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Ganaxolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Fintepla drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ganaxolone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ganaxolone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215904). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Fintepla. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Immedica Pharma AB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor; Anion Channel Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IImmedica Pharma AB

Patent Landscape[6]

Patent Cliff

Nov 28, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7858609Nov 28, 2026

8618087Nov 28, 2026

9029355Nov 28, 2026

8367651Nov 28, 2026

8022054Nov 28, 2026

6 more patents

9056116Nov 28, 2026

8318714Nov 28, 2031

10603308Aug 10, 2037

12144801Aug 10, 2037

12268696Sep 30, 2042

12115169Sep 30, 2042

Fintepla

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q4 2029

Trials by Indication[1]

Epilepsy4 trials

Seizure3 trials

Status Epilepticus2 trials

Postpartum Depression2 trials

CDKL5 Deficiency Disorder2 trials

Treatment2 trials

Dravet syndrome2 trials

Treatment Resistant Depression1 trial

Infantile Spasms1 trial

GAN1 trial

Fragile X Syndrome1 trial

Post-Traumatic Stress Disorder, PTSD1 trial

Smoking Cessation1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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