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 15 indications[4].[1]

Fintepla is one of 268 small molecule programs targeting Partial Epilepsy. It is currently in Approved.

Indications

Total Trials

Active Trials

267

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Partial EpilepsyApproved

CDKL5 DisorderApproved

Postpartum DepressionActive, not recruiting

Complex Partial EpilepsyApproved

Fragile X SyndromeActive, not recruiting

Epilepsy SyndromeActive, not recruiting

Post-Traumatic Stress DisorderApproved

SeizureActive, not recruiting

EpilepsyActive, not recruiting

Major Depressive DisorderActive, not recruiting

Partial EpilepsyApproved

Approved

CDKL5 DisorderApproved

Approved

Postpartum DepressionPhase 2

Active, not recruiting

Complex Partial EpilepsyApproved

Approved

Fragile X SyndromePhase 2

Active, not recruiting

Epilepsy SyndromeApproved

Active, not recruiting

Post-Traumatic Stress DisorderApproved

Approved

SeizurePhase 3

Active, not recruiting

EpilepsyPhase 3

Active, not recruiting

Major Depressive DisorderPreclinical

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

386 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Fintepla

IImmedica Pharma AB

Approved

23 2

Daliresp

AstraZeneca

Phase 3

1 3

Latuda

SSunovion Respiratory Development Inc.

Phase 3

3 4

Risperdal

WWim Janssens

Phase 3

2 5

Celebrex

PPhiladelphia Eye Associates

Phase 3

2 6

Quetiapine XR

AstraZeneca

Phase 3

4 7

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 8

Comparator: Pbo

Merck & Co.

Phase 3

3 9

Levophed

GGeneral Hospital of Ningxia Medical University

Venlafaxine ER

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

Timeline

Expected Milestones

Q3 2028

Phase 3Not yet recruiting

Double-Blind

NCT05249556

Clinical

Trials by Indication[1]

Epilepsy4 trials

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

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

Show 1 more trial

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

Terminated·MMarinus Pharmaceuticals·Phase 3·NCT05604170·117 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

Postpartum Depression2 trials

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

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

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

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

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

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

9 more indications

Post-Traumatic Stress Disorder, PTSD1 trial

Ganaxolone in Posttraumatic Stress Disorder (PTSD)

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

Infantile Spasms1 trial

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

Completed·MMarinus Pharmaceuticals·Phase 2·NCT00441896·57 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

GAN1 trial

Ganaxolone Expanded Access Program Compassionate Use

No longer available·MMarinus Pharmaceuticals··NCT04678479

Double-blind1 trial

Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old

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

Fragile X Syndrome1 trial

Ganaxolone Treatment in Children With Fragile X Syndrome

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

CDKL5 Deficiency Disorder1 trial

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

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

Unspecified2 trials

Open-label Extension to Protocol 1042-0500

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

Open-label Extension to Protocol 1042-0600

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

Regulatory

FDA Approval Timeline[5]

Jun 1, 2022

ZTALMY

NDA NDA215904

Sources

References

[1]
ClinicalTrials.gov — 23 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

Q3 2028

Trials by Indication[1]

Epilepsy4 trials

Seizure3 trials

Postpartum Depression2 trials

Treatment2 trials

Status Epilepticus2 trials

Post-Traumatic Stress Disorder, PTSD1 trial

Infantile Spasms1 trial

Treatment Resistant Depression1 trial

GAN1 trial

Double-blind1 trial

Smoking Cessation1 trial

Fragile X Syndrome1 trial

CDKL5 Deficiency Disorder1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News