ADVERTISEMENT
ADVERTISEMENT

The unique mission of the Epilepsy Therapy Project, an initiative of the Epilepsy Foundation, is to accelerate new therapies for people living with epilepsy and seizures. As a reflection of our commitment and as a service to the community we are pleased to provide here the pipeline of epilepsy therapies in various stages of development. We thank all of the individuals and organizations whose efforts are reflected in these seeds of hope. The Epilepsy Therapy Project makes no claims of accuracy of the following data. Although every effort is made to continuously update this list, some errors are inevitable. Companies or academicians or others who are directly involved with any of the therapies listed here are strongly encouraged to keep us updated by contacting kmacher@efa.org of any needed changes.

Impact Statement


Phases

Rather than only use the traditional Phase I,II, and III (which can also be ambiguous), we have chosen more meaningful "break points" for epilepsy therapies:

  • Phase 0: Preclinical—Not Yet In Humans
  • Phase I: First Clinical Use—The Therapy Has Been Tested In A Small Number of Humans (Usually Non-Patient Volunteers)
  • Phase IIa: Early Patient Use—A Few Patients With Seizures Have Been Exposed To The Therapy; Small Clinical Trials Are Underway Or Completed
  • Phase IIb: Critical Proof of Concept—A Large Trial, Suitable As A Registration Study, Has Shown Positive Results (Devices move directly to Phase III)
  • Phase III: Late Clinical Use—The Therapy Is In The Final Stages Of Acquiring All The Data Needed For Registration; Many Patients Have Received the Therapy
  • Registration (R): The Therapy Has Been Accepted for Potential Approval by the FDA (Filing Has Been Accepted)
  • Approved and To The Patients (US): The Therapy Is Available To Patients In The US
  • Approved and To The Patients (ex-US): The Therapy Is Available To Patients outside of the US

When support has been provided by the Epilepsy Therapy Project, the therapy is listed under the "Phase" column(s) in blue.

When support has been provided by other sources, the therapy is listed under the "Phase" column(s) in orange.


Sponsors

When support has been provided by ETP or its partners, the organization's abbreviated name is listed under the "Sponsors" column.

ETP - Epilepsy Therapy Project | CURE - Citizens United for Research in Epilepsy | EF - Epilepsy Foundation | FACES - Finding a Cure for Epilepsy and Seizures | MFF - Milken Family Foundation | Anon - Anonymous Sponsor


Categories

Drugs | Enhanced Drug Delivery | Dietary Supplements | Therapeutic Devices | Seizure Detection & Prediction | Epilepsy Diagnosis | Safety Devices | Newly Marketed & Available for Patients | Dormant Projects

In each of the following categories the therapies are listed in alphabetical order, and when available, are linked to more information. The company name or institution associated with each therapy is also provided.

> >
Phase 0
DRUGS Company / Institution
Sponsors
Phase
Approved
O
I
IIa
IIb
III
R
US
ex-US
Adenosine-Augmentation Therapies (AAT's) for Epilepsy Therapy R.S. Dow Neurobiology Laboratories and Legacy Research Institute
ETP, EF, CURE
Phase 0










Alprazolam R.S. Dow Neurobiology Laboratories and Legacy
Research Institute
Phase I
Phase IIa



AMP-X-0079 AurimMed Pharma, Inc.
EF
Phase 0










antagoNAT Platform OPKO


Phase 0








Asian Herbs for Epilepsy Harvard Medical School
ETP
Phase 0










AV-101 VistaGen Therapeutics, Inc.
ETP
Phase 0










BGG492* Novartis International AG


Phase 0
Phase I
Phase IIa








BK Channel Antagonists: Use of for Seizure Prevention; paxilline Carnegie Mellon University
ETP, MFF
Phase 0










Brivaracetam UCB, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III






C-10068 Concert Pharmaceuticals, Inc.


Phase 0










Cannabidiol (CBD) University of California, SF; NYU, Mass General, Great Ormond Street Hospital, and GW Pharma
EF


Phase 0
Phase I
Phase IIa








Cannabidivarin GW Pharma and

Otsuka Pharmaceuticals


Phase 0










CNV1061436 Convergence Pharmaceuticals


Phase 0
Phase I






CPP-115 Catalyst Pharmaceutical Partners


Phase 0
Phase I









CTP-354 (previously C-21191) Concert Pharmaceuticals, Inc.


Phase 0










Deoxyglucose (2DG) for Intractable Seizures University of Virginia
ETP, EF, MFF
Phase 0
Phase I
Phase IIa








DG (2DG) for Therapy of Epilepsy, Preclinical, IND-enabling Studies University of Wisconsin
NeuroGenomeX, Inc.
ETP, EF
Phase 0
Phase I









Diazepam, Intranasal Acorda Therapeutics


Phase 0
Phase I
Phase IIa
Phase IIb






Diazepam, Intranasal Neurelis


Phase 0
Phase I









Dynamin: A Target for Novel Anti-epileptic Drugs Children's Medical Research Institute, The University of Sydney, BioLink
ETP, FACES, EF
Phase 0










Galanin Gene Delivery to the Hippocampus for Mesial Temporal Lobe Epilepsy Asklepios BioPharmaceutical, Inc.
ETP, EF
Phase 0










Galanin NAX 810-2 - Galanin Based Therapy for Refractory Epilepsy University of Utah
ETP, EF, MFF
Phase 0










Galanin Receptor-2 Based Therapy NeuroAdjuvants, Inc.


Phase 0










Ganaxolone for Treatment in Epilepsy Marinus Pharmaceuticals
ETP
Phase 0
Phase I
Phase IIa








Ginseng Extracts: Preclinical Evaluation in the Treatment of Seizures Baylor College of Medicine
ETP, EF
Phase 0










HE3286 treatment of drug resistant epilepsy Harbor Therapeutics, Inc.
ETP, EF
Phase 0










Herbal Extracts and Extract-derived Compounds; In Vitro and In Vivo Testing for Treatment of Epilepsy Harvard Medical School
ETP, FACES, EF
Phase 0










Huperzine (lead therapy) / Therapy with a novel MOA Insero Health
ETP, EF, MFF
Phase 0
Phase I








ICA-105665 Pfizer/Neusentis Unit


Phase 0
Phase I
Phase IIa








Levitracetam - Intravenous Administration in Neonates University of San Diego


Phase 0
Phase I
Phase IIa








Magnetonanoparticles for Enhanced Therapy of Epilepsy UCLA School of Medicine
ETP, EF
Phase 0










Memantine and other NMDA Receptor Channel Compounds to Treat a Variety of CNS Disorders Including Epilepsy Adamas Pharmaceuticals
ETP
Phase 0










Midazolam, intranasal (USL-261) Upsher-Smith Laboratories


Phase 0
Phase I
Phase IIa








MPP-021 MediProPharma


Phase 0










Naluzotan Proximagen
Phase 0
Phase I
Phase IIa








NPY Gene Transfer in Subjects with Intractable Mesial Temporal Lobe Epilepsy* The Ohio State University
Neurologix, Inc.
ETP, MFF
Phase 0










NTP-A NeuroTherapeutics
Pharma
ETP
Phase 0










P529 (Palomid) Paloma Pharmaceuticals


Phase 0










Propofol hemisuccinate: Pulmonary Delivery for the Control of Intractable Seizures University of California Davis, Epalex
ETP, EF
Phase 0










R-PID, S-PID and racemic PID; Second Generation Valproic Acid The Hebrew University of Jerusalem
ETP
Phase 0











T2000 Taro Pharmaceuticals


Phase 0
Phase I









T-2007 Taro Pharmaceuticals


Phase 0
Phase I









Targeting Glycolysis as a New Approach to the Treatment of Epilepsy Baylor College of Medicine
ETP, MFF
Phase 0
Phase I
Phase IIa








Tellurium Compounds (AS101 and SAS) with Neuroprotective Activity in Epilepsy Bar Ilan University
ETP, EF
Phase 0










Tonabersat Upsher-Smith Laboratories


Phase 0
Phase I









T-type Calcium Channel Antagonists as Novel AEDS Baylor College of Medicine
ETP, MFF, FACES
Phase 0










UCB 0942 UCB, Inc.


Phase 0
Phase I









VX765 Vertex Pharmaceuticals


Phase 0
Phase I
Phase IIa
Phase IIb







YKP3089 SK Life Sciences


Phase 0
Phase I
Phase IIa
Phase IIb







ENHANCED DRUG DELIVERY Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Application of Drug Directly to Brain New York University


Phase 0






Carbamazepine, IV Lundbeck


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III


Convection Enhanced Delivery of Anticonvulsant Toxins for the Treatment of Intractable Partial Epilepsy University of California Davis, and Medgenesis Therapeutix
ETP, EF
Phase 0






GDNF Local Delivery to Brain MedGenesis Therapeutix, Inc.


Phase 0






Diazepam Auto-injector (Vanquix)* King Pharmaceuticals / Pfizer


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III


Diazepam Injection for Emergency Treatment of Seizures (XeriJect) Xeris Pharmaceuticals, Inc.
ETP, EF
Phase 0






ICV Dosing Stanford University
and ICVrx, Inc.
ETP
Phase 0
Phase I
Phase IIa




Magnesium Valproate BioLink Life Sciences, Inc..

Phase 0
Phase I
Phase IIa
X
Topiramate Extended Release (USL-255) Upsher-Smith Laboratories


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III


Topiramate IV for Neonatal Seizures University of Minnesota
and Ligang Pharmaceuticals (formerly CyDex)
ETP, EF
Phase 0
Phase I





Topiramate IV: Enhanced Method of Administration in Babies, Older Children and Adults University of Minnesota and Ligang Pharmaceuticals (formerly CyDex)
ETP, EF
Phase 0







DIETARY SUPPLEMENTS Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Triheptanoin: Phase 11A Clinical Trial The University of Queensland, Australia
ETP, EF
Phase 0
Phase I
Phase IIa



THERAPEUTIC DEVICES Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Closed-looped Microstimulation with Multi-electrode Arrays to Suppress Epileptic Seizures Emory University School of Medicine
ETP, FACES
Phase 0






Deep Brain Stimulation - 1Hz rTMS for Treatment of Temporal Lobe Epilepsy Children's Hospital Boston
ETP, EF, CURE
Phase 0
Phase I
Phase IIa




Devices: Second Generation Designing Greater Efficacy University of Pennsylvania
ETP, EF, CURE
Phase 0
Phase I
Phase IIa




Focused Ultrasound for Epilepsy International HIFU


Phase 0
Phase I





High Definition Cathodal Transcranial Direct Current for Treatment of Focal Status Epilepticus Soterix Medical Inc.
ETP, EF
Phase 0
Phase I





Minimally invasive mapping and ablation to treat epilepsy Mayo Clinic, Rochester, NY
EF
Phase 0
Phase I





MR-guided focused ultrasound for treatment of mesial TLE Swedish Neuroscience Institute
EF
Phase 0
Phase I





Subdural Pharmacotherapy Device New York University, School of Medicine
ETP, EF
Phase 0






Trigeminal Nerve Stimulation Device NuroRestore
ETP, EF
Phase 0
Phase I






SEIZURE DETECTION & PREDICTION Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Affectiva Wrist Sensor Massachusetts Institute of Technology


Phase 0
Phase I
Phase IIa




EpiLert Seizure Alert Device Biolert LTD
ETP, EF
Phase 0
Phase I
Phase IIa




Posttraumatic Pharmacoresistant Epileptogenesis: Animal Models University of Washington School of Medicine
ETP, CURE
Phase 0






Seizure Advisory System NeuroVista


Phase 0
Phase I
Phase IIa




Seizure Detection Device Cyberonics


Phase 0
Phase I
Phase IIa




Sleep and Smart Shirts Massachusetts General Hospital


Phase 0
Phase I






EPILEPSY DIAGNOSIS Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Direct Network Visualization of Drug Efficacy Using ofMRI Stanford University
ETP, EF
Phase 0




EEG Headset: No prep, rapid measurement Advanced Neurometrics


Phase 0
Phase I
Phase IIa




Eight Channel Wireless EEG Headset Imec


Phase 0
Phase I




Eye Movements and Epilepsy---Eye-Com Biosensor Children's Hospital, Oakland, CA


Phase 0
Phase I
Phase IIa




Factors Determining Placebo Response in Drug-Resistant Focal Epilepsy Mount Sinai School of Medicine
EF


Phase 0
Phase I




Fast Ripple Detection: Online Intracranial EEG Acquisition System Columbia University Medical Center
ETP, EF
Phase 0
Phase I
Phase IIa




Model of TLE SynapCell SAS


N/A






Multi-scale Human Electrophysiology and Stimulation Mayo Clinic, Rochester
ETP, EF
N/A






Photosensitivity Model: Assessment of Narrow Spectrum Antiepileptic Drugs New York University
ETP, EF, MFF
N/A






SUDEP: Heart and Brain Signals Advanced Brain Monitoring


Phase 0






Validation of the ANI-SI Dry EEG Headset in Time-Critical Applications Advanced Neurometrics, Inc.
ETP, EF
Phase 0
Phase I




Wireless EEG Seizure Patch Epitel, Inc.
ETP, EF
Phase 0
Phase I





SAFETY DEVICES Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Airbag Head Protection for People with Epilepsy Hovding Sverige AB
EF
Phase 0
Phase I




Head Protection in Epilepsy Megan Dickison


Phase 0
Phase I






NEWLY MARKETED & AVAILABLE FOR PATIENTS Company / Institution
Sponsors
Phase
Available
O I IIa IIb III R US ex-US
Dense EEG Arrays: Non-invasive Electrical Geodesics, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X X
Eslicarbazepine Acetate
Sunovion Pharmaceuticals, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X X
Midazolam, oromucosal solution

Approved in other jurisdictions but waiting at FDA
ViroPharma


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III




X
MRI-guided Laser Ablation of Epilepsy Foci Visualase, Inc.
ETP, EF
Phase 0
Phase I
Phase IIa



Registration
X
Oxcarbazepine: Extended Release (SPN-804)

On the US market by mid 2013
Supernus Pharmaceuticals, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X
Perampanel

US market availability for patients TBD
Eisai Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X
X
Responsive Neurostimulation NeuroPace, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X
Retigabine: Drug Valeant/GSK


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration

X

X
SAMi Smartphone Based Movement Detector HiPass Design Ltd
ETP
Phase 0
Phase I
Phase IIa


X
X
SmartWatch: Seizure Detection Smart Monitor Corporation
ETP, EF, Anon
Phase 0
Phase I
Phase IIa


X
Thalamus Stimulation

Approved in other jurisdictions but waiting at FDA
Medtronic, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X
Topiramate Extended Release (SPN-538)

On the market by mid 2013
Supernus Pharmaceuticals, Inc.


Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration
X
Trigeminal Nerve Stimulation (eTNS™) for Drug Resistant Partial Seizures

Approved in other jurisdictions but waiting at FDA
NeuroSigma, Inc.
ETP, EF
Phase 0
Phase I
Phase IIa
Phase IIb



X
t-VNS,
Vagal stimulation via the ear


Approved in other jurisdictions but waiting at FDA
Cerbomed and Cyberonics
Phase 0
Phase I
Phase IIa
Phase IIb
Phase III


X

DORMANT PROJECTS Company / Institution
Sponsors
Phase
Approved
O I IIa IIb III R US ex-US
Beclamide*


Phase 0
Phase I
Phase IIa






Brain Cooling Flint Hills Scientific


Phase 0








Carisbamate* Johnson and Johnson


Phase 0

Phase I
Phase IIa
Phase IIb
Phase III
Registration



Closed-loop Feedback in a Rat Model of Chronic Epilepsy for Seizure Control Arizona State University
ETP, EF
N/A








Controlling Brain Excitability by Electrical Stimulation Yale University
ETP, EF
Phase 0
Phase I
Phase IIa






Intracerebral Injection of Anticonvulsant Containing Spray-dried Biocompatible Microparticles for Long-Term Treatment of Epilepsy* Texas Tech University Health Sciences Center, School of Pharmacy
ETP, EF
Phase 0
Phase I
Phase IIa
Phase IIb
Phase III
Registration



JZP-4 Jazz


Phase 0
Phase I
Phase IIa






Nefiracetam*


Phase 0








Non Invasive Nonlinear Seizure Prediction Device University of Michigan
ETP, EF
Phase 0
Phase I
Phase IIa






Phase Resetting using DC Stimulation for Seizure Blockage University of Kansas Medical Center
ETP, EF, FACES
Phase 0








Propylisopropyl acetamide (PID)


Phase 0








Seizure Detection Device: Low Power Analog Flint Hills Scientific
ETP
Phase 0








Seletracetam (UCB-44212)* UCB


Phase 0








SPD


Phase 0








Stiripentol Biocodex
Phase 0
Phase I
Phase IIa





X
Talampanel Efficacy in Neonatal Seizures and Brain Injury* Children's Hospital, Harvard Medical School; Ivax @ Teva
ETP, EF
Phase 0
Phase I
Phase IIa






Valnoctamide


Phase 0
Phase I
Phase IIa






Valproate pivoxil


Phase 0
Phase I







Valrocemide (TV1901)


Phase 0
Phase I
Phase IIa






ADVERTISEMENT
ADVERTISEMENT