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Traumatic Brain Injury

26
Pipeline Programs
30
Companies
50
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
0
13
0
5
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Novartis
EXELONApproved
rivastigmine
Novartis
Cholinesterase Inhibitor [EPC]transdermal2007
20M Part D

Competitive Landscape

38 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
3 programs
1
Transcranial electric stimulationN/A
transcranial electric stimulationN/A
RivastigminePHASE_3
Spine BioPharma
2 programs
1
1
LevetiracetamPhase 41 trial
Autologous bone marrow mononuclear cell transplantationPhase 11 trial
Active Trials
NCT02028104Withdrawn0Est. Sep 2016
NCT00618436Completed52Est. Sep 2009
Oregon Therapeutics
1
1
Whole blood transfusionPhase 31 trial
melatoninPhase 21 trial
Branched Chain Amino AcidsN/A1 trial
Tele-CABAN/A1 trial
Active Trials
NCT04603443Completed160Est. Sep 2025
NCT04200976Completed94Est. Aug 2021
NCT04932096Completed21Est. Mar 2025
+1 more trials
Defence Therapeutics
1
1
hypertonic saline mixed DextranPhase 31 trial
1 gram Tranexamic AcidPhase 21 trial
CellAegis Technologies autoRIC deviceN/A1 trial
Active Trials
NCT03176823Completed44Est. Mar 2024
NCT01990768Completed967Est. Nov 2017
NCT01642524Completed114Est. Jul 2011
Sandoz
SandozAustria - Kundl
3 programs
1
RivastigminePhase 31 trial
Transcranial electric stimulationN/A
transcranial electric stimulationN/A
Active Trials
NCT00171795Completed67Est. May 2005
Verinos Pharma
2 programs
1
1
VAS203Phase 31 trial
VAS203Phase 21 trial
Active Trials
NCT02012582Completed32Est. Sep 2012
NCT02794168Completed224Est. Jun 2020
Moleac
MoleacSingapore - Singapore
1 program
1
Traditional Chinese MedicinePhase 31 trial
Active Trials
NCT04861688Completed182Est. Feb 2023
Abbott
AbbottABBOTT PARK, IL
5 programs
1
1
SLV334Phase 21 trial
Eon-mini IPGPhase 11 trial
Blood drawN/A2 trials
Brain Injury Assessment Study at Hennepin County Medical CenterN/A1 trial
i-STAT TBI TestN/A1 trial
Active Trials
NCT04171960Completed1,106Est. Nov 2023
NCT00179335Completed45Est. Sep 2006
NCT02706574Unknown774Est. Jul 2022
+3 more trials
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
4 programs
1
2
NE3107Phase 21 trial
Sodium LactatePhase 22 trials
D-CycloserinePhase 11 trial
Trans-spinal Electrical StimulationN/A1 trial
Active Trials
NCT04183998Completed2Est. Jan 2022
NCT02312635Unknown30Est. Dec 2016
NCT05970575Terminated4Est. Jul 2025
+2 more trials
Pfizer
PfizerNEW YORK, NY
2 programs
1
PrecedexPhase 21 trial
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)N/A1 trial
Active Trials
NCT00507104Completed100Est. Nov 2008
NCT01007773Withdrawn0Est. Jan 2012
Abliva
AblivaSweden - Lund
2 programs
2
NeuroSTAT 5 mg/kg/dayPhase 21 trial
cyclosporinePhase 21 trial
Active Trials
NCT01825044Completed16Est. Sep 2017
NCT01692834Completed65Est. Jan 2010
ADEL
ADELKorea - Seoul
1 program
1
AnakinraPhase 21 trial
Active Trials
NCT02997371Unknown60Est. Oct 2021
Prevail Therapeutics
1
DuloxetinePhase 21 trial
Active Trials
NCT01223001Terminated8Est. Jul 2011
BioVie
1 program
1
NE3107Phase 2
SanBio Co Ltd
1 program
1
SB623 cellsPhase 21 trial
Active Trials
NCT02416492Completed63Est. Mar 2019
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
11 programs
1
Assigned InterventionsPhase 11 trial
Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With TBI, PTSD, or BothN/A1 trial
Health & WellnessN/A1 trial
Internet-based Interacting Together Everyday: Recovery After Childhood TBIN/A1 trial
SAA-TBIN/A1 trial
+6 more programs
Active Trials
NCT01334463Completed186Est. Jan 2016
NCT01334398Completed74Est. Nov 2014
NCT01214694Completed117Est. Dec 2015
+8 more trials
Young BioPharma
1
OSC+Phase 11 trial
Active Trials
NCT05913505Unknown50Est. Apr 2024
electroCore
electroCoreNJ - Rockaway
1 program
1
gammaCore active devicePhase 11 trial
Active Trials
NCT02974959Completed14Est. Nov 2020
Human BioSciences
Human BioSciencesWV - Martinsburg
11 programs
ASMTN/A1 trial
Decision AidN/A1 trial
Emotion BuilderN/A1 trial
Epigenetic Effects on Traumatic Brain Injury RecoveryN/A1 trial
FANCIN/A1 trial
+6 more programs
Active Trials
NCT01745146Completed90Est. Sep 2016
NCT03833375Completed41Est. Mar 2020
NCT02432300Completed17Est. Jun 2016
+8 more trials
Biocorp
2 programs
Transcranial electric stimulationN/A1 trial
transcranial electric stimulationN/A1 trial
Active Trials
NCT07271524Not Yet Recruiting25Est. Dec 2027
NCT06822283Completed19Est. Feb 2024
Tenax Therapeutics
Tenax TherapeuticsCHAPEL HILL, NC
2 programs
OxycytePHASE_21 trial
OxycytePHASE_21 trial
Active Trials
NCT00908063Terminated18Est. Sep 2014
NCT00174980Terminated9Est. Apr 2008
iNova Pharmaceuticals
iNova PharmaceuticalsAustralia - Chatswood
1 program
Animal assisted therapyN/A1 trial
Active Trials
NCT05217030Completed70Est. Dec 2019
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
Blast Traumatic Brain InjuryN/A1 trial
Active Trials
NCT01666964Unknown200Est. May 2015
icometrix
1 program
CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBIN/A1 trial
Active Trials
NCT02210221Completed4,559Est. Mar 2021
QuantalX
QuantalXIsrael - Kfar Svaa
1 program
Delphi-MD deviceN/A1 trial
Active Trials
NCT06963775Not Yet Recruiting215Est. Jul 2030
A&D Medical
A&D MedicalMI - Ann Arbor
1 program
Esophageal Cooling DeviceN/A
GE HealthCare
1 program
Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain InjuriesN/A1 trial
Active Trials
NCT02021877Completed396Est. Jul 2014
Baxter
BaxterCosta Rica - Cartago
1 program
Hemodynamic ABI MonitorN/A
Myomo
MyomoMA - Burlington
1 program
MyoPro Motion-GN/A1 trial
Active Trials
NCT03215771Completed16Est. Jun 2020
Oculogica
OculogicaWI - New Richmond
1 program
Neuro Kinetics IPASN/A1 trial
Active Trials
NCT03156010Completed201Est. Apr 2023

+8 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Spine BioPharmaLevetiracetam
Fresenius KabiDipeptiven
Oregon TherapeuticsWhole blood transfusion
MoleacTraditional Chinese Medicine
Verinos PharmaVAS203
TevaArmodafinil
Defence Therapeuticshypertonic saline mixed Dextran
SandozRivastigmine
Angeles TherapeuticsSodium Lactate
Angeles TherapeuticsNE3107
Oregon Therapeuticsmelatonin
Angeles TherapeuticsSodium Lactate
ADELAnakinra
SanBio Co LtdSB623 cells
Defence Therapeutics1 gram Tranexamic Acid

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 6,283 patients across 50 trials

Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

Start: Aug 2007Est. completion: Sep 200952 patients
Phase 4Completed

Optimized Therapy in Severe Traumatic Brain Injured Patients

Start: Jan 2005Est. completion: Feb 201112 patients
Phase 4Completed
NCT06184828Oregon TherapeuticsWhole blood transfusion

Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)

Start: Aug 2024Est. completion: Sep 2025100 patients
Phase 3Unknown
NCT04861688MoleacTraditional Chinese Medicine

NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

Start: Aug 2021Est. completion: Feb 2023182 patients
Phase 3Completed

Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury

Start: Jun 2016Est. completion: Jun 2020224 patients
Phase 3Completed
NCT00983437TevaArmodafinil

Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Start: Aug 2009Est. completion: Jan 201149 patients
Phase 3Terminated
NCT01642524Defence Therapeuticshypertonic saline mixed Dextran

The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)

Start: Apr 2004Est. completion: Jul 2011114 patients
Phase 3Completed
NCT00171795SandozRivastigmine

Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Start: Nov 2002Est. completion: May 200567 patients
Phase 3Completed

Sodium Lactate in Severe TBI

Start: Jan 2028Est. completion: Jul 2038264 patients
Phase 2Not Yet Recruiting

Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury

Start: Dec 2023Est. completion: Jul 20254 patients
Phase 2Terminated

Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

Start: Jan 2023Est. completion: Mar 202521 patients
Phase 2Completed

Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)

Start: Sep 2020Est. completion: Jun 20260
Phase 2Withdrawn

IL-1ra Dose-range Study for Moderate-to-severe TBI Patients

Start: Oct 2017Est. completion: Oct 202160 patients
Phase 2Unknown

A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)

Start: Jul 2016Est. completion: Mar 201963 patients
Phase 2Completed
NCT01990768Defence Therapeutics1 gram Tranexamic Acid

Prehospital Tranexamic Acid Use for Traumatic Brain Injury

Start: May 2015Est. completion: Nov 2017967 patients
Phase 2Completed
NCT01825044AblivaNeuroSTAT 5 mg/kg/day

Copenhagen Head Injury Ciclosporin (CHIC) Study

Start: Apr 2013Est. completion: Sep 201716 patients
Phase 2Completed

Safety of Dexmedetomidine in Severe Traumatic Brain Injury

Start: Jan 2010Est. completion: Jan 20120
Phase 2Withdrawn

Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury

Start: Nov 2009Est. completion: Sep 201232 patients
Phase 2Completed

Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)

Start: Oct 2009Est. completion: Sep 201418 patients
Phase 2Terminated

A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.

Start: Apr 2009Est. completion: Aug 201057 patients
Phase 2Terminated

An Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury

Start: Aug 2007Est. completion: Aug 20087 patients
Phase 2Terminated

Study of Oxycyte in Severe Closed Head Injury

Start: Sep 2005Est. completion: Apr 20089 patients
Phase 2Terminated

Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury

Start: Sep 1996Est. completion: Jul 20118 patients
Phase 2Terminated

Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Start: Feb 2023Est. completion: Apr 202450 patients
Phase 1Unknown

Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)

Start: Mar 2021Est. completion: Apr 20211 patients
Phase 1Terminated
NCT02974959electroCoregammaCore active device

Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

Start: Oct 2016Est. completion: Nov 202014 patients
Phase 1Completed
NCT03008434Colorado TherapeuticsAssigned Interventions

Traumatic Brain Injury and Yoga

Start: Oct 2015Est. completion: Apr 201610 patients
Phase 1Completed

Augmentation of Cognitive Training in Children With TBI With D-Cyloserine

Start: Dec 2012Est. completion: Dec 201630 patients
Phase 1Unknown
NCT01588691AbbottEon-mini IPG

Traumatic Brain Injury Peripheral Nerve Study

Start: Dec 2011Est. completion: Nov 20143 patients
Phase 1Completed

Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

Start: May 2011Est. completion: Jun 201118 patients
Phase 1Completed
NCT02028104Spine BioPharmaAutologous bone marrow mononuclear cell transplantation

Stem Cell Therapy in Traumatic Brain Injury

Start: Jan 2010Est. completion: Sep 20160
Phase 1Withdrawn
NCT01692834Ablivacyclosporine

A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy Volunteers

Start: Jun 2009Est. completion: Jan 201065 patients
Phase 1Completed

Modulating Inflammation in Neuro-Trauma

Start: May 2026Est. completion: Mar 202716 patients
N/ANot Yet Recruiting
NCT06963775QuantalXDelphi-MD device

Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

Start: Mar 2026Est. completion: Jul 2030215 patients
N/ANot Yet Recruiting
NCT07271524BiocorpTranscranial electric stimulation

Non-invasive Deep Brain Stimulation to Improve Spatial Navigation Abilities in Individuals Following Traumatic Brain Injury

Start: Dec 2025Est. completion: Dec 202725 patients
N/ANot Yet Recruiting
NCT06766435Abbotti-STAT TBI Test

Evaluation of the Abbott i-STAT TBI Biomarker Test

Start: Jan 2025Est. completion: Oct 2025450 patients
N/ARecruiting
NCT06822283Biocorptranscranial electric stimulation

Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging

Start: Sep 2021Est. completion: Feb 202419 patients
N/ACompleted
NCT04603443Oregon TherapeuticsBranched Chain Amino Acids

SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI

Start: Jun 2021Est. completion: Sep 2025160 patients
N/ACompleted

Clinical Evaluation of the i-STAT TBI Test

Start: Jul 2020Est. completion: Nov 20231,106 patients
N/ACompleted

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

Start: Sep 2019Est. completion: Aug 202194 patients
N/ACompleted
NCT03176823Defence TherapeuticsCellAegis Technologies autoRIC device

Remote Ischemic Conditioning as a Treatment for Traumatic Brain Injury

Start: May 2019Est. completion: Mar 202444 patients
N/ACompleted
NCT04183998Angeles TherapeuticsTrans-spinal Electrical Stimulation

Restorative Neuromodulation for Upper Extremity Functions

Start: May 2019Est. completion: Jan 20222 patients
N/ACompleted
NCT03611062Human BioSciencesVR Executive Functions Training

VR-based EF Rehabilitation for Pediatric TBI

Start: Aug 2018Est. completion: Aug 202027 patients
N/ACompleted

Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients

Start: Feb 2018Est. completion: Mar 202041 patients
N/ACompleted
NCT03156010OculogicaNeuro Kinetics IPAS

Oculomotor Assessment of Traumatic Brain Injury (TBI)

Start: Sep 2017Est. completion: Apr 2023201 patients
N/ACompleted

Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)

Start: Aug 2017Est. completion: Jun 201975 patients
N/ACompleted
NCT04186429Human BioSciencesEpigenetic Effects on Traumatic Brain Injury Recovery

Epigenetic Effects on Traumatic Brain Injury Recovery

Start: Jul 2017Est. completion: Aug 2024401 patients
N/ACompleted
NCT03215771MyomoMyoPro Motion-G

Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke

Start: Dec 2016Est. completion: Jun 202016 patients
N/ACompleted
NCT02706574AbbottBrain Injury Assessment Study at Hennepin County Medical Center

Brain Injury Assessment Study at Hennepin County Medical Center

Start: May 2016Est. completion: Jul 2022774 patients
N/AUnknown

Strategic Memory and Reasoning Training for Cognitive Problems

Start: May 2016Est. completion: Nov 2019100 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 6,283 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.