Traumatic Brain Injury

14
Pipeline Programs
13
Companies
19
Clinical Trials
1 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
5
0
2
4
Early DiscoveryClinical DevelopmentMarket

On Market (3)

Approved therapies currently available

Novartis
EXELONApproved
rivastigmine
Novartis
Cholinesterase Inhibitor [EPC]transdermal2007
U
NUVIGILApproved
armodafinil
Unknown Company
oral2007
U
RIVASTIGMINEApproved
rivastigmine
Unknown Company
Cholinesterase Inhibitor [EPC]transdermal2019

Competitive Landscape

13 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
3 programs
1
1
RivastigminePhase 31 trial
Transcranial electric stimulationN/A1 trial
transcranial electric stimulationN/A1 trial
Active Trials
NCT07271524Not Yet Recruiting25Est. Dec 2027
NCT06822283Completed19Est. Feb 2024
NCT00171795Completed67Est. May 2005
Fresenius Kabi
Fresenius KabiGermany - Bad Homburg
1 program
1
DipeptivenPhase 41 trial
Active Trials
NCT02130674Completed12Est. Feb 2011
Teva
TevaIsrael - Petach Tikva
1 program
1
ArmodafinilPhase 31 trial
Active Trials
NCT00983437Terminated49Est. Jan 2011
Tenax Therapeutics
Tenax TherapeuticsCHAPEL HILL, NC
2 programs
2
OxycytePhase 21 trial
OxycytePhase 21 trial
Active Trials
NCT00908063TerminatedEst. Sep 2014
NCT00174980TerminatedEst. Apr 2008
ADEL
ADELKorea - Seoul
1 program
1
Anakinra Prefilled SyringePhase 21 trial
Active Trials
NCT02997371UnknownEst. Oct 2021
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
1
JNJ-17299425Phase 21 trial
Active Trials
NCT01814982Terminated7Est. Aug 2008
Abliva
AblivaSweden - Lund
1 program
1
NeuroSTAT 5 mg/kg/dayPhase 21 trial
Active Trials
NCT01825044Completed16Est. Sep 2017
Abbott
AbbottABBOTT PARK, IL
3 programs
1
Eon-mini IPGPhase 11 trial
Brain Injury Assessment Study at Hennepin County Medical CenterN/A1 trial
i-STAT TBI TestN/A2 trials
Active Trials
NCT02706574Unknown774Est. Jul 2022
NCT06766435Recruiting450Est. Oct 2025
NCT04171960Completed1,106Est. Nov 2023
+1 more trials
United Therapeutics
United TherapeuticsMD - Silver Spring
1 program
1
PNT001Phase 11 trial
Active Trials
NCT04677829Terminated1Est. Apr 2021
Opko Health
Opko HealthMIAMI, FL
1 program
1
TT301Phase 11 trial
Active Trials
NCT01357421CompletedEst. Jun 2011
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
Blast Traumatic Brain InjuryN/A1 trial
Active Trials
NCT01666964Unknown200Est. May 2015
Pfizer
PfizerNEW YORK, NY
1 program
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)N/A1 trial
Active Trials
NCT00507104Completed100Est. Nov 2008
UP
UCB PharmaBelgium - Brussels
1 program
lacosamideN/A1 trial
Active Trials
NCT01110187Terminated11Est. May 2012

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Fresenius KabiDipeptiven
TevaArmodafinil
NovartisRivastigmine
ADELAnakinra Prefilled Syringe
AblivaNeuroSTAT 5 mg/kg/day
Tenax TherapeuticsOxycyte
Johnson & JohnsonJNJ-17299425
Tenax TherapeuticsOxycyte
United TherapeuticsPNT001
AbbottEon-mini IPG
Opko HealthTT301
NovartisTranscranial electric stimulation
Abbotti-STAT TBI Test
Novartistranscranial electric stimulation
Abbotti-STAT TBI Test

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 2,840 patients across 19 trials

Optimized Therapy in Severe Traumatic Brain Injured Patients

Start: Jan 2005Est. completion: Feb 201112 patients
Phase 4Completed
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

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

Start: Nov 2002Est. completion: May 200567 patients
Phase 3Completed
NCT02997371ADELAnakinra Prefilled Syringe

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

Start: Oct 2017Est. completion: Oct 2021
Phase 2Unknown
NCT01825044AblivaNeuroSTAT 5 mg/kg/day

Copenhagen Head Injury Ciclosporin (CHIC) Study

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

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

Start: Oct 2009Est. completion: Sep 2014
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 2008
Phase 2Terminated

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

Start: Mar 2021Est. completion: Apr 20211 patients
Phase 1Terminated
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 2011
Phase 1Completed
NCT07271524NovartisTranscranial 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
NCT06822283Novartistranscranial electric stimulation

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

Start: Sep 2021Est. completion: Feb 202419 patients
N/ACompleted
NCT04171960Abbotti-STAT TBI Test

Clinical Evaluation of the i-STAT TBI Test

Start: Jul 2020Est. completion: Nov 20231,106 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
NCT01666964Novo NordiskBlast Traumatic Brain Injury

Hormone Deficiency After Brain Injury During Combat

Start: Oct 2012Est. completion: May 2015200 patients
N/AUnknown

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Start: May 2010Est. completion: May 201211 patients
N/ATerminated
NCT00507104PfizerPituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)

Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)

Start: Sep 2006Est. completion: Nov 2008100 patients
N/ACompleted

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 2,840 patients
13 companies competing in this space