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Tranexamic Acid

Phase 3

Hemorrhagic Shock | Small molecule | Other |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jul 30, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
NO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03469947California Prehospital and In Hospital Antifibrinolytic Therapy Via TXAPHASE3 COMPLETED 200Mar 1, 2015Jul 29, 2024Jul 30, 2024 -
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Study Endpoints
Primary Endpoints
Survival at 24 hours
24 hours

Mortality at 24 hours

Survival at 48 hours
48 hours

Mortality at 48 hours

Survival at 28 days
28 days

Mortality at 28 days

Secondary Endpoints
Blood Transfusion
24 hours
Length of Hospital Stay
28 days
Adverse Events
28 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Prehospital Tranexamic AcidEXPERIMENTAL1 gram of Tranexamic Acid will be given during medical transport
Matched ControlsNO_INTERVENTIONRetrospective matched controls
Interventions
NameTypeDescription
Tranexamic AcidDRUG1 gram of prehospital Tranexamic Acid
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Blunt or penetrating trauma with signs and symptoms of hemorrhagic shock * Systolic blood pressure less than 90 mmHg at scene of injury, during air and/or ground medical transport, or on arrival to designated trauma centers * Any sustained blunt or penetrating injury within 3 ...

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