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Firibastat

Phase 3

Hypertension | Small molecule | Cardiovascular |Quantum Biopharma Ltd.|Last Updated: Oct 20, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment515
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04277884Firibastat in Treatment-resistant HypertensionPHASE3 COMPLETED 515Jun 25, 2020Sep 20, 2022Oct 20, 202220 United States, Czechia +4
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Study Endpoints
Primary Endpoints
Systolic Blood Pressure at office (mmHg)
From Day 1 to Day 84

Automatic Office Blood Pressure measurement

Secondary Endpoints
Diastolic Blood Pressure at office (mmHg)
From Day 1 to Day 84
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)
From Day 1 to Day 84
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)
From Day 1 to Day 84
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FiribastatEXPERIMENTALCapsules
PlaceboPLACEBO_COMPARATORMatching capsules
Interventions
NameTypeDescription
FiribastatDRUGOral administration 2×250 mg capsules bid
PlaceboDRUGOral administration 2 capsules bid
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Men and women ≥18 years of age at Screening * Diagnosis of primary HTN for at least 6 months prior to Screening Exclusion Criteria: * Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease). * Automated office SBP \>18...

Countries:United StatesCzechiaFranceGermanyPolandSpain
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