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BR1015-A

Phase 1

Essential Hypertension | Small molecule | Cardiovascular |Co-Diagnostics, Inc.|Last Updated: Feb 19, 2026

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07421375A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-1 and BR1015-2 Under Fasting ConditionsPHASE1 NOT YET_RECRUITING 58Apr 2, 2026May 31, 2026Feb 19, 2026 -
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Study Endpoints
Primary Endpoints
AUCt of Fimasartan
From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).

Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Fimasartan

AUCt of Indapamide
From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).

Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Indapamide

Cmax of Fimasartan
From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).

Maximum Concentration of Drug in Plasma of Fimasartan

Cmax of Indapamide
From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).

Maximum Concentration of Drug in Plasma of Indapamide

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BR1015-AEXPERIMENTAL -
BR1015-1+BR1015-2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BR1015-ADRUGOne tablet administered alone
BR1015-1DRUGOne tablet administered alone
BR1015-2DRUGOne tablet administered alone
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subjects with a body mass index (BMI) of more than 18.0 kg/m² and less than 30.0 kg/m² at the screening visit. * Subjects who provide written informed consent voluntarily after receiving and understanding sufficient explanation regarding the purpose and procedures of the clini...

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