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6R-BH4

Phase 2

Hypertension | Small molecule | Cardiovascular |BioMarin Pharmaceutical Inc.|Last Updated: Jul 21, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00325962A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic HypertensionPHASE2 COMPLETED 84 — — May 1, 2006Dec 1, 2008Jul 21, 200924 United States
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Study Endpoints
Primary Endpoints
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.
Secondary Endpoints
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial diastolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in insulin sensitivity after 8 weeks of treatment in subjects with both type 2 diabetes and poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in eNOS activity and endothelial dysfunction after 8 weeks of treatment in subjects with poorly controlled hypertension
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
6R-BH4 (sapropterin dihydrochloride)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures. * At least 18 years of age. * Willing and able to comply with all study-related procedures. * History of documented essen...

Countries:United States
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Competitive Landscape -Hypertension 42 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron, LY3971297
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN3 — Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
Orchestra BioMed Holdings, Inc.OBIO3NAUndisclosed
CVRx, Inc.CVRX1NAMedical Management
Medtronic PlcMDT4NAUndisclosed
IQVIA Holdings IncIQV1NAUndisclosed
Verve Medical, IncVERV1NAActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1NATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
Harvard Bioscience, Inc.HBIO1 — Undisclosed
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