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REGN7544

Phase 2

Postural Orthostatic Tachycardia Syndrome (POTS) | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: May 4, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06593600Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)PHASE2 ACTIVE NOT_RECRUITING 82Nov 13, 2024Jul 6, 2026May 4, 202616 United States, Canada
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Study Endpoints
Primary Endpoints
Change in Heart Rate (HR) from supine to standing (DeltaHR)
At Day 8
Secondary Endpoints
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Through 90 Days
Severity of TEAEs
Through 90 Days
DeltaHR
At Day 15 and 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low DoseEXPERIMENTALRandomized 1:1:1
High DoseEXPERIMENTALRandomized 1:1:1
Matching PlaceboPLACEBO_COMPARATORRandomized 1:1:1
Interventions
NameTypeDescription
REGN7544DRUGSubcutaneous (SC) administration
PlaceboDRUGSC administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria: 1. Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening: 1. Increase in HR ≥30 beats per minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol 2. Absence of orthos...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06593600Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06593600studyFirstPostDate: changed