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REGN13335

Phase 2

Pulmonary Arterial Hypertension (PAH) | Small molecule | Cardiovascular |Regeneron Pharmaceuticals, Inc.|Last Updated: May 29, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment99
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07318597Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)PHASE2 RECRUITING 99May 6, 2026Sep 17, 2028May 29, 20266 United States, Latvia +2
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Study Endpoints
Primary Endpoints
Change from baseline in Pulmonary Vascular Resistance (PVR)
At week 24
Secondary Endpoints
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Through end of study, up to approximately 2.5 years
Severity of TEAEs
Through end of study, up to approximately 2.5 years
Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations
At week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DBTP-Arm1EXPERIMENTAL -
DBTP-Arm2EXPERIMENTAL -
DBTP-Arm3PLACEBO_COMPARATOR -
OLE-Arm1EXPERIMENTAL -
OLE-Arm2EXPERIMENTAL -
Interventions
NameTypeDescription
REGN13335DRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. Receiving background Standard Of Care (SOC) therapy f...

Countries:United StatesLatviaSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07318597primaryCompletionDate: changed
LOWMay 29, 2026NCT07318597primaryCompletionDate: changed
LOWMay 29, 2026NCT07318597primaryCompletionDate: changed
LOWMay 26, 2026NCT07318597Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07318597studyFirstPostDate: changed