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REGN13335

Phase 2

Pulmonary Arterial Hypertension (PAH) | Small molecule | Cardiovascular |Regeneron Pharmaceuticals, Inc.|Trials Updated: Sep 25, 2026

REGN13335 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Nov 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

REGN13335 clinical trials

REGN13335 · 1 trial · 1 indication

Phase 2 1
NCT07318597Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH)
RECRUITING99 Analytics
PHASE2RECRUITING
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH)Unlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites32

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 StatesAustraliaBelgiumFranceGermanyLatviaPolandSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 25, 2026NCT07318597lastUpdatePostDate: changed
LOWSep 25, 2026NCT07318597lastUpdatePostDate: changed
LOWSep 16, 2026NCT07318597lastUpdatePostDate: changed
LOWSep 16, 2026NCT07318597lastUpdatePostDate: changed
LOWSep 16, 2026NCT07318597lastUpdatePostDate: changed
LOWSep 16, 2026NCT07318597lastUpdatePostDate: changed
LOWAug 20, 2026NCT07318597lastUpdatePostDate: changed
LOWAug 20, 2026NCT07318597lastUpdatePostDate: changed
LOWAug 20, 2026NCT07318597lastUpdatePostDate: changed
LOWAug 20, 2026NCT07318597lastUpdatePostDate: changed
LOWAug 5, 2026NCT07318597lastUpdatePostDate: changed
LOWJul 27, 2026NCT07318597lastUpdatePostDate: changed
LOWJul 27, 2026NCT07318597lastUpdatePostDate: changed
LOWJul 27, 2026NCT07318597lastUpdatePostDate: changed

Frequently asked questions about REGN13335

What is REGN13335?

REGN13335 is an investigational small molecule being developed by Regeneron Pharmaceuticals for pulmonary arterial hypertension (PAH). It is currently in Phase 2 clinical development and has not been approved by the FDA. It is being studied in adults 18 years and older with PAH.

What is REGN13335 used for?

REGN13335 is being studied for the treatment of pulmonary arterial hypertension (PAH), a cardiovascular condition. It is an investigational therapy and is not approved for any indication. Its only clinical study enrolls adults with PAH and is currently recruiting participants.

Who makes REGN13335?

REGN13335 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the Phase 2 study evaluating the drug in adults with pulmonary arterial hypertension.

What phase is REGN13335 in?

REGN13335 is in Phase 2 clinical development. It is investigational and has not received FDA approval. The Phase 2 trial is currently recruiting, with an planned enrollment of 99 participants, and no trials of REGN13335 have been completed to date.

What clinical trials is REGN13335 in?

REGN13335 is being evaluated in one clinical trial, NCT07318597, titled Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH). The Phase 2 trial is randomized, double-blind, and placebo-controlled, with an enrollment of 99 adults, and is recruiting across the United States, Australia, Belgium, France, Germany, Latvia, Poland, South Korea, Spain, and the United Kingdom.