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Seralutinib

Phase 3

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Gossamer Bio, Inc.|Last Updated: May 19, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment706
FDA Designations
No designations recorded
Clinical trial landscape

Seralutinib · 2 trials · 1 indication

Phase 3 2
NCT06274801Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)Pulmonary Arterial Hypertension
ACTIVE NOT_RECRUITING316 Analytics
NCT05934526Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)Pulmonary Arterial Hypertension
COMPLETED390 Analytics
PHASE3ACTIVE NOT_RECRUITING
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Pulmonary Arterial Hypertension
NCT06274801316
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PHASE3COMPLETED
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
Pulmonary Arterial Hypertension
NCT05934526390
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
From baseline to end of study (up to 48 months or availability of commercial product)
Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24
Baseline to 24 weeks
Secondary Endpoints
Changes in distance achieved on the Six-Minute Walk Test (6MWT)
Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Changes in NT-proBNP
Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study
Baseline to 48 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Seralutinib 90 mgEXPERIMENTALSeralutinib inhaled orally twice per day (BID)
PlaceboPLACEBO_COMPARATORPlacebo inhaled orally twice daily (BID) up to 48 weeks
Interventions
NameTypeDescription
SeralutinibDRUGCapsule containing seralutinib
Gereic Dry Powder InhalerDEVICEGeneric dry powder inhaler for seralutinib delivery
PlaceboDRUGMatching capsule containing placebo
Generic Dry Powder InhalerDEVICEGeneric dry powder inhaler for seralutinib or placebo delivery
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion Criteria: 1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol. 2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been inform...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileColombiaCzechiaDenmarkFranceGermanyGreeceIrelandIsraelItalyJapanLatviaLithuaniaMexicoNetherlandsPolandPortugalRomaniaSaudi ArabiaSerbiaSingaporeSouth KoreaSpainUnited KingdomAustria
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Competitive Landscape -Pulmonary Arterial Hypertension 40 trials
CompanyTickerTrialsLead PhaseDrugs
United Therapeutics CorporationUTHR5PHASE3Ralinepag
Merck & Co., Inc.MRK6PHASE3Riociguat
Insmed IncorporatedINSM4PHASE3Treprostinil Palmitil
Johnson & JohnsonJNJ4PHASE3Selexipag
Liquidia CorporationLQDA4PHASE3L606
Tenax Therapeutics, Inc.TENX3PHASE3TNX-103
Gossamer Bio, Inc.GOSS2PHASE3Seralutinib
Inhibikase Therapeutics, Inc.IKT1PHASE3IKT-001
Regeneron Pharmaceuticals, Inc.REGN1PHASE2REGN13335
Pfizer Inc.PFE2PHASE2PF-07868489
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
Abbott LaboratoriesABT1N/AUndisclosed
Third Pole Therapeutics, Inc.THRD1N/AUndisclosed
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Recent Changes (Last 90 Days)
MEDIUMJun 19, 2026NCT05934526TRIAL_REMOVED: changed
MEDIUMJun 19, 2026NCT05934526TRIAL_REMOVED: changed
MEDIUMJun 19, 2026NCT05934526TRIAL_REMOVED: changed
LOWMay 26, 2026NCT06274801primaryCompletionDate: changed
LOWMay 24, 2026NCT06274801studyFirstPostDate: changed