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Seralutinib

Phase 3

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Gossamer Bio, Inc.|Last Updated: May 19, 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 Trials2
Total Enrollment706
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06274801Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)PHASE3 ACTIVE NOT_RECRUITING 316 — — Sep 3, 2024Dec 1, 2026May 19, 2026115 United States, Argentina +28
NCT05934526Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)PHASE3 COMPLETED 390 — — Dec 28, 2023Dec 22, 2025May 19, 2026166 United States, Argentina +29
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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 — 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
Merck & Co., Inc.MRK6PHASE3Riociguat, Sotatercept, Frespaciguat, Background PAH Therapy
United Therapeutics CorporationUTHR5PHASE3Ralinepag, treprostinil
Insmed IncorporatedINSM4PHASE3Treprostinil Palmitil
Johnson & JohnsonJNJ4PHASE3Selexipag, Macitentan, selexipag
Liquidia CorporationLQDA4PHASE3L606, LIQ861 Treprostinil, LIQ861
Tenax Therapeutics, Inc.TENX3PHASE3TNX-103
Gossamer Bio, Inc.GOSS2PHASE3Seralutinib, GB002
Inhibikase Therapeutics, Inc.IKT1PHASE3IKT-001
Regeneron Pharmaceuticals, Inc.REGN1PHASE2REGN13335
Pfizer Inc.PFE2PHASE2PF-07868489
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
Abbott LaboratoriesABT1NAUndisclosed
Third Pole Therapeutics, Inc.THRD1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06274801primaryCompletionDate: changed
LOWMay 24, 2026NCT06274801studyFirstPostDate: changed