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Efzofitimod /kg

Phase 3

Pulmonary Sarcoidosis | Small molecule | Other |aTyr Pharma, Inc.|Last Updated: Jun 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_CONTROLLEDDMC
Total Trials1
Total Enrollment268
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05415137Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary SarcoidosisPHASE3 COMPLETED 268Sep 15, 2022Jul 14, 2025Jun 4, 202691 United States, Brazil +7
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Study Endpoints
Primary Endpoints
Change from baseline in mean daily oral corticosteroid (OCS) dose at Week 48
Baseline to Week 48
Secondary Endpoints
Change from baseline in KSQ-Lung score at Week 48
Baseline to Week 48
Steroid withdrawal rate
Baseline to Week 48
Change from baseline in absolute value of FVC at Week 48
Baseline to Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Efzofitimod 3 mg/kgEXPERIMENTAL -
Efzofitimod 5 mg/kgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Efzofitimod 3 mg/kgDRUGEfzofitimod IV infusion every 4 weeks for a total of 12 doses
Efzofitimod 5 mg/kgDRUGEfzofitimod IV infusion every 4 weeks for a total of 12 doses
PlaceboDRUGPlacebo IV infusion every 4 weeks for a total of 12 doses
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites91

Inclusion Criteria: * Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence * Evid...

Countries:United StatesBrazilFranceGermanyItalyJapanNetherlandsSpainUnited Kingdom
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Recent Changes (Last 90 Days)
HIGHJun 4, 2026NCT05415137Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 4, 2026NCT05415137Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 4, 2026NCT05415137Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 4, 2026NCT05415137Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 26, 2026NCT05415137primaryCompletionDate: changed
LOWMay 24, 2026NCT05415137studyFirstPostDate: changed