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Rilzabrutinib dose 1

Phase 2

Graves' Disease | Small molecule | Other |Sanofi|Last Updated: May 22, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
ORPHAN_DRUGFAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06984627A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' DiseasePHASE2 RECRUITING 30Sep 2, 2025Sep 23, 2026May 22, 202613 Canada, Germany +3
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Study Endpoints
Primary Endpoints
Percent change from baseline in FT4 levels
At Week16

Free thyroxine

Secondary Endpoints
Percent change from baseline in FT3 levels
At Week16
Proportion of participants with FT4 levels within normal limits
At Week16
Proportion of participants with FT3 levels within normal limits
At Week16
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rilzabrutinib dose 1EXPERIMENTALRilzabrutinib
Rilzabrutinib dose 2EXPERIMENTALRilzabrutinib
Interventions
NameTypeDescription
Rilzabrutinib dose 1DRUGPharmaceutical form:Tablet-Route of administration:Oral
Rilzabrutinib dose 2DRUGPharmaceutical form:Tablet-Route of administration:Oral
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening. * A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at s...

Countries:CanadaGermanyItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06984627primaryCompletionDate: changed
LOWMay 24, 2026NCT06984627studyFirstPostDate: changed