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Aritinercept

Phase 1

Myasthenia Gravis, Generalized | Small molecule | Neurology |Aurinia Pharmaceuticals 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_CONTROLLEDDMC
Total Trials1
Total Enrollment81
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07596901Study of Aritinercept in Patients With Generalized Myasthenia GravisPHASE1 RECRUITING 81Apr 22, 2026Mar 2, 2029May 19, 20263 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Baseline to study completion, up to 73 weeks
Secondary Endpoints
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score
Baseline to 16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AritinerceptEXPERIMENTALDouble-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
PlaceboPLACEBO_COMPARATORDouble-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Interventions
NameTypeDescription
AritinerceptDRUGFor subcutaneous injection
PlaceboOTHERFor subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: * Adult patients (18-85 years old) * Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG * Additional inclusion criteria are defined in the protocol Key Exclusion Criteria: * Current or medical history of malignancy within the last 5 years * Pregnant, breastfeed...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07596901primaryCompletionDate: changed
LOWMay 24, 2026NCT07596901studyFirstPostDate: changed
LOWMay 21, 2026NCT07596901NEW_TRIAL: changed
LOWMay 21, 2026NCT07596901NEW_TRIAL: changed