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DNTH103

Phase 2

Myasthenia Gravis, Generalized | Small molecule | Neurology |Dianthus Therapeutics, Inc.|Last Updated: Jun 8, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06282159A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)PHASE2 ACTIVE NOT_RECRUITING 65Feb 23, 2024Oct 1, 2028Jun 8, 202656 United States, Argentina +12
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Baseline (Day 1) to Week 13

Number of participants with TEAEs and treatment-emergent SAEs will be reported.

Secondary Endpoints
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
Baseline (Day 1) to Week 13
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score
Baseline (Day 1) to Week 13
Change from Baseline to Week 13 in Myasthenia Gravis Composite (MGC) Scale Score
Baseline (Day 1) to Week 13
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Claseprubart 300 mg Q2WEXPERIMENTAL -
Claseprubart 600 mg Q2WEXPERIMENTAL -
Interventions
NameTypeDescription
ClaseprubartDRUGDay 1: IV loading dose Week 1 to Week 11: Claseprubart administered SC every 2 weeks
PlaceboDRUGDay 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out. 2. Adult males and females, 18 to 75 years of age (inclusive) at Screening. 3. Weight range between 40-120 kg at Screening. 4. Diagnosis of gMG by the following tests: Acetylchol...

Countries:United StatesArgentinaCanadaCzechiaDenmarkFranceIsraelItalyNetherlandsNorth MacedoniaNorwayPolandSerbiaSweden
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Recent Changes (Last 90 Days)
MEDIUMJun 8, 2026NCT06282159Completion: 2027-08 → 2028-10
MEDIUMJun 8, 2026NCT06282159Completion: 2027-08 → 2028-10
MEDIUMJun 8, 2026NCT06282159Completion: 2027-08 → 2028-10
LOWMay 26, 2026NCT06282159primaryCompletionDate: changed
LOWMay 24, 2026NCT06282159studyFirstPostDate: changed