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ATH434

Phase 2

Multiple System Atrophy | Small molecule | Neurology |Alterity Therapeutics Limited|Last Updated: Jul 28, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment15
FDA Designations
ORPHAN_DRUGFAST_TRACK
Clinical trial landscape

ATH434 · 2 trials · 1 indication

Phase 2 2
NCT07729852Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in FranceMultiple System Atrophy
NOT YET_RECRUITING5 Analytics
NCT05864365A Biomarker Study of ATH434 in Participants With MSAMultiple System Atrophy
COMPLETED10 Analytics
PHASE2NOT YET_RECRUITING
Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France
Multiple System Atrophy
NCT077298525
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PHASE2COMPLETED
A Biomarker Study of ATH434 in Participants With MSA
Multiple System Atrophy
NCT0586436510
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Study Endpoints
Primary Endpoints
Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline to completion of study treatment, an average of 1 year.

All AEs will be reviewed at every participant contact and documented in the CRF. All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.

Change From Baseline in Clinical Laboratory Parameters
Baseline to completion of study treatment, an average of 1 year.

Clinical laboratory parameters include hematology and blood chemistry panels.

Change From Baseline in Vital Signs
Baseline to completion of study treatment, an average of 1 year.

Vital signs include blood pressure, pulse, temperature, and respiration rate.

Duration of Exposure to ATH434
Baseline to completion of study treatment, an average of 1 year.

Total duration of treatment with investigational product per participant.

Cumulative Dose of ATH434
Baseline to completion of study treatment, an average of 1 year.

Total cumulative dose of investigational product administered per participant.

Change in brain volume as measured by MRI
Change from Baseline to Week 52
Secondary Endpoints
Change in iron content in substantia nigra as measured by MRI
Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score
Change from Baseline to Week 52
Change in Patient Global Impression of Change (PGI-C)
Change from Baseline to Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATH434 75mg BIDEXPERIMENTALParticipants who completed the prior ATH434-201 Phase 2 trial will receive ATH434 75 mg orally twice daily (BID). Treatment consists of an initial 12-month treatment phase, followed by an ongoing extension phase based on investigator assessment of continued clinical benefit, safety, and tolerability
ATH434EXPERIMENTAL -
Interventions
NameTypeDescription
ATH434DRUGATH434 75 mg tablets administered orally twice daily (BID).
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Eligibility Criteria
Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Completed Alterity protocol ATH434-201. * Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator. Exclusion Criteria: * Discontinued prior ATH434 treatment (ATH434-201) for any reason. * Significant medical or psychiatric condition ...

Countries:FranceUnited States
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Recent Changes (Last 90 Days)
LOWJul 28, 2026NCT07729852NEW_TRIAL: changed
LOWJul 28, 2026NCT07729852NEW_TRIAL: changed