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ANPD001

Phase 1

Parkinson Disease | Biologics | Neurology |Aspen Neuroscience, Inc.|Trials Updated: May 14, 2026

ANPD001 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

ANPD001 clinical trials

ANPD001 · 1 trial · 1 indication

Phase 1 1
NCT06344026Phase 1/2a Study of ANPD001 in Parkinson DiseaseParkinson Disease
ENROLLING BY_INVITATION9 Analytics
PHASE1ENROLLING BY_INVITATION
Phase 1/2a Study of ANPD001 in Parkinson Disease
Parkinson Disease
NCT063440269
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Study Endpoints

Primary Endpoints

Incidence and severity of treatment emergent adverse events (Safety and Tolerability)
1 year (primary follow up)

incidence and severity of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

Secondary Endpoints

"ON" time without troublesome dyskinesia
1 year (primary follow up) and 5 years (long term follow up)
Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV)
1 year (primary follow up) and 5 years (long term follow up)
Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state
1 year (primary follow up) and 5 years (long term follow up)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ANPD001EXPERIMENTAL -

Interventions

NameTypeDescription
ANPD001BIOLOGICALBiologic: ANPD001 is an experimental product derived from the patient's own skin cells converted to induced pluripotent stem cells. The stem cells were differentiated into precursors for brain cells that produce dopamine.
Custom DeviceDEVICEA custom device to facilitate slow injection of small volumes of investigational drugs (including cell therapies), under MRI guidance
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Age 40-75 years of age at time of consent in the trial-ready cohort study ANPD001-01 * Met all eligibility requirements for inclusion in the trial-ready cohort in clinical study ANPD001-01 * Diagnosed with Parkinson Disease at least 4 years ago * Unequivocal motor response to ...

Countries:United States
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Competitive Landscape -Parkinson's Disease 90 trials (matched to "Parkinson Disease")

Top 16 of 24 competitors

CompanyTickerTrialsLead PhaseDrugs
Biohaven Ltd.BHVN1PHASE3BHV-8000
Eli Lilly and CompanyLLY4PHASE2LY3884961, LY4006896, LY3962681
Supernus Pharmaceuticals, Inc.SUPN2PHASE3Onapgo (SPN-830)
Annovis Bio IncANVS1PHASE3Buntanetap
Prothena Corp. PlcPRTA3PHASE3Prasinezumab
Denali Therapeutics Inc.DNLI1PHASE2BIIB122
BayerBAYRY4PHASE3bemdaneprocel, AB-1005
AC Immune SAACIU2PHASE2ACI-7104.056
Gain Therapeutics, Inc.GANX2PHASE2GT-02287
MeiraGTx Holdings PlcMGTX1PHASE2AAV-GAD
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
Hoffmann-La RocheRHHBY1PHASE2RO7568282
Serina Therapeutics, Inc.SER1PHASE1SER-252
Ardelyx, Inc.ARDX1PHASE2Tenapanor
Aspen NeuroscienceASPE1PHASE1ANPD001
Merck & Co., Inc.MRK1EARLY_PHASE1MK-0947
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