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ALN-SNCA

Phase 1

Parkinsons Disease | Small molecule | Neurology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

ALN-SNCA · 1 trial · 1 indication

Phase 1 1
NCT07216066First-in-Human Study of ALN-SNCA in Adult Participants With Early Parkinson's Disease (PD)Parkinsons Disease
RECRUITING46 Analytics
PHASE1RECRUITING
First-in-Human Study of ALN-SNCA in Adult Participants With Early Parkinson's Disease (PD)
Parkinsons Disease
NCT0721606646
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Study Endpoints

Primary Endpoints

Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Through Week 80
Severity of TEAEs
Through Week 80

Secondary Endpoints

Concentration of alpha (a)-synuclein protein in CSF
Through Week 48
Change from baseline in concentration of a-synuclein protein in CSF
Through Week 48
Concentration of ALN-SNCA in plasma
Through Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-SNCA Dose EscalationEXPERIMENTAL -
Matching PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALN-SNCADRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: 1. Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) criteria, as assessed by the investigator, with bradykinesia plus at least one of the other cardinal signs of Parkinson's disease (resting tremor, rigidity), without any other known or suspe...

Countries:CanadaNetherlands
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT07216066primaryCompletionDate: changed
LOWMay 24, 2026NCT07216066studyFirstPostDate: changed

Frequently asked questions about ALN-SNCA

What is ALN-SNCA used for in Parkinson's Disease?

ALN-SNCA is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development, with an ongoing first-in-human study in adult participants with early Parkinson's Disease. The drug is being studied as a potential therapy for this neurological condition.

Who makes ALN-SNCA?

ALN-SNCA is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is currently conducting clinical trials to evaluate the safety and efficacy of ALN-SNCA in patients with early Parkinson's Disease.

What phase is ALN-SNCA in?

ALN-SNCA is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is a first-in-human study designed to evaluate the drug in adult participants with early Parkinson's Disease.

What clinical trials is ALN-SNCA in?

ALN-SNCA is being studied in a Phase 1 clinical trial with the identifier NCT07216066. This first-in-human study is recruiting 46 adult participants with early Parkinson's Disease at sites in Canada and the Netherlands. The trial is randomized, double-blind, and placebo-controlled, with participants aged 50 years and older.

Is ALN-SNCA FDA approved?

ALN-SNCA is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Parkinson's Disease. The drug is being evaluated in a first-in-human study to assess its safety, tolerability, and potential efficacy in patients with early Parkinson's Disease.