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NEU-411

Phase 2

Parkinson Disease | Small molecule | Neurology |Qiagen N.V.|Last Updated: Apr 24, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

NEU-411 · 1 trial · 5 indications

Phase 2 1
NCT06680830A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's DiseaseParkinson Disease
RECRUITING150 Analytics
PHASE2RECRUITING
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo
From enrollment to the end of treatment at 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
From enrollment to the end of study at 54 weeks

Secondary Endpoints

Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NEU-411EXPERIMENTALOrally-administered NEU-411
PlaceboPLACEBO_COMPARATOROrally-administered matching placebo

Interventions

NameTypeDescription
NEU-411DRUGNEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
PlaceboOTHEROrally-administered matched placebo
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites70

Inclusion Criteria: 1. Aged 40-80 years at time of screening, inclusive 2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD) 3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx) 4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5 Exclusi...

Countries:United StatesIsraelItalyPolandSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT06680830studyFirstPostDate: changed

Frequently asked questions about NEU-411

What is NEU-411 used for?

NEU-411 is an investigational small molecule being developed for the treatment of early Parkinson's disease. It is currently being studied in a Phase 2 clinical trial in patients who test positive for a companion diagnostic biomarker. The drug is administered as an oral therapy.

Who is developing NEU-411?

NEU-411 is being developed by Qiagen N.V., a company traded on the stock exchange under the ticker QGEN. Qiagen is conducting a Phase 2 clinical trial of NEU-411 in patients with early Parkinson's disease.

What phase is NEU-411 in?

NEU-411 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 study is recruiting participants with early Parkinson's disease who are positive for a companion diagnostic biomarker.

What clinical trials is NEU-411 in?

NEU-411 is being evaluated in a Phase 2 study with the identifier NCT06680830. This trial is a randomized, double-blind, placebo-controlled study that includes an open-label extension. It is recruiting 150 participants with early Parkinson's disease across the United States, Israel, Italy, Poland, Spain, and the United Kingdom.

Is NEU-411 being tested in a biomarker-selected population?

Yes, NEU-411 is being studied in a biomarker-selected population. The Phase 2 trial enrolls participants who test positive for a companion diagnostic, meaning the study is designed to evaluate the drug specifically in patients identified by this biomarker. This approach aims to target the therapy to a defined patient subgroup.

What is the design of the NEU-411 Phase 2 trial?

The NEU-411 Phase 2 trial, NCT06680830, is a randomized, double-blind, placebo-controlled study with an open-label extension. It enrolls 150 participants aged 40 years and older with early Parkinson's disease. The trial is actively recruiting and is being conducted in multiple countries including the United States, Israel, and several European nations.