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BIIB122

Phase 2

Parkinson Disease | Small molecule | Neurology |Denali Therapeutics Inc.|Last Updated: May 27, 2026

Target and mechanism

Molecular targetLRRK2
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

BIIB122 · 1 trial · 1 indication

Phase 2 1
NCT06602193Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)Parkinson Disease
ACTIVE NOT_RECRUITING50 Analytics
PHASE2ACTIVE NOT_RECRUITING
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
12 weeks

Secondary Endpoints

Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12
12 weeks
Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIIB122 225 mgEXPERIMENTALOral 225 mg dose, once daily (QD)
BIIB122 Matching PlaceboPLACEBO_COMPARATOROral BIIB122 matching placebo, once daily (QD)

Interventions

NameTypeDescription
BIIB122 225 mgDRUGAdministered as specified in the treatment arm
BIIB122-Matching PlaceboOTHERAdministered as specified in the treatment arm
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years * For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years * Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant. * Have a clinical diagnosis of PD meeting the Mov...

Countries:United StatesGermanyIsraelSpain
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Frequently asked questions about BIIB122

What is BIIB122 used for in Parkinson Disease?

BIIB122 is an investigational small molecule being studied for the treatment of Parkinson Disease, specifically in participants with LRRK2-associated Parkinson's disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does BIIB122 target?

BIIB122 targets LRRK2, a protein kinase implicated in the pathogenesis of Parkinson's disease. By inhibiting LRRK2, the drug aims to address a genetic and biological pathway associated with the disease, though its efficacy and safety are still being evaluated in clinical trials.

Who makes BIIB122?

BIIB122 is being developed by Denali Therapeutics Inc., a biopharmaceutical company focused on neurodegenerative diseases. Denali Therapeutics is publicly traded under the ticker symbol DNLI on the NASDAQ stock exchange.

What phase is BIIB122 in?

BIIB122 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is assessing its safety and pharmacodynamic effects in participants with LRRK2-associated Parkinson's disease.

What clinical trials is BIIB122 in?

BIIB122 is being evaluated in a Phase 2 clinical trial with the identifier NCT06602193. This randomized, double-blind, placebo-controlled study is investigating the safety and pharmacodynamic effects of BIIB122 in participants with LRRK2-associated Parkinson's disease. The trial is active but not recruiting, with an enrollment of 50 participants across the United States, Germany, Israel, and Spain.