Recent Updates
Recently added Catalysts

BIIB122

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06602193Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)PHASE2 ACTIVE NOT_RECRUITING 50Oct 24, 2024Feb 28, 2028May 27, 202620 United States, Germany +2
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMMay 28, 2026NCT06602193Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 28, 2026NCT06602193Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06602193primaryCompletionDate: changed
LOWMay 24, 2026NCT06602193studyFirstPostDate: changed