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DNL126

Phase 1

Mucopolysaccharidosis Type IIIA | Small molecule | Rare Disease |Denali Therapeutics Inc.|Last Updated: Dec 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06181136Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)PHASE1 ACTIVE NOT_RECRUITING 20Dec 7, 2023Aug 1, 2028Dec 5, 20254 United States
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Study Endpoints
Primary Endpoints
Percentage change from baseline in cerebrospinal fluid (CSF) concentration of heparan sulfate (HS)
49 weeks
Secondary Endpoints
Percentage change from baseline in urine concentration of HS (normalized to creatinine)
49 weeks
Change from baseline in liver volume
49 weeks
Percentage change from baseline in serum neurofilament light chain (NfL) concentration
73 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A1EXPERIMENTALParticipants with MPS IIIA
Cohort A2EXPERIMENTALParticipants with MPS IIIA
Cohort A3EXPERIMENTALParticipants with MPS IIIA
Cohort B1EXPERIMENTALParticipants with MPS IIIA
Cohort B2EXPERIMENTALParticipants with MPS IIIA
Interventions
NameTypeDescription
DNL126DRUGintravenous repeating dose
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Eligibility Criteria
Age Range0 Years — 18 Years
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Confirmed diagnosis of MPS IIIA * For Cohort A2: No more than 1 participant may have predictors of a slow-progressing phenotype * For Cohort A3: Approximately 2 participants will have predictors of the slow-progressing phenotype * For Cohort B1: Have a severe phenotype bas...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06181136primaryCompletionDate: changed
LOWMay 24, 2026NCT06181136studyFirstPostDate: changed