Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 45/100

Failure Rate

8.0%

2 terminated/withdrawn out of 25 trials

Success Rate

87.5%

+1.0% vs industry average

Late-Stage Pipeline

4%

1 trials in Phase 3/4

Results Transparency

14%

2 of 14 completed trials have results

Key Signals

3 recruiting2 with results

Enrollment Performance

Analytics

Phase 1
17(73.9%)
Phase 2
5(21.7%)
Phase 3
1(4.3%)
23Total
Phase 1(17)
Phase 2(5)
Phase 3(1)

Activity Timeline

Global Presence

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Clinical Trials (25)

Showing 20 of 25 trials
NCT06075537Phase 2Enrolling By Invitation

An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

Role: lead

NCT07328451Phase 1Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Role: lead

NCT06602193Phase 2Recruiting

Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Role: lead

NCT05842941Phase 2Completed

HEALEY ALS Platform Trial - Regimen G DNL343

Role: collaborator

NCT07354724Phase 1Not Yet Recruiting

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease

Role: lead

NCT05262023Phase 1Active Not Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

Role: lead

NCT06181136Phase 1Active Not Recruiting

Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)

Role: lead

NCT05348785Phase 2Active Not Recruiting

A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80

Role: collaborator

NCT03757351Phase 1Terminated

Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis

Role: collaborator

NCT04251026Phase 1Active Not Recruiting

A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

Role: lead

NCT05371613Phase 2Recruiting

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Role: lead

NCT05523206Completed

A Natural History Study of Biomarkers and Clinical Outcomes in Mucopolysaccharidosis Type IIIA (MPS IIIA; Sanfilippo Syndrome)

Role: collaborator

NCT05006352Phase 1Completed

A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

Role: lead

NCT05418673Phase 3Terminated

A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale

Role: collaborator

NCT06281158Phase 1Completed

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

Role: lead

NCT04007536Completed

A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome

Role: lead

NCT05450549Phase 1Completed

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

Role: lead

NCT04557800Phase 1Completed

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

Role: lead

NCT04268784Phase 1Completed

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers

Role: lead

NCT05119790Phase 1Completed

A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects

Role: collaborator