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Denali Therapeutics Inc

DNLI
Healthcare|Biotechnology|USA
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Clinical Trials (25)

TrialConditionsPhaseStatusEnrollmentDesignDrug
NCT05371613
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)
Mucopolysaccharidosis II
P2P3
Recruiting63RCT, Double-blindtividenofusp alfa, idursulfase
NCT06602193
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Parkinson Disease
P2
Active50RCT, Double-blindBIIB122 225 mg
NCT06181136
Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)
Mucopolysaccharidosis Type IIIA
P1P2
Active20Open-labelDNL126
NCT05262023
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
Frontotemporal Dementia
P1P2
Active85RCT, Double-blindDNL593, Placebo
NCT04251026
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
Mucopolysaccharidosis II
P1P2
Active47Open-labeltividenofusp alfa
NCT07328451
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
P1
Recruiting68RCT, Double-blindDNL628, Placebo
NCT07354724
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease
Late-onset Pompe Disease
P1
Recruiting32Open-labelDNL952
NCT05418673
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
Parkinson Disease
P3
Terminated7RCT, Double-blindBIIB122, BIIB122-Matching Placebo
NCT06075537
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
Mucopolysaccharidosis II
P2P3
By Invite99Open-labeltividenofusp alfa
NCT05842941
HEALEY ALS Platform Trial - Regimen G DNL343
Amyotrophic Lateral Sclerosis
P2P3
Completed249RCT, Double-blindDNL343, Matching Placebo
NCT05348785
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
Parkinson Disease
P2
Completed650RCT, Double-blindBIIB122, BIIB122-Matching Placebo
NCT04551534
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers
Healthy Volunteers
P1
Completed122RCT, Double-blindDNL201, Placebo
NCT03757325
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease
Alzheimer Disease
P1
Completed16RCT, Double-blindDNL747, Placebo
NCT05006352
A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
P1
Completed29RCT, Double-blindDNL343, Placebo
NCT05119790
A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects
Healthy Volunteers
P1
Completed7Open-label[14C] BIIB122 ([14C] DNL151)
NCT06281158
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
Healthy Volunteers
P1
Completed7Open-label[14C]-DNL343
NCT04581772
A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers
Healthy Volunteers
P1
Completed31RCT, Open-labelDNL343, Placebo, DNL343
NCT05005338
A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects
Healthy Volunteers
P1
Completed8Open-labelBIIB122 (DNL151), [14C] BIIB122 ([14C] DNL151)
NCT04268784
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers
Healthy Volunteers
P1
Completed96RCT, Double-blindDNL343, Placebo
NCT03710707
Study to Evaluate DNL201 in Subjects With Parkinson's Disease
Parkinson Disease
P1
Completed29RCT, Double-blindDNL201, Placebo
NCT05450549
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Healthy Participant
P1
Completed47RCT, Double-blindDNL919, Placebo
NCT03757351
Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
P1
Terminated15RCT, Double-blindDNL747, Placebo
NCT04557800
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers
Healthy Volunteers
P1
Completed186RCT, Double-blindDNL151, Placebo
NCT04007536
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
Mucopolysaccharidosis II
Completed18
NCT05523206
A Natural History Study of Biomarkers and Clinical Outcomes in Mucopolysaccharidosis Type IIIA (MPS IIIA; Sanfilippo Syndrome)
Mucopolysaccharidosis III-A
Completed15