Denali Therapeutics Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-08-07: Study NCT07758595; Company role Lead sponsor; Phase Phase 1; Status Recruiting.
- 2026-05-12: Study NCT07354724; Company role Lead sponsor; Phase Phase 1; Status Recruiting.
- 2026-01-30: Study NCT07328451; Company role Lead sponsor; Phase Phase 1; Status Recruiting.
- 2024-10-24: Study NCT06602193; Company role Lead sponsor; Phase Phase 2; Status Active not recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-08-07 | NCT07758595 A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease | Lead sponsor | Phase 1 | Recruiting | Alzheimer's Disease; Healthy Participants | 178 | 2030-04 |
| 2026-05-12 | NCT07354724 A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease | Lead sponsor | Phase 1 | Recruiting | Late-onset Pompe Disease | 32 | 2028-08 |
| 2026-01-30 | NCT07328451 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease | Lead sponsor | Phase 1 | Recruiting | Alzheimer Disease, Early Onset | 68 | 2027-02 |
| 2024-10-24 | NCT06602193 Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) | Lead sponsor | Phase 2 | Active not recruiting | Parkinson Disease | 50 | 2028-02-28 |
| 2024-03-01 | 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 | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 7 | 2024-04-30 |
| 2023-12-07 | NCT06181136 Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A) | Lead sponsor | Phase 1, Phase 2 | Active not recruiting | Mucopolysaccharidosis Type IIIA | 20 | 2028-08 |
| 2023-09-20 | 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 | Lead sponsor | Phase 2, Phase 3 | Enrolling by invitation | Mucopolysaccharidosis II | 99 | 2027-06 |
| 2023-05-24 | NCT05842941 HEALEY ALS Platform Trial - Regimen G DNL343 | Collaborator Lead: Merit E. Cudkowicz, MD | Phase 2, Phase 3 | Completed Results posted | Amyotrophic Lateral Sclerosis | 249 | 2024-10-29 |
| 2022-09-27 | NCT05523206 A Natural History Study of Biomarkers and Clinical Outcomes in Mucopolysaccharidosis Type IIIA (MPS IIIA; Sanfilippo Syndrome) | Collaborator Lead: Sanguine Biosciences | Observational | Completed | Mucopolysaccharidosis III-A | 15 | 2025-01-28 |
| 2022-08-26 | 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 | Collaborator Lead: Biogen | Phase 3 | Terminated Results posted | Parkinson Disease | 7 | 2023-07-27 |
| 2022-07-21 | 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) | Lead sponsor | Phase 2, Phase 3 | Active not recruiting | Mucopolysaccharidosis II | 65 | 2027-12 |
| 2022-07-14 | NCT05450549 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants | Lead sponsor | Phase 1 | Completed | Healthy Participant | 47 | 2023-06-08 |
| 2022-04-19 | 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 | Collaborator Lead: Biogen | Phase 2 | Completed | Parkinson Disease | 650 | 2026-03-09 |
| 2022-02-01 | NCT05262023 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) | Lead sponsor | Phase 1, Phase 2 | Active not recruiting | Frontotemporal Dementia | 85 | 2028-11 |
| 2021-08-27 | NCT05119790 A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects | Collaborator Lead: Biogen | Phase 1 | Completed | Healthy Volunteers | 7 | 2021-11-05 |
| 2021-08-11 | NCT05006352 A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis | Lead sponsor | Phase 1 | Completed | Amyotrophic Lateral Sclerosis | 29 | 2024-06-05 |
| 2021-07-28 | NCT05005338 A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects | Collaborator Lead: Biogen | Phase 1 | Completed | Healthy Volunteers | 8 | 2021-09-23 |
| 2020-12-23 | NCT04581772 A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 31 | 2021-06-04 |
| 2020-07-16 | NCT04251026 A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome | Lead sponsor | Phase 1, Phase 2 | Active not recruiting | Mucopolysaccharidosis II | 47 | 2031-02 |
| 2020-02-20 | NCT04268784 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 96 | 2021-08-03 |
| 2019-10-23 | NCT04007536 A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome | Lead sponsor | Observational | Completed | Mucopolysaccharidosis II | 18 | 2024-03-01 |
| 2019-02-13 | NCT03757325 Study to Evaluate DNL747 in Subjects With Alzheimer's Disease | Lead sponsor | Phase 1 | Completed | Alzheimer Disease | 16 | 2019-12-05 |
| 2018-12-14 | NCT03757351 Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis | Collaborator Lead: Sanofi | Phase 1 | Terminated | Amyotrophic Lateral Sclerosis | 15 | 2020-06-18 |
| 2018-12-04 | NCT03710707 Study to Evaluate DNL201 in Subjects With Parkinson's Disease | Lead sponsor | Phase 1 | Completed | Parkinson Disease | 29 | 2019-12-06 |
| 2017-11-16 | NCT04557800 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 186 | 2021-02-19 |
| 2017-06-01 | NCT04551534 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 122 | 2018-08-08 |
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