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Clinical trials
catalyst calendar across sponsors →Studies where DNLI is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
18 interventional · 1 observational
Held by 11 tracked-famous managers (BAILLIE GIFFORD & CO, Holocene Advisors, LP, Artisan Partners Limited Partnership, MILLENNIUM MANAGEMENT LLC, MARSHALL WACE, LLP, +6 more) · FINRA short interest 12.1 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter SyndromeNCT04251026Incidence and severity of treatment-emergent adverse events (TEAEs)Non-randomized · Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: tividenofusp alfa | Mucopolysaccharidosis II | 47 | Feb 2031 | ≤ 1,654 d | 2025-08-07 |
| A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's DiseaseNCT07758595Part A: Incidence and severity of treatment-emergent averse events (TEAEs)Randomized · Double-masked · Treatment | Phase 1 | Not yet recruiting | Drug: DNL921, Placebo | Alzheimer's Disease, Healthy Participants | 178 | Apr 2030 | ≤ 1,350 d | 2026-08-11 |
| Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)NCT06181136Change from baseline in the natural logarithm of cerebrospinal fluid (CSF) heparan sulfate (HS) concentrationNon-randomized · Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: DNL126 | Mucopolysaccharidosis Type IIIA | 20 | Aug 2028 | ≤ 743 d | 2026-07-13 |
| A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe DiseaseNCT07354724Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: DNL952 | Late-onset Pompe Disease | 32 | Aug 2028 | ≤ 743 d | 2026-08-17 |
| 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)NCT05371613Percent change from baseline in cerebrospinal fluid (CSF) heparan sulfate (HS) concentration (Cohort A)Randomized · Double-masked · Treatment | Phase 2/3 | Recruiting | Drug: tividenofusp alfa, idursulfase | Mucopolysaccharidosis II | 63 | Dec 2027 | ≤ 499 d | 2025-08-05 |
| 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-0007NCT06075537Incidence and intensity of treatment-emergent adverse events (TEAEs)Non-randomized · Open-label · Treatment | Phase 2/3 | Enrolling by invitation | Drug: tividenofusp alfa | Mucopolysaccharidosis II | 99 | Jun 2027 | ≤ 315 d | 2026-06-11 |
| Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)NCT06602193Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind periodRandomized · Double-masked · Treatment | Phase 2 | Active, not recruiting | Drug: BIIB122 225 mg · Other: BIIB122-Matching Placebo | Parkinson Disease | 50 | Mar 2027 | ≤ 224 d | 2026-05-27 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's DiseaseNCT07328451Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind periodRandomized · Double-masked · Treatment | Phase 1 | Recruiting | Drug: DNL628, Placebo | Alzheimer Disease, Early Onset | 68 | Feb 2027 | ≤ 193 d | 2026-07-01 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)NCT05262023Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)Randomized · Double-masked · Treatment | Phase 1/2 | Active, not recruiting | Drug: DNL593, Placebo | Frontotemporal Dementia | 85 | Dec 2026 | ≤ 134 d | 2026-01-15 |
| A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male ParticipantsNCT06281158PK Parameter: AUC0-∞Open-label · Treatment | Phase 1 | Completed | Drug: [14C]-DNL343 | Healthy Volunteers | 7 | 2024-04-30actual | — | 2024-06-20 |
| A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter SyndromeNCT04007536observationalChanges in adaptive behavior over time as measured by Vineland Adaptive Behavior Scales, Second Edition (VABS II) and/or Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | — | Completed | Other: No Intervention | Mucopolysaccharidosis II | 18 | 2024-03-01actual | — | 2024-06-10 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy ParticipantsNCT05450549Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL919, Placebo | Healthy Participant | 47 | 2023-06-08actual | — | 2023-08-16 |
| A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral SclerosisNCT05006352Incidence of treatment-emergent adverse events (TEAEs) throughout the double-blind periodRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL343, Placebo | Amyotrophic Lateral Sclerosis | 29 | 2022-12-15actual | — | 2024-09-19 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy VolunteersNCT04268784Incidence and severity of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL343, Placebo | Healthy Volunteers | 96 | 2021-08-03actual | — | 2022-02-07 |
| A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy VolunteersNCT04581772PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasmaRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: DNL343, Placebo, DNL343 | Healthy Volunteers | 31 | 2021-06-04actual | — | 2021-06-11 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy VolunteersNCT04557800Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL151, Placebo | Healthy Volunteers | 186 | 2021-02-19actual | — | 2022-03-07 |
| Study to Evaluate DNL201 in Subjects With Parkinson's DiseaseNCT03710707Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL201, Placebo | Parkinson Disease | 29 | 2019-12-06actual | — | 2020-01-13 |
| Study to Evaluate DNL747 in Subjects With Alzheimer's DiseaseNCT03757325Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL747, Placebo | Alzheimer Disease | 16 | 2019-12-05actual | — | 2020-02-26 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy VolunteersNCT04551534Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL201, Placebo | Healthy Volunteers | 122 | 2018-08-08actual | — | 2020-09-16 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19