Pipeline — registered trials by phase
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
— · Mucopolysaccharidosis II · Completed · est. 2024-03-01
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease
— · Alzheimer's Disease, Healthy Participants · Recruiting · est. 2030-04
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 · Completed · est. 2024-04-30
Study to Evaluate DNL201 in Subjects With Parkinson's Disease
— · Parkinson Disease · Completed · est. 2019-12-06
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers
— · Healthy Volunteers · Completed · est. 2021-08-03
A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers
— · Healthy Volunteers · Completed · est. 2021-06-04
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers
— · Healthy Volunteers · Completed · est. 2018-08-08
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease
— · Alzheimer Disease · Completed · est. 2019-12-05
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers
— · Healthy Volunteers · Completed · est. 2021-02-19
A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis
— · Amyotrophic Lateral Sclerosis · Completed · est. 2022-12-15
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
— · Healthy Participant · Completed · est. 2023-06-08
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease
— · Late-onset Pompe Disease · Recruiting · est. 2028-08
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
— · Alzheimer Disease, Early Onset · Recruiting · est. 2027-02
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
— · Mucopolysaccharidosis II · Active Not Recruiting · est. 2031-02
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
— · Parkinson Disease · Active Not Recruiting · est. 2027-03
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
— · Frontotemporal Dementia · Active Not Recruiting · est. 2026-12
Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)
— · Mucopolysaccharidosis Type IIIA · Active Not Recruiting · est. 2028-08
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 · Active Not Recruiting · est. 2027-12
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 · Enrolling By Invitation · est. 2027-06
No approved products listed under this sponsor in Drugs@FDA (partnered or subsidiary products may be listed elsewhere).
Source: ClinicalTrials.gov (trials where Denali is lead sponsor; 19 active or completed) and Drugs@FDA (0 approved products). Registry data can include older or partnered programs; the company's own pipeline page is the official list.
SEC filings — insider trading forms excluded
- 10-Q2026-08-06Quarterly report
- 8-K2026-08-06Current report (material event)
- SCHEDULE 13G/A2026-08-04SCHEDULE 13G/A
- 8-K2026-07-28Current report (material event)
- SCHEDULE 13G/A2026-07-08SCHEDULE 13G/A
- 8-K2026-06-18Current report (material event)
- 8-K2026-06-04Current report (material event)
- 8-K2026-05-22Current report (material event)
- SCHEDULE 13G2026-05-15SCHEDULE 13G
- 10-Q2026-05-07Quarterly report
- 8-K2026-05-07Current report (material event)
- SCHEDULE 13G/A2026-05-06SCHEDULE 13G/A
- DEFA14A2026-04-21DEFA14A
- ARS2026-04-21Annual report to holders
- DEF 14A2026-04-21Proxy statement
- 8-K2026-04-03Current report (material event)
- 8-K2026-03-31Current report (material event)
- SCHEDULE 13G/A2026-03-26SCHEDULE 13G/A
- 8-K2026-03-25Current report (material event)
- 10-K2026-02-26Annual report
- S-82026-02-26Employee stock plan
- 8-K2026-02-26Current report (material event)
- 8-K2026-01-06Current report (material event)
- 8-K2025-12-10Current report (material event)
- 424B52025-12-10Prospectus (offering)
- 424B52025-12-09Prospectus (offering)
- 8-K2025-12-04Current report (material event)
- 8-K2025-12-04Current report (material event)
- 10-Q2025-11-06Quarterly report
- 8-K2025-11-06Current report (material event)
- SCHEDULE 13G/A2025-11-05SCHEDULE 13G/A
- 8-K2025-10-14Current report (material event)
- SCHEDULE 13G/A2025-08-12SCHEDULE 13G/A
- 10-Q2025-08-11Quarterly report
- 8-K2025-08-11Current report (material event)
- 8-K2025-07-07Current report (material event)
- 8-K2025-06-03Current report (material event)
- 10-Q2025-05-06Quarterly report
- 8-K2025-05-06Current report (material event)
- ARS2025-04-17Annual report to holders
Source: SEC EDGAR. Forms 3/4/5 and 144 (insider transactions) are intentionally left out.