Company profile
Denali Therapeutics Inc.
NASDAQ:DNLIBiotechnology: Biological Products (No Diagnostic Substances)
Drug pipeline (1)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| DNL-201 | phase1 | — | 2 | no active trials |
Revenue is the latest reported period from SEC filings. A combination product's amount appears on each of its constituent assets, so those rows are not additive.
Clinical trials (18)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT06281158 | phase1 | completed | 2024-03-01 | 2024-04-30 | Denali Therapeutics Inc. | A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants |
| NCT04251026 | phase1_2 | active_not_recruiting | 2020-07-16 | 2031-02-01 | Denali Therapeutics Inc. | A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome |
| NCT05371613 | phase2_3 | recruiting | 2022-07-21 | 2027-12-01 | Denali Therapeutics Inc. | 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) |
| NCT05006352 | phase1 | completed | 2021-08-11 | 2022-12-15 | Denali Therapeutics Inc. | A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis |
| NCT04581772 | phase1 | completed | 2020-12-23 | 2021-06-04 | Denali Therapeutics Inc. | A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers |
FDA applications (1)
| Application | Type | Applicant | Products | |||
|---|---|---|---|---|---|---|
| BLA 761485 | BLA | Denali Therapeutics Inc. | ||||
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