Company profile

Denali Therapeutics Inc.

NASDAQ:DNLIBiotechnology: Biological Products (No Diagnostic Substances)

Drug pipeline (1)

AssetStageRevenueTrialsStatus
DNL-201phase1—2no 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 IDPhaseStatusStartCompletionSponsor nameTitle
NCT06281158phase1completed2024-03-012024-04-30Denali 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
NCT04251026phase1_2active_not_recruiting2020-07-162031-02-01Denali Therapeutics Inc.A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
NCT05371613phase2_3recruiting2022-07-212027-12-01Denali 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)
NCT05006352phase1completed2021-08-112022-12-15Denali Therapeutics Inc.A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis
NCT04581772phase1completed2020-12-232021-06-04Denali Therapeutics Inc.A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

FDA applications (1)

ApplicationTypeApplicantProducts
BLA 761485BLADenali Therapeutics Inc.