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Denali Therapeutics (DNLI) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Dnl921Healthy Participants, Alzheimer's DiseasePhase IRecruitingA Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's DiseaseAug 06, 2026―
Dnl952Late-Onset Pompe DiseasePhase IRecruitingA Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe DiseaseJan 12, 2026
Dnl628Alzheimer Disease, Early OnsetPhase IRecruitingA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's DiseaseDec 24, 2025
Biib122 225 MgParkinson DiseasePhase IIActive Not RecruitingSafety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)Sep 16, 2024
Dnl126Mucopolysaccharidosis Type Iiiaphase1AndPhase2Active Not RecruitingStudy of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)Dec 04, 2023―
Tividenofusp AlfaMucopolysaccharidosis Iiphase2AndPhase3Enrolling By InvitationAn 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-0007Sep 18, 2023
Idursulfase, Tividenofusp AlfaMucopolysaccharidosis Iiphase2AndPhase3RecruitingA 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)May 09, 2022
Biib122Parkinson DiseasePhase IICompletedA 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 80Apr 04, 2022
Dnl593Frontotemporal Dementiaphase1AndPhase2Active Not RecruitingA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)Feb 01, 2022
Tividenofusp AlfaMucopolysaccharidosis Iiphase1AndPhase2Active Not RecruitingA Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter SyndromeJan 28, 2020―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Denali Therapeutics (DNLI) have in its pipeline
Denali Therapeutics DNLI is currently developing the following drugs: Dnl921, Dnl952, Dnl628, Biib122 225 Mg, Dnl126, Tividenofusp Alfa, Idursulfase, Tividenofusp Alfa, Biib122, Dnl593. These drug candidates are in various stages of clinical development as the company works toward FDA approval.