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Denali Therapeutics (DNLI)
NASDAQ:DNLI
Dnl628
Alzheimer Disease, Early Onset
Phase I
Not Yet Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Dec 24, 2025
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Dnl126
Mucopolysaccharidosis Type Iiia
Phase I/II
Active Not Recruiting
Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)
Dec 04, 2023
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Idursulfase, Tividenofusp Alfa
Mucopolysaccharidosis Ii
Phase II/III
Recruiting
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)
May 09, 2022
Biib122
Parkinson Disease
Phase II
Active Not Recruiting
A 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 80
Apr 04, 2022
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Tividenofusp Alfa
Mucopolysaccharidosis Ii
Phase I/II
Active Not Recruiting
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
Jan 28, 2020
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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
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
DNLI is currently developing the following drugs: Dnl628, Biib122 225 Mg, Dnl126. These drug candidates are in various stages of clinical development as the company works toward FDA approval.