Tividenofusp alfa
- Generic Name
- Tividenofusp alfa
- Drug Type
- Biotech
- CAS Number
- 2641020-57-5
- Unique Ingredient Identifier
- QLD7UJN8CF
- Background
Tividenofusp alfa, also known as DNL-310, is a brain-penetrant enzyme replacement therapy being investigated for the treatment of Hunter syndrome.
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
- First Posted Date
- 2023-10-10
- Last Posted Date
- 2025-04-13
- Lead Sponsor
- Denali Therapeutics Inc.
- Target Recruit Count
- 99
- Registration Number
- NCT06075537
- Locations
- 🇪🇸
Hospit U. Vall d'Hebron - PPDS, Barcelona, Spain
🇨🇦McGill University Health Center, Montréal, Canada
🇺🇸UNC Children's Research Institute, Chapel Hill, North Carolina, United States
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)
- Conditions
- Mucopolysaccharidosis II
- Interventions
- First Posted Date
- 2022-05-12
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- Denali Therapeutics Inc.
- Target Recruit Count
- 54
- Registration Number
- NCT05371613
- Locations
- 🇬🇧
Royal Free Hospital, London, United Kingdom
🇹🇷Cukurova University Medical Faculty Balcali Hospital, Adana, Turkey
🇪🇸Hospital Infantil Universitario Niño Jesus, Madrid, Spain
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
- First Posted Date
- 2020-01-31
- Last Posted Date
- 2024-04-26
- Lead Sponsor
- Denali Therapeutics Inc.
- Target Recruit Count
- 47
- Registration Number
- NCT04251026
- Locations
- 🇳🇱
Erasmus Medical Center, Rotterdam, South Holland, Netherlands
🇺🇸UNC Children's Research Institute, Chapel Hill, North Carolina, United States
🇺🇸UCSF Benioff Children's Hospital, Oakland, California, United States
Drug Development Updates
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