cipaglucosidase alfa
cipaglucosidase alfa: sourced relationships with 1 company · 4 clinical trials tracked · 1 FDA decision.
cipaglucosidase alfa evidence translation
What we can confirm
1 FDA record · 4 tracked trials
What it means
What to watch
Prepared research question
How could cipaglucosidase alfa → FOLD affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (3)
| Company | Dated record stage |
|---|---|
| AMICUS THERAPEUTICS, INC. (FOLD) Reported 2023-09-28 · Current development: unknownSource | Approved |
| AMICUS THERAPEUTICS, INC. (FOLD) Reported 2023-09-28 · Current development: unknownSource | Approved |
| AMICUS THERAPEUTICS, INC. (FOLD) Reported 2023-09-28 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (4)
A Global Prospective Observational Registry of Patients With Pompe Disease
Primary endpoint: Evaluate long-term safety of Pompe disease treatments
An Open-label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Cipaglucosidase Alfa/Miglustat in Both ERT-experienced and ERT-naïve Pediatric Subjects With Infantile-onset Pompe Disease Aged 0 to < 18 Years
Primary endpoint: Proportion of subjects with infusion-associated reactions (IARs)
An Open-label Study of the Safety, Pharmacokinetics, Efficacy, Pharmacodynamics, and Immunogenicity of Cipaglucosidase Alfa/Miglustat in Pediatric Subjects Aged 0 to < 18 Years With Late-onset Pompe Disease
Primary endpoint: Incidence of treatment-emergent adverse events (TEAEs) from baseline
A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo
Primary endpoint: Change From Baseline to Week 52 in 6 Minute Walk Distance (6MWD)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with cipaglucosidase alfa?
cipaglucosidase alfa has dated SEC/FDA relationship records for AMICUS THERAPEUTICS, INC..
How many clinical trials involve cipaglucosidase alfa?
BioSniper tracks 4 clinical trials involving cipaglucosidase alfa.
What is cipaglucosidase alfa's latest FDA decision?
The most recent tracked FDA decision for cipaglucosidase alfa is Approval for 1 INDICATIONS AND USAGE POMBILITI is indicated, in combination with Opfolda, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). POMBILITI is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-g, dated September 28, 2023.