Olipudase alfa clinical trials
Also written GZ402665.
How each study uses olipudase alfa is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 31 Aug 2022 · XENPOZYME · BLA 761261 (FDA, Drugs@FDA)
- European Union
- 24 Jun 2022 · Xenpozyme · EMEA/H/C/004850 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
6 studies that test it; most in 2013 (2)
| Year | Studies |
|---|---|
| 2006 | 1 |
| 2013 | 2 |
| 2015 | 2 |
| 2021 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 6 · Other 0
Studies
Open first, then newest update. How each study uses olipudase alfa is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 6
- A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in FranceCompletedPhase 2SanofiNCT06949358Written as Olipudase alfa
- Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase DeficiencyCompletedPhase 2/3Genzyme, a Sanofi CompanyNCT02004691Written as Olipudase alfa
- A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase DeficiencyCompletedPhase 2Genzyme, a Sanofi CompanyNCT02004704Written as GZ402665
- Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase DeficiencyCompletedPhase 1/2Genzyme, a Sanofi CompanyNCT02292654Written as Olipudase alfa
- Tolerability and Safety Study of Recombinant Human Acid Sphingomyelinase in Acid Sphingomyelinase Deficiency PatientsCompletedPhase 1Genzyme, a Sanofi CompanyNCT01722526Written as Recombinant human acid sphingomyelinase
- Safety Study of rhASM Enzyme Replacement Therapy in Adults With Acid Sphingomyelinase Deficiency (Niemann-Pick Disease)TerminatedPhase 1Genzyme, a Sanofi CompanyNCT00410566Written as rhASM
Codes
What other systems call olipudase alfa · ClinicalTrials.gg INT000488
- MeSH (NLM) C000608782olipudase alfaOne source ClinicalTrials.gov
- UNII (FDA) 6D5766Q4OPOLIPUDASE ALFAOne source FDA
- RxNorm 2610407One source FDA
- NCI Thesaurus C166929Olipudase AlfaOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000608782 | olipudase alfa | One source ClinicalTrials.gov |
| UNII (FDA) | 6D5766Q4OP | OLIPUDASE ALFA | One source FDA |
| RxNorm | 2610407 | — | One source FDA |
| NCI Thesaurus | C166929 | Olipudase Alfa | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.