Sebelipase alfa clinical trials
Also written SBC-102 and Kanuma.
How each study uses Sebelipase 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
- 8 Dec 2015 · KANUMA · BLA 125561 (FDA, Drugs@FDA)
- European Union
- 28 Aug 2015 · Kanuma · EMEA/H/C/004004 (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 2011 (3)
| Year | Studies |
|---|---|
| 2011 | 3 |
| 2013 | 1 |
| 2014 | 2 |
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 Sebelipase 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
- Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase DeficiencyCompletedPhase 3Alexion Pharmaceuticals, Inc.NCT01757184Written as Sebelipase Alfa
- Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase DeficiencyCompletedPhase 2Alexion Pharmaceuticals, Inc.NCT02112994Written as Sebelipase Alfa
- Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase DeficiencyTerminatedPhase 2Alexion Pharmaceuticals, Inc.NCT02193867Written as Sebelipase Alfa
- Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase DeficiencyCompletedPhase 2/3Alexion Pharmaceuticals, Inc.NCT01371825Written as Sebelipase alfa (SBC-102)
- Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase DeficiencyCompletedPhase 1/2Alexion Pharmaceuticals, Inc.NCT01307098Written as Sebelipase alfa 0.35 mg/kg
- Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase DeficiencyCompletedPhase 2Alexion Pharmaceuticals, Inc.NCT01488097Written as sebelipase alfa
Codes
What other systems call Sebelipase alfa · ClinicalTrials.gg INT000362
- MeSH (NLM) C000603932Sebelipase alfaOne source NLM
- UNII (FDA) K4YTU42T8GSEBELIPASE ALFAConfirmed FDA, NLM, Wikidata
- RxNorm 1726975Confirmed FDA, Wikidata
- Wikidata Q21789862sebelipase alfaConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C152312Sebelipase AlfaOne source FDA
- DrugBank DB11563One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000603932 | Sebelipase alfa | One source NLM |
| UNII (FDA) | K4YTU42T8G | SEBELIPASE ALFA | Confirmed FDA, NLM, Wikidata |
| RxNorm | 1726975 | — | Confirmed FDA, Wikidata |
| Wikidata | Q21789862 | sebelipase alfa | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C152312 | Sebelipase Alfa | One source FDA |
| DrugBank | DB11563 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.