Drugs / asfotase alfa
asfotase alfa
also known as
ENB-0040 · ALXN-1215 · Asfotasa alfa · Asfotase Alfa was formerly referred to as ENB-0040 · Strensiq
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | STRENSIQ | — | 2020-06-12 | fda.gov ↗ |
| Approved | US (FDA) | STRENSIQ | — | 2015-10-23 | fda.gov ↗ |
| Approved | EU (EMA) | Strensiq | — | 2015-08-28 | europa.eu ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00739505 | Aug 2008 → Jan 2009 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT00744042 | Sep 2008 → May 2010 | infantile hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 26 trials · 3 met primary | ||||||
| Phase 2 | NCT02797821 | Jun 2016 → Jun 2017 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT02456038 | Aug 2014 → Jul 2015 | hypophosphatasia | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 2 | NCT01163149 | Jun 2010 → Jun 2016 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | Mixed |
| Phase 2 | NCT01203826 | Apr 2010 → Jun 2016 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT00894075 | Jul 2009 → Dec 2014 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01205152 | Apr 2009 → Aug 2016 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01176266 | Jul 2010 → Sep 2016 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06079372 | Apr 2024 → Jul 2025 overdue | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04189315 | Apr 2020 → Aug 2022 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02531867 | Jun → Nov 2015 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02496689 | — | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00952484 Comparator | Sep 2009 → Jul 2010 | childhood hypophosphatasia | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asfotase Alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02531867 ↗ |
| Known as | ALXN-1215 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108311 ↗ |
| Known as | Asfotasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108311 ↗ |
| Known as | Asfotase Alfa was formerly referred to as ENB-0040 | “Asfotase Alfa was formerly referred to as ENB-0040” NCT00744042 ↗ |
| Known as | ENB-0040 | “Asfotase Alfa was formerly referred to as ENB-0040” NCT00952484 ↗3“Asfotase alfa was formerly referred to as ENB-0040” NCT00739505 ↗ “Asfotase alfa was formerly referred to as ENB-0040” NCT01163149 ↗ |
| Known as | Strensiq | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108311 ↗ |
| Action | Restore | “Asfotase alfa is an enzyme replacement therapy” PMID 32417537 ↗ May 2020 |
| Modality | Protein / enzyme biologic | “Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa” NCT00739505 ↗ |
| Route | Intravenous | “IV infusion of Asfotase Alfa” NCT00739505 ↗ |