asfotase alfa
Trade name: strensiq
Recombinant proteinapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Oct 23, 2015
Asfotase alfa, sold under the brand name Strensiq, is a medication used in the treatment of people with perinatal/infantile- and juvenile-onset hypophosphatasia. — Wikipedia
Clinical trial activity
21 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
15
Phase 3
5
Phase 4
2
Earliest trial started Sep 1, 2004 (NCT00430859)
Timeline
Indications
Approved for
Mechanism of action
- PyrophosphateHYDROLYTIC ENZYME
Pyrophosphate hydrolytic enzyme
First-in-class enzyme replacement therapy of TNSALP in case of hypophosphatasia (HPP)
- Alkaline phosphataseSupplementation
Alkaline phosphatase supplementation
Approval history
- approvedFast trackBreakthroughOct 23, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- WikipediaAsfotase alfa ↗
- NCATSZ633861EIM ↗
- ChEMBLCHEMBL2108311 ↗
Also known as
- alkaline phosphatase
- alkaline phosphatase
- alkaline phosphatase
- alxn1215
- alxn1215
- alxn-1215
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alfa
- asfotase alpha
- asfotase alpha
- asfotase alpha
- asfotase alpha
- asfotase alpha
- enb-0040
- enb-0040
- enb-0040
- enb-0040
- strensiq
- strensiq
- strensiq
- strensiq
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06079359 | Phase 3 | Jan 1, 2024 | Alexion |
| NCT06079372 | Phase 3 | Dec 9, 2023 | Alexion |
| NCT06079281 | Phase 3 | Dec 4, 2023 | Alexion |
| NCT04980248 | Phase 1 | Jul 22, 2021 | Alexion |
| NCT04411472 | Phase 3 | Oct 15, 2020 | AM-Pharma |
| NCT04189315 | Phase 4 | Dec 31, 2019 | Alexion |
| NCT02797821 | Phase 2 | Jun 1, 2016 | Alexion |
| NCT02496689 | N/A | Jul 8, 2015 | Alexion |
| NCT02531867 | Phase 4 | Jun 1, 2015 | Alexion |
| NCT02182440 | Phase 2 | Dec 18, 2014 | AM-Pharma, PPD, Radboud University |
| NCT02456038 | Phase 2 | Aug 1, 2014 | Osaka University, Translational Research Informatics Center, Kobe, Hyogo, Japan |
| NCT01176266 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2010 | Alexion |
| NCT01163149 | Phase 2 | Jun 1, 2010 | Alexion |
| NCT01203826 | Phase 2 | Apr 1, 2010 | Alexion |
| NCT00952484 | Phase 2 | Sep 1, 2009 | Alexion |
| NCT00894075 | Phase 2 | Jul 1, 2009 | Alexion, Shriners Hospitals for Children |
| NCT01205152 | Phase 2 | Apr 1, 2009 | Alexion |
| NCT00744042 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2008 | Alexion |
| NCT00739505 | Phase 1 | Aug 1, 2008 | Alexion |
| NCT00457613 | Phase 2 | Nov 1, 2004 | Radboud University |
Showing 20 of 21 trials
Page 1 / 2
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alexion | For profit | 16 | 16 | 5 | 2008 |
| AM-Pharma | For profit | 3 | 3 | 2 | 2004 |
| Radboud University | Academic/Hospital | 3 | 1 | 1 | 2004 |
| Osaka University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| PPD | For profit | 1 | 0 | 1 | 2014 |
| Shriners Hospitals for Children | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Translational Research Informatics Center, Kobe, Hyogo, Japan | Academic/Hospital | 1 | 1 | 1 | 2014 |
7 organizations
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