Drugs / Ilofotase Alfa
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT05890794 | May → Jul 2023 | hypophosphatasia | AM-Pharma | Completed | Met primary |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT06168799 | Dec 2023 → Oct 2025 | — | AM-Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02182440 | Dec 2014 → May 2017 | acute kidney injury | AM-Pharma | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-03-09 | Pfizer | Results AM‐Pharma announces Phase II study results of recAP in sepsis‐associated Acute Kidney Injury pfizer.com ↗
AM‐Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury (AKI), the largest therapeutic study in AKI to date. |
| 2016-05-10 | Pfizer | Results AM‐Pharma publishes safety and pharmacokinetic data from Phase I recAP trial pfizer.com ↗
Using data from this Phase I trial and pharmacokinetic (PK) modelling, the optimal dosing regimen for the ongoing STOP‐AKI, adaptive Phase II study was predicted to consist of 1 hour infusions of 250, 500 and 1,000 U/kg recAP, once daily, for three consecutive days. |
| 2016-04-26 | Pfizer | Regulatory AM‐Pharma receives FDA fast track designation for recAP in Acute Kidney Injury, and reports completion of first stage in Phase II trial pfizer.com ↗
AM‐Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory diseases, announces that it has received fast track designation from the U.S. Food and Drug Administration (FDA) for recAP to treat Acute Kidney Injury (AKI). |
All press releases naming this drug 3 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ilofotase Alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05890794 ↗ |
| Known as | recAP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02182440 ↗ |
| Action | Restore | “a therapy designed to replace the missing AP and restore enzyme activity” PMID 41378916 ↗ Mar 2026 |
| Modality | Protein / enzyme biologic | “A human recombinant AP (recAP) was developed” PMID 27678541 ↗ Sep 2016 |
| Route | Intravenous | “1 hour IV infusion once daily for 3 days” NCT02182440 ↗ |