Drugs / Ferriprox
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | FERRIPROX | — | 2018-04-20 – 2021-04-30 | fda.gov ↗ |
| Approved | US (FDA) | FERRIPROX | — | 2011-10-14 | fda.gov ↗ |
| Approved | EU (EMA) | Ferriprox | — | 1999-08-25 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT01767103 | Jan 2013 → Apr 2014 | — | ApoPharma | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01835496 Comparator | May 2013 → Apr 2014 | sickle cell disease | ApoPharma | Completed | No outcome recorded |
| — | NCT01996683 Comparator | Nov 2014 → Nov 2015 | beta thalassemia | Ain Shams University | Unknown | No outcome recorded |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ferriprox | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01996683 ↗ |
| Route | Oral | “following a single oral dose of 33mg/kg Ferriprox®.” NCT01767103 ↗ |