Drugs / Methylthioninium
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Methylthioninium chloride Proveblue | — | 2011-05-06 | europa.eu ↗ |
Trials 1 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03379389 | Mar 2018 → May 2019 | urinary tract infection | Fundação Educacional Serra dos Órgãos | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01642511 Background | Jan 2012 → Nov 2014 | breast cancer | Shandong Cancer Hospital and Institute | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01668914 Background | Feb 2014 → Sep 2017 | breast cancer | Shandong Cancer Hospital and Institute | Completed | 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 | Methylthioninium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03379389 ↗ |
| Route | Subcutaneous | “injected subcutaneously above the primary tumor or around the biopsy cavity” NCT01642511 ↗ |