Drugs / Darunavir-ritonavir
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | PREZISTA | — | 2008-10-21 – 2019-03-21 | fda.gov ↗ |
| Approved | EU (EMA) | Prezista | — | 2007-02-11 | europa.eu ↗ |
| Approved | US (FDA) | PREZISTA | — | 2006-06-23 | fda.gov ↗ |
Trials 1 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01231685 | Dec 2011 → Mar 2016 | HIV infectious disease, fibrotic liver disease, hepatitis C virus infection | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02486133 Background | Jul 2015 → May 2018 | HIV infectious disease | Technical University of Munich | Completed | No outcome recorded |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darunavir-ritonavir | “Darunavir-ritonavir” NCT01231685 ↗ |
| Known as | Prezista | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02486133 ↗ |