Drugs / Trametinib Dimethyl Sulfoxide
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | MEKINIST | — | 2014-01-08 – 2025-03-07 | fda.gov ↗ |
| Approved | EU (EMA) | Spexotras | — | 2024-01-05 | europa.eu ↗ |
| Approved | US (FDA) | MEKINIST | — | 2013-05-29 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02224781 | Sep 2015 → Sep 2023 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | Met primary |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trametinib Dimethyl Sulfoxide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02224781 ↗ |
| Action | Inhibit | “dual BRAF/MEK inhibition” PMID 36166727 ↗ Sep 2022 |
| Route | Oral | “Given PO” NCT02224781 ↗ |