Drugs / Levoketoconazole
Levoketoconazole
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | RECORLEV | — | 2021-12-30 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04212000 | Dec 2019 → Jan 2020 | — | Cortendo AB | Completed | No outcome recorded |
| Phase 1 | NCT03880825 | Mar → May 2019 | — | Cortendo AB | Completed | No outcome recorded |
| Phase 1 | NCT03768388 | Nov → Dec 2018 | — | Cortendo AB | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00494663 | Jul 2007 → Mar 2008 | type 2 diabetes mellitus | DiObex | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00622089 | Jan → Dec 2008 | type 2 diabetes mellitus | DiObex | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03621280 | Jan 2019 → Dec 2022 | endogenous Cushing syndrome | Cortendo AB | Completed | No outcome recorded |
| Phase 3 | NCT03277690 | Sep 2017 → Jun 2020 | endogenous Cushing syndrome | Cortendo AB | Completed | No outcome recorded |
| Phase 3 | NCT01838551 | Aug 2014 → Apr 2018 | endogenous Cushing syndrome | Cortendo AB | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Levoketoconazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03880825 ↗ |
| Known as | 2S,4R-ketoconazole | “An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome” NCT03621280 ↗ |
| Known as | DIO-902 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00494663 ↗ |
| Route | Oral | “The study drug is a tablet and will be taken by mouth with water.” NCT00494663 ↗ |