Drugs / Levoketoconazole
Levoketoconazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed endogenous Cushing syndrome 1 milestone | |||||
| Filed | US (FDA) | RECORLEV | endogenous Cushing syndrome | — | “with a New Drug Application that is currently under review by the FDA for the treatment of endogenous Cushing’s syndrome” xerispharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | RECORLEV | — | 2021-12-30 | fda.gov ↗ |
Trials 8
| 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 · 1 met primary | ||||||
| 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 | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-06-03 | Xeris Pharmaceuticals | Results Xeris Presents New Post Hoc Analysis on Effects of Levoketoconazole (Recorlev®) in Cushing’s Syndrome Patients at ENDO 2024 xerispharma.com ↗
In patients with Cushing’s syndrome maintained on Recorlev, a lower baseline mUFC was associated with higher cortisol normalization rate. |
| 2023-01-30 | Xeris Pharmaceuticals | Regulatory Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev® xerispharma.com ↗
today announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals, Inc. , orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative. |
| 2022-11-01 | Xeris Pharmaceuticals | Results Xeris Biopharma Announces Results of the Extended Evaluation of Recorlev® (Levoketoconazole) From the Phase 3 Sonics Study Published in the European Journal of Endocrinology xerispharma.com ↗
With a median treatment duration of 15 months, levoketoconazole was well tolerated and no new drug-related safety signals were observed. |
| 2022-05-12 | Xeris Pharmaceuticals | Results Xeris Announces Full Results From the Logics Study of Recorlev® and Presentation of New Burden of Illness in Cushing’s Syndrome Data at AACE Annual Meeting May 12-14 xerispharma.com ↗
The study, which included titration-maintenance, randomized withdrawal and restoration phases, met its previously reported primary endpoint of significantly more patients on placebo having loss of mean urinary-free cortisol (mUFC) response than those who continued on levoketoconazole at end of RW phase. |
| 2021-12-30 | Xeris Pharmaceuticals | Regulatory Xeris Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome xerispharma.com ↗
FDA approval supported by positive results from the pivotal Phase 3 SONICS and LOGICS studies demonstrating Recorlev to be a safe and effective therapeutic option in the treatment of Cushing's syndrome |
All press releases naming this drug 5 releases
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 ↗ |