Product Description
Levoketoconazole, an orally administered ketoconazole stereoisomer, is in clinical trials for the treatment of CS. Cushing’s syndrome (CS) is associated with numerous comorbidities, including diabetes mellitus (DM) (Sourced from: https://www.frontiersin.org/articles/10.3389/fendo.2021.595894/full)
Mechanisms of Action: GR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Cushing Syndrome *
Approval Status: Approved
Approved Countries: United States
Approved Indications: Cushing Syndrome
Known Adverse Events: Hypertension | Abdominal Pain | Back Pain | Headache | Pain Unspecified | Insomnia | Erythema | Arthritis | Myalgia | Hypokalemia | Uterine Hemorrhage | Dyspepsia | Edema | Injuries/wounds Unspecified
Company: Xeris Biopharma Holdings
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, Spain, United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: ACTH-Secreting Pituitary Adenoma|Cushing Syndrome|Pituitary ACTH Hypersecretion
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2017-004647-20 | P3 |
Completed |
Cushing Syndrome |
2023-01-09 |
|
| OPTICS | P3 |
Completed |
Cushing Syndrome|ACTH-Secreting Pituitary Adenoma|Pituitary ACTH Hypersecretion |
2022-12-31 |
55% |