Overview
A derivative of the insecticide dichlorodiphenyldichloroethane that specifically inhibits cells of the adrenal cortex and their production of hormones. It is used to treat adrenocortical tumors and causes CNS damage, but no bone marrow depression.
Background
A derivative of the insecticide dichlorodiphenyldichloroethane that specifically inhibits cells of the adrenal cortex and their production of hormones. It is used to treat adrenocortical tumors and causes CNS damage, but no bone marrow depression.
Indication
For treatment of inoperable adrenocortical tumours; Cushing's syndrome
Associated Conditions
- Cushing's Syndrome
- Inoperable Adrenocortical carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/17 | Phase 2 | Recruiting | |||
2022/12/02 | Phase 2 | Terminated | |||
2022/04/25 | N/A | Completed | King's College Hospital NHS Trust | ||
2018/07/11 | Phase 3 | Recruiting | |||
2014/02/07 | Phase 1 | Completed | |||
2008/10/23 | Phase 2 | Terminated | |||
2008/10/22 | Phase 3 | UNKNOWN | University of Turin, Italy | ||
2006/03/17 | Phase 3 | Completed | |||
2004/10/20 | Phase 3 | Completed | Collaborative Group for Adrenocortical Carcinoma Treatment |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| HRA Pharma Rare Diseases | 76336-080 | ORAL | 500 mg in 1 1 | 1/19/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/28/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mitotane Tablets | 国药准字HJ20230105 | 化学药品 | 片剂 | 9/5/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||