LYSODREN (mitotane)
LYSODREN is indicated for the treatment of Adrenocortical Carcinoma.
How LYSODREN Works
Mitotane is an adrenal cytotoxic agent with a mechanism of action that is not fully understood. It directly suppresses the adrenal cortex and modifies the peripheral metabolism of steroids. This results in a reduction of 17-hydroxycorticosteroids—notably in the absence of decreased plasma corticosteroid levels—and an increased formation of 6-β-hydroxycortisol.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1970-07-08
- Routes
- ORAL
- Dosage Forms
- TABLET
LYSODREN Approval History
What LYSODREN Treats
1 indicationsLYSODREN is approved for 1 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Carcinoma
LYSODREN Boxed Warning
ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant i...
WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See full prescribing information for complete boxed warning. Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs ( 2.3 , 5.1 ).
What's emerging in LYSODREN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LYSODREN treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03583710 | 2017-0948 NCI-2018-01101, 2017-0948 | Ph 3 | recruiting | Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence |
| NCT05634577 results posted | 2022-0705 NCI-2022-10009 | Ph 2 | terminated | A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma |
| NCT06831175 | 2024-1549 | Ph 2 | recruiting | Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma |
| NCT02057237 results posted | MITO222 | Ph 1 | completed | A Safety and Feasibility Study of Mitotane in Prostate Cancer |
| NCT00778817 results posted | NCI-2009-00291 NCI-2009-00291, UCCRC-16402A | Ph 2 | terminated | IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYSODREN FDA Label Details
Indications & Usage
FDA Label (PDF)LYSODREN is indicated for the treatment of Adrenocortical Carcinoma.
WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporar...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment