Drug

Mitotane

Established medicine

ClassCytochrome P450 11B1 inhibitorResearchOngoing clinical research

Also known as Lysodren, o,p'-DDD, op'DDD - mitotane, Mitotan+3 more

Lysodren, o,p'-DDD, op'DDD - mitotane, Mitotan, Mitotano, 1,1-dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl) ethane, Mitotanum.

RxNorm7004 ChEMBLCHEMBL1670 ATCL01XX23UNII78E4J5IB5J

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized Registry Trial of Adjuvant Mitotane vs. Mitotane With Cisplatin/Etoposide After Primary Surgical Resection of Localized Adrenocortical Carcinoma With High Risk of Recurrence (ADIUVO-2 Trial)

Clinical trial2026-04-07Results expected Q1 2029 · ClinicalTrials.gov

Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma

Clinical trial2025-06-03Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma

Clinical trial2024-07-10Terminated · ClinicalTrials.gov

Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study

Clinical trial2024-02-28Results posted · ClinicalTrials.gov

Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence

Clinical trial2018-12-01Primary completion · ClinicalTrials.gov

First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment

Clinical trial2016-09-21Results posted · ClinicalTrials.gov

A Safety and Feasibility Study of Mitotane in Prostate Cancer

Clinical trial2015-12-17Results posted · ClinicalTrials.gov

Multi-Institutional Phase II Study of IMC-A12, a Recombinant Human IgG1 Monoclonal Antibody Directed at the Type I Insulin-Like Growth Factor Receptor IGF1R, in Adrenocortical Carcinoma: IMC-A12 With Mitotane vs Mitotane Alone

Clinical trial2014-03-01Terminated · ClinicalTrials.gov

Approval: Lysodren (EMA)

Regulatory2004-04-28EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Mitotane

Aliases & brands

Lysodreno,p'-DDDop'DDD - mitotaneMitotanMitotano1,1-dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl) ethaneMitotanum

RxNorm CUI

7004

ChEMBL ID

CHEMBL1670

ATC codes

L01XX23

UNII

78E4J5IB5J

Primary mechanism

Cytochrome P450 11B1 inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Cytochrome P450 11B1, mitochondrial

CYP11B1 · P15538

INHIBITORCytochrome P450 11B1 inhibitor

Cholesterol side-chain cleavage enzyme, mitochondrial

CYP11A1 · P05108

INHIBITORCytochrome P450 11A1 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2004-04-28

Latest approval

2004-04-28

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2004-04-28Approval

Approval: Lysodren (EMA)

Indication: Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not… Show full indication

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.