# Mitotane

Source: https://onco.cc/drugs/mitotane/  
OnCo record `mitotane` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A relative of the insecticide DDT that is the only drug specific to adrenal cortex cancer; it needs blood-level monitoring and permanent steroid replacement.

## Summary

Approved 1970. Adjuvant use for high-risk resected ACC (Terzolo 2007; ADIUVO 2023 negative for low risk), monotherapy for indolent advanced disease, and combined with EDP chemotherapy (FIRM-ACT). Therapeutic range 14-20 mg/L; toxicities include neurologic effects, GI intolerance, adrenal insufficiency (hydrocortisone replacement at higher doses), CYP3A4 induction affecting other drugs.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Lysodren
- Modality: Adrenolytic agent (DDD derivative)
- Mechanism: Metabolised in adrenocortical cells to an acyl chloride that binds mitochondrial proteins and inhibits steroidogenesis (SOAT1 inhibition causes ER stress); cytotoxic to adrenocortical tissue.
- Approvals: US 1970: Inoperable adrenocortical carcinoma (functional and non-functional); EU 2004: Advanced adrenocortical carcinoma

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Mitotane
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=mitotane

## Connected records

- cancers: [Adrenocortical carcinoma](https://onco.cc/cancers/adrenocortical/), [Advanced and metastatic adrenocortical carcinoma (ENSAT stage IV or unresectable)](https://onco.cc/cancers/advanced-adrenocortical-carcinoma/), [Localised adrenocortical carcinoma (ENSAT stage I to III, resectable)](https://onco.cc/cancers/localised-adrenocortical-carcinoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- key papers: [ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma](https://onco.cc/key-papers/paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023/), [European Society of Endocrinology and ENSAT clinical practice guidelines on the management of adrenocortical carcinoma in adults](https://onco.cc/key-papers/paper-ese-ensat-adrenocortical-carcinoma-guideline-eur-j-endocrinol-2018/), [FIRM-ACT: combination chemotherapy in advanced adrenocortical carcinoma](https://onco.cc/key-papers/paper-firm-act-edp-mitotane-adrenocortical-carcinoma-nejm-2012/)
- terms: [Adrenalectomy](https://onco.cc/terms/adrenalectomy/)
- trials: [ADIUVO](https://onco.cc/trials/adiuvo/), [ADIUVO-2](https://onco.cc/trials/adiuvo-2/)

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JSON: https://onco.cc/api/v1/entities/mitotane.json