Wednesday, July 8, 2026

Drug profile · INN

mitotane

mitotane (LYSODREN) is a cytochrome p450 11b1 inhibitor. Associated with S.A.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01XX23
US status approved
Patents linked 10
Pipeline programs 1
News articles 0
Drug details — mitotane
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
10
Programs
1
Data quality
0.89

Quick answer

mitotane (LYSODREN) is a cytochrome p450 11b1 inhibitor. Associated with S.A.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN mitotane
Brand LYSODREN
Mechanism Cytochrome P450 11B1 inhibitor
Target Cholesterol side-chain cleavage enzyme, mitochondrial
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01XX23
Originator S.A.

Mechanism of action

Cytochrome P450 11B1 inhibitor

Primary target: Cholesterol side-chain cleavage enzyme, mitochondrial

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. UC-IMM-2302 Phase 2 · Ningbo Cancer Hospital · Patients with dMMR/MSI (non-colorectal/non-endometrial) loca

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 12263227

    Optimized mRNA encoding CAS9 for use in LNPs

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12227763

    Methods and compositions for treating cancer

    Expires Mon Feb 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12188060

    Messenger RNA encoding Cas9 for use in genome-editing systems

    Expires Mon Jan 02 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12016932

    Gene editing for hemophilia A with improved factor VIII expression

    Expires Mon Jun 20 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11833225

    Methods and compositions for efficient gene deletion

    Expires Mon Nov 30 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11827877

    Compositions and methods for genomic editing by insertion of donor polynucleotides

    Expires Mon Nov 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11649438

    Methods and compositions for treating cancer

    Expires Mon May 11 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11529427

    Gene editing for hemophilia A with improved factor VIII expression

    Expires Mon Dec 15 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11332760

    Compositions and methods for genomic editing by insertion of donor polynucleotides

    Expires Mon May 12 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11254912

    Methods and compositions for treating cancer

    Expires Mon Feb 17 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is mitotane?

mitotane (LYSODREN) is a cytochrome p450 11b1 inhibitor. Associated with S.A.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for mitotane?

LYSODREN is a marketed brand name for mitotane. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mitotane?

mitotane has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.