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Mitotane

Generic Name
Mitotane
Brand Names
Lysodren
Drug Type
Small Molecule
Chemical Formula
C14H10Cl4
CAS Number
53-19-0
Unique Ingredient Identifier
78E4J5IB5J

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.

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
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LYSODREN
00463221
Tablet - Oral
500 MG
12/31/1979

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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