MedPath

Diacerein

Generic Name
Diacerein
Drug Type
Small Molecule
Chemical Formula
C19H12O8
CAS Number
13739-02-1
Unique Ingredient Identifier
4HU6J11EL5

Overview

Diacerein is a prodrug which is metabolized to rhein. It is currently approved in France for the treatment of osteoarthritis although the use of diacerein is restricted due to the side effects including severe diarrhea . Diacerein is under investigation for the treatment of Insulin Resistance, Diabetes Mellitus (Type 2), and Diabetes-Related Complications.

Background

Diacerein is a prodrug which is metabolized to rhein. It is currently approved in France for the treatment of osteoarthritis although the use of diacerein is restricted due to the side effects including severe diarrhea . Diacerein is under investigation for the treatment of Insulin Resistance, Diabetes Mellitus (Type 2), and Diabetes-Related Complications.

Indication

For the treatment of osteoarthritis affecting the hip or knee .

Associated Conditions

  • Osteoarthritis in the Hip Joint
  • Osteoarthritis of the Knee

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/04
Phase 2
Completed
2024/03/13
Phase 1
Not yet recruiting
International Bio service
2022/02/07
Phase 2
UNKNOWN
University of Campinas, Brazil
2020/04/17
N/A
Completed
2018/03/22
Phase 1
Completed
Castle Creek Pharmaceuticals, LLC
2018/03/22
Phase 1
Completed
Castle Creek Pharmaceuticals, LLC
2018/03/21
Phase 1
Completed
Castle Creek Pharmaceuticals, LLC
2018/03/21
Phase 1
Completed
Castle Creek Pharmaceuticals, LLC
2018/03/21
Phase 1
Completed
Castle Creek Pharmaceuticals, LLC
2018/01/19
Phase 4
UNKNOWN
Whan-Seok Choi

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

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
Diacerein Capsules
国药准字H20244889
化学药品
胶囊剂
9/10/2024
Diacerein Capsules
国药准字H20243806
化学药品
胶囊剂
5/28/2024
Diacerein Capsules
国药准字H20233671
化学药品
胶囊剂
6/7/2023
Diacerein Capsules
国药准字HJ20150131
化学药品
胶囊剂
10/12/2020
Diacerein Capsules
国药准字HJ20150130
化学药品
胶囊剂
10/12/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ARTRODAR CAP 50MG
N/A
N/A
N/A
12/31/2007

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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