Iguratimod

Iguratimod was first approved by China Food and Drug Administration (CFDA) on August 15, 2011, then approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on June 29, 2012. It was developed by Simcere and marketed as 艾得辛®/Iremod® by Simcere and as Kolbet® by Taisho Toyama and by Eisai in Japan. 

Iguratimod is a nuclear factor NF-κB activation inhibitor used in the treatment of rheumatoid arthritis.

Iremod® is available as tablet for oral use, containing 25 mg of free Iguratimod, and the recommended dose is 25 mg once daily or 25 mg at a time, twice daily.

Index：

General Information

Update Date：2016-03-28

Drug Name：
Iguratimod
Research Code：
T-614
Trade Name：
Iremod® / Kolbet® / Careram®
MOA：
Nuclear factor NF-κB activation inhibitor
Indication：
Rheumatoid arthritis
Status：
Approved
Company：
Simcere (Originator) , Taisho Toyama,Eisai
Sales：
ATC Code：
Approved Countries or Area

Update Date：2015-07-29

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2012-06-29 Marketing approval Careram Rheumatoid arthritis Tablet, Film coated 25 mg Eisai
2012-06-29 Marketing approval Kolbet Rheumatoid arthritis Tablet, Film coated 25 mg Toyama Chemical, Taisho Toyama
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Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2011-08-15 Marketing approval 艾得辛/Iremod Rheumatoid arthritis Tablet, Film coated 25 mg Simcere
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Chemical Structure

Update Date：2015-08-27

Molecular Weight 374.37
Formula C17H14N2O6S
CAS No. 123663-49-0 (Iguratimod);
Chemical Name N-[7-[(Methanesulfonyl)amino]-4-oxo-6-phenoxy-4H-1-benzopyran-3-yl]formamide
Iguratimod （Free Acid/Base）Parameters：
MW HD HA FRB* PSA* cLogP*
374.37 2 8 4 119 1.905±1.402
*：Calculated by ACD/Labs software V11.02.
Related Patents

Update Date：2015-11-17

No. Major Technical Classification Publication No. Patent No. Legal Status Filling Date Estimated Expiry Date
1 Formulation CN101564382A Refusal 2009/1/14
2 Others CN101486702A CN101486702B Granted 2009/3/4 2029/3/4
3 Composition CN103826624A Examination 2012/8/29
4 Formulation CN103211770A Examination 2013/4/11
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Synthesis & Impurities

Update Date：2015-10-16


1. US4954518.


1. Chem. Pharm. Bull. 2000, 48, 131-139.

2. Chin. J. New. Drugs. 2006, 15, 2042-2044.

3. Shanghai Chem. Ind. 2007, 32, 22-24.


1. CN1462748A.

2. Chem. Pharm. Bull. 2000, 48, 131-139.

Impurity database is being updated！