123663-49-0,Iguratimod,The latest news,ANQING CHICO PHARMACEUTICAL CO., LTD.
Abstract:
Iguratimod, identified by CAS number 123663-49-0. is a disease-modifying antirheumatic drug (DMARD) developed primarily for the treatment of rheumatoid arthritis (RA). With its unique mechanism of action involving the inhibition of nuclear factor kappa B (NF-κB) activation, Iguratimod offers an alternative therapeutic approach for RA patients.
Keywords:
Iguratimod, CAS 123663-49-0. T-614. DMARD, rheumatoid arthritis, NF-κB inhibitor, market analysis,
Introduction:
Rheumatoid arthritis is a chronic autoimmune disorder characterized by inflammation of the joints, leading to pain and potential joint destruction. Traditional treatments have included nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, but the need for disease-modifying therapies has led to the development of DMARDs. Iguratimod, a novel DMARD, has shown promise in managing RA symptoms and slowing disease progression.
Chemical Name: N-(3-Formamido-4-oxo-6-phenoxy-4H-chromen-7-yl)methanesulfonamide
Synonyms: T-614
CAS Number: 123663-49-0
Molecular Formula: C17H14N2O6S
Molecular Weight: 374.37 g/mol
1. Original Research and Development
Iguratimod (code name T-614)(CRM01T) was originally developed by Toyama Chemical of Japan (later acquired by Fuji Film) as a new drug for the treatment of rheumatoid arthritis (RA) and osteoarthritis (OA). It was first submitted for marketing application in Japan in 2003. KOLBET 2.5mg Tablets(Iratimod Tablets コルベット tablets) was approved for marketing in August 2012 and research and marketing efforts were carried out in collaboration with Eisai Japan. In China, Elamud Tablets were first developed by Tianjin Institute of Pharmaceutical Research and Simcere Pharmaceutical in 2003. In 2004. it obtained the clinical approval from CDE. In January 2008. Simcere Pharmaceutical completed the clinical research and submitted the NDA to the National Medical Products Administration. In August 2011. it was approved for marketing under the trade name Aidexin. Approved for the treatment of active rheumatoid arthritis.
3. Market Presence and Global Sales (Estimates)
| Year | Estimated Global Sales (USD) |
|---|---|
| 2020 | $200 million |
| 2021 | $220 million |
| 2022 | $250 million |
| 2023 | $280 million |
| 2024 | $310 million |
Iguratimod’s sales growth is primarily driven by its strong performance in the Chinese and Japanese markets, where it is widely adopted as a cost-effective and well-tolerated oral DMARD. Though it remains a niche product globally due to limited approvals, its increasing inclusion in combination therapies has enhanced uptake in Asia.
4. Mechanism of Action
Iguratimod acts by:
Suppressing NF-κB activation, a key regulator of immune responses.
Reducing IL-6. TNF-α, and immunoglobulin production.
Inhibiting osteoclast differentiation, thus preventing bone erosion.
This mechanism differentiates it from methotrexate, leflunomide, and biologics targeting TNF or IL-6 directly.
5. Competitive Landscape
Despite being unique, Iguratimod faces strong competition from:
Traditional DMARDs: Methotrexate, sulfasalazine.
Biologics: Etanercept, adalimumab, tocilizumab.
JAK inhibitors: Tofacitinib, baricitinib.
Its advantages include oral administration, cost-effectiveness, and safety profile—particularly in long-term use among elderly patients.
Disadvantages include limited geographic approval and lack of large-scale international Phase III trials, which hinder its adoption in Western markets.
6. Generics and IP Status
Patent Status (Japan): Basic patents expired in 2022. allowing local generic manufacturing to commence.
China: Multiple local generics already on the market since 2023 under various local manufacturers.
No known filings or marketing authorizations in the EU or US, likely due to strategic focus and clinical trial limitations.
7. Research Developments & News
2022–2024: Studies in China explored Iguratimod as adjunct therapy with methotrexate and biologics, showing improved efficacy in RA control and B-cell inhibition.
2023: Investigated for potential off-label use in systemic lupus erythematosus (SLE) and IgG4-related diseases.
2024: A multi-center trial in Asia initiated to evaluate Iguratimod’s efficacy in interstitial lung disease (ILD) associated with RA.
Conclusion
Iguratimod has established itself as a valuable treatment option for rheumatoid arthritis in Asia, particularly Japan and China. Despite lacking regulatory approval in Western countries, its novel mechanism, favorable safety profile, and cost-effectiveness have carved out a significant regional market. Future growth depends on expanded indications, international clinical trials, and entry into new markets through generics or partnerships.
Active Pharmaceutical Ingredient
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