Drugs / Iguratimod
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06244628 | Jan 2024 → Jun 2027 expected | chronic graft versus host disease | Xuzhou Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03023592 | Feb 2017 → Feb 2018 | Sjogren syndrome | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07057778 | Jul 2025 → Dec 2026 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05302024 | Mar 2022 → Dec 2023 | thrombocytopenia due to immune destruction | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05281068 | Sep 2021 → Sep 2023 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04830644 | Mar 2021 → Apr 2022 | Sjogren syndrome | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT02936375 | Sep 2017 → Nov 2020 | lupus nephritis | RenJi Hospital | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00965757 | Jul 2009 → Sep 2011 | rheumatoid arthritis | Eisai Inc. | Completed | No outcome recorded |
| Phase 411 trials · 1 missed | ||||||
| Phase 4 | NCT06945666 | Aug 2025 → Jan 2027 expected | rheumatoid arthritis | Jie Chang | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04981145 | Jan 2022 → Dec 2024 overdue | Sjogren syndrome | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Missed primary |
| Phase 4 | NCT05626348 | Dec 2021 → Jun 2025 overdue | rheumatoid arthritis | Qilu Hospital of Shandong University | Recruiting | No outcome recorded |
| Phase 4 | NCT06146972 | Jun 2021 → Mar 2024 | rheumatoid arthritis | Yanfeng Hou | Unknown | No outcome recorded |
| Phase 4 | NCT04928066 | Mar 2020 → Jun 2023 | rheumatoid arthritis | Qilu Hospital of Shandong University | Completed | No outcome recorded |
| Phase 4 | NCT03368274 | Sep 2017 → Jun 2018 | immunoglobulin G4-related sclerosing disease | Wen Zhang | Unknown | No outcome recorded |
| Phase 4 | NCT03855007 | Jan 2016 → Sep 2023 | rheumatoid arthritis | Qilu Hospital of Shandong University | Completed | No outcome recorded |
| Phase 4 | NCT02275299 | Sep 2013 → Feb 2016 | rheumatoid arthritis | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT01893151 | Jul 2012 → Dec 2015 | rheumatoid arthritis | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT01554917 | May 2012 → Aug 2015 | rheumatoid arthritis | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01548001 | May 2012 → Nov 2016 | rheumatoid arthritis | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | Mixed |
| Phase not applicable4 trials | ||||||
| — | NCT05789030 | Jul 2022 → Apr 2026 overdue | autoimmune disease | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| — | NCT04515706 | Jan 2021 → Jan 2023 | diffuse cutaneous systemic sclerosis | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT03054545 | May 2017 → May 2018 | lupus nephritis | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT02839941 | Aug 2016 → Jul 2019 | — | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2/3 | NCT05216757 Comparator | Mar 2022 → Dec 2024 | osteoarthritis, hand | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03660059 Background | Sep 2018 → Apr 2021 | rheumatoid arthritis | Astellas Pharma Inc | Completed | Met primary |
| Phase 4 | NCT05803135 Comparator | Mar 2023 → Jan 2025 | rheumatoid arthritis | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| — | NCT07115641 Background | Aug 2025 → May 2026 overdue | rheumatoid arthritis | Wangjing Hospital, China Academy of Chinese Medical Sciences | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-06-08 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Seven Iremod® Study Results Announced at EULAR to Explore Novel Therapies for Rheumatoid Arthritis simcere.com ↗
Simcere Pharmaceutical has recently announced seven study results regarding its Class 1 innovative drug Iremod ® (Iguratimod Tablets) at the European Congress of Rheumatology (EULAR Annual Meeting), including results from the study investigating the novel combination therapies of Iremod ® in rheumatoid arthritis (RA), and a basic study targeting hundreds of millions of patients with osteoarthritis (OA). |
| 2021-06-24 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Iremod ® (Iguratimod Tablets) Press Conference on Phase IV Clinical Study Results Held in Beijing simcere.com ↗
Results from the study showed that 71.9% of patients who received Iguratimod treatment reached primary efficacy endpoint -- ACR20 at 24 weeks, while the secondary endpoints of ACR50 and ACR70 response at 24 weeks were 47.4% and 24.0%, respectively. |
| 2021-06-10 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Simcere Unveils Latest Clinical Data of Iguratimod and Abatacept at EULAR Iguratimod (IGU) alone demonstrated superior efficacy compared to Methotrexate (MTX) (POS0664) IGU-based monotherapy and combined therapies are tolerant and effective for treating undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) (pos0647) simcere.com ↗
IGU monotherapy and IGU+MTX were found to be superior to MTX at week 52 with a higher ACR20 response of 77.44%(230/297, P=0.0019) and 77.05%(235/305, P=0.0028) versus 65.87%(193/293). |
| 2015-12-01 | Eisai Inc. | Regulatory EISAI AND TOYAMA CHEMICAL CLEAR ALL-CASE SURVEILLANCE CONDITION FOR APPROVAL OF ANTIRHEUMATIC AGENT IGURATIMOD (BRAND NAMES: CARERAM® TABLETS 25 MG/KOLBET® TABLETS 25 MG) eisai.com ↗
Based on the safety and efficacy data submitted, the MHLW lifted this condition for approval after determining that there are no issues that require new measures to ensure proper use of the product. |
| 2012-06-29 | Eisai Inc. | Regulatory Eisai and Toyama Chemical Receive Approval to Market Anti-rheumatic Agent Iguratimod in Japan eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) and Toyama Chemical Co., Ltd. (Headquarters: Tokyo, President: Masuji Sugata, “Toyama Chemical”) announced today that they have received approval from Japan’s Ministry of Health, Labour and Welfare to market iguratimod (generic name; development code: T-614) for the treatment of rheumatoid arthritis. |
| 2011-08-31 | Eisai Inc. | Regulatory Toyama Chemical and Eisai Submit Marketing Authorization Application for Anti-Rheumatic Agent T-614 eisai.com ↗ |
| 2009-03-24 | Eisai Inc. | Regulatory Toyama Chemical and Eisai Decide to Conduct Additional Study for Anti-Rheumatic Drug T-614 eisai.com ↗ |
All press releases naming this drug 9 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Iguratimod | “hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod.” NCT03660059 ↗25“Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.” NCT03368274 ↗ |
| Known as | Careram | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107455 ↗ |
| Known as | IGU | “This multicentre randomised controlled trial aimed to compare the efficacy and safety of iguratimod (IGU) and hydroxychloroquine (HCQ) in patients with active primary Sjögren's...” PMID 41423293 ↗ Dec 20253“Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan.” PMID 39056160 ↗ Jul 2024 “Iguratimod (IGU) is a new small molecular, anti-rheumatic drug and has shown the potential for drug repurposing from rheumatoid arthritis (RA) to LN treatment.” PMID 34380536 ↗ Aug 2021 “Iguratimod (IGU) is a new disease-modifying anti-rheumatic drug (DMARD) with a low price” PMID 34327344 ↗ Mar 2021 |
| Known as | Kolbet | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107455 ↗ |
| Known as | T614 | “then take Iguratimod (T614), 25mg, Bid orally for three months.” NCT03368274 ↗ |
| Action | Inhibit | “Macrophage migration inhibitory factor inhibitor” CHEMBL2107455 ↗3“E3 ubiquitin ligase TRAF3IP2 inhibitor” CHEMBL2107455 ↗ “osteoclastogenesis inhibition” NCT05216757 ↗ “Cyclooxygenase-2 inhibitor” CHEMBL2107455 ↗ |
| Modality | Small molecule | “Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD)” PMID 39056160 ↗ Jul 2024 |
| Route | Oral | “25 mg/tablet, taken orally” NCT01548001 ↗ |
| Target | MIF | “Macrophage migration inhibitory factor inhibitor” CHEMBL2107455 ↗ |
| Target | PTGS2 | “Cyclooxygenase-2 inhibitor” CHEMBL2107455 ↗ |
| Target | TRAF3IP2 | “E3 ubiquitin ligase TRAF3IP2 inhibitor” CHEMBL2107455 ↗ |