Zelhou

(Iguratimod)

Phase 3Small molecule

Jiangsu Simcere Pharmaceutical Co., Ltd.

Iguratimod is used to treat rheumatoid arthritis, an autoimmune disease that causes joint pain and inflammation. It helps reduce symptoms and slow down damage to the joints.[1] Zelhou is currently being investigated across 6 indications[3], with its most advanced program in Phase 3.[1]

Zelhou is one of 168 small molecule programs targeting Diffuse Scleroderma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

167

Competitors

Pipeline

Status by Indication[3][1]

Indication

Diffuse SclerodermaActive, not recruiting

Kidney TransplantActive, not recruiting

Systemic SclerosisActive, not recruiting

RelapseNot yet recruiting

Rheumatoid ArthritisUnknown status

EfficacyRecruiting

Diffuse SclerodermaPreclinical

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

Systemic SclerosisPreclinical

Active, not recruiting

RelapsePhase 2

Not yet recruiting

Rheumatoid ArthritisPhase 3

Unknown status

EfficacyPhase 3

Recruiting

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Phase 3

7 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Efficacy

NCT05626348

Q3 2027

Phase 2Not yet recruiting

Relapse

NCT07057778

Clinical

Trials by Indication[1]

Rheumatoid Arthritis7 trials

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT02275299·240 enrolled

Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

Completed· Eisai logo

Eisai··NCT01850966·2,747 enrolled

Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT01893151·200 enrolled

Show 4 more trials

Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis

Recruiting·YYanfeng Hou·Phase 4·NCT06146972·117 enrolled

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT01548001·910 enrolled

Clinical Trial of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis

Not yet recruiting·WWangjing Hospital, China Academy of Chinese Medical Sciences·N/A·NCT07115641·240 enrolled

A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT01554917·1,759 enrolled

Immune Thrombocytopenia2 trials

The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05281068·120 enrolled

Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05302024·100 enrolled

Lupus Nephritis2 trials

The Iguratimod Effect on Lupus Nephritis (IGeLU)

Unknown status·RRenJi Hospital·Phase 2·NCT02936375·120 enrolled

Iguratimod as Treatment for Refractory Lupus Nephritis

Unknown status·RRenJi Hospital·N/A·NCT03054545·30 enrolled

Kidney Transplant1 trial

Iguratimod in Kidney Transplant Recipients

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT02839941·60 enrolled

Clinical Efficacy and Safety1 trial

The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

Completed·QQilu Hospital of Shandong University·Phase 4·NCT03855007·400 enrolled

9 more indications

Relapse1 trial

Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT07057778·120 enrolled

Systemic Sclerosis1 trial

Iguratimod in Systemic Sclerosis

Unknown status·RRenJi Hospital·N/A·NCT04515706·20 enrolled

Primary Sjögren's Syndrome1 trial

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04981145·78 enrolled

Primary Sjogren's Syndrome1 trial

A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 2·NCT04830644·144 enrolled

Osteoarthritis1 trial

Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO)

Unknown status·PPeking University People's Hospital·Phase 2/3·NCT05216757·150 enrolled

Sjögren's Syndrome1 trial

Study of Iguratimod in Sjögren's Syndrome

Unknown status·PPeking Union Medical College Hospital·Phase 1/2·NCT03023592·30 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD

Unknown status·XXuzhou Medical University·Phase 3·NCT06244628·20 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA

Completed·QQilu Hospital of Shandong University·Phase 4·NCT04928066·100 enrolled

Efficacy1 trial

The Clinical Efficacy of Immunomodulators in RA Patients

Recruiting·QQilu Hospital of Shandong University·Phase 4·NCT05626348·400 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Iguratimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Iguratimod compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Iguratimod. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Jiangsu Simcere Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase-2 Inhibitor; E3 Ubiquitin Ligase TRAF3IP2 Inhibitor; Macrophage Migration Inhibitory Factor Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Jiangsu Simcere Pharmaceutical Co., Ltd.

Zelhou

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Rheumatoid Arthritis7 trials

Immune Thrombocytopenia2 trials

Lupus Nephritis2 trials

Kidney Transplant1 trial

Clinical Efficacy and Safety1 trial

Relapse1 trial

Systemic Sclerosis1 trial

Primary Sjögren's Syndrome1 trial

Primary Sjogren's Syndrome1 trial

Osteoarthritis1 trial

Sjögren's Syndrome1 trial

Safety and Efficacy1 trial

Efficacy and Safety1 trial

Efficacy1 trial

References

Drug Info

Quick Facts

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