Ivarmacitinib is currently evaluated across multiple clinical trials investigating a broad spectrum of inflammatory, autoimmune, and oncological conditions, including rheumatoid arthritis, atopic dermatitis, polymyalgia rheumatica, palmoplantar pustulosis, Hodgkin lymphoma, and advanced hepatocellular carcinoma. Academic medical institutions—including Shanghai Jiao Tong University School of Medicine, Tongji Hospital, and Peking University People's Hospital—sponsor these Phase 1 through Phase 4 investigations assessing both monotherapy and combination regimens. Participant recruitment status across this trial portfolio encompasses actively recruiting, not yet recruiting, and withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07451665 | NOT_YET_RECRUITING | Takayasu Arteritis (TAK) |
Chinese SLE Treatment And Research Group |
2026-04-01 | PHASE4 |
| NCT07505186 | NOT_YET_RECRUITING | Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-05-01 | PHASE2 |
| NCT07641010 | NOT_YET_RECRUITING | Hodgkin Lymphoma |
Shanghai Jiao Tong University School of Medicine |
2026-06-30 | PHASE1; PHASE2 |
| NCT07570745 | RECRUITING | Graft-Versus-Host Disease(GVHD); Bone Marrow Transplantation |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2026-05-01 | PHASE2 |
| NCT07276620 | NOT_YET_RECRUITING | Atopic Dermatitis (AD) |
Xiangya Hospital of Central South University |
2025-11-30 | |
| NCT07452445 | NOT_YET_RECRUITING | Rheumatoid Arthritis |
Tongji Hospital |
2026-03-01 | PHASE4 |
| NCT07324473 | NOT_YET_RECRUITING | Hepatocellular Carcinomas; Resistance to Immunotherapy; Immunomodulation; Drug Repurposing |
First Affiliated Hospital of Chongqing Medical University |
2026-01-01 | PHASE2 |
| NCT07313202 | NOT_YET_RECRUITING | Patients With Advanced Solid Tumors Who Discontinued Treatment Due to irAE |
Fujian Cancer Hospital |
2025-12-10 | PHASE2 |
| NCT07266168 | NOT_YET_RECRUITING | Polymyalgia Rheumatics (PMR) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-01-20 | |
| NCT07550452 | NOT_YET_RECRUITING | Atopic Dermatitis (AD) |
Peking University People's Hospital |
2026-03-31 | |
| NCT06731153 | NOT_YET_RECRUITING | Triple Negative Breast Cancer (TNBC); Metastatic Breast Cancer |
Fudan University |
2024-12 | PHASE2 |
| NCT07634848 | WITHDRAWN | Behcet's Syndrome |
Liu Tian |
2026-06-01 | PHASE2 |
| NCT07381114 | NOT_YET_RECRUITING | aGVHD |
Institute of Hematology & Blood Diseases Hospital, China |
2026-02-14 | PHASE1; PHASE2 |
| NCT07270003 | RECRUITING | Palmoplantar Pustulosis (PPP) |
Xijing Hospital |
2025-10-01 |
(data from https://clinicaltrials.gov, updated on 2026-03-05)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).