AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis - LARVOL DELTA

BH19 'JAK in the box?' Long-term safety concerns with oral Janus kinase inhibitors for alopecia areata. (PubMed, Br J Dermatol) - "The findings were synthesized to provide an overview of the safety profiles of baricitinib, ritlecitinib, deuruxolitinib, ivarmacitinib and other JAK inhibitors. Long-term safety data were scarce, with only one study (the phase IIb/III ALLEGRO trial on ritlecitinib) extending to 2 years, while others had follow-ups of 52 weeks or shorter...Given the chronic nature of AA and the potential for extended use of JAK inhibitors, further long-term studies are necessary to better assess the risks of malignancies, cardiovascular events and other rare but serious AEs associated with this drug class. Although short-term studies indicate efficacy and tolerability, the absence of longitudinal research underpins the need for cautious clinical use and informed patient decision making."

Journal • Review • Acne Vulgaris • Alopecia • Breast Cancer • Cardiovascular • Immunology • Infectious Disease • Melanoma • Myocardial Infarction • Oncology • Pain • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma

Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and Adults (clinicaltrials.gov) - P=N/A | N=1000 | Not yet recruiting | Sponsor: Xiangya Hospital of Central South University

New trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Prospective, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Ivarmacitinib in the Treatment of Palmoplantar Pustulosis (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Xijing Hospital

New trial • Immunology • Psoriasis

Ivarmacitinib reduces the need for adding/escalating medications in moderate-to-severe rheumatoid arthritis patients: a post hoc analysis from a phase III trial. (PubMed, Front Pharmacol) - P3 | "Ivarmacitinib significantly reduces the need for adding/escalating medications compared to placebo, thereby potentially decreasing treatment burden. However, the post hoc, exploratory nature of this study requires further validation for the findings."

Journal • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ivarmacitinib improves patient-reported outcomes across multiple domains in patients with active ankylosing spondylitis: a post hoc analysis of a phase II/III trial. (PubMed, Front Pharmacol) - P2/3 | "Ivarmacitinib significantly enhances multiple dimensions of PROs in active AS patients, supporting its utility in managing PROs in AS. Switching to ivarmacitinib also provides substantial benefits, this indicates that initiating ivarmacitinib treatment, even after an initial period of placebo leads to meaningful improvements in PROs."

Journal • P2/3 data • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies

Re: "Ivarmacitinib for the Treatment of Adults with Severe Alopecia Areata: Results from a Phase 3 Trial.". (PubMed, J Am Acad Dermatol) - No abstract available

Journal • P3 data • Alopecia • Immunology

Ivarmacitinib: A Novel Selective JAK1 Inhibitor for the Treatment of Rheumatoid Arthritis-Letter to the Editor. (PubMed, Int J Rheum Dis) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo (clinicaltrials.gov) - P2 | N=176 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Dermatology • Immunology • Vitiligo

Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial. (PubMed, J Dermatolog Treat) - P3 | "The adverse events were generally comparable between Ivarmacitinib and placebo groups, regardless of previous systemic treatments. Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous systemic treatments."

Clinical • Journal • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Ivarmacitinib ointment for the treatment of adults with mild-to-moderate atopic dermatitis: phase 3 part of a randomized, double-blind, placebo-controlled, phase 2/3 clinical trial. (PubMed, Br J Dermatol) - "Twice-daily ivarmacitinib ointment (0.5% or 1%) produced rapid, durable, and well-tolerated improvement in signs, symptoms, and itch in adults with mild-to-moderate AD, supporting its potential as a safe, steroid-sparing topical therapy."

Clinical • Journal • P2/3 data • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pruritus

A Novel JAK1 Inhibitor SHR0302 for Treatment of Chronic Graft-Verse-Host Disease: A Phase I Clinical Trial (ASH 2023) - "In summary, SHR0302 in combination with prednisone had a good safety and could achieve a high response for naïve-treatment cGVHD, which suggests that SHR0302 combination might become an optimal choice for naïve-treatment cGVHD."

Clinical • P1 data • Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Dyslipidemia • Graft versus Host Disease • Hypertriglyceridemia • Immunology • Metabolic Disorders • Transplantation

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of JAK1 Inhibitor Ivarmacitinib in Combination with Topical Corticosteroids in the Treatment of Moderate-to-Severe Chronic Hand Eczema (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The First Hospital of Hebei Medical University; The First Hospital of Hebei Medical University

New P4 trial • Atopic Dermatitis • Contact Dermatitis • Dermatology • Immunology

Efficacy and Safety of Ivarmacitinib Sulfate Tablets in the Treatment of SAPHO Syndrome: A Single-Arm, Single-Center, Open-Label Clinical Trial (ChiCTR) - P4 | N=20 | Not yet recruiting | Sponsor: The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University

New P4 trial • Acne Vulgaris • Immunology

Ivarmacitinib for the Treatment of Sjögren’s Syndrome (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University o

New P4 trial

Effect of Ivarmacitinib on Joint Swelling and Tenderness in Patients with Moderate-to-severe Rheumatoid Arthritis: A Post-hoc Study of a Phase III Clinical Trial (ACR Convergence 2025) - P3 | "Ivarmacitinib significantly improves joint swelling and tenderness in patients with moderate-to-severe RA. Moreover, ivarmacitinib 8 mg provides superior long-term benefits in improving tenderness of small joints than large joints."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy of Ivarmacitinib in Patients with Moderate-to-severe Rheumatoid Arthritis Stratified by Baseline Characteristics: A Post-hoc Study of a Phase III Clinical Trial (ACR Convergence 2025) - P3 | "Ivarmacitinib provides consistent efficacy across various subgroups in patient with moderate-to-severe RA."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers. (PubMed, Drug Des Devel Ther) - "In healthy Chinese male volunteers, the bioavailability of the SHR0302 oral solution was comparable to that of the SHR0302 tablet. The drug was safe and well tolerated following a single dose."

Clinical • Journal • P1 data • PK/PD data

Determination of 13 janus kinase inhibitors in anti-alopecia cosmetics by ultra-high performance liquid chromatography-tandem triple quadrupole composite linear ion trap mass spectrometry (PubMed, Se Pu) - "Anti-alopecia cosmetics are often found to contain illegal additions of prohibited drugs such as minoxidil， finasteride and other substances...An ultra-high performance liquid chromatography-multiple reaction monitoring-information dependent acquisition-enhanced production scanning （UHPLC-MRM-IDA-EPI） method was developed to determine 13 JAK inhibitors in anti-alopecia cosmetics， including baricitinib， tofacitinib， ritlecitinib， peficitinib， abrocitinib， upadacitinib， ivarmacitinib， fedratinib， filgotinib， ruxolitinib， momelotinib， pacritinib and bozitinib...Recoveries of the 13 JAK inhibitors ranged from 94.7% to 102.2% for the water-soluble matrix and from 92.4% to 99.2% for the cream matrix， with relative standard deviations （RSDs） ≤8.8%. This method is characterized by high efficiency， rapidity， accuracy， sensitivity and simplicity， making it a powerful tool for rapid risk screening and simultaneous quantitative analysis of JAK inhibitors in anti-alopecia cosmetics."

Journal • Alopecia • Immunology

Ivarmacitinib for the Treatment of Adults with Severe Alopecia Areata: Results from a Phase 3 Trial. (PubMed, J Am Acad Dermatol) - "Once-daily ivarmacitinib 4 mg or 8 mg resulted in meaningful hair regrowth and demonstrated an acceptable safety profile in patients with severe AA."

Clinical • Journal • P3 data • Alopecia • Cardiovascular • Immunology • JAK1

A Multi-Cohort, Phase II Study of SHR0302 Combined With PD-1/PD-L1 Inhibitior for Treatment Naïve or Acquired Resistant to Immunology NSCLC (IASLC-WCLC 2025) - "Cohort 2 enrolled NSCLC whose disease progressed due to acquired resistance to first-line PD-1 inhibitor, and they will be administered with a combination of Adebrelimab (PD-L1 inhibitor) and SHR0302. Both cohorts will be treated until patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint of this trial is progression - free survival (PFS), while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety."

P2 data • Ankylosing Spondylitis • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Inflammatory Arthritis • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Rheumatology • Seronegative Spondyloarthropathies • Solid Tumor • IFNG

Biologics and Small Molecules for Psoriasis in China: Global Integration and Domestic Innovation (EADV 2025) - " Biosimilars: Domestic TNF-α inhibitors (e.g., Yisaipu) reduced costs by 50–60%, increasing systemic therapy uptake. Innovative Biologics: IL-17A inhibitors (frunevetmab, sailizumab [Phase III PASI75: 90.7%]) and IL-23- targeted piconchizumab (NDA 2024) demonstrated non-inferiority to global counterparts (secukinumab, guselkumab). Small Molecules: Local JAK1 (ivarmacitinib [NDA filed]) and TYK2 inhibitors (D-2570 [Phase II]) showed comparable efficacy/safety to upadacitinib and deucravacitinib. Emerging Therapies: Bispecifics (XKH004 [IL-17A/F]), IL-36R mAb HB0034 (GPP-focused), CRISPR-edited IL- 23/Th17 modulators, and engineered MSCs entered late-stage development... China's psoriasis therapeutics have transitioned from import dependency to globally competitive innovation. Domestic biosimilars and novel agents now challenge foreign dominance, while cost-reduction strategies improve accessibility for 6–8 million patients. With 15+ candidates in global trials, China..."

Clinical • Dermatology • Immunology • Psoriasis • IL17A • IL23A • JAK1 • TYK2

New molecules in the therapy of chronic graft-versus-host disease. (PubMed, Curr Opin Hematol) - "Expanding therapeutic options in cGvHD require decision-making based on organ involvement, prior therapy, and tolerability. Emerging compounds offer the potential to modulate chronic inflammation and fibrosis more precisely, supporting a move toward personalized and combinatorial approaches in advanced-line settings."

Journal • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Transplantation

A prospective clinical study on advanced or metastatic non-small cell lung cancer in the first-line treatment of adebelimab combined with emacetinib +/- chemotherapy (ChiCTR) - P4 | N=68 | Not yet recruiting | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Early itch relief with ivarmacitinib improves quality of life, working productivity, and sleep quality in patients with moderate-to-severe atopic dermatitis: a post hoc analysis of a phase III trial. (PubMed, J Dermatolog Treat) - P3 | "Sleep disturbance due to itch was also significantly improved in the EIR group from week 4 to week 40, though the difference at week 52 was not statistically significant. Early itch relief with ivarmacitinib showed significant improvements in QoL, sleep, and work productivity in patients with moderate-to-severe AD."

Clinical • HEOR • Journal • P3 data • Retrospective data • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Sleep Disorder

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Anesthesia