Ivarmacitinib

Generic Name: Ivarmacitinib

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₂N_₈O_₂S

CAS Number: 1445987-21-2

Unique Ingredient Identifier: K6K4B9Z5TV

Background: Ivarmacitinib (SHR0302) is a selective inhibitor of Janus kinase 1 (JAK1) under investigation for the treatment of various immuno-inflammatory conditions. While ivarmactinib has yet to receive marketing authorization, as of February 2022 clinical trials are ongoing or completed evaluating its use in atopic dermatitis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, graft-versus-host disease, vitiligo, ulcerative colitis, alopecia areata, and primary membranous nephropathy.

Clinical Trials

A Trial of SHR0302Base in Patients With Vitiligo

Phase 2

Recruiting

Conditions: Vitiligo

Interventions: Drug: SHR0302Base gel
Drug: SHR0302Base gel placebo

First Posted Date: 2025-01-24

Last Posted Date: 2025-03-19

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 152

Registration Number: NCT06790862

Locations: 🇨🇳
Dermatology Hospital affiliated to Shandong First Medical University, Jinan, Shandong, China

JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC

Phase 2

Not yet recruiting

Conditions: Triple Negative Breast Cancer (TNBC)
Metastatic Breast Cancer

Interventions: Drug: Ivarmacitinib
Drug: Camrelizumab (SHR-1210)
Drug: Eribulin

First Posted Date: 2024-12-12

Last Posted Date: 2024-12-12

Lead Sponsor: Fudan University

Target Recruit Count: 40

Registration Number: NCT06731153

Locations: 🇨🇳
Breast cancer institute of Fudan University Cancer Hospital, Shanghai, Shanghai, China

Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

Phase 2

Recruiting

Conditions: Relapsed/Refractory Peripheral T Cell Lymphoma

Interventions: Drug: SHR-0302
Drug: SHR-2554

First Posted Date: 2024-07-25

Last Posted Date: 2024-08-21

Lead Sponsor: Fudan University

Target Recruit Count: 25

Registration Number: NCT06519526

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, China

Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma

Phase 1

Not yet recruiting

Conditions: Peripheral T Cell Lymphoma

Interventions: Drug: SHR0302

First Posted Date: 2023-06-12

Last Posted Date: 2023-06-12

Lead Sponsor: Henan Cancer Hospital

Target Recruit Count: 30

Registration Number: NCT05900089

Locations: 🇨🇳
Henan cancer hospital, Zhengzhou, Henan, China

To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability

Phase 1

Completed

Conditions: Graft-versus-host Disease

Interventions: Drug: SHR0302

First Posted Date: 2023-05-12

Last Posted Date: 2023-12-08

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 16

Registration Number: NCT05856058

Locations: 🇨🇳
Beijing Hospital, Beijing, Beijing, China

Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata

Phase 3

Active, not recruiting

Conditions: Alopecia Areata

Interventions: Drug: SHR0302
Drug: Placebo

First Posted Date: 2022-07-22

Last Posted Date: 2023-09-05

Lead Sponsor: Reistone Biopharma Company Limited

Target Recruit Count: 330

Registration Number: NCT05470413

Locations: 🇨🇳
Zhujiang Hospital of Southern Medical University, Guanzhou, Guangdong, China
🇨🇳
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
🇨🇳
Henan Provincial People's Hospital, Zhengzhou, Henan, China

and more 28 locations

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis

Phase 3

Recruiting

Conditions: Non-radiographic Axial Spondyloarthritis

Interventions: Drug: SHR0302 placebo
Drug: SHR0302

First Posted Date: 2022-04-12

Last Posted Date: 2022-09-02

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 300

Registration Number: NCT05324631

Locations: 🇨🇳
Beijing Hospital, Beijing, Beijing, China

A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

Phase 3

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Placebo
Drug: SHR0302

First Posted Date: 2022-01-06

Last Posted Date: 2023-09-05

Lead Sponsor: Reistone Biopharma Company Limited

Target Recruit Count: 368

Registration Number: NCT05181137

Locations: 🇨🇳
Zhongda Hospital Southeast University, Nanjing, Jiangsu, China
🇺🇦
Clinical Hospital "Feofaniia", Kyiv, Ukraine
🇺🇦
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Lviv, Ukraine

and more 110 locations