SHR0302

Phase 3Small molecule

RReistone Biopharma Company Limited

SHR0302 is one of 239 small molecule programs targeting Arthritis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

238

Competitors

Pipeline

Status by Indication[3][1]

Indication

ArthritisActive, not recruiting

LymphomaActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Atopic DermatitisActive, not recruiting

Ulcerative ColitisActive, not recruiting

Alopecia AreataActive, not recruiting

VitiligoActive, not recruiting

Ankylosing SpondylitisActive, not recruiting

ArthritisPhase 3

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Rheumatoid ArthritisPhase 1

Active, not recruiting

Atopic DermatitisPhase 2/Phase 3

Active, not recruiting

Ulcerative ColitisPhase 3

Active, not recruiting

Alopecia AreataPhase 3

Active, not recruiting

VitiligoPhase 2

Active, not recruiting

Ankylosing SpondylitisPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

SHR0302

RReistone Biopharma Company Limited

Phase 3

1 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Oncaspar

SServier

Preclinical

15 4

Zofran

Novartis

Preclinical

2 5

Norvir

AbbVie

Preclinical

1 6

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 7

Tafasitamab

Incyte

Preclinical

7 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—10

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—

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

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Vitiligo

NCT07251595

Clinical

Trials by Indication[1]

Rheumatoid Arthritis3 trials

Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT03254966·194 enrolled

Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02665910·48 enrolled

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT04333771·566 enrolled

Alopecia Areata2 trials

A Phase II Study in Patients With Alopecia Areata

Completed·RReistone Biopharma Company Limited·Phase 2·NCT04346316·94 enrolled

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

Unknown status·RReistone Biopharma Company Limited·Phase 3·NCT05470413·330 enrolled

Ulcerative Colitis2 trials

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

Unknown status·RReistone Biopharma Company Limited·Phase 3·NCT05181137·368 enrolled

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

Completed·RReistone Biopharma Company Limited·Phase 2·NCT03675477·164 enrolled

Lymphoma1 trial

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

Not yet recruiting·HHenan Cancer Hospital·Phase 1·NCT05900089·30 enrolled

Single Ascending Dose1 trial

First-in-Human Single Ascending Dose of SHR0302

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02423538·64 enrolled

12 more indications

Oral1 trial

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

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT05856058·16 enrolled

Hepatic Impairment1 trial

Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04293029·24 enrolled

Vitiligo1 trial

A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo

Recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT07251595·176 enrolled

Atopic Dermatitis1 trial

Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis

Unknown status·RReistone Biopharma Company Limited·Phase 2/3·NCT04717310·645 enrolled

Interaction1 trial

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT05392127·24 enrolled

Clinical Trial1 trial

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

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT07098117·32 enrolled

First Line Therapy1 trial

SHR0302 and Steroid As First Line Therapy for Chronic GVHD

Completed·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 1·NCT04146207·28 enrolled

Ankylosing Spondylitis1 trial

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 2/3·NCT04481139·504 enrolled

Arthritis1 trial

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

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT05324631·300 enrolled

Tics1 trial

Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02892370·14 enrolled

Crohn's Disease1 trial

A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

Completed·RReistone Biopharma Company Limited·Phase 2·NCT03677648·112 enrolled

Unspecified2 trials

Study on the Bioavailability of SHR0302 in Healthy Subjects

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04712838·24 enrolled

A SHR0302 BA Study on Healthy Subjects

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT06202612·16 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for SHR0302. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SHR0302 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SHR0302. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Reistone Biopharma Company Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: RReistone Biopharma Company Limited

SHR0302

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Trials by Indication[1]

Rheumatoid Arthritis3 trials

Alopecia Areata2 trials

Ulcerative Colitis2 trials

Lymphoma1 trial

Single Ascending Dose1 trial

Oral1 trial

Hepatic Impairment1 trial

Vitiligo1 trial

Atopic Dermatitis1 trial

Interaction1 trial

Clinical Trial1 trial

First Line Therapy1 trial

Ankylosing Spondylitis1 trial

Arthritis1 trial

Tics1 trial

Crohn's Disease1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

Related News