{"id":"shr0302","safety":{"commonSideEffects":[{"rate":"20-30%","effect":"Fatigue"},{"rate":"15-25%","effect":"Nausea"},{"rate":"10-20%","effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"SHR0302 works by inhibiting the PI3K/AKT/mTOR pathway, which is involved in cell proliferation and survival. This inhibition leads to anti-tumor effects. SHR0302 has shown promise in preclinical studies as a potential treatment for various cancers.","oneSentence":"SHR0302 is a small molecule that targets the PI3K/AKT/mTOR pathway.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:32.232Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced solid tumors"},{"name":"Relapsed or refractory multiple myeloma"}]},"trialDetails":[{"nctId":"NCT06519526","phase":"PHASE2","title":"Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma","status":"RECRUITING","sponsor":"Fudan University","startDate":"2024-08-12","conditions":"Relapsed/Refractory Peripheral T Cell Lymphoma","enrollment":25},{"nctId":"NCT07251595","phase":"PHASE2","title":"A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo","status":"RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2025-12-05","conditions":"Non-segmental Vitiligo","enrollment":176},{"nctId":"NCT07098117","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2024-06-19","conditions":"Preoperative Sedation of Adults","enrollment":32},{"nctId":"NCT06925048","phase":"PHASE2","title":"SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC","status":"NOT_YET_RECRUITING","sponsor":"Chunxia Su","startDate":"2025-04-30","conditions":"Non-Small Cell Lung Cancer, JAK Inhibitor, Immunology","enrollment":86},{"nctId":"NCT06202612","phase":"PHASE1","title":"A SHR0302 BA Study on Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2024-01-16","conditions":"Autoimmune Diseases","enrollment":16},{"nctId":"NCT04146207","phase":"EARLY_PHASE1","title":"SHR0302 and Steroid As First Line Therapy for Chronic GVHD","status":"COMPLETED","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","startDate":"2020-04-02","conditions":"Chronic GVHD","enrollment":28},{"nctId":"NCT05856058","phase":"PHASE1","title":"To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2023-05-29","conditions":"Graft-versus-host Disease","enrollment":16},{"nctId":"NCT04333771","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2020-07-31","conditions":"Rheumatoid Arthritis","enrollment":566},{"nctId":"NCT04717310","phase":"PHASE2, PHASE3","title":"Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis","status":"UNKNOWN","sponsor":"Reistone Biopharma Company Limited","startDate":"2020-12-30","conditions":"Atopic Dermatitis","enrollment":645},{"nctId":"NCT05470413","phase":"PHASE3","title":"Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata","status":"UNKNOWN","sponsor":"Reistone Biopharma Company Limited","startDate":"2022-04-18","conditions":"Alopecia Areata","enrollment":330},{"nctId":"NCT05136456","phase":"PHASE2","title":"Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy","status":"UNKNOWN","sponsor":"Reistone Biopharma Company Limited","startDate":"2021-12-15","conditions":"Primary Membranous Nephropathy","enrollment":61},{"nctId":"NCT05181137","phase":"PHASE3","title":"A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis","status":"UNKNOWN","sponsor":"Reistone Biopharma Company Limited","startDate":"2021-11-05","conditions":"Ulcerative Colitis","enrollment":368},{"nctId":"NCT04481139","phase":"PHASE2, PHASE3","title":"A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2020-10-14","conditions":"Ankylosing Spondylitis","enrollment":504},{"nctId":"NCT05900089","phase":"PHASE1","title":"Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma","status":"NOT_YET_RECRUITING","sponsor":"Henan Cancer Hospital","startDate":"2023-05-30","conditions":"Peripheral T Cell Lymphoma","enrollment":30},{"nctId":"NCT03675477","phase":"PHASE2","title":"A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.","status":"COMPLETED","sponsor":"Reistone Biopharma Company Limited","startDate":"2019-04-13","conditions":"Ulcerative Colitis","enrollment":164},{"nctId":"NCT04875169","phase":"PHASE3","title":"Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Reistone Biopharma Company Limited","startDate":"2021-04-30","conditions":"Atopic Dermatitis","enrollment":336},{"nctId":"NCT04162899","phase":"PHASE2","title":"A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Reistone Biopharma Company Limited","startDate":"2019-11-06","conditions":"Atopic Dermatitis","enrollment":105},{"nctId":"NCT03677648","phase":"PHASE2","title":"A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease","status":"COMPLETED","sponsor":"Reistone Biopharma Company Limited","startDate":"2019-05-14","conditions":"Crohn's Disease","enrollment":112},{"nctId":"NCT04957550","phase":"PHASE3","title":"To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-08-30","conditions":"Psoriatic Arthritis","enrollment":444},{"nctId":"NCT05392127","phase":"PHASE1","title":"A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2022-07-15","conditions":"Rheumatoid Arthritis","enrollment":24},{"nctId":"NCT05404724","phase":"PHASE1","title":"Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2022-06-25","conditions":"Rheumatoid Arthritis","enrollment":14},{"nctId":"NCT05324631","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2022-08-16","conditions":"Non-radiographic Axial Spondyloarthritis","enrollment":300},{"nctId":"NCT04774809","phase":"PHASE2, PHASE3","title":"Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo","status":"TERMINATED","sponsor":"Reistone Biopharma Company Limited","startDate":"2020-01-29","conditions":"Vitiligo","enrollment":75},{"nctId":"NCT05047341","phase":"PHASE1","title":"A Study of Human Substance Balance and Biotransformation of [14C]SHR0302","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-09-07","conditions":"Rheumatoid Arthritis (RA)","enrollment":6},{"nctId":"NCT04712838","phase":"PHASE1","title":"Study on the Bioavailability of SHR0302 in Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-03-15","conditions":"Healthy Subjects","enrollment":24},{"nctId":"NCT04293029","phase":"PHASE1","title":"Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2020-05-20","conditions":"Hepatic Impairment","enrollment":24},{"nctId":"NCT03254966","phase":"PHASE2","title":"Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2017-11-24","conditions":"Rheumatoid Arthritis","enrollment":194},{"nctId":"NCT04346316","phase":"PHASE2","title":"A Phase II Study in Patients With Alopecia Areata","status":"COMPLETED","sponsor":"Reistone Biopharma Company Limited","startDate":"2020-05-13","conditions":"Alopecia Areata","enrollment":94},{"nctId":"NCT02892370","phase":"PHASE1","title":"Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2016-08","conditions":"Rheumatoid Arthritis","enrollment":14},{"nctId":"NCT02665910","phase":"PHASE1","title":"Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2016-05","conditions":"Rheumatoid Arthritis","enrollment":48},{"nctId":"NCT02423538","phase":"PHASE1","title":"First-in-Human Single Ascending Dose of SHR0302","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2015-04","conditions":"Rheumatoid Arthritis","enrollment":64}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":24,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Ivarmacitinib","SHR0302 Ointment 2%","SHR0302 Ointment 1%","SHR0302 Ointment 0.5%"],"phase":"phase_3","status":"active","brandName":"SHR0302","genericName":"SHR0302","companyName":"Jiangsu HengRui Medicine Co., Ltd.","companyId":"jiangsu-hengrui-medicine-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SHR0302 is a small molecule that targets the PI3K/AKT/mTOR pathway. Used for Advanced solid tumors, Relapsed or refractory multiple myeloma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":9,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}