[{"orgOrder":0,"company":"Xiling Lab","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scimount Announces FDA Approval of SMP-100's IND Application for the Treatment of Irritable Bowel Syndrome","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Xiling Lab"},{"orgOrder":0,"company":"OnQuality Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OnQuality Pharmaceuticals to Present Preclinical Data for OQL051, a Novel Chemotherapy-Induced Diarrhea Therapeutic, at AACR","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"OnQuality Pharma"},{"orgOrder":0,"company":"Zhiyi Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zhiyi Biotech Received Clinical Approval from U.S. FDA for SK10 in Chemotherapy-induced Diarrhea","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Zhiyi Biotech"},{"orgOrder":0,"company":"Asieris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Asieris Obtained IND Approval from US FDA for APL-1401, a New Drug for the Treatment of Moderately-to-Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Asieris Pharmaceuticals"},{"orgOrder":0,"company":"Triastek","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Triastek Receives FDA IND Clearance for 3D Printed Medicine","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Undisclosed","graph2":"Triastek"},{"orgOrder":0,"company":"OnQuality Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OnQuality Announces FDA Clearance of IND Application for OQL051, for the Prophylaxis of Chemotherapy-Induced Diarrhea","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"OnQuality Pharma"},{"orgOrder":0,"company":"Asieris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Asieris Obtained IND Approval from NMPA for APL-1401, a Drug for the Treatment of Moderately-to-Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Asieris Pharmaceuticals"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
APL-1401 is an oral drug got IND approval from NMPA for treatment of moderately-to-severely active ulcerative colitis, The IND application had previously been approved by the U.S. Food and Drug Administration.
OQL051 sia first-in-disease, oral, gut-restricted CDK4/6 inhibitor – is designed to prevent the development of CID in patients receiving cytotoxic chemotherapies. The drug works by temporarily arresting the rapidly dividing intestinal mucosal cells in G1 phase.
T21 is a novel potential treatment capable of colon-targeted drug delivery. With a unique 3D dosage form design, T21 can reach the targeted colon segment of the GI tract.
The study is a randomized, double-blind Phase Ib study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patients with moderate to severely active UC.
Pre-clinical studies have indicated that SK10 can reduce the toxicity of chemotherapeutic drugs towards intestinal epithelial cells, regulate the expression of apoptosis-related proteins, reduce inflammatory cytokines, and enhance mucosal barrier function.
Preclinical data from in vitro and in vivo experiments showing that OQL051, a gut-restricted CDK4/6 inhibitor, had significant efficacy in protecting gastrointestinal tissues from damage and decreasing diarrhea caused by chemotherapy for prevention of CID.
First randomized, double-blinded, placebo-controlled Phase I clinical trial to investigate the safety and pharmacokinetics after oral administration of SMP-100 in healthy volunteers.