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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":"Ossium Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ossium Health Announces FDA Clearance of its Investigational New Drug Application for Treatment of Perianal Fistulizing Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Ossium Health"},{"orgOrder":0,"company":"Noveome Biotherapeutics","sponsor":"Not 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Receives Rare Pediatric Disease Designation and Orphan Drug Designation for the Treatment of Necrotizing Enterocolitis in Neonates","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Noveome Biotherapeutics"},{"orgOrder":0,"company":"Prometheus Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prometheus Biosciences Receives FDA Clearance of IND Application for its Second Precision Program, PRA052","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Prometheus Biosciences"},{"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":"9 Meters Biopharma","sponsor":"Gustave Roussy","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"9 Meters Biopharma Announces Continued Immuno-Oncology Collaboration with Gustave Roussy","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"9 Meters Biopharma"},{"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":"AltruBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AltruBio Announces FDA Clearance of IND Application for ALTB-268, a Next-Generation Immune Checkpoint Enhancer for the Treatment of Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AltruBio"},{"orgOrder":0,"company":"BenevolentAI","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BenevolentAI Submits CTA for BEN-8744, an Oral PDE10 Inhibitor, As A First-in-class Treatment For Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"BenevolentAI"},{"orgOrder":0,"company":"Biora Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biora Therapeutics Receives Pre-IND Feedback from FDA and Provides Update on Key Programs for 2023","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Biora Therapeutics"},{"orgOrder":0,"company":"Renexxion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Renexxion"},{"orgOrder":0,"company":"Immuron","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Immuron US DoD Naval Medical Research Center Responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Immuron"},{"orgOrder":0,"company":"ExeGi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ExeGi Pharma Announces Clearance of Investigational New Drug (IND) Application for EXE-346 a Live Biotherapeutic Biologic Drug","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"ExeGi"}]
Find FDA Investigational New Drug (IND) Submissions for Gastroenterology
EXE-346 is a live biotherapeutic product (LBP) a blend of probiotic bacteria formulated in extremely high potency. The product is currently under development to manage excessive stool frequency in patients who have undergone an ileal pouch-anal anastomosis (IPAA).
The Naval Medical Research Center (NMRC) has executed a research agreement with Immuron to develop and clinically evaluate a new therapeutic CampETEC, targeting Campylobacter and ETEC infections.
Naronapride possess both serotonin 5HT4 receptor agonistic and dopamine D2 receptor antagonistic properties. It is currently being investigaetd for chronic idiopathic constipation (CIC) and gastro-esophageal reflux disease (GERD).
PGN-600 is an orally delivered liquid formulation of tofacitinib for the treatment of ulcerative colitis. Tofacitinib is a Janus Kinase (JAK) inhibitor which causes gut inflammation in ulcerative colitis. Thus, by blocking JAK tofacitinib reduces inflammation.
BEN-8744 is an orally administered, peripherally restricted small molecule PDE10 inhibitor under development as a first-in-class treatment for ulcerative colitis and with the potential for other indications within inflammatory bowel disease.
ALTB-268 is a next-generation PSGL-1 antibody agonist that acts as an immune checkpoint enhancer (ICE) that downregulate chronically activated T-cells by inhibiting the T-cell effector function, promoting T-cell exhaustion and apoptosis.
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 therapeutic effect of immune checkpoint inhibitors (ICIs), such as antibodies to CTLA-4 and PD-1, might be enhanced by preventing bacterial antigens, toxins, and certain metabolites in the gut from interacting with the host immune system utilizing NM-102.
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.
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