[{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona completes its six months double blind Phase 2a trial of Tesomet in hypothalamic obesity","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Reports Positive Topline Results from Phase 2 Trial of Tesomet in Hypothalamic Obesity","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Receives Positive Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Announces Poster Presentation at the European Congress of Endocrinology Virtual Annual Meeting","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona receives Pre-IND Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Boehringer Ingelheim GmbH","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Saniona Refines Pipeline to Focus on Rare Diseases; Regains GABAa5 Negative Allosteric Modulator Program from Boehringer Ingelheim","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Reports Positive Topline Results from Tesomet Phase 2 Open-Label Extension Study in Hypothalamic Obesity","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Saniona","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Saniona Annonces Partnership with Foundation for Prader-Willi Research to Support its Prader-Willi Syndrome Clinical Trial with Tesomet","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona to Host Research and Development (R&D) Day on Leveraging Ion Channel Targeting Expertise for Rare Diseases","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Preclinical","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Preclinical"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Hosts Research and Development Day on Proprietary Ion Channel Drug Discovery Engine and Pipeline Programs","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Preclinical","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Preclinical"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Initiates Phase 1 Clinical Trial of SAN711","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Gets U.S. FDA Orphan Drug Designation for Tesomet in Hypothalamic Obesity","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Completes Submission of Manufacturing Data for Tesomet Capsules To U.S. FDA","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Initiates Phase 2b Clinical Trial of Tesomet for Hypothalamic Obesity","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Initiates Multiple Ascending Dose Stage of SAN711 Phase 1 Clinical Trial","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Boehringer Ingelheim GmbH","pharmaFlowCategory":"D","amount":"$84.0 million","upfrontCash":"Undisclosed","newsHeadline":"Saniona Ion Channel Research Collaboration with Boehringer Ingelheim Advances to Next Stage","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Discovery","country":"DENMARK","productType":"Small molecule","productStatus":"Undisclosed","date":"March 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Discovery"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Initiates Positron Emission Tomography (PET) Stage of SAN711 Phase 1 Clinical Trial","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Provides Update on Ongoing Review of Tesofensine in Mexico","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona's Clinical Trial in Hypothalamic Obesity Published in Scientific Journal","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Phase II"},{"orgOrder":0,"company":"Saniona","sponsor":"University of Arhus","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona\u2019s Preclinical Candidate SAN903 Shows Robust Dampening of Fibrosis in Chronic Kidney Disease Model","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Preclinical","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Preclinical"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Reports Positive Top Line Results from the SAN711 Phase 1 Clinical Trial","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona\u2019s Anti-Inflammatory and Anti-Fibrotic Candidate SAN903 is Ready for Clinical Studies","therapeuticArea":"Nephrology","highestDevelopmentStatus":"IND Enabling","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"IND Enabling"}]
Find Clinical Drug Pipeline Developments & Deals by Saniona
SAN903 is a novel, potential first-in-class medicine based on inhibition of the calcium-activated potassium ion channel, KCa3.1. Preclinical data for SAN903 showed the potential to become first-line treatment in patients suffering from inflammatory bowel disease.
Data from the trial demonstrated that SAN711 was safe and well tolerated across all dosing cohorts with a favorable absorption and distribution profile. There were no serious adverse events, and all subjects completed the study.
SAN903 was administrated daily during unilateral urinary obstruction the total fibrotic area was reduced by up to 43% (p>0.0001). SAN903 was well tolerated at all doses.
Tesomet (tesofensine), is a novel, proprietary molecule, and investigational fixed-dose combination therapy of, a triple monoamine reuptake inhibitor and metoprolol (a beta-1 selective blocker).
Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.
SAN711 is an investigational, potential first-in-class positive allosteric modulator of GABA-A α3 receptors, may have the potential to restore spinal inhibitory tone and prevent abnormal pain signaling to the brain.
Saniona and Boehringer Ingelheim entered into the ongoing research collaboration in 2020. The collaboration is focused on a novel, undisclosed CNS ion channel target for schizophrenia.
The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, as evaluated through the single ascending dose and multiple ascending dose phases of the study.
Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of the study.
The initiation of this Phase 2b clinical trial of tesomet represents the culmination of the significant work and primary endpoint of study is the percentage change in body weight from baseline to week 36.