[{"orgOrder":0,"company":"Kintai Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kintai Therapeutics Advances Anti-Obesity Agent KTX-0200 into IND-Enabling Studies Following Positive Preclinical Data Demonstrating Sustained Weight Loss and Improved Health Markers","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Kintai Therapeutics"},{"orgOrder":0,"company":"Endevica Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data on Endevica Bio\u2019s Lead Compound, TCMCB07, Published in \u201cACS Pharmacology & Translational Science\u201d Suggest a Platform Approach for Producing Drug-Like Peptides","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Endevica Bio"},{"orgOrder":0,"company":"Endevica Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Endevica Reports the U.S. FDA Accepted Its Investigational New Drug (IND) Application for TCMCB07, a Melanocortin\u20104 Antagonist Peptide","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Endevica Bio"},{"orgOrder":0,"company":"9 Meters Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"9 Meters Biopharma Presents Preclinical Data on Glucose-Dependent Insulinotropic Polypeptide (GIP) Monoclonal Antibodies for Obesity at the American College of Gastroenterology 2022 Annual Scientific Meeting","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"9 Meters Biopharma"},{"orgOrder":0,"company":"9 Meters Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"9 Meters Biopharma Announces Successful Pre-IND Meeting with FDA Regarding Its GIP Antagonist NM-136 for Obesity","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"9 Meters Biopharma"},{"orgOrder":0,"company":"Veru","sponsor":"Raymond James & Associates","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Veru Announces Proposed Public Offering of Common Stock","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Veru"},{"orgOrder":0,"company":"Veru","sponsor":"Raymond James & Associates","pharmaFlowCategory":"D","amount":"$33.0 million","upfrontCash":"Undisclosed","newsHeadline":"Veru Announces Pricing of Public Offering of Common Stock","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Veru"},{"orgOrder":0,"company":"Veru","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with GLP-1 Drugs for Weight Loss","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Veru"},{"orgOrder":0,"company":"Resalis Therapeutics","sponsor":"Sunstone Life Science Ventures","pharmaFlowCategory":"D","amount":"$11.0 million","upfrontCash":"Undisclosed","newsHeadline":"Resalis Therapeutics Raises \u20ac10 Million Series A to Complete First Clinical Trial for RES-010 in Obesity","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Resalis Therapeutics"},{"orgOrder":0,"company":"TransThera Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TransThera Initiates IND-Enabling Studies for TT-02332, a Novel, Highly Potent and CNS-Penetrating NLRP3 Inhibitor","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"TransThera Biosciences"}]
Find FDA Investigational New Drug (IND) Submissions for Nutrition and Weight Loss in UNITED STATES
TT-02332 is a novel, highly potent and CNS-penetrating NLRP3 inhibitor. It is being evaluated for the treatment of obesity, inflammatory bowel disease & dermatitis.
VERU-024 (enobosarm) is a novel selective androgen receptor modulator which is beig evaluated in preclinical studies to prevent muscle loss while augmenting fat loss in combination with GLP-1 drugs for weight loss.
The proceeds will be used to initiate and complete the first-in-human Phase 1 clinical trial and reach Phase 2 readiness for Resalis’ lead program, RES-010, a non-coding RNA-based compound, in obesity.
Veru intends to use the proceeds to fund its clinical stage drug development, including a Phase 2b trial to evaluate VERU-024 (enobosarm), an oral selective androgen receptor modulator, for the treatment to augment fat loss and to prevent muscle loss in sarcopenic obese.
Veru intends to use the proceeds to fund its clinical stage drug development, including a Phase 2b trial to evaluate VERU-024 (enobosarm), an oral selective androgen receptor modulator, for the treatment to augment fat loss and to prevent muscle loss in sarcopenic obese.
NM-136 is a novel humanized monoclonal antibody antagonist targeting glucose-dependent insulinotropic polypeptide (GIP). Pre-clinical data has demonstrated that anti-GIP monoclonal antibodies can effectively produce weight loss in obese mice without affecting food consumption.
NM-136, an anti-GIP humanized mAb, for targeted obesity disorders has demonstrated that the anti-GIP hu-mAb has a robust half-life, excellent humanness score, a high affinity for the GIP receptor.
TCMCB07 to be a first-in-class peptide drug. We are confident that its ability to cross the blood-brain barrier and act on previously inaccessible target receptors will be profoundly beneficial for patient outcomes.
Endevica’s lead compound, TCMCB07, describes unique mechanisms and properties of drug, specifically in treatment of cachexia, and potential for producing a platform for drug-like peptides based on the evidence.
Treatment with KTX-0200 led to sustained weight loss of 14% in chronic diet-induced obesity rodent models known to be predictive of clinical efficacy across anti-obesity drug mechanisms.