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Details:
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).
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
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.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 28, 2021
Details:
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.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Endocrinology Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
Tesomet capsules contain two active ingredients as microspheres of fixed-dose combination therapy of tesofensine (triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker) used for treatment for hypothalamic obesity and Prader-Willi syndrome.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2021
Details:
Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2021
Details:
The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2021
Details:
Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first half of this year.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Saniona
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 19, 2021
Details:
Saniona is preparing to start a Phase 2b study of Tesomet in Prader-Willi Syndrome this year. In a Phase 2a trial, adults patients receiving Tesomet achieved a significant reduction in hyperphagia and a clinically meaningful reduction in body weight at a dose of 0.5 mg/day.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
Details:
Tesomet was well-tolerated in hypothalamic obesity patients throughout the duration of the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. All patients who entered the OLE study completed it.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Rare Diseases and Disorders Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
FDA recommended that Saniona conduct a supportive Phase 2b study prior to initiating a Phase 3 study to confirm the safety and efficacy of the doses intended for commercialization.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
The poster to be presented will highlight the results from a phase 2 clinical trial of Tesomet for hypothalamic obesity, at the 22nd European Congress of Endocrinology virtual annual meeting being held 5-9 September 2020.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Nutrition and Weight Loss Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
LOPRESSOR® and ICAZ® are oral treatments of essential hypertension. LOPRESSOR® is a beta blocker indicated in treatment of hypertension. ICAZ® is a calcic inhibitor indicated in the treatment of essential hypertension.
Lead Product(s): Metoprolol Tartrate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Lopressor
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SIT Laboratorio Farmaceutico
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 03, 2020
Details:
The positive feedback regarding the proposed regulatory path for Tesomet confirmed that Tesomet may be advanced via the 505(b)2 pathway, and the agency indicated agreement with Saniona on the design, the proposed doses, and duration of the potential Phase 2b clinical trial in PWS.
Lead Product(s): Tesofensine,Metoprolol Tartrate
Therapeutic Area: Genetic Disease Product Name: Tesomet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
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