Robust weight loss in obesity
Tesofensine is a unique triple monamine reuptake inhibitor: an effective weight loss drug
How Tesofensine works
Tesofensine is a monoamine reuptake inhibitor that modulates brain activity by increasing the levels of three neurotransmitters – dopamine, serotonin and noradrenaline – which are each intimately involved in regulating appetite, food-seeking behavior and metabolism. The weight reducing effect of tesofensine has been confirmed in a six-month Phase 2 clinical trial in patients with obesity (the TIPO-1 trial). The TIPO-1 trial indicates that tesofensine at the expected recommended dose of 0.50 mg per day provides a weight loss of 10 percent or more in 24 weeks, which is in the same ballpark of some of the best GLP-1 analogs. As opposed to the GLP-1 analogs, tesofensine is provided in tablets and will not require titration.
Saniona’s partner Medix completed a Phase 3 program studying tesofensine (0.25 and 0.50 mg daily) in people with obesity. The Phase 3 study confirmed the compelling efficacy and favorable safety profile of tesofensine in obesity previously observed in Phase 2.
TESOFENSINE STATUS
Saniona’s partner Medix has submitted a new drug application to the Mexican food and drug administration, COFEPRIS, for approval of tesofensine for the treatment of patients with obesity. In February 2023 COFEPRIS’ technical committee expressed a favorable opinion on tesofensine for treatment of obesity.