U.S. FDA Grants Orphan Drug Designation for Tesomet

Release Date: 30-Sep-2021

US FDA has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity (HO). Hypothalamic obesity (HO) is a rare disorder caused by injury to a region of the brain known as the hypothalamus. It is caused by intractable weight gain that persists despite restricted food intake. Saniona, a biopharmaceutical company is in its mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome.


Tesomet is the first and only investigational treatment for HO to receive orphan drug designation. Tesomet is a fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker).


No medications are approved specially for HO, and there is no treatment for this disease. Many HO patients are treated with approaches used for general obesity such as surgery, medication and lifestyle counseling, but are mostly ineffective. The number of patients with HO is estimated to between 16,000 and 40,000 in Europe and 10,000 and 25,000 in the U.S.

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