
Jul 17 2025
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U.S. FDA Grants Orphan Drug Designation to Tesomet In Hypothalamic obesity (HO)
Saniona, a clinical-stage biopharmaceutical company focused on rare diseases, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) to treat hypothalamic obesity (HO). Tesomet is the first and only HO investigational treatment to be designated as an orphan drug. Saniona plans to start two Phase 2b Tesomet studies in the second half of this year, one in HO and the other in Prader-Willi syndrome (PWS).
Source: Saniona
Hypothalamic obesity (HO) is a severe and heterogeneous disease related to several conditions, such as hypothalamic damage caused by tumors and their treatment, inflammatory, trauma, neurosurgery, cerebral aneurysm, single-gene mutations (e.g., leptin, leptin receptor, CART, POMC), rare congenital disorders with midline, genetic syndromes, and the use of psychotropic drugs. The weight gain pattern in HO patients is characterized by a sudden onset and rapid acceleration after hypothalamic damage. The symptoms of HO vary by the cause and include uncontrollable hunger, rapid, excessive weight gain, and a low metabolic rate. If the pituitary gland is involved, symptoms may consist of small underdeveloped testes in males and delayed puberty. This condition most often occurs because of injury to the hypothalamus due to a tumor, swelling in the brain, brain surgery, or head trauma.
- As the most common cause of this condition, Craniopharyngiomas range between 1.5 to 2.8 cases per million population.
However, the current Hypothalamic obesity (HO) treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (Setmelanotide, Tesomet, Exenatide, Tesofensine, and ZGN-440) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.
In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Hypothalamic obesity (HO) treatment. The key companies in the advanced development stage are Rhythm Pharmaceuticals, Inc., Saniona, Amylin Pharmaceuticals, LLC., and Zafgen, Inc., targeting HO.
Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Hypothalamic Obesity (HO) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.
Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.
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