S1 Biopharma is focused on developing innovative therapies for sexual dysfunction, particularly targeting conditions such as hypoactive sexual desire disorder (HSDD) and erectile dysfunction (ED). Their lead product, Lorexys, is a first-in-class treatment designed specifically for women with HSDD. It combines two FDA-approved antidepressants, bupropion and trazodone, in a fixed-dose formulation that aims to balance neurotransmitters—dopamine, serotonin, and norepinephrine—critical for sexual response. This unique formulation not only seeks to enhance efficacy but also to mitigate the side effects typically associated with each drug. Lorexys has received 505(b)(2) status from the FDA, which allows for an expedited approval process due to the established safety profiles of its components.

In addition to Lorexys, S1 Biopharma is advancing other drug candidates, including Orexa for erectile dysfunction, through clinical trials. The company emphasizes the importance of understanding the central nervous system's role in sexual health, which informs their approach to therapy development. S1 Biopharma is actively seeking partnerships and collaborations to facilitate the commercialization of its products, aiming to address the significant unmet needs in sexual dysfunction treatment for both men and women. Their clinical development plans are designed to meet regulatory expectations, including comprehensive data on potential drug interactions, thereby positioning the company for future success in the biopharmaceutical landscape.

United States

Founded in 2008, S1 Biopharma is developing first-in-class drugs for the treatment of sexual dysfunction and hypoactive sexual desire disorder (HSDD) in both women and men. The company’s non-hormonal therapies work uniquely by restoring the natural balance of neurotransmitters in the brain.

Since our company’s inception, we have been committed to innovation, integrity, the use of the highest quality science and a deep understanding of the biology underlying these disorders to develop effective treatments with safety as a priority.

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S1 Biopharma

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