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S1B-307 is a small molecule therapeutic candidate being developed by S1 Biopharma (also known as S1 Pharmaceuticals) for the treatment of various sexual health conditions. The drug is primarily targeted at Female Orgasmic Disorder (FOD) and Female Sexual Arousal Disorder (FSAD), but it is also being investigated for male indications, including delayed ejaculation and treatment-resistant erectile dysfunction. Developed via the FDA's 505(b)(2) regulatory pathway, S1B-307 is designed as a non-hormonal therapy that likely modulates neurobiological pathways involved in the sexual response cycle. As of recent pipeline updates, the program is in the IND-enabling and Phase 1 preparation stages.
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