S1 Biopharma, Inc.
S1 Biopharma is a clinical-stage biopharmaceutical company dedicated to developing first-in-class, non-hormonal therapies for sexual dysfunction in women and men. Their mission is to bring innovative treatments to address significant unmet medical needs related to sexual health, focusing on restoring the natural balance of neurotransmitters in the brain to improve sexual desire and function.
Industries
Nr. of Employees
small (1-50)
S1 Biopharma, Inc.
7 World Trade Center, 250 Greenwich St., 46th Floor, New York City, NY 10007
Patents
Products
Lorexys (SIP-104)
Oral non-hormonal fixed-dose combination therapy designed to restore balance of key neurotransmitters (dopamine, serotonin, norepinephrine) for the treatment of hypoactive sexual desire disorder in women; completed Phase 2a and positioned for Phase 2b.
Orexa (S1P-205)
Oral therapy candidate developed specifically for hypoactive sexual desire disorder in men; advanced to Phase 2a clinical planning with a double-blind placebo-controlled study design.
Additional pipeline candidates (S1B-3006, S1B-307)
Development-stage drug candidates listed in the company's sexual dysfunction pipeline; limited public detail on mechanisms or clinical stage in provided content.
Lorexys (SIP-104)
Oral non-hormonal fixed-dose combination therapy designed to restore balance of key neurotransmitters (dopamine, serotonin, norepinephrine) for the treatment of hypoactive sexual desire disorder in women; completed Phase 2a and positioned for Phase 2b.
Orexa (S1P-205)
Oral therapy candidate developed specifically for hypoactive sexual desire disorder in men; advanced to Phase 2a clinical planning with a double-blind placebo-controlled study design.
Additional pipeline candidates (S1B-3006, S1B-307)
Development-stage drug candidates listed in the company's sexual dysfunction pipeline; limited public detail on mechanisms or clinical stage in provided content.
Services
Structuring and executing out-licensing and commercialization agreements to enable regional market entry and milestone-based collaborations.
Structuring and executing out-licensing and commercialization agreements to enable regional market entry and milestone-based collaborations.
Expertise Areas
- Clinical trial management
- CNS drug development
- Fixed-dose combination formulation
- Therapeutics for sexual dysfunction (HSDD, FSD, male HSDD)
Key Technologies
- CNS-targeted pharmacotherapy
- Fixed-dose combination oral formulations
- Adaptive clinical trial designs (crossover, MAD)
- IND and 505(b)(2) regulatory pathways
News & Updates
Participation in a review of late-stage innovations in women’s health by CEO Nick Sitchon.
Participation in a panel hosted by Duane Morris and the Chinese Biopharmaceutical Association.
Presentation of expanded analysis of Phase 2a data on Lorexys for HSDD.
Patent grants for Lorexys in Europe and Asia for treatment of HSDD.
Announcement of S1P-205, the first drug in development for male HSDD.
Support for FDA approval of Lorexys for HSDD.
Participation in a review of late-stage innovations in women’s health by CEO Nick Sitchon.
Participation in a panel hosted by Duane Morris and the Chinese Biopharmaceutical Association.
Presentation of expanded analysis of Phase 2a data on Lorexys for HSDD.
Patent grants for Lorexys in Europe and Asia for treatment of HSDD.
Announcement of S1P-205, the first drug in development for male HSDD.
Support for FDA approval of Lorexys for HSDD.