Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for rare and orphan endocrine diseases. Headquartered in Redwood City, California, Soleno leverages its expertise in peptide chemistry and small-molecule pharmacology to advance treatments that address unmet medical needs. The company’s mission centers on improving outcomes and quality of life for patients suffering from hormonal disorders that currently have limited or no approved therapeutic options.
The company’s lead product, Recorlev® (levoketoconazole), is an oral inhibitor of cortisol synthesis designed to treat adults with endogenous Cushing’s syndrome. After successfully completing pivotal clinical studies, Soleno obtained U.S. Food and Drug Administration approval for Recorlev and has initiated commercial launch activities. The company’s commercial strategy includes direct-to-physician outreach, collaboration with specialty pharmacies, and engagement with patient advocacy groups to drive awareness and access.
Beyond Recorlev, Soleno is advancing its pipeline with an investigational program for congenital adrenal hyperplasia (CAH), a genetic disorder characterized by impaired cortisol production. Preclinical and early clinical data suggest that levoketoconazole may offer a differentiated safety and efficacy profile relative to existing therapies. Soleno continues to explore additional endocrine indications and potential combination regimens to broaden its impact on rare disease care.
Founded in 2010, Soleno has assembled a leadership team with deep experience in endocrinology, drug development, and commercial operations. Under the direction of its executive management and board of directors, the company has forged strategic collaborations and secured grant funding to support its research initiatives. Soleno intends to expand its global footprint through regulatory filings in key markets and partnerships that facilitate patient access to its therapies worldwide.
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