Soleno Therapeutics (NASDAQ: SLNO) is a biopharmaceutical company focused on the development and commercialization of therapies for rare diseases. Its lead product is VYKAT XR (diazoxide choline extended-release tablets), a treatment for Prader-Willi syndrome. The company received FDA approval for VYKAT XR and has been advancing commercialization in the United States as of FY2025, per the 10-K filed 2026-02-25. Revenue is generated through prescription drug sales of VYKAT XR to patients with Prader-Willi syndrome, a rare genetic disorder. Soleno is also pursuing regulatory pathways for VYKAT XR (referred to as DCCR outside the U.S.) in markets outside the United States. The company operates in the orphan drug segment of the biopharmaceutical industry, where regulatory exclusivity and small patient populations define the competitive environment.

Revenue model

Prescription drug sales of VYKAT XR (diazoxide choline extended-release tablets) in the United States. International commercialization of DCCR is a stated objective but not confirmed as generating revenue in the FY2025 filing excerpts.

Products and services

VYKAT XR (diazoxide choline extended-release tablets), an FDA-approved treatment for Prader-Willi syndrome. Previously referred to as DCCR during clinical development. International regulatory path for DCCR outside the U.S. is ongoing as of the FY2025 10-K.

Customers and end markets

Patients diagnosed with Prader-Willi syndrome, a rare genetic disorder. End market is the orphan/rare disease segment of the pharmaceutical market.

Value-chain role

Drug developer and commercial-stage biopharmaceutical company. Holds FDA approval for VYKAT XR and is responsible for U.S. commercialization. Pursuing regulatory approvals in markets outside the United States.

Geographic exposure

United States (primary commercial market as of FY2025). International regulatory activities for DCCR noted in the 10-K filed 2026-02-25, but no confirmed international commercial revenue in the excerpts provided.

Source: SEC 10-K, filed 2026-02-25

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