What Soleno Therapeutics does

Soleno Therapeutics is a clinical-stage-to-commercial biopharmaceutical company focused on developing and commercializing therapeutics for rare genetic disorders, with a singular focus on Prader-Willi syndrome (PWS), a genetic condition affecting an estimated 350,000-400,000 people globally with a birth incidence of approximately 1 in 15,000. The company's lead and only commercial product is VYKAT XR (diazoxide choline) extended-release tablets, a once-daily oral formulation that received FDA approval on March 26, 2025 as the first and only treatment indicated for hyperphagia (insatiable hunger) in PWS patients aged 4 and older. The product generated $190 million in revenue in the post-approval period and is protected by formulation patents extending into the 2040s.

The underlying technology is a proprietary extended-release formulation of diazoxide choline designed to deliver sustained drug exposure via once-daily oral dosing, differentiating it from legacy immediaterelease diazoxide and supporting durable reductions in hyperphagia and behavioral symptoms as demonstrated through three years of Phase III follow-up data (p<0.0001 across all six behavioral domains). Soleno commercializes VYKAT XR through a sales-led, physician-prescribed specialty pharmacy model in the United States, targeting endocrinologists and genetic specialists treating PWS patients. The company supports adoption through medical affairs, patient support programs, and partnerships with the three major PWS advocacy organizations (Foundation for Prader-Willi Research, PWSA-USA, IPWSO). An EU marketing application was filed but withdrawn in April 2026.

Soleno was founded in California in 2004, headquartered in Redwood City, CA, and listed on Nasdaq under ticker SLNO until May 2026, when it was acquired by Neurocrine Biosciences for approximately $2.9 billion ($53.00 per share, with roughly 88.9% of shares tendered). Soleno now operates as a wholly owned subsidiary of Neurocrine. During 2025-2026 the company faced multiple securities class action lawsuits alleging misrepresentation of VYKAT XR safety and commercial viability, which remained a residual risk at the time of acquisition.

Name

Soleno Therapeutics

Legal name

Soleno Therapeutics, Inc.

Website

https://soleno.life

Company type

Public

Founded year

2004

Operating status

Acquired

Headcount range

101–250 employees

Short description

Soleno Therapeutics is a US biopharmaceutical company that develops and commercializes VYKAT XR (diazoxide choline extended-release), the first and only FDA-approved once-daily oral treatment for hyperphagia in Prader-Willi syndrome patients aged 4 and older. Now a wholly owned Neurocrine Biosciences subsidiary.

Ownership category

akta.pro rank

Product category

Rare Disease Therapeutics

NAICS

Offices of Optometrists (62132)

SIC

Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Rare Endocrine & Growth Disorder Therapies (HLAIAIAJ)

akta.pro secondary industry

Rare Ophthalmology Disorder Therapies (HLAIAIAK)

Keywords

• Rare disease therapeutics
• Prader-Willi syndrome treatment
• Orphan drug development
• Specialty pharmaceuticals
• Extended-release formulations

Headquarters

HQ city

Redwood City

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. VYKAT XR Product Sales: Direct product sales of VYKAT XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia in Prader-Willi syndrome patients. Generated $190 million in revenue in 2024/2025 following FDA approval in March 2025.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Soleno Therapeutics develops and commercializes VYKAT XR (diazoxide choline extended-release tablets), an FDA-approved once-daily prescription therapy indicated to treat hyperphagia in patients aged 4 and older with Prader-Willi syndrome (PWS). The company focuses exclusively on rare disease therapeutics, with VYKAT XR being the first and only FDA-approved treatment specifically for hyperphagia in PWS. Following its acquisition by Neurocrine Biosciences in May 2026, Soleno operates as a wholly owned subsidiary.

Product overview

Soleno Therapeutics is a biopharmaceutical company focused on rare diseases, primarily developing and commercializing therapeutics for Prader-Willi syndrome (PWS). The company's single commercial product is VYKAT XR (diazoxide choline) extended-release tablets, an FDA-approved once-daily oral treatment for hyperphagia in patients aged 4 and older with PWS. DCCR is the same drug compound referred to by its clinical development name. Following acquisition by Neurocrine Biosciences in 2026, Soleno operates as a wholly owned subsidiary.

Differentiator

Problem solved

Functional benefit

Brands

• VYKAT XR: Once-daily oral treatment (diazoxide choline) for hyperphagia in individuals aged 4 and older with Prader-Willi syndrome
• Soleno Medical Affairs

Products and services

• VYKAT XR VYKAT XR (diazoxide choline extended-release tablets) is a once-daily prescription therapy FDA-approved on March 26, 2025 to treat hyperphagia in patients aged 4 and older with Prader-Willi syndrome. It is the first and only FDA-approved therapy indicated for hyperphagia in PWS and is sold through specialty pharmacies and prescribing physicians.

Quantifiable outcome

• Phase III data demonstrated statistically significant and sustained improvements in hyperphagia and all six behavioral domains (p<0.0001 at all time points) through three years
• +1 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Four partnerships are on record, tiered flagship and minor.

• Neurocrine BiosciencesflagshipStrategic or Co-development Partner · 6 April 2026Neurocrine Biosciences acquired Soleno Therapeutics for approximately $2.9 billion in May 2026. The acquisition added VYKAT XR to Neurocrine's portfolio, expanding into endocrinology and rare diseases. Soleno became a wholly owned subsidiary of Neurocrine.
• Foundation for Prader-Willi ResearchminorOthersPatient advocacy organization collaborating with Soleno to advance awareness and advocacy in the PWS community. The foundation supports research and provides resources for patients and families.
• Prader-Willi Syndrome Association USAminorOthersNational patient advocacy organization providing support, information, and resources for people with PWS and caregivers. Soleno supports their efforts to raise awareness of the condition.
• International Prader-Willi Syndrome OrganizationminorOthersGlobal advocacy organization serving the international PWS community. Soleno collaborates with IPWSO to advance global awareness and support for patients and families.

Scale indicators6 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• BioMarin Pharmaceutical: Global rare disease biopharma with a multi-asset portfolio of orphan drugs targeting genetic and metabolic conditions. Comparable in commercial rare disease infrastructure, payer engagement, and product expansion strategy for high-need genetic disorders.
• Ultragenyx Pharmaceutical: Commercial-stage rare disease biopharma focused on genetic and metabolic disorders, with multiple approved orphan therapies. Highly comparable to Soleno in patient population focus, regulatory strategy, and commercial model for ultra-rare conditions.
• Harmony Biosciences: Commercial-stage rare disease biopharma with a single approved CNS product generating strong revenue. Closely mirrors Soleno's small-cap, single-asset, rare-disease commercial model and prescriber-driven distribution approach.
• Travere Therapeutics: Rare disease biopharma developing therapies for genetic and metabolic conditions with FDA-approved orphan products. Comparable in target therapeutic areas (rare metabolic/genetic disorders) and specialty commercial motion.

Broad incumbents

• Recordati Rare Diseases: Specialty pharma with a dedicated rare disease division commercializing orphan therapies globally. Comparable in rare disease commercial infrastructure and physician-led specialty distribution.
• Regeneron Pharmaceuticals: Large biopharma with a meaningful rare disease franchise (e.g., Eylea, Inmazeb) alongside broader therapeutic areas. Comparable in capabilities to develop and commercialize high-value orphan biologics for underserved populations.
• Alexion (AstraZeneca Rare Disease): Established leader in rare disease biopharma, now part of AstraZeneca, with a broad portfolio of approved orphan therapies. Comparable in regulatory, payer, and global rare disease commercialization capabilities, though at significantly larger scale.
• Vertex Pharmaceuticals: Commercial-stage biopharma with a portfolio of high-value therapies for serious rare genetic diseases (e.g., cystic fibrosis, sickle cell). Comparable in pricing power, payer engagement, and durable orphan exclusivity economics.

Emerging players

• BridgeBio Pharma: Clinical- and early-commercial-stage rare disease biopharma targeting genetic diseases. Comparable in therapeutic area focus and small-cap orphan drug development economics.
• Ionis Pharmaceuticals: Antisense-based rare disease biopharma with multiple approved and pipeline orphan assets. Comparable in developing novel therapies for genetic disorders with high unmet need and small patient populations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/soleno

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries2 records

Funding overview

Funding rounds6 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Soleno Therapeutics