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Market opportunity

A metered oro-buccal tadalafil spray in development for erectile dysfunction

$6.98B market*

Fast-tracked pathway​

The global erectile-dysfunction drug market is established and sizeable.

Ro states that it has treated approximately two million members for erectile dysfunction, while Hims & Hers reported approximately 2.584 million subscribers across all specialties in the first quarter of 2026.

*ESTIMATED BY 2034

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505(b)(2)

Pathway

8

Years of research development

70m

NanoCelle doses

37

Countries licensed

Compound annual
growth rate of 9%

Erectile dysfunction is a common condition affecting tens of millions of men in the United States and a substantially larger population worldwide. US estimates commonly cited by public-health sources range from approximately 30 million to 50 million affected men. Prevalence increases with age, while diabetes, cardiovascular disease, obesity, sedentary lifestyles, smoking, some medicines and psychological factors contribute to demand across age groups.

The global erectile-dysfunction drug market is established and sizeable. Third-party market research cited in NanoCelle Virile materials estimates growth from approximately US$2.68 billion in 2023 to US$6.89 billion by 2034, representing a forecast compound annual growth rate of about 9%. Forecasts vary by source and methodology and should be refreshed immediately before publication.

Seizing a multi-billion dollar
market with rapid growth potential

Digital healthcare is reshaping how men access treatment. Telehealth platforms have demonstrated that privacy, convenience and home delivery can attract large patient populations. Ro states that it has treated approximately two million members for erectile dysfunction, while Hims & Hers reported approximately 2.584 million subscribers across all specialties in the first quarter of 2026.

NanoCelle Virile’s opportunity is to enter an existing category with a differentiated experience rather than create a new market. The proposed commercial pathway is US-first, self-pay and digital-first, supported by prescriber education and later pharmacy and international expansion. Illustrative internal scenarios show that even a small share of a conservative 30-million-person US affected population could support meaningful revenue, depending on eligibility, conversion, usage, pricing, reimbursement and net revenue per dose.

Cutting-edge treatment with a clear pathway to market

The central commercial proposition is earlier-exposure potential, discretion and tadalafil duration, subject to human clinical validation and regulatory approval.

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