Scienture Launches REZENOPY Nasal Spray with FDA Approval for 10mg Dosage
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 22 2025
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Scienture provided an update on the commercial launch of REZENOPY. As previously disclosed, Scienture, a wholly owned subsidiary of Scienture Holdings, entered into a definitive agreement with Summit Biosciences in March 2025, for the exclusive U.S. commercialization rights to REZENOPY Nasal Spray 10 mg, which received FDA approval on April 19, 2024. "REZENOPY represents a significant advancement in overdose response as the highest-strength naloxone available on the market at 10 mg. It is specifically designed for patients who often require multiple doses of lower-strength naloxone for stabilization in emergency situations," commented Narasimhan Mani, President and co-CEO of Scienture. "By delivering a higher dose of naloxone, REZENOPY is intended to support opioid receptor antagonism and may help address overdose situations where multiple or potent opioids are involved."
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About SCNX
Scienture Holdings, Inc., through its wholly owned subsidiary, Scienture, LLC, is a specialty pharmaceutical company focused on providing enhanced value to patients, physicians and caregivers by offering specialty products to satisfy unmet market needs. Scienture, LLC is focused on developing and commercializing products for the treatment of central nervous system and cardiovascular diseases. Scienture LLC is developing a range of product candidates, including new potential treatments for hypertension, migraine, pain and thrombosis and other related disorders. The Company's product candidates include SCN- 102 (hypertension), SCN- 104 (CNS-Pain), SCN- 106 (Cardiovascular) and SCN- 107 (Pain). SCN-102 is an oral liquid formulation of losartan potassium in development for the treatment of hypertension. SCN-104 is a multi-dose pen-based delivery system for self-injection and increased patient convenience, which is in development for the acute treatment of migraine headaches.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Summit Biosciences Secures U.S. Patent for Rezenopy Nasal Spray Effective January 2026
- Patent Approval: The U.S. Patent and Trademark Office has granted Summit Biosciences Inc. a patent for Rezenopy (naloxone HCl) Nasal Spray 10 mg, effective January 6, 2026, expiring on February 5, 2041, enhancing the product's intellectual property protection in the U.S. market.
- Commercialization Agreement: Scienture LLC has signed an exclusive commercialization agreement with Summit for U.S. rights to Rezenopy, with Summit responsible for manufacturing and supply while Scienture holds the new drug application (NDA) and manages sales and marketing, ensuring smooth market entry.
- Market Potential: According to IQVIA data, total annual U.S. naloxone sales reached approximately $154 million with unit volume of 9.3 million, indicating significant market opportunities for Rezenopy in addressing the opioid overdose crisis.
- Financial Growth: Scienture reported a third-quarter net revenue increase from approximately $65,000 to $590,000, with gross profit rising from roughly $4,000 to $575,000, reflecting strong growth momentum following the product launch.
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Scienture Launches REZENOPY® with $154 Million Annual Sales Potential
- Significant Market Potential: The U.S. naloxone market boasts annual sales of approximately $154 million and a unit volume of 9.3 million, indicating a strong demand for overdose countermeasures, with the launch of REZENOPY® poised to fill this market gap.
- Product Advantages: REZENOPY® is the highest-strength naloxone nasal spray available, specifically designed for patients who often require multiple doses of lower-strength naloxone, which is expected to significantly enhance emergency response effectiveness and improve patient survival rates.
- Smooth Commercialization Progress: Scienture anticipates loading REZENOPY® into the wholesale channel in Q1 2026, with commercial availability beginning in early Q2 2026, marking a rapid response capability to meet market demands.
- Deepening Strategic Partnerships: The exclusive agreement with Summit Biosciences not only secures REZENOPY®'s market position in the U.S. but also lays a solid foundation for Scienture's future product development and market expansion efforts.
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