Aspire Biopharma Submits Pre-IND Request to FDA for Fast-Acting Sublingual Aspirin with Significant Clinical Benefits
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
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Source: Newsfilter
- FDA Submission Progress: Aspire submitted its Pre-IND meeting request to the FDA on November 3, 2025, for its fast-acting sublingual aspirin, marking a significant milestone that is expected to accelerate the clinical development process toward potential FDA approval.
- Breakthrough Clinical Data: Clinical trials demonstrated that Aspire's sublingual aspirin inhibits platelet aggregation in under two minutes, acting approximately four to five times faster than chewed aspirin, which holds significant clinical implications for improving treatment outcomes in heart attack patients.
- Substantial Market Potential: With over 800,000 people in the U.S. experiencing heart attacks annually, Aspire's product could provide a faster and more reliable treatment option, addressing the urgent market demand for effective medical solutions.
- Optimized Regulatory Pathway: Aspire plans to pursue a 505(b)(2) regulatory pathway, which allows the FDA to consider data from previously approved drugs, potentially reducing development time and costs, thereby enhancing its competitive position in the market.
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About ASBP
Aspire Biopharma Holdings, Inc. is an early-stage biopharmaceutical company. It develops and markets a technology for novel delivery mechanisms for FDA approved drugs, nutraceuticals, and supplements. It has developed and acquired technologies that are a Novel Soluble Formulation which address emergencies and drug efficacy, dosage management, and response time. Its Sublingual Aspirin Product, which addresses cardiology emergencies and pain management, is a granular or powder formulation of a soluble, Ph-neutral, fast-acting aspirin. It also has numerous pharmaceutical and nutraceutical applications under development in various areas, including but not limited to a Viagra/Cialis combination product which is faster acting, requiring decreased dosages with the benefit of a longer half-life, various bi-hormonal drugs such as testosterone, estrogen and weight loss drugs, and thyroid drugs, as well as various supplements including a rapid-absorbing pre-workout and a melatonin sleep aid.
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.
Aspire Biopharma Submits Pre-IND Request to FDA for Fast-Acting Sublingual Aspirin with Significant Clinical Benefits
- FDA Submission Progress: Aspire submitted its Pre-IND meeting request to the FDA on November 3, 2025, for its fast-acting sublingual aspirin, marking a significant milestone that is expected to accelerate the clinical development process toward potential FDA approval.
- Breakthrough Clinical Data: Clinical trials demonstrated that Aspire's sublingual aspirin inhibits platelet aggregation in under two minutes, acting approximately four to five times faster than chewed aspirin, which holds significant clinical implications for improving treatment outcomes in heart attack patients.
- Substantial Market Potential: With over 800,000 people in the U.S. experiencing heart attacks annually, Aspire's product could provide a faster and more reliable treatment option, addressing the urgent market demand for effective medical solutions.
- Optimized Regulatory Pathway: Aspire plans to pursue a 505(b)(2) regulatory pathway, which allows the FDA to consider data from previously approved drugs, potentially reducing development time and costs, thereby enhancing its competitive position in the market.
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