Aspire Biopharma Enters Agreement with Microsize
Aspire Biopharma has entered into an agreement with Microsize. Microsize specializes in particle size reduction, micronization, and solubility enhancement for drugs. Aspire has partnered with Microsize to support the ongoing development of its lead drug candidate: acetylsalicylic acid 162 mg sublingual powder, an investigational new drug undergoing development for the emergency treatment of suspected acute myocardial infarction. This collaboration is expected to deliver optimized drug product to support an upcoming clinical trial and the planned submission of a Section 505(b)(2) New Drug Application for Aspire's sublingual aspirin near the end of 2026. The clinical trial will evaluate serum thromboxane B2 inhibition in 32 healthy volunteers, comparing (162 mg) against the current standard of care-two chewed 81 mg aspirin tablets. This collaboration marks a critical step for Aspire, securing critical expertise to support its ongoing and future product development and regulatory efforts.
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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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