Aspire Biopharma Announces New Clinical Trials for Sublingual Aspirin and Rapid-Acting ED Medication, Eyes 2025–2026 FDA Submissions
Reuters
Oct 01
Aspire Biopharma Announces New Clinical Trials for Sublingual Aspirin and Rapid-Acting ED Medication, Eyes 2025-2026 FDA Submissions
Aspire Biopharma Holdings Inc. (NASDAQ: ASBP) has announced upcoming milestones for its pipeline of sublingual drug delivery products. The company plans to submit a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its high-dose sublingual aspirin in the second half of 2025, following a review of clinical trial results with the agency. Additionally, Aspire intends to finalize the formulation and manufacture of a sublingual semaglutide product and conduct an initial Phase 1 pharmacokinetic clinical cross-over study in the first half of 2026. For its needle-free, rapid-acting erectile dysfunction medication, Aspire plans to develop and validate the manufacturing process and produce a cGMP batch in early 2026, with a Phase 1 clinical test scheduled for the second or third quarter of 2026. Results of these clinical studies have not yet been presented and are expected in the future as the company advances its development programs.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aspire Biopharma Holdings Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1080343) on October 01, 2025, and is solely responsible for the information contained therein.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.