This section highlights FDA-related milestones and regulatory updates for drugs developed by Aspire Biopharma (ASBP).
Over the past two years, Aspire Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Sublingual and BUZZ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Sublingual Aspirin FDA Regulatory Events
Sublingual Aspirin is a drug developed by Aspire Biopharma for the following indication: Diabetes, Weight Management.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sublingual Aspirin
- Announced Date:
- October 1, 2025
- Indication:
- Diabetes, Weight Management
Announcement
Aspire Biopharma Holdings, announced pipeline progress and key milestones expected through the remainder of 2025 and early 2026. The company is focusing its pipeline on reformulating approved drugs for multi-billion-dollar markets by utilizing its disruptive, patent-pending sublingual delivery technology.
AI Summary
Aspire Biopharma is reformulating approved drugs using a patent-pending sublingual delivery system to target multi-billion-dollar markets. Its goal is to boost drug absorption, cut side effects, and improve patient compliance.
Key milestones through early 2026 include: for high-dose aspirin, an FDA meeting in H2 2025 to discuss the 505(b)(2) pathway and an NDA submission later that year; for sublingual ED medication, finalizing formulation and manufacturing in H1 2026 with a Phase 1 pharmacokinetic study mid-2026; and for sublingual semaglutide, completing formulation work and launching an initial Phase 1 crossover study in H1 2026.
Aspire plans to use partnerships to speed market entry. This approach could bring new, rapid-onset versions of drugs for heart health, men's health, and metabolic disorders faster. It believes its sublingual platform can deliver faster, safer treatments and improve patient outcomes.
Read Announcement
BUZZ BOMB FDA Regulatory Events
BUZZ BOMB is a drug developed by Aspire Biopharma for the following indication: New Sublingual Pre-Workout Supplement.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BUZZ BOMB
- Announced Date:
- July 9, 2025
- Indication:
- New Sublingual Pre-Workout Supplement
Announcement
Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from the Company's sampling of its sublingual pre-workout supplement, BUZZ BOMB™.
AI Summary
Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from sampling its sublingual pre-workout supplement, BUZZ BOMB™. This new product uses nano technology to deliver caffeine directly through the tissues under the tongue, offering rapid energy delivery and enhanced mental focus. With 50mg of caffeine per serving, BUZZ BOMB™ is designed to provide nearly instant energy for athletes and gym enthusiasts, making it a convenient alternative to traditional pre-workout mixes.
The supplement is available in four flavors, packaged in easy-to-use single servings. Early testers, including personal trainers and gym goers, praised its fast-acting benefits and ease of use, noting improvements in workout energy and endurance. Aspire Biopharma plans to officially launch BUZZ BOMB™ at the FITCON and Fit Expo conventions in August, aiming to make it a go-to energy solution in the competitive pre-workout market.
Read Announcement
