ASPIRE BIOPHARMA HOLDINGS INC · Data as of 2026-09-08
Q3 2026
Aspire will conduct a Phase One clinical test in approximately the third quarter of 2026 for pharmokinetical validation of product properties, using approximately eight volunteers, and to establish criteria for an NDA with the FDA.Source filing
Sep 2026–Apr 2027
Aspire plans to submit its FDA 505(b)(2) approval request in late 2026 or early 2027 for the prescription strength high dose aspirin product given the history of aspirin (and over 100 years of history).Source filing
Q4 2026
Aspire anticipates, based on these results, to request a pre-IND meeting with the FDA in the fourth quarter of 2026, followed by Phase Two clinical testing.Source filing
Q4 2026
Aspire intends to submit an NDA for the testosterone product under 505(b)(2) to the FDA in the fourth quarter of 2026 at the earliest.Source filing
2027
These results will be the backbone of a 505(b)(2) submission to the FDA planned for the first six months of 2027, once the next clinical trial is concluded.Source filing