New sublingual delivery system designed to enhance bioavailability and avoid gastric side effects many patients experience with clopidogrel.
Clopidogrel, currently sold under the brand name Plavix, was the 41st most commonly prescribed medication in the United States, with more than 15.2 million combined branded and generic prescriptions in 2023
ESTERO, FL / ACCESS Newswire / January 27, 2026 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a biopharmaceutical company developing multi-faceted patent-pending drug delivery technology, today announced the filing of a new provisional patent application with the United States Patent and Trademark Office (USPTO). The application, titled "A Sublingual Powder Formulation of Clopidogrel and Methods of Use Thereof," covers the first-ever sublingual formulation of clopidogrel, the active pharmaceutical ingredient (API) in the widely prescribed blood thinner Plavix.
This development represents a series of sublingual-based therapeutic alternatives the Company intends to commercialize via the FDA's 505(b)(2) regulatory pathway. Aspire's strategic pipeline focuses on reformulating approved generic therapeutics to address unmet needs where no sublingual alternatives currently exist, thus bringing the benefits of reducing or eliminating gastric irritation to products with these known side effects.
Clopidogrel (currently sold under the brand name Plavix) is a prescription antiplatelet medication indicated for acute coronary syndrome and for patients with a recent history of myocardial infarction, stroke or established peripheral arterial disease. It works by making platelets less "sticky," stopping them from clumping together in the blood vessels. It is also often used in combination with aspirin after a procedure to place a coronary artery stent to prevent blood clots from forming in the stent. Clopidogrel is also prescribed as a daily regimen to lessen the chance of future clotting events. Aspire believes its investigational new drug, acetylsalicylic acid 162 mg sublingual powder (OTASA), designed for the emergency treatment of suspected acute myocardial infarction (heart attack), if approved, could be utilized with clopidogrel as a Dual Antiplatelet Therapy or (DAPT).
Advancing Pharmacokinetic Performance
The filing seeks protection for Aspire's clopidogrel using its sublingual delivery system. Traditional tablet forms of clopidogrel prescribed for daily use can cause gastric irritation as a primary side effect (https://www.nhs.uk/medicines/clopidogrel/side-effects-of-clopidogrel/. Aspire's technology is designed to optimize the pharmacokinetic performance of clopidogrel by improving its absorption into the bloodstream directly from under the tongue, potentially increasing bioavailability, and significantly reducing or eliminating gastric irritation compared to traditional oral tablets.
Plavix, developed by Sanofi, was approved by the FDA in 1997, with a generic version approved in May 2012. Clopidogrel remains a widely prescribed antiplatelet drug, with over 15.2 million prescriptions in the U.S. in 2023, ranking it among the top 41 most common medications, used for preventing clots after heart attacks, strokes, and other vascular events according to ClinCalc. The standard recommended dosage of clopidogrel is 75 mg once daily.
CEO Commentary
"The filing of this provisional patent application for a sublingual formulation of clopidogrel marks another important step in Aspire Biopharma's mission to innovate established therapeutics," said Kraig Higginson, Interim CEO of Aspire. "Clopidogrel is a foundational treatment for millions of patients at risk of life-threatening vascular events, but the current standard of care-traditional tablets-has limitations for many due to gastric side effects that come with oral clopidogrel. Our novel sublingual technology is designed to avoid the gastric tract, enabling people to use clopidogrel with potentially less concern and less side effects."
About Clopidogrel
Clopidogrel lowers the risk of heart attack, stroke, or blood clots. It prevents blood cells (platelets) from clumping together to form a clot. It belongs to a group of medications called antiplatelets.
About Aspire Biopharma Holdings, Inc.
Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs to the body rapidly and precisely. This technology offers the potential to improve effectiveness and reduce side effects by going directly to the bloodstream and avoiding the gastrointestinal tract. Aspire Biopharma's delivery technology can be applied to many different active pharmaceutical ingredients (APIs) and other bioactive substances, spanning both small and large molecule therapeutics, nutraceuticals and supplements.
For more information, please visit www.aspirebiolabs.com
Aspire Biopharma Holdings, Inc.
Contact
PCG Advisory
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Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Aspire's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and
developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; Aspire's acetylsalicylic acid sublingual powder, 162 mg (OTASA) is an investigational new drug and has not been approved for marketing for any indication, our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; that the Company will be able to meet the deadlines or conditions imposed by the Hearings Panel or regain compliance with all applicable requirements for continued listing, and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
SOURCE: Aspire Biopharma Holdings, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/aspire-biopharma-files-provisional-patent-application-for-industry-fi-1130803
