Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Powder Formulation of Clopidogrel (Generic Plavix(R)) to Address Gastric Bleeding Risks

Rhea-AI Summary

Aspire Biopharma (Nasdaq:ASBP) announced filing a provisional patent application with the USPTO for the first-ever sublingual powder formulation of clopidogrel.

The filing covers a sublingual delivery system intended to improve clopidogrel pharmacokinetics by enabling absorption under the tongue, potentially increasing bioavailability and reducing or eliminating gastric irritation associated with oral tablets. Aspire plans to pursue commercialization via the FDA 505(b)(2) pathway and positions this program alongside its other reformulation efforts, including an investigational acetylsalicylic acid 162 mg sublingual powder (OTASA) intended for emergency myocardial infarction treatment.

Positive

• Filed provisional USPTO patent for the first sublingual clopidogrel formulation
• Targets reduced gastric irritation compared with oral clopidogrel tablets
• Development aimed at 505(b)(2) regulatory pathway to leverage existing safety data

Negative

• Provisional patent application does not guarantee grant or enforceable rights
• No clinical data or FDA approval for the sublingual clopidogrel formulation disclosed
• Commercial timeline and regulatory outcome for 505(b)(2) pathway remain unspecified

Key Figures

Clopidogrel prescriptions: 15.2 million prescriptions Drug ranking: 41st most commonly prescribed OTASA dose: 162 mg +1 more

4 metrics

Clopidogrel prescriptions 15.2 million prescriptions Combined branded and generic in U.S. in 2023

Drug ranking 41st most commonly prescribed Clopidogrel usage ranking in the United States

OTASA dose 162 mg Investigational sublingual aspirin powder (OTASA) dose

Standard clopidogrel dose 75 mg once daily Standard recommended dosage of clopidogrel

Market Reality Check

Price: $1.61 Vol: Volume 374,676 is well be...

low vol

$1.61 Last Close

Volume Volume 374,676 is well below 20-day average of 1,444,998 (relative volume 0.26x). low

Technical Shares trade at $1.76, below the 200-day moving average of $12.56 and close to the 52-week low of $1.6547.

Peers on Argus

ASBP fell 6.63% while peers were mixed: one notable gainer (QTTB up 4.7%) and se...

ASBP fell 6.63% while peers were mixed: one notable gainer (QTTB up 4.7%) and several modest decliners. No peers appeared in the momentum scanner, pointing to a stock-specific move rather than a coordinated biotechnology sector reaction.

Historical Context

5 past events · Latest: Jan 22 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 22	Product inventory update	Positive	-5.2%	Delivered two million BUZZ BOMB units and built strategic inventory.
Jan 21	Brand redesign launch	Positive	-5.0%	Comprehensive BUZZ BOMB rebrand with new website and packaging.
Jan 20	Patent filing clinical	Positive	-9.1%	Provisional patent for sublingual alprazolam and planned Phase 1 trial.
Jan 14	Reverse stock split	Negative	-26.4%	1-for-40 reverse split to address Nasdaq bid-price compliance.
Jan 07	Regulatory meeting FDA	Positive	+19.6%	Successful pre-IND FDA meeting for OTASA with supportive feedback.

Pattern Detected

Recent history shows frequent selling on positive operational news and a sharp drop on the reverse split, with only the OTASA pre-IND update drawing a positive price reaction.

Recent Company History

Over the last few weeks, Aspire Biopharma has issued multiple updates around its sublingual drug-delivery strategy and consumer products. On Jan 7, 2026, a positive pre-IND FDA meeting for OTASA and a planned study in 32 volunteers saw the stock gain 19.62%. Subsequent positive news on BUZZ BOMB’s rebrand and delivery of two million units, plus a provisional patent for sublingual alprazolam, were followed by declines of 4.98%, 5.24%, and 9.05%. A 1-for-40 reverse split on Jan 16, 2026 led to a 26.44% drop. Today’s clopidogrel patent filing fits the same sublingual reformulation theme against this pressured trading backdrop.

Market Pulse Summary

This announcement extends Aspire Biopharma’s sublingual drug-delivery strategy to clopidogrel, a wid...

Analysis

This announcement extends Aspire Biopharma’s sublingual drug-delivery strategy to clopidogrel, a widely used antiplatelet with over 15.2 million U.S. prescriptions in 2023. The provisional patent targets improved bioavailability and reduced gastric irritation versus oral tablets, complementing the company’s OTASA program and prior alprazolam filing. Recent history also includes a reverse split, exchange of about $1.75M of debt into equity, and an equity line of up to $100M, highlighting both pipeline ambitions and ongoing financing and going-concern risks to monitor.

Key Terms

sublingual, bioavailability, pharmacokinetic, myocardial infarction, +2 more

6 terms

sublingual medical

"New sublingual delivery system designed to enhance bioavailability and avoid..."

Sublingual describes a way to take a drug or supplement by placing it under the tongue so active ingredients are absorbed through the thin tissue there directly into the bloodstream. Like taking a shortcut compared with swallowing a pill, this can produce faster effects, simpler dosing and sometimes more predictable delivery. Investors watch for sublingual formulations because they can affect a product’s market appeal, regulatory pathway, pricing and competitive positioning.

bioavailability medical

"New sublingual delivery system designed to enhance bioavailability and avoid..."

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

pharmacokinetic medical

"Aspire's technology is designed to optimize the pharmacokinetic performance of clopidogrel..."

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

myocardial infarction medical

"indicated for acute coronary syndrome and for patients with a recent history of myocardial infarction..."

Myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked and heart muscle is damaged—like a garden hose being pinched so a patch of lawn starts to die. For investors, heart attacks matter because they drive demand for drugs, devices, hospitals and rehabilitation, affect health-care costs and workforce productivity, and can lead to regulatory actions, litigation or shifts in insurance and pricing that impact company earnings.

peripheral arterial disease medical

"stroke or established peripheral arterial disease. It works by making platelets less..."

Peripheral arterial disease is a condition where fatty buildup and narrowing in the arteries reduce blood flow to the legs and feet, causing pain, slow wound healing, and higher risk of infection. Investors care because PAD drives demand for diagnostics, drugs, medical devices and procedures, influences healthcare costs and reimbursement decisions, and can affect sales, regulatory milestones and long-term revenue for companies in cardiovascular and wound-care markets.

505(b)(2) regulatory

"alternatives the Company intends to commercialize via the FDA's 505(b)(2) regulatory pathway."

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

AI-generated analysis. Not financial advice.

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 41^st 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
Kevin McGrath
+1-646-418-7002
kevin@pcgadvisory.com

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

FAQ

What did Aspire Biopharma (ASBP) file on January 27, 2026 regarding clopidogrel?

Aspire filed a provisional patent application with the USPTO for a sublingual powder formulation of clopidogrel intended to improve absorption and reduce gastric irritation.

How could Aspire's sublingual clopidogrel affect gastric side effects from Plavix (ASBP)?

Aspire says the sublingual route is designed to absorb drug under the tongue, potentially reducing or eliminating gastric irritation seen with traditional oral tablets.

Will Aspire (ASBP) seek FDA approval for the sublingual clopidogrel and by what pathway?

Aspire intends to pursue commercialization via the FDA 505(b)(2) regulatory pathway, which can rely partly on existing safety data from approved products.

Is the sublingual clopidogrel from Aspire (ASBP) FDA-approved and available now?

No. Aspire has filed a provisional patent application; the formulation has not been shown to have clinical results or received FDA approval.

Does Aspire plan to pair sublingual clopidogrel with any other therapies?

Aspire suggests its investigational OTASA (acetylsalicylic acid 162 mg sublingual powder) could be used alongside clopidogrel as dual antiplatelet therapy if approved.