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Auxilius Pharma today announced the signing of a USD 4 million Series A financing round that will accelerate the company’s research, development, and clinical advancement of its lead cardiovascular program, AUX-001, an innovative once-daily formulation designed for the treatment and prevention of chronic stable angina.

A New Stage of Growth and Development

The newly secured capital will support the completion of pharmaceutical optimization for AUX-001 and fund the next key clinical milestone: a Phase 1b trial. Participants in this financing round include ff.VC ASI II, NIF ASI, and NanoGroup S.A. - EU-based venture capital institutions investing in emerging biotech projects.

Lead Program: AUX-001

AUX-001 is positioned to become the first new innovative oral therapy for chronic stable angina in the United States since 2006. Based on a modernized formulation of nicorandil developed using proprietary extended-release technology, AUX-001 is intended for once-daily administration and can significantly simplify treatment for a patient population commonly affected by considerable levels of polypharmacy.

Traditional immediate-release (IR) nicorandil requires multiple daily doses and is currently available in the EU, Australia, New Zealand, Japan, South Korea, and China, but not in the United States. Leveraging a unique dual mechanism of action, nicorandil remains the only anti-anginal that improves both symptoms as well as the long-term prognosis of the typically underlying coronary artery disease, of which exercise-induced chronic angina is the hallmark symptom. Through its effect on the vascular wall of both larger as well as smaller branches of coronary arteries, nicorandil ameliorates the impact of both macro- and microvascular coronary disease.

Regulatory and Clinical Progress

Auxilius Pharma’s R&D strategy in chronic angina, a therapeutic area with substantial unmet need, has been recognized by investors and supported by steady regulatory progress. A successful pre-IND meeting with the U.S. Food and Drug Administration (FDA) in 2022 confirmed AUX-001’s suitability for the cost-effective and predictable 505(b)(2) regulatory pathway.

In preparation for IND submission, Auxilius Pharma presented results from the first-in-human Phase 1 pharmacokinetic study at the European Society of Cardiology and American Heart Association Scientific Sessions. The data demonstrated:

• A once-daily pharmacokinetic profile with a half-life exceeding 9 hours, compared to 52 minutes for IR nicorandil
• Improvements in safety and tolerability compared to IR nicorandil
• Minimal impact on hemodynamic parameters
• No effect on QTc interval duration

Based on the FDA-confirmed 505(b)2 approval pathway, Auxilius Pharma may be eligible to bypass Phase 2 clinical trial and could seek U.S. market authorization for AUX-001 as early as 2028. Following U.S. approval, the company plans to expand availability in global markets through strategic partnerships. Auxilius Pharma’s broader R&D pipeline includes additional cardiovascular products addressing high-unmet need indications. Regarding AUX-001, Auxilius is considering multiple additional indications if the initial CSAP indication is successfully obtained, including chronic angina in patients with frequent comorbid conditions such as coronary microvascular disease and heart failure.

Market Opportunity: Chronic Stable Angina

Chronic Stable Angina Pectoris (CSAP) affects more than 11 million people in the U.S. and 16 million in Europe, with an estimated 550,000 new cases annually in the U.S. and over 650,000 in Europe. As the symptomatic expression of atherosclerotic coronary artery disease, CSAP frequently requires patients to receive multiple anti-anginal medications to manage daily or weekly symptoms.

Despite the prevalence and burden of chronic angina, no novel anti-anginal therapy has been introduced in the U.S. for nearly two decades. Nonetheless, physician interest in new treatment options remains high. In a recent survey of U.S. cardiologists and primary care physicians conducted by Auxilius, more than 70% of physicians indicated they would rapidly adopt a once-daily therapy with a clinical profile similar to AUX-001. These survey results have been submitted for presentation at the American College of Cardiology (ACC) 2026 Annual Scientific Session.

About Auxilius Pharma

Auxilius Pharma is a privately held biotechnology company specializing in value-added medicines in cardiology. The company focuses on unlocking the therapeutic potential of existing drug compounds through innovative optimization, delivering improvements in efficacy, safety, and patient convenience.

Press Contact:

Michelle Stansbury

Michelle@LittlePenguinPR.com