Kardigan Accelerates Development of Transformative Cardiovascular Medicines Across Three Critical Disease Areas
Kardigan, a pioneering heart health company dedicated to modernizing cardiovascular drug development, today unveiled the three late-stage clinical programs that anchor its rapidly advancing pipeline. These programs represent a strategic focus on diseases with high unmet medical needs—dilated cardiomyopathy (DCM), acute severe hypertension (ASH), and calcific aortic valve stenosis (CAVS)—where no approved therapies currently exist to halt disease progression or deliver curative outcomes. Each program has been carefully selected to address the underlying drivers of disease, reflecting Kardigan’s mission to develop multiple innovative cardiovascular medicines at an unprecedented pace.
Cardiovascular Disease Remains the Leading Global Health Challenge
Cardiovascular disease (CVD) continues to dominate as the leading cause of death worldwide, despite decades of medical advancements and public health initiatives. According to recent studies, more people die from cardiovascular causes each year than from all forms of cancer and accidents combined. In the United States alone, heart disease claims more lives than any other condition, underscoring the urgent need for new, transformative therapies.
Despite the high prevalence and profound impact of cardiovascular disease, traditional drug development has been characterized by incremental innovation, limited investment, and sporadic focus. For many patients, existing therapies manage symptoms but do little to address the fundamental mechanisms of disease progression. This gap has left millions of patients without options that could meaningfully change the course of their condition, highlighting a critical unmet need in the cardiology space.
A New Paradigm in Cardiovascular Drug Development
“To create meaningful change for patients suffering from cardiovascular diseases, we need to think differently about how we develop new drugs,” said Tassos Gianakakos, co-founder, chief executive officer, and chair of Kardigan. “At Kardigan, we are uniting real-world patient data, artificial intelligence insights, and deep cardiovascular expertise to advance therapies with the potential to transform outcomes.
Each of our therapeutic candidates is designed to address a specific subset of patients in key disease areas where it is possible to halt disease progression or even deliver a functional cure. We are grateful for the continued support of our clinical collaborators, who share our conviction that the time is now to pioneer a new scientific strategy aimed at making cardiovascular disease preventable, curable, and no longer the leading cause of death in the world.”
Kardigan’s approach integrates cutting-edge technology with deep clinical expertise. By leveraging the Prolaio platform—an advanced AI and real-world data analytics system—the company is able to extract actionable insights from patient populations, informing trial design, identifying optimal patient segments, and potentially reducing the time and cost required to develop breakthrough therapies. This integration of data-driven insights with traditional clinical research is central to Kardigan’s strategy of transforming cardiovascular care.
A Diversified Late-Stage Pipeline with Transformational Potential
Kardigan’s pipeline features three late-stage programs, each targeting a different but complementary cardiovascular disease area. Collectively, these programs are designed to move beyond symptom management, creating the potential for treatments that fundamentally alter disease trajectories and provide durable clinical benefit. Importantly, the knowledge and data generated from these programs are expected to fuel Kardigan’s broader R&D efforts, advancing the company’s mission to develop synergistic therapies across cardiovascular diseases.
1. Dilated Cardiomyopathy (DCM): Targeting the Heart’s Core Function
Dilated cardiomyopathy is a condition characterized by weakening and enlargement of the heart muscle, impairing its ability to pump blood effectively. Patients with DCM face a high risk of progression to advanced heart failure, arrhythmias, and sudden cardiac death. While current treatments focus primarily on symptom management and slowing disease progression, no therapies exist that directly target the underlying genetic or molecular drivers of DCM.
Kardigan’s lead program in this area is danicamtiv, a potential first-in-class cardiac myosin activator. Danicamtiv is designed to directly enhance cardiac contractility by activating both atrial and ventricular myosin function, potentially restoring cardiac performance in patients with genetic forms of DCM driven by sarcomeric mutations. By addressing the root cause of cardiac dysfunction, danicamtiv represents a shift from conventional symptom-based therapies to disease-modifying intervention.
Clinical data supporting danicamtiv are compelling. A Phase 2a study demonstrated meaningful improvements in cardiac function, and results will be presented at the Heart Failure Society of America Annual Scientific Meeting 2025 during a late-breaking oral session on September 29, 2025. Kardigan in-licensed exclusive worldwide development and commercialization rights to danicamtiv, which was originally discovered at MyoKardia and further developed by Bristol Myers Squibb.
2. Acute Severe Hypertension (ASH): Addressing a Critical Gap in Care
Acute severe hypertension is defined by sudden, extreme elevations in blood pressure that require urgent management to prevent life-threatening complications such as heart attack, stroke, or organ damage. Despite its severity, ASH is often under-recognized and under-studied, particularly as a distinct disease condition separate from chronic hypertension. No therapies are currently indicated specifically for ASH, leaving a significant unmet need for interventions that can rapidly stabilize blood pressure and reduce short-term cardiovascular risk.
Kardigan is advancing tonlamarsen, an angiotensinogen-targeted therapy, as a potential bridging treatment for patients experiencing ASH. Tonlamarsen is designed to interrupt the dangerous cycle of acute hypertension, with the potential to lower blood pressure and reduce the risk of organ damage, heart failure, and other severe cardiovascular events. By focusing on the acute pathophysiology of ASH, this program aims to fill a critical therapeutic void and improve both immediate and long-term patient outcomes.
Tonlamarsen was in-licensed from Ionis, granting Kardigan exclusive worldwide development and commercialization rights. The drug exemplifies the company’s strategy of targeting diseases that have been historically overlooked but carry significant morbidity and mortality.
3. Calcific Aortic Valve Stenosis (CAVS): Offering a Potential Alternative to Surgery
Calcific aortic valve stenosis is a progressive condition characterized by calcium accumulation on the aortic valve, leading to narrowing of the valve opening and compromised blood flow. It is the most common cause of aortic stenosis in adults across the US and European Union, and its prevalence increases with age. Current standard of care relies primarily on “watchful waiting” until valve replacement surgery becomes necessary, as there are no approved pharmacologic treatments to halt or reverse calcification. This represents a critical unmet need, particularly for patients at higher surgical risk or those seeking non-invasive alternatives.
Kardigan is developing ataciguat, a once-daily, oral soluble guanylate cyclase activator, as a potential first-in-class therapy for CAVS. By targeting the biological pathways that drive valvular calcification, ataciguat may slow disease progression and offer an alternative to surgery, potentially improving quality of life and reducing the burden of invasive interventions. The program was in-licensed from Sanofi and Mayo Clinic, reflecting Kardigan’s commitment to acquiring innovative therapies with the potential for substantial clinical impact.
Strategic Integration and Synergistic Insights Across Programs
“Our portfolio has been carefully designed to align with Kardigan’s criteria for developing synergistic therapies that target critical disease drivers,” said Jay Edelberg, MD, Ph.D., co-founder and chief medical officer. “In each case, we aim to move beyond symptom management toward functional cures. With opportunities for cross-program learning, Kardigan’s cardiac intelligence platform will enable effective patient segmentation, streamline clinical trials, and ultimately deliver novel therapies to those who stand to benefit the most.”
The integration of AI-driven analytics, real-world patient data, and deep cardiovascular expertise provides Kardigan with a unique advantage. By understanding disease heterogeneity at a granular level, the company can design more efficient clinical trials, identify optimal patient cohorts, and accelerate development timelines. This approach not only enhances the likelihood of clinical success but also ensures that therapies are tailored to the patients most likely to benefit, maximizing impact and value.
Commitment to Transforming Patient Outcomes
Kardigan’s focus on diseases with high unmet need reflects a broader commitment to transforming the landscape of cardiovascular medicine. Each program in the pipeline represents a calculated step toward addressing the leading causes of morbidity and mortality in cardiovascular disease. From genetic cardiomyopathies to acute hypertensive crises and progressive valvular disease, Kardigan is tackling conditions that have historically lacked effective therapeutic options.
By moving beyond incremental improvements and seeking to alter the natural course of disease, Kardigan is positioning itself at the forefront of a new era in cardiology. The company’s strategy underscores the importance of precision medicine, data-driven insights, and a patient-centric approach in developing therapies that can prevent, halt, or even reverse life-threatening cardiovascular conditions.
The Future of Cardiovascular Innovation
Kardigan’s three late-stage programs exemplify a vision for cardiovascular medicine that extends beyond conventional boundaries. Through strategic partnerships, innovative drug candidates, and a commitment to scientific rigor, the company aims to redefine what is possible in the treatment of heart disease.
The knowledge gained from these programs is expected to inform ongoing discovery efforts, creating opportunities to develop additional therapies that address unmet needs across the cardiovascular spectrum.As the burden of cardiovascular disease continues to rise globally, the need for transformative solutions has never been greater.
Kardigan’s integrated approach—combining advanced technology, rigorous clinical research, and a focus on patient outcomes—offers a blueprint for the future of cardiovascular care. By targeting the root causes of disease and pursuing functional cures, the company aspires to make cardiovascular disease preventable, treatable, and ultimately no longer the leading cause of death worldwide.
