A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

Start Date19 Dec 2024

Sponsor / Collaborator

Cytokinetics, Inc.

NCT04464525

/ WithdrawnPhase 3

Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF

The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

Start Date18 Dec 2020

Sponsor / Collaborator

Cytokinetics, Inc.

NCT04175808

/ CompletedPhase 1

Single-dose and Randomized, Single-center, Placebo- and Active-controlled, Crossover Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Subjects

The primary objective of this study is to assess the effect of a single therapeutic (50 mg) oral dose of omecamtiv mecarbil (OM) on the QT interval / QT interval corrected for heart rate (QTc), relative to placebo, in healthy adults.
The QT interval is the section on an electrocardiogram (ECG) that represents the time it takes for the electrical system to fire an impulse through the ventricles and then recharge, or the time it takes for the heart muscle to contract and then recover.

Start Date14 Nov 2019

Sponsor / Collaborator

Cytokinetics, Inc.

100 Clinical Results associated with Omecamtiv Mecarbil

100 Translational Medicine associated with Omecamtiv Mecarbil

100 Patents (Medical) associated with Omecamtiv Mecarbil

291

Literatures (Medical) associated with Omecamtiv Mecarbil

04 Feb 2026·CURRENT PHARMACEUTICAL DESIGN

Unveiling Heart Failure: Gender-Specific Insights and Innovations in Women's Cardiac Health

Article

Author: Bhati, Akash ; Shah, Kamal ; Bhatia, Deepika ; Dewangan, Hitesh Kumar ; Sharma, Navneet

Heart failure (HF) is a critical global health concern, affecting women due to unique biological, epidemiological, and sociocultural factors. Despite accounting for a significant percentage of cardiovascular disease (CVD) mortality among women, HF remains unexplored, particularly in areas such as gender-specific diagnostic challenges and therapeutic strategies. This review explores the intricate pathophysiology of HF, focusing on inflammation, oxidative stress, endothelial dysfunction, and fibrosis as pivotal contributors to disease progression. Moreover, it highlights advancements in pharmacological treatments, including ARNI, SGLT2 inhibitors, and novel therapeutic agents like vericiguat (for selective patients) and omecamtiv mecarbil (modest benefits), while addressing the potential of lifestyle interventions, such as diet, exercise, in mitigating HF risk. Artificial intelligence emerges as a promising potential for enhancing diagnostic precision, patient management, and outcome prediction, heralding a new era in HF care. By integrating gender-specific research and innovations, this study aims to refine strategies for improving women's cardiac health, ultimately reducing the global burden of HF.

01 Feb 2026·JACC-Heart Failure

Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure With Reduced Ejection Fraction According to Age

Article

Author: Heitner, Stephen B ; Metra, Marco ; McMurray, John J V ; Teerlink, John R ; Claggett, Brian L ; Lu, Henri ; Vaduganathan, Muthiah ; Diaz, Rafael ; Inciardi, Riccardo M ; Solomon, Scott D ; Malik, Fady ; Felker, G Michael

BACKGROUND:

Older age is associated with a high prevalence of comorbidities and worse cardiovascular (CV) outcomes in patients with heart failure (HF) with reduced ejection fraction. Omecamtiv mecarbil, a selective cardiac myosin activator, exerts minimal effects on blood pressure and heart rate and has limited extracardiac activity, and thus it may be well-tolerated in older individuals. The safety profile and clinical benefits of omecamtiv mecarbil across the age spectrum remain uncertain.

OBJECTIVES:

This study aims to assess CV outcomes, treatment response, and tolerability to omecamtiv mecarbil according to age in patients enrolled in the GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) trial.

METHODS:

GALACTIC-HF was a randomized, global, double-blind clinical trial testing omecamtiv mecarbil vs placebo in patients with symptomatic HF with reduced ejection fraction. Key eligibility criteria included an age between 18-85 years, elevated natriuretic peptides, and a left ventricular ejection fraction (LVEF) ≤35%. We examined the treatment effect of omecamtiv mecarbil vs placebo for the primary endpoint of CV death or first HF event (hospitalization or urgent visit for HF) in both the overall population and the severe HF subgroup (LVEF ≤30%, NYHA functional class III/IV, HF hospitalization within 6 months), as well as safety outcomes according to prespecified age groups (<65 or ≥65 years).

RESULTS:

A total of 8,232 patients (age 64.5 ± 11.4 years, 54.5% ≥65 years, 21% female) were included. The rate of the primary outcome was 21.4 per 100 patient years (py) in those <65 years of age and 28.8 per 100 py in those ≥65 years of age. The treatment effect of omecamtiv mecarbil for the primary outcome (HR: 0.92 [95% CI: 0.86-0.99]; P = 0.03) was consistent in age groups (P_interaction = 0.76) and irrespective of age as a continuous variable (P_interaction = 0.19, after adjusting for treatment interactions with known modifiers of the effects of omecamtiv mecarbil: LVEF and baseline atrial fibrillation status). In patients with severe HF, omecamtiv mecarbil significantly reduced the risk of the primary outcome in both patients <65 years of age (HR: 0.77 [95% CI: 0.64-0.92]) and those ≥65 years of age (HR: 0.83 [95% CI: 0.71-0.97]; P_interaction = 0.47). The safety profile of omecamtiv mecarbil was consistent irrespective of age (P_interaction > 0.05 for all).

CONCLUSIONS:

In GALACTIC-HF, older individuals were well-represented and faced higher risks of CV events. Treatment with omecamtiv mecarbil was safe irrespective of age and reduced the risk of CV death or first HF event across the age spectrum, especially in those with severe HF. (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure [GALACTIC-HF]; NCT02929329.).

05 Jan 2026·EUROPEAN HEART JOURNAL

Serum magnesium and outcomes in heart failure with reduced ejection fraction: the GALACTIC-HF trial

Article

Author: Teerlink, John R ; Metra, Marco ; Jhund, Pardeep S ; Solomon, Scott D ; Heitner, Stephen B ; Henderson, Alasdair D ; Ono, Ryohei ; Yang, Mingming ; Docherty, Kieran F ; Kupfer, Stuart ; Divanji, Punag H ; Malik, Fady I ; Chimura, Misato ; Felker, G Michael ; Liu, Genzhou ; McMurray, John J V

Abstract:

Background and Aims:

The frequency and prognostic significance of abnormalities in serum magnesium concentrations have not been described in a contemporary heart failure (HF) population. The authors evaluated the prognostic significance of magnesium concentrations in patients with HF with reduced ejection fraction (HFrEF) enrolled in GALACTIC-HF trial.

Methods:

GALACTIC-HF was a randomized, double-blind, multicentre, event-driven trial that investigated the efficacy and safety of omecamtiv mecarbil compared with placebo in HF patients with left ventricular ejection fraction ≤ 35%. The primary outcome was the composite of a first worsening HF event or cardiovascular death.

Results:

A total of 6147 outpatients had baseline serum magnesium data. Of these, 1082 (17.6%) had magnesium concentrations below .75 mmol/L, 4410 (71.7%) had concentrations within the normal range, and 655 (10.7%) had concentrations above .95 mmol/L. The incidence rate (per 100 person-years) for the primary composite outcome was highest in patients with hypermagnesaemia (34.9, 95% confidence interval 31.2–39.0), while rates were similar between those with hypomagnesaemia (21.5, 19.4–23.8), and normal magnesium (20.9, 19.9–22.0). Similar trends were observed for the components of the primary outcome and all-cause death. The incidence rate of sudden death and ventricular tachyarrhythmia did not differ among the three magnesium groups, but the risk of death from worsening HF was highest in patients with hypermagnesaemia.

Conclusions:

In GALACTIC-HF, 10.7% of outpatients with HFrEF had hypermagnesaemia, which was associated with a higher risk of the primary outcome compared with normal magnesium concentrations. Abnormal magnesium levels were not associated with a higher risk of sudden death or ventricular tachyarrhythmias. These findings do not support routine correction of hypomagnesaemia.

233

News (Medical) associated with Omecamtiv Mecarbil

18 Mar 2026

·www.biospace.com

Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4) - March 18, 2026

SOUTH SAN FRANCISCO, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on March 13, 2026 it granted stock options to purchase an aggregate of 8,628 shares of common stock and 5,719 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting to 5 employees, whose employment commenced in February and March 2026 as a material inducement to their employment. The RSUs will vest over 3 years, with 40% of the RSUs vesting on the first anniversary of the applicable grant date, an additional 40% of the RSUs vesting on the second anniversary of the grant date and the final 20% vesting on the third anniversary of the grant date, in each case, subject to each respective employee’s continued service with the Company. The stock options that were granted are subject to an exercise price of $60.06 per share, which is equal to the closing price of the Company’s common stock on March 13, 2026 and will vest over 4 years, with 1/4 th of the shares underlying the employee’s option vesting on the one-year anniversary of the grant date and the remaining shares thereafter vesting in monthly installments at a rate of 1/48 th of the shares underlying such stock options over the subsequent 36 months, subject to each respective employee’s continued service with the Company. The stock options have a 10-year term. These awards are subject to the terms and conditions of the Company's Amended and Restated 2004 Equity Incentive Plan and the applicable award agreements pursuant to which the awards were granted. The stock options and RSUs were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4). About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO™ ( aficamten ) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is also being studied for the potential treatment of non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil , an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten , an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit and follow us on X , LinkedIn , Facebook and YouTube . Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics' filings with the Securities and Exchange Commission particularly under the caption “Risk Factors” in Cytokinetics’ latest Annual Report on Form 10-K. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Affairs (415) 290-7757

Drug Approval

16 Mar 2026

·www.biospace.com

Cytokinetics Announces Four Presentations at the American College of Cardiology Annual Scientific Session & Expo

New Analyses from Three Trials in Obstructive HCM Support Findings from Previously Published Data on MYQORZO™ (aficamten) SOUTH SAN FRANCISCO, Calif., March 16, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced four presentations related to MYQORZO™ (aficamten) at the American College of Cardiology (ACC) Annual Scientific Session & Expo taking place March 28–30, 2026 in New Orleans, LA. Recently approved for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) by the U.S. Food and Drug Administration, European Commission, and the China National Medical Products Administration, MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. “We are pleased to contribute further evidence that we believe will help physicians and patients with clinical decision making,” said Stephen Heitner, M.D., Senior Vice President, Clinical Research and Development. “The new data can help empower evidence-based choices of therapy for patients living with symptomatic oHCM, showing that aficamten improves exercise capacity, when compared to placebo or the beta blocker, metoprolol, while maintaining its safety profile.” Scientific Presentations Include: Evaluation of Aficamten or Beta-Blocker Monotherapy Versus Placebo in Patients with Obstructive Hypertrophic Cardiomyopathy: A Pooled Analysis of SEQUOIA-HCM and MAPLE-HCM (1186-09) Moderated Poster Presentation, March 30,2026, 11:00 AM-12:00 PM CT, E Hall P. Christian Schulze, M.D., Ph.D., Chair of the Department of Medicine and Division of Cardiology, Angiology and Intensive Medical Care at the University Hospital Jena A new analysis based on combined data from SEQUOIA-HCM ( S afety, E fficacy, and Quantitative U nderstanding of O bstruction I mpact of A ficamten in HCM ) and MAPLE-HCM ( M etoprolol vs A ficamten in P atients with L VOT Obstruction on E xercise Capacity in HCM) evaluated aficamten or metoprolol monotherapy versus placebo. Patients (n=371) were pooled into three groups: aficamten as monotherapy, metoprolol as monotherapy, and placebo without background beta-blockers. For patients with symptomatic oHCM, treatment with beta-blocker monotherapy was no different compared to placebo across many clinically relevant outcomes (exercise capacity, symptoms, cardiac biomarkers and Valsalva gradient). Conversely, aficamten as monotherapy was superior to both metoprolol and placebo, consistent with previously published 1 findings and supporting the emerging role of aficamten in the treatment of symptomatic oHCM. Clinical Implications Associated with Temporary Treatment Interruption and Reinitiation of Aficamten Therapy in Obstructive Hypertrophic Cardiomyopathy (906-11) Oral Presentation, March 29, 2026, 9:30 AM-10:30 AM CT, Hall E Martin Maron, M.D., Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital & Medical Center; and National Principal Investigator of SEQUOIA-HCM This new analysis evaluated data from SEQUOIA-HCM and FOREST-HCM ( F ollow-up, O pen-Label, R esearch E valuation of S ustained T reatment with Aficamten in HCM ) related to the safety of interrupting treatment with aficamten . The analysis, which included 182 participants, evaluated the impact of discontinuing treatment with aficamten for a four-week washout period after assessment of the primary endpoint at 24-weeks as occurred per protocol in SEQUOIA-HCM . Most of these patients subsequently reinitiated treatment in the open-label extension, FOREST-HCM. The analyses showed that washout of aficamten was not associated with increased risk of cardiac adverse events or rebound compared to placebo. One (0.7%) patient in the aficamten arm experienced an adverse event of mild worsening heart failure due to an acute drop in hemoglobin. Three patients experienced recurrence of HCM symptoms of moderate severity after discontinuing aficamten consistent with the loss of therapeutic drug effect during washout. Importantly, reinitiation of aficamten yielded a favorable therapeutic response, suggesting aficamten can be safely discontinued if treatment interruptions are required for non-cardiac medical reasons, such as surgery or cancer treatment. Aficamten Versus Metoprolol in Patients with Hypertension and Obstructive Hypertrophic Cardiomyopathy (1395-221) Poster Presentation, March 28, 2026, 2PM-3PM CT, Hall E Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University A new analysis of MAPLE-HCM evaluated the efficacy and safety of treatment with aficamten vs. metoprolol in patients with hypertension at baseline, which is common in patients with oHCM. In this analysis of 175 patients, 50% had a history of hypertension, and 81% were treated with a beta-blocker and/or calcium channel blocker before randomization in MAPLE-HCM. While blood pressure increased slightly with aficamten (+3.6±14.0 mmHg) compared to a decrease with metoprolol , (−8.3±18.2 mmHg), the analysis showed there was no statistically significant difference in the rates of uncontrolled hypertension, defined as systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg emergent during treatment (34% vs. 25% in the aficamten and metoprolol arms respectively; p=0.38). Aficamten was equally effective and displayed a similar safety pro of hypertension history. These findings suggest aficamten is suitable as therapy independent of hypertension history and given the decrease in LVOT gradient during treatment with aficamten , may allow for greater optionality in the choice of antihypertensive agents. Electrocardiographic Changes and Associations with Echocardiographic Changes in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy: Insights from the SEQUOIA-HCM Trial (1514-243) Poster Presentation, March 29, 2026, 2PM-3PM CT, Hall E Alberto Foà, M.D., Ph.D., Cardiologist, Brigham and Women's Hospital, Harvard Medical School; Heart Failure and Transplant Unit - IRCCS Azienda Ospedaliero-Universitaria di Bologna A new analysis of SEQUOIA-HCM examined electrocardiographic (ECG) changes in patients with symptomatic oHCM following 24 weeks of treatment with aficamten or placebo. The results showed that, compared to placebo, aficamten decreased the presence of ST segment changes (adjusted odds ratio 0.23; 95% CI 0.11, 0.46; p5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial. Please see full Prescribing Information , including Boxed WARNING and Medication Guide . About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms. HCM is the most common monogenic inherited cardiovascular disorder, with well over 300,000 patients diagnosed in the U.S. 3 However, there are an estimated 400,000-800,000 additional patients who remain undiagnosed. 4,5,6 Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM). 3 People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease. 7 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes. 8 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO™ ( aficamten ) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is also being studied for the potential treatment of non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil , an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten , an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit and follow us on X , LinkedIn , Facebook and YouTube . Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements, express or implied, related to Cytokinetics’ research and development activities; clinical trial initiation, design, enrollment, conduct, progress, continuation, completion, timing and results; regulatory submissions, review processes, approval timing and outcomes, including with respect to supplemental applications and approvals in jurisdictions outside the United States; the scope, expansion, modification, durability or continuation of labeling and promotional claims; commercial readiness, launch timing, market access and reimbursement; anticipated patient, prescriber and payer adoption; expectations regarding market opportunity, growth and market share; pipeline development and expansion into additional indications or geographies; access to and use of capital; and Cytokinetics’ business strategy, objectives and future plans. Such statements are based on management's current expectations and assumptions; however, actual results may differ materially due to various risks and uncertainties, including, but not limited to, uncertainties inherent in drug development and commercialization; the timing, conduct and outcomes of clinical trials; regulatory review and approval processes in the United States and other jurisdictions; differences in regulatory requirements, labeling, market access or promotional restrictions across jurisdictions; the ability to obtain, expand, maintain or continue desired labeling, promotional claims or commercial positioning for approved products; potential legal, intellectual property or regulatory constraints affecting commercialization and marketing claims; patient and prescriber acceptance of MYQORZO as compared to alternative therapies; the availability and terms of reimbursement from commercial and government payers; manufacturing, supply and distribution risks; competition; and the availability of sufficient capital to execute Cytokinetics’ business plans. These forward-looking statements speak only as of the date they are made, and Cytokinetics undertakes no obligation to subsequently update any such statement, except as required by law. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission (the “SEC”). CYTOKINETICS ® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO TM is a trademark of Cytokinetics in the U.S., and a registered trademark in the European Union. Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Affairs (415) 290-7757 References Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424 Hartman JJ, Hwee DT, Roebrt-Paganin J, et al. Aficamten is a small-molecule cardiac myosin inhibitor designed to treat hypertrophic cardiomyopathy. Nat Cardiovasc Res. 2024;3(8) :1003-1016. doi:10.1038/s44161-024-00505-0 Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552 CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 doi:10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575 Symphony Health 2016-2021 Patient Claims Data DoF; Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. Am J Cardiol. 2016; 15;117(10):1651-1654. Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260. Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21

Clinical ResultDrug ApprovalClinical StudyAHA

11 Mar 2026

·allsci.com

AnaCardio and Helsinn secure US patent for AC01 calcium sensitizing heart failure treatment

Sweden-based biopharma AnaCardio AB, which focuses on development of contractile agents for heart failure, and Switzerland-based partner Helsinn Healthcare SA announced the issuance of US Patent No. 12,569,476 by the United States Patent and Trademark Office (USPTO). The patent covers the use of AC01, a first-in-class calcium sensitizing inotrope and oral ghrelin mimetic small molecule, for the treatment of heart failure with reduced ejection fraction (HFrEF). This dual mechanism targets cardiac contractile dysfunction through enhanced myofilament calcium sensitivity while simultaneously engaging the ghrelin receptor pathway, which has been linked to cardioprotective and metabolic effects in failing hearts. AnaCardio US patent extends AC01 exclusivity into the 2040s The biopharmaceutical patent provides protection in the United States until June 2, 2042, with potential patent term extensions beyond that date. The patent is co-owned by AnaCardio AB and Helsinn Healthcare SA. The Helsinn Healthcare AnaCardio partnership, which originated with Helsinn’s out-licensing of the compound to AnaCardio, now benefits from what the companies describe as a layered intellectual property position supporting AC01 well into the 2040s. AC01 contractile agent: mechanism and clinical development AC01 functions through two pharmacological pathways. As a calcium sensitizer, the AC01 contractile agent increases the responsiveness of cardiac myofilaments to intracellular calcium, improving the force of heart contractions without raising intracellular calcium concentrations. This distinction is relevant because traditional inotropes that increase calcium influx carry risks of arrhythmia and elevated myocardial oxygen demand. As an oral ghrelin mimetic, AC01 activates the growth hormone secretagogue receptor (GHS-R1a), which is expressed in cardiovascular tissue. Ghrelin receptor activation has been associated with anti-apoptotic signaling, improved cardiac remodeling, and metabolic regulation in preclinical heart failure models. The combination of these two mechanisms in a single oral small molecule differentiates AC01 from existing agents in the HFrEF treatment landscape. AnaCardio completed a Phase Ib/IIa trial (NCT information via AnaCardio pipeline) enrolling 58 patients with HFrEF across sites in Italy and the Netherlands. The company disclosed positive topline results, reporting that AC01 demonstrated a favorable safety and tolerability profile alongside exploratory efficacy signals described as rapid and sustained improvements in cardiac function and hemodynamics over 28 days. A second study enrolling 62 patients across the United Kingdom, Italy, and Sweden (trial record) has also been conducted. As of late 2025, AnaCardio stated plans to advance AC01 into Phase IIb development. Specific clinical results for individual endpoints and detailed adverse event data have not yet appeared in peer-reviewed publications. The AC01 heart failure treatment enters a field with several mechanistically relevant comparators. Levosimendan, marketed by Orion Pharma (Finland), is the most established calcium sensitizer in clinical use. Approved in multiple countries for acute decompensated heart failure, levosimendan enhances myofilament calcium sensitivity and produces vasodilation through potassium channel activation. It is administered intravenously, and ongoing trials are evaluating repetitive infusion regimens in advanced chronic heart failure (NCT record). AC01’s oral formulation and dual mechanism represent a differentiation strategy relative to levosimendan’s IV-only route and single-pathway activity. Omecamtiv mecarbil, developed by Cytokinetics (US) in partnership with Amgen (US), operates through a distinct contractility mechanism as a cardiac myosin activator. Rather than sensitizing myofilaments to calcium, it directly targets cardiac myosin ATPase to increase the duration and magnitude of systolic contraction. Omecamtiv mecarbil completed the Phase III GALACTIC-HF trial (NCT01920711), but a US FDA approval filing was met with a complete response letter in February 2023. Its mechanism does not overlap with ghrelin signaling, distinguishing it from AC01’s pharmacological profile. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Drug Approval

100 Deals associated with Omecamtiv Mecarbil

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KEGG	Wiki	ATC	Drug Bank
D09648	Omecamtiv Mecarbil	-	DB11816

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	NDA/BLA	United States	Cytokinetics, Inc.	04 Feb 2022
Chronic heart failure	NDA/BLA	European Union	Cytokinetics, Inc.	-
Heart failure with reduced ejection fraction	Phase 3	United States	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	Canada	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	France	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	Germany	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	Hungary	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	Italy	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	Netherlands	Cytokinetics, Inc.	09 Apr 2019
Heart failure with reduced ejection fraction	Phase 3	Poland	Cytokinetics, Inc.	09 Apr 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02929329 (GALACTIC-HF, Pubmed \| Eur J Heart Fail)	Phase 3	Heart failure with normal ejection fraction	7,790	Omecamtiv mecarbil	wzawsfirah(kmndfvlbju) = wxypnzlhmg syddnwutnj (prxreekkzz, 20.8 - 22.7) View more	Positive	13 Jan 2026
				Placebo	wzawsfirah(kmndfvlbju) = ogbaevyfwt syddnwutnj (prxreekkzz, 31.8 - 38.0)
NCT02929329 (GALACTIC-HF, Pubmed \| JACC Heart Fail)	Phase 3	Hydrops Fetalis \| Reduced ejection fraction co-occurrent and due to chronic heart failure \| Chronic heart failure natriuretic peptides	-	Omecamtiv mecarbil	gwqsskgafh(opfkcczirx): adjusted HR = 0.8 (95% CI, 0.73 - 0.88) View more	Positive	01 Dec 2023
				Placebo
NCT03759392 (METEORIC-HF, CTgov)	Phase 3	Heart failure with reduced ejection fraction	276	Omecamtiv Mecarbil (Omecamtiv Mecarbil)	psxnjnmjhm(nxmfwjlvpt) = zodkjtfsjr giehjfdxdf (tlyykulndp, 0.1718) View more	-	07 Mar 2023
				Placebo (Placebo)	psxnjnmjhm(nxmfwjlvpt) = vblnmdmbul giehjfdxdf (tlyykulndp, 0.2412) View more
NCT02929329 (GALACTIC-HF, Pubmed \| Eur J Heart Fail)	Not Applicable	Heart failure with reduced ejection fraction	8,232	Omecamtiv mecarbil	xewdvhqnes(unmzvdrjbd): HR = 0.94 (95% CI, 0.8 - 1.09), P-Value = 0.095	-	04 Jan 2023
				Placebo
NCT03759392 (METEORIC-HF, Pubmed) Manual	Phase 3	Chronic heart failure	276	Omecamtiv Mecarbil	ffpeliqfns(kufrqxwuzs) = tpqwrdtsqx lztvvhcocm (rqczwdegji ) View more	Negative	19 Jul 2022
				Placebo	ffpeliqfns(kufrqxwuzs) = gltsmyveym lztvvhcocm (rqczwdegji ) View more
NCT02929329 (GALACTIC-HF, Pubmed \| JAMA Cardiol)	Phase 3	Heart Failure	8,232	Omecamtiv mecarbil	peckegfzgy(tscfyuzfke): HR = 0.88 (95% CI, 0.75 - 1.03)	-	13 Oct 2021
				Placebo
NCT02929329 (GALACTIC-HF, CTgov)	Phase 3	Hydrops Fetalis \| Reduced ejection fraction co-occurrent and due to chronic heart failure \| Chronic heart failure	8,256	Placebo (Placebo)	fqoaixfbut = khhoaakvha eejemqicim (fvajwoidix, onoddzqwts - eulrmiznng) View more	-	20 Jul 2021
				Standard of Care+Omecamtiv Mecarbil (Omecamtiv Mecarbil)	fqoaixfbut = cpqpgzdluw eejemqicim (fvajwoidix, rhukkvensh - tpyshmvqux) View more
NCT02929329 (GALACTIC-HF, Pubmed \| J Am Coll Cardiol)	Not Applicable	Hydrops Fetalis \| Reduced ejection fraction co-occurrent and due to chronic heart failure \| Chronic heart failure	-	Omecamtiv Mecarbil	xatsjqsmno(sdrnofpyml): Hazard Ratio = 0.83 (95% CI, 0.73 - 0.95)	Positive	28 Apr 2021
				Placebo
NCT02929329 (GALACTIC-HF, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Heart Failure, Systolic	8,232	Omecamtiv Mecarbil	tuugfoaplk(omxsgadwvd) = gwvouywqpf fyjahjxfku (wqiemzgbhy ) View more	Positive	14 Jan 2021
				Placebo	tuugfoaplk(omxsgadwvd) = lpjtjjrhze fyjahjxfku (wqiemzgbhy ) View more
NCT02695420 (CTgov)	Phase 2	Heart failure with reduced ejection fraction	81	25 mg Omecamtiv Mecarbil	tqfxzcektb(olxslmmxzs) = ahkvqfbxir iefjwwcbxn (kzregtgzad, 4.7) View more	-	31 Jan 2020

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