A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants

The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.

开始日期2023-09-05

申办/合作机构

Bristol Myers Squibb Co.

NCT05952089 / Completed临床1期

An Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of Danicamtiv on the Pharmacokinetics of Midazolam in Patients With Stable Heart Failure With Reduced Ejection Fraction

The purpose of this study is assess the effect of danicamtiv, as an inducer on the drug levels of midazolam in participants with heart failure with reduced ejection fraction (HFrEF).

开始日期2023-08-17

申办/合作机构

Bristol Myers Squibb Co.

NCT05806359 / Completed临床1期

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

开始日期2023-03-31

申办/合作机构

Bristol Myers Squibb Co.

100 项与 Danicamtiv 相关的临床结果

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100 项与 Danicamtiv 相关的转化医学

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100 项与 Danicamtiv 相关的专利（医药）

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项与 Danicamtiv 相关的文献（医药）

2023-10-17·Journal of the American Heart Association

Effect of the Novel Myotrope Danicamtiv on Cross‐Bridge Behavior in Human Myocardium

Article

作者: Stelzer, Julian E ; Holmes, Joshua B ; Choi, Joohee ; Campbell, Kenneth S

BackgroundOmecamtiv mecarbil (OM) and danicamtiv both increase myocardial force output by selectively activating myosin within the cardiac sarcomere. Enhanced force generation is presumably due to an increase in the total number of myosin heads bound to the actin filament; however, detailed comparisons of the molecular mechanisms of OM and danicamtiv are lacking.Methods and Results The effect of OM and danicamtiv on Ca 2+ sensitivity of force generation was analyzed by exposing chemically skinned myocardial samples to a series of increasing Ca 2+ solutions. The results showed that OM significantly increased Ca 2+ sensitivity of force generation, whereas danicamtiv showed similar Ca 2+ sensitivity of force generation to untreated preparations. A direct comparison of OM and danicamtiv on dynamic cross‐bridge behavior was performed at a concentration that produced a similar force increase when normalized to predrug levels at submaximal force (pCa 6.1). Both OM and danicamtiv‐treated groups slowed the rates of cross‐bridge detachment from the strongly bound state and cross‐bridge recruitment into the force‐producing state. Notably, the significant OM‐induced prolongation in the time to reach force relaxation and subsequent commencement of force generation following rapid stretch was dramatically reduced in danicamtiv‐treated myocardium. ConclusionsThis is the first study to directly compare the effects of OM and danicamtiv on cross‐bridge kinetics. At a similar level of force enhancement, danicamtiv had a less pronounced effect on the slowing of cross‐bridge kinetics and, therefore, may provide a similar improvement in systolic function as OM without excessively prolonging systolic ejection time and slowing cardiac relaxation facilitating diastolic filling at the whole‐organ level.

2023-08-18·Circulation Research

Danicamtiv Increases Myosin Recruitment and Alters Cross-Bridge Cycling in Cardiac Muscle

Article

作者: Mahoney-Schaefer, Max ; Mandrycky, Christian ; Turner, Kyrah L ; Regnier, Michael ; Moussavi-Harami, Farid ; Kooiker, Kristina B ; Tanner, Bertrand C W ; Martinson, Amy ; Geeves, Michael A ; Irving, Thomas C ; Zheng, Yahan ; Gao, Chengqian ; Davis, Jennifer ; Ma, Weikang ; Costales Arenas, Elijah Gabriela ; Flint, Galina ; Freeman, Jeremy C ; McMillen, Timothy S ; Tu, An-Yu ; Mohran, Saffie ; Qi, Lin

BACKGROUND:Modulating myosin function is a novel therapeutic approach in patients with cardiomyopathy. Danicamtiv is a novel myosin activator with promising preclinical data that is currently in clinical trials. While it is known that danicamtiv increases force and cardiomyocyte contractility without affecting calcium levels, detailed mechanistic studies regarding its mode of action are lacking.METHODS:Permeabilized porcine cardiac tissue and myofibrils were used for X-ray diffraction and mechanical measurements. A mouse model of genetic dilated cardiomyopathy was used to evaluate the ability of danicamtiv to correct the contractile deficit.RESULTS:Danicamtiv increased force and calcium sensitivity via increasing the number of myosins in the ON state and slowing cross-bridge turnover. Our detailed analysis showed that inhibition of ADP release results in decreased cross-bridge turnover with cross bridges staying attached longer and prolonging myofibril relaxation. Danicamtiv corrected decreased calcium sensitivity in demembranated tissue, abnormal twitch magnitude and kinetics in intact cardiac tissue, and reduced ejection fraction in the whole organ.CONCLUSIONS:As demonstrated by the detailed studies of Danicamtiv, increasing myosin recruitment and altering cross-bridge cycling are 2 mechanisms to increase force and calcium sensitivity in cardiac muscle. Myosin activators such as Danicamtiv can treat the causative hypocontractile phenotype in genetic dilated cardiomyopathy.

2023-08-18·Circulation Research

Danicamtiv Recruits Myosin Motors to Aid the Failing Heart

Communications

作者: Landim-Vieira, Maicon ; Knollmann, Bjorn C

项与 Danicamtiv 相关的新闻（医药）

2024-04-29

·GlobeNewswire-Health Care

Cytokinetics to Host Investor Event and Conference Call to Discuss the Primary Results From SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress

SOUTH SAN FRANCISCO, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced it will host an investor event and conference call on May 13, 2024 at 4:00 PM Western European Summer Time (11:00 AM Eastern Time) to discuss the primary results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), which are being presented in a Late Breaking Clinical Trial session at Heart Failure 2024, an International Congress of the European Society of Cardiology. The event will be held at the Pestana Palace Lisboa Hotel in Lisbon, Portugal in the Lustiano I room, and simultaneously webcasted online. Members of Cytokinetics’ management will be joined by: Martin Maron, M.D., Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital and Medical Center, and Principal Investigator of SEQUOIA-HCMGregory Lewis, M.D., Jeffrey and Mary Ellen Jay Chair and Section Head, Heart Failure Medical Director, Cardiopulmonary Exercise Testing Laboratory, Professor of Medicine, Harvard Medical SchoolCaroline Coats, M.D., Ph.D., Lead Clinician, West of Scotland Inherited Cardiac Conditions Service, Honorary Senior Lecturer, School of Cardiovascular and Metabolic Health, University of GlasgowPerry Elliott, M.D., Professor of Cardiovascular Medicine, Director of the Institute for Cardiovascular Science, University College London Interested parties must register to attend in person or online at https://cytokinetics-SEQUOIA-HCM-investor-event.open-exchange.net/registration. Registered attendees may access the virtual event platform by visiting the Investor & Media section of the Cytokinetics website at www.cytokinetics.com. A link to the webcast replay will be archived on the Cytokinetics website until November 13, 2024. About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in two ongoing Phase 3 clinical trials: MAPLE-HCM, evaluating aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM and ACACIA-HCM, evaluating aficamten in patients with non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. For additional information about Cytokinetics, visit www.cytokinetics.com 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. 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

临床3期

2024-03-25

·BioSpace

Cytokinetics Announces Four Upcoming Presentations at the American College of Cardiology 73rd Annual Scientific Session

SOUTH SAN FRANCISCO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq: CYTK) today announced four presentations at the American College of Cardiology 73rd Annual Scientific Session (ACC.24) taking place in Atlanta, GA from April 6, 2024 – April 8, 2024. Title: 1075-11 - Efficacy and Safety of Aficamten in the First Cohort of Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Completing 1-Year Follow-Up: Findings From the FOREST-HCM Study Presenter: Sara Saberi, M.D., M.S., Associate Professor of Internal Medicine, University of Michigan Health Frankel Cardiovascular Center Session: 1075 - Bulking Up: Advances in Hypertrophic Cardiomyopathy Date: April 7, 2024 Presentation Time: 2:00 PM-2:10 PM Eastern Time Location: Moderated Poster Theater 03 Title: 1226-128 - Association Between Beta Blocker Use and Incidence of New Atrial Fibrillation and Flutter Post-Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy Presenter: Morris M. Kim, M.D., Cardiovascular Disease Fellow, Oregon Health & Science University Session: 1226 - Heart Failure and Cardiomyopathies: Special Populations 02 Date: April 6, 2024 Presentation Time: 10:45 AM-11:30 AM Eastern Time Location: Hall B4-5 Title: 1343-122 - Standard of Care Medication Patterns of Use Before and After Septal Myectomy in Patients with Obstructive Hypertrophic Cardiomyopathy Presenter: Tristan B. Post, M.D., Clinical Research Coordinator, Oregon Health & Science University Session: 1343 - Heart Failure and Cardiomyopathies: Pharmacology 08 Date: April 7, 2024 Presentation Time: 9:15 AM-10:00 AM Eastern Time Location: Hall B4-5 Title: 1075-03 - Racial and Ethnic Differences in Cardiovascular Outcomes in Patients Diagnosed with Hypertrophic Cardiomyopathy Presenter: Nosheen Reza, M.D., Assistant Professor of Medicine, Perelman School of Medicine at the University of Pennsylvania Session: 1075 - Bulking Up: Advances in Hypertrophic Cardiomyopathy Date: April 7, 2024 Presentation Time: 1:00 PM-1:10 PM Eastern Time Location: Moderated Poster Theater 03 About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in two ongoing Phase 3 clinical trials: MAPLE-HCM, evaluating aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM and ACACIA-HCM, evaluating aficamten in patients with non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. 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. 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 and 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

临床3期

2024-03-04

·BioSpace

Cytokinetics to Participate in March 2024 Investor Conferences

SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the company is scheduled to participate in the following investor conferences in March: LeerinkGlobal Biopharma Conference: Robert I. Blum, President and Chief Executive Officer, Andrew Callos, Executive Vice President and Chief Commercial Officer, and Fady I. Malik, Executive Vice President of Research & Development, will participate in a fireside chat on Monday, March 11, 2024 at 1:20 PM Eastern Time at the Fontainebleau Miami Beach Hotel in Miami Beach, FL. Jefferies Biotech on the Bay Summit: Management will participate in one-on-one meetings on Tuesday, March 12, 2024 at the W South Beach Hotel in Miami Beach, FL. Barclays26th Annual Global Healthcare Conference: Robert I. Blum, President and Chief Executive Officer, Andrew Callos, Executive Vice President and Chief Commercial Officer, and Fady I. Malik, Executive Vice President of Research & Development, will participate in a fireside chat on Wednesday, March 13, 2024 at 9:00 AM Eastern Time at the Loews Miami Beach Hotel in Miami Beach, FL. Interested parties may access the live webcasts of the fireside chats by visiting the Investors & Media section of the Cytokinetics website at . The webcast replay will be archived on the Cytokinetics website for 90 days following the conclusion of the event. About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in two ongoing Phase 3 clinical trials: MAPLE-HCM, evaluating aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM and ACACIA-HCM, evaluating aficamten in patients with non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. 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. 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 and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Communications, Investor Relations (415) 290-7757

临床3期

100 项与 Danicamtiv 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
射血分数降低的心力衰竭	临床2期	荷兰	Bristol Myers Squibb Co.	2018-02-06
射血分数降低的心力衰竭	临床2期	法国	Bristol Myers Squibb Co.	2018-02-06
射血分数降低的心力衰竭	临床2期	美国	Bristol Myers Squibb Co.	2018-02-06
射血分数降低的心力衰竭	临床2期	瑞典	Bristol Myers Squibb Co.	2018-02-06
射血分数降低的心力衰竭	临床2期	德国	Bristol Myers Squibb Co.	2018-02-06
射血分数降低的心力衰竭	临床2期	英国	Bristol Myers Squibb Co.	2018-02-06
扩张型心肌病	临床前	瑞典	Bristol Myers Squibb Co.	2018-02-06
扩张型心肌病	临床前	荷兰	Bristol Myers Squibb Co.	2018-02-06
扩张型心肌病	药物发现	法国	Bristol Myers Squibb Co.	2018-02-06
射血分数降低的心力衰竭	药物发现	波兰	Bristol Myers Squibb Co.	2018-02-06

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03447990 (Pubmed \| Eur J Heart Fail) 人工标引	临床2期	心脏衰竭	40	Danicamtiv	(構觸網製選蓋遞積窪鑰) = 糧鹽鬱鏇鹽願積獵築餘繭夢淵鬱遞醖遞廠鹹顧 (窪繭鹹襯餘憲鬱膚築夢 ) 更多	积极	2020-09-01
				Placebo	(構觸網製選蓋遞積窪鑰) = 窪窪遞糧鏇積積鹽憲淵繭夢淵鬱遞醖遞廠鹹顧 (窪繭鹹襯餘憲鬱膚築夢 )
ESC2020	N/A	-	-	danicamtiv	觸鑰簾顧鬱壓鬱網鬱夢(觸衊鑰鏇憲遞顧願選壓) = 鏇獵顧齋鬱鏇鬱繭鑰衊構壓顧衊鬱繭網醖獵糧 (獵鹽鏇觸積窪衊鹹觸鏇 ) 更多	-	2020-08-28
				danicamtiv	觸鑰簾顧鬱壓鬱網鬱夢(觸衊鑰鏇憲遞顧願選壓) = 獵築鹹齋蓋襯構壓鏇願構壓顧衊鬱繭網醖獵糧 (獵鹽鏇觸積窪衊鹹觸鏇 ) 更多