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.

开始日期2024-12-19

申办/合作机构

Cytokinetics, Inc.

NCT04464525

/ Withdrawn临床3期

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.

开始日期2020-12-18

申办/合作机构

Cytokinetics, Inc.

NCT04175808

/ Completed临床1期

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.

开始日期2019-11-14

申办/合作机构

Cytokinetics, Inc.

100 项与 Omecamtiv Mecarbil 相关的临床结果

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100 项与 Omecamtiv Mecarbil 相关的转化医学

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100 项与 Omecamtiv Mecarbil 相关的专利（医药）

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255

项与 Omecamtiv Mecarbil 相关的文献（医药）

2026-02-04·CURRENT PHARMACEUTICAL DESIGN

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

Article

作者: 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.

2026-02-01·JACC-Heart Failure

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

Article

作者: Heitner, Stephen B ; Metra, Marco ; McMurray, John J V ; Claggett, Brian L ; Teerlink, John R ; Lu, Henri ; Vaduganathan, Muthiah ; Diaz, Rafael ; Solomon, Scott D ; Inciardi, Riccardo M ; 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.).

2026-01-05·EUROPEAN HEART JOURNAL

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

Article

作者: 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 ; Malik, Fady I ; Divanji, Punag H ; Chimura, Misato ; Felker, G Michael ; McMurray, John J V ; Liu, Genzhou

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.

288

项与 Omecamtiv Mecarbil 相关的新闻（医药）

2026-03-27

·终身学习-星辰如梦

【药品分享】拉尼兰诺片——口服泛PPAR激动剂

Lanifibranor（拉尼兰诺）片是一款由法国Inventiva公司研发的口服泛PPAR激动剂，目前全球尚未正式上市，正处于NASH适应症III期临床关键阶段。基本信息通用名：Lanifibranor（拉尼兰诺）药物类别：泛PPAR受体激动剂（均衡激活PPARα/δ，部分激活PPARγ）研发公司：Inventiva（法国）中国权益：正大天晴（中国生物制药）于2022年9月获得大中华区（大陆、港澳台）开发、生产、商业化权益主要适应症：非酒精性脂肪性肝炎（NASH/MASH）（伴有肝纤维化）剂型规格：400mg片剂（每日一次口服）作用机制与临床优势三重作用机制 PPARα：调节脂质代谢，降低肝脏脂肪（ steatosis） PPARγ：抗炎、改善胰岛素抵抗 PPARδ：抗纤维化、改善线粒体功能 IIb期（NATIVE）关键结果（发表于NEJM） NASH逆转且纤维化不恶化：49%（安慰剂29%）纤维化改善≥1期且NASH不恶化：42%（安慰剂24%）同时改善：转氨酶、血糖、血脂、胰岛素抵抗安全性：耐受性好，主要为轻度胃肠道反应上市情况 Lanifibranor（拉尼兰诺）是目前全球NASH领域进度最领先的口服泛 PPAR激动剂，也是首个在II期同时显著改善NASH与肝纤维化的药物。全球尚未上市，中美欧均处于III期关键阶段；中国由正大天晴主导开发，已获突破性治疗认定。美国FDA：已授予突破性疗法认定（BTD）+快速通道资格；关键III期试验NATiV3正在进行中（针对F2/F3期肝纤维化NASH）。欧盟EMA：已获优先药物资格（PRIME）；同步推进III期与上市准备。中国（NMPA）注册申报情况： 2023年3月临床申请获受理；2023年7月拟纳入突破性治疗药物程序。临床试验情况专利情况 Lanifibranor（拉尼兰诺）由法国Inventiva公司拥有全球核心专利，专利壁垒极强，核心化合物专利至2039年到期。中国由正大天晴获得独家授权。核心化合物专利：基础专利WO2007026097（PCT）；中国同族专利CN101277919B 专利权人：Inventiva S.A.（法国）申请日：2006年8月8日到期日：2026年8月7日各国调整后到期日：2039年11月8日（美/欧/日/中，含期限调整）保护化合物、晶型、盐、水合物、制备方法、所有适应症（NASH/MASH、纤维化、肝硬化、代谢疾病）、制剂、联合用药。专利号：CN101277919B 保护Lanifibranor化合物、药用盐、异构体。申请日：2006-08-08 授权日：2010-06-02 法定到期日：2026-08-07 调整后到期日：2039-11-08（含专利期限补偿PTE）晶型专利：CN117794926A（2024 公开，Inventiva）保护多种晶型、制备、用途（NASH）。用途专利：CN101848690B 保护治疗NASH、肝纤维化、肝硬化。制剂专利：CN107277396B 保护400mg片剂、缓释制剂、每日一次方案。联合用药专利：CN110547695A 保护与GLP-1、FXR激动剂联用。专利壁垒极高壁垒，仿制药极难突破：多层保护：化合物 → 晶型 → 制剂 → 用途 → 联合用药超长保护期：核心至2039年，外围至2045年+ 中国授权稳固：正大天晴获完整专利实施权侵权风险：任何厂家2039年前生产、进口Lanifibranor均侵权；规避设计难度大（PPAR 泛激动剂结构特异性强）。其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide新型的非阿片类小分子镇痛药-Suzetrigine奥麦利昔芬口腔薄膜立项调研报告纳米技术双氯芬酸乳胶剂药学研究2025年9月药品批准信息快讯（八）——利斯的明透皮贴剂分享2025年9月药品批准信息快讯（九）——米托坦片分享CDE-《化学仿制药参比制剂目录（第一百批）》（征求意见稿）[附: 药品分享——阿达苏(洛沙平吸入剂)]药品分享-塞来昔布盐酸曲马多片药品分享——伐莫洛龙口服混悬液【药品分享】盐酸菲优拉生片【药品分享】拉坦噻吗滴眼液【药品分享】Baxdrostat 片【药品分享】Omecamtiv Mecarbil缓释片【药品分享】曲地匹坦（Rolapitant）【药品分享】Zasocitinib 胶囊【药品分享】甲磺酸阿帕替尼片【药品分享】巴氯芬口服溶液【药品分享】奥德昔巴特胶囊【药品分享】扎维吉泮鼻喷雾剂【药品分享】左羟丙哌嗪糖浆【药品分享】利丙双卡因凝胶贴膏【药品分享】司来吉兰改良型新药（缓释片）【药品分享】复方甘菊利多卡因凝胶【药品分享】盐酸索安非托片【药品分享】地塞米松口溶膜【药品分享】盐酸来罗西利片【药品分享】马来酸噻吗洛尔凝胶【药品分享】褪黑素颗粒【药品分享】罗氟司特乳膏【药品分享】盐酸芬戈莫德胶囊【药品分享】示踪用盐酸米托蒽醌注射液【药品分享】美洛昔康纳米晶注射液【药品分享】Clascoterone 5%外用溶液【药品分享】马来酸依那普利口服溶液【药品分享】注射用双氯芬酸钠利多卡因【药品分享】马来酸依那普利叶酸片—复方降压药【药品分享】依曲帕米鼻喷雾剂—用于治疗成人阵发性室上性心动过速的可自行给药鼻喷雾剂【药品分享】奥卡西平口服混悬液—一款可用于儿童的钠通道调节类抗癫痫药【药品分享】泊沙康唑口服混悬液——一种常用的抗真菌药物【药品分享】舒沃替尼片【药品分享】依伏卡塞片——第二代口服拟钙剂【药品分享】西诺氨酯片——第三代抗癫痫发作药物【药品分享】匹妥布替尼片——非共价可逆 BTK 抑制剂（用于复发 / 难治套细胞淋巴瘤（MCL））【药品分享】贝美前列素【产品分享】达普司他片【药品分享】水合氯醛糖浆——镇静催眠药【产品分享】苏沃雷生（Suvorexant）——全球首个食欲素受体拮抗剂类催眠药【药品分享】贝沙罗汀【药品分享】地夫可特干混悬剂——一种糖皮质激素类药物【药品分享】伊卢多啉片——治疗成人腹泻型肠易激综合征（IBS‑D）的首创口服阿片受体调节剂【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH）的 α1 - 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临床3期突破性疗法专利侵权

2026-03-25

·终身学习-星辰如梦

【药品分享】甲磺酸艾多替尼片——全球首款专为肺癌脑转移设计的第三代EGFR-TKI

甲磺酸艾多替尼片（TY-9591）是浙江同源康医药自主研发的第三代 EGFR-TKI（氘代奥希替尼），核心优势为血脑屏障穿透率高，专为肺癌脑转移设计。目前该药处于上市审评阶段（NDA已受理），尚未正式获批上市。基本信息通用名：甲磺酸艾多替尼片研发代码：TY-9591 药物类型：口服、小分子、高选择性EGFR酪氨酸激酶抑制剂（TKI）化学特征：奥希替尼的氘代衍生物（氘代优化）原研公司：浙江同源康医药股份有限公司靶点：高效、ATP 竞争性、不可逆抑制EGFR 敏感突变（19del/L858R）及T790M 耐药突变。核心优势（氘代改良）：减少毒性代谢物：显著降低有毒代谢产物AZD5104生成，提升安全性。高剂量耐受：支持160mg QD高剂量给药（奥希替尼标准剂量 80mg）。强入脑能力：血脑屏障穿透率显著提升，颅内药物浓度更高。适应症（拟申报）：用于治疗表皮生长因子受体（EGFR）外显子19缺失（19del）或外显子21（L858R）置换突变，并伴有中枢神经系统（CNS）转移的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。关键临床数据（ESAONA研究）其通过氘代技术优化，在关键的颅内病灶控制上，头对头临床试验数据显著优于奥希替尼（iORR 92.8% vs 76.1%）。基于关键 II 期、多中心、随机对照试验（头对头对比奥希替尼）：入组：224 例EGFR 敏感突变伴脑转移的 NSCLC 患者。给药：艾多替尼 160mg QD vs 奥希替尼 80mg QD。核心疗效（颅内）：颅内客观缓解率（iORR）：92.8% vs 76.1%（p=0.0006，优效显著）；全身客观缓解率（ORR）：84.7% vs 75.2% 安全性： ≥3 级治疗相关不良事件（TRAEs）：31.5% vs 15.0%；常见≥3级不良反应：肌酸磷酸激酶升高、QT间期延长、粒细胞减少、白细胞减少。特殊关注：间质性肺病（6.3%）、QT延长（4.5%），可控可管理。上市情况甲磺酸艾多替尼片是全球首款专为肺癌脑转移设计的第三代EGFR-TKI。2026年2月6日，NDA获NMPA受理并纳入优先审评。目前正处于加速审批中。注册受理情况临床试验情况专利情况甲磺酸艾多替尼（TY-9591）作为奥希替尼的氘代衍生物，其专利布局以化合物（氘代结构）、晶型、制剂、适应症（脑转移）为核心，形成了自主知识产权壁垒，但同时也面临阿斯利康（奥希替尼原研）的潜在专利挑战。化合物专利：专利名称为氘代奥希替尼衍生物及其制备方法和医药用途，2019年4月（CN113784971A同族）申请，2039年4月到期（20年专利期），专利权人为南京明德新药研发公司 → 转让至同源康医药（中国区）。保护特定氘代位点的奥希替尼结构（区别于原研），覆盖甲磺酸盐（艾多替尼）及药学上可接受的盐，保护高剂量（160mg）给药方案及低毒性代谢特征。晶型专利：CN113784971B（甲磺酸艾多替尼A/B型晶型），保护高纯度、高稳定性晶型，提升生物利用度。制剂专利：保护160mg 片剂处方、工艺及高血脑屏障穿透制剂配方用途专利：CN114827654B，保护EGFR突变伴脑转移NSCLC的一线治疗用途。首个且唯一针对肺癌脑转移的三代 EGFR-TKI适应症专利。专利壁垒阿斯利康（奥希替尼原研）化合物通式专利：CN107922344B（同族 WO2013014448），2012.7.25申请，保护至2032年。权利要求为马库什通式，明确覆盖 “氘代奥希替尼” 。奥希替尼具体化合物/盐专利：CN103702990B、CN104109161B，保护奥希替尼游离碱及甲磺酸盐。艾多替尼为甲磺酸氘代奥希替尼，等同侵权风险极高。艾多替尼化合物专利（ZL202010123456.7）：2019年申请，若被认定为“显而易见的氘代改进”，专利可能被无效。其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide新型的非阿片类小分子镇痛药-Suzetrigine奥麦利昔芬口腔薄膜立项调研报告纳米技术双氯芬酸乳胶剂药学研究2025年9月药品批准信息快讯（八）——利斯的明透皮贴剂分享2025年9月药品批准信息快讯（九）——米托坦片分享CDE-《化学仿制药参比制剂目录（第一百批）》（征求意见稿）[附: 药品分享——阿达苏(洛沙平吸入剂)]药品分享-塞来昔布盐酸曲马多片药品分享——伐莫洛龙口服混悬液【药品分享】盐酸菲优拉生片【药品分享】拉坦噻吗滴眼液【药品分享】Baxdrostat 片【药品分享】Omecamtiv Mecarbil缓释片【药品分享】曲地匹坦（Rolapitant）【药品分享】Zasocitinib 胶囊【药品分享】甲磺酸阿帕替尼片【药品分享】巴氯芬口服溶液【药品分享】奥德昔巴特胶囊【药品分享】扎维吉泮鼻喷雾剂【药品分享】左羟丙哌嗪糖浆【药品分享】利丙双卡因凝胶贴膏【药品分享】司来吉兰改良型新药（缓释片）【药品分享】复方甘菊利多卡因凝胶【药品分享】盐酸索安非托片【药品分享】地塞米松口溶膜【药品分享】盐酸来罗西利片【药品分享】马来酸噻吗洛尔凝胶【药品分享】褪黑素颗粒【药品分享】罗氟司特乳膏【药品分享】盐酸芬戈莫德胶囊【药品分享】示踪用盐酸米托蒽醌注射液【药品分享】美洛昔康纳米晶注射液【药品分享】Clascoterone 5%外用溶液【药品分享】马来酸依那普利口服溶液【药品分享】注射用双氯芬酸钠利多卡因【药品分享】马来酸依那普利叶酸片—复方降压药【药品分享】依曲帕米鼻喷雾剂—用于治疗成人阵发性室上性心动过速的可自行给药鼻喷雾剂【药品分享】奥卡西平口服混悬液—一款可用于儿童的钠通道调节类抗癫痫药【药品分享】泊沙康唑口服混悬液——一种常用的抗真菌药物【药品分享】舒沃替尼片【药品分享】依伏卡塞片——第二代口服拟钙剂【药品分享】西诺氨酯片——第三代抗癫痫发作药物【药品分享】匹妥布替尼片——非共价可逆 BTK 抑制剂（用于复发 / 难治套细胞淋巴瘤（MCL））【药品分享】贝美前列素【产品分享】达普司他片【药品分享】水合氯醛糖浆——镇静催眠药【产品分享】苏沃雷生（Suvorexant）——全球首个食欲素受体拮抗剂类催眠药【药品分享】贝沙罗汀【药品分享】地夫可特干混悬剂——一种糖皮质激素类药物【药品分享】伊卢多啉片——治疗成人腹泻型肠易激综合征（IBS‑D）的首创口服阿片受体调节剂【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH）的 α1 - 受体阻滞剂【药品分享】索格列净片——全球首个获批的SGLT1/SGLT2 双重抑制剂【药品分享】奥吡卡朋胶囊——新一代的儿茶酚-氧位-甲基转移酶抑制剂（COMT）【药品分享】奎扎替尼片——一种口服高选择性 FLT3 抑制剂【药品分享】硫酸拉罗替尼胶囊 / 口服溶液——全球首个高选择性口服 TRK 抑制剂【药品分享】司帕生坦片——成人IgA肾病领域首个非免疫抑制疗法【药品分享】黄体酮阴道栓剂/阴道缓释凝胶剂——主要用于辅助生殖技术（ART）中的黄体支持【药品分享】替戈拉生片——首款国产钾离子竞争性酸阻滞剂类药物（P-CAB）【药品分享】拉坦前列烯酯滴眼剂——一种新型眼科用药【药品分享】布比卡因脂质体注射液——一种长效局部麻醉药【药品分享】甲磺酸加诺沙星片——一种喹诺酮类抗菌药【药品分享】磷酸芦可替尼乳膏——中国首款且唯一获批的白癜风治疗靶向药【药品分享】甲磺酸洛美他派胶囊——全球唯一口服MTP抑制剂【药品分享】依达拉奉口服混悬液——肌萎缩侧索硬化症（ALS，渐冻人症）新药【药品分享】依达拉奉右莰醇舌下片——全球卒中领域首个获FDA突破性疗法认定的舌下脑保护剂【药品分享】马来酸氟诺替尼片——JAK2/FLT3/CDK6 三靶点抑制剂【药品分享】普拉替尼胶囊——国内首个获批的高选择性 RET（转染重排）酪氨酸激酶抑制剂【药品分享】右美托咪定舌下膜——新型 α₂肾上腺素受体激动剂舌下膜剂【药品分享】卡匹色替片——全球首个获批上市的AKT抑制剂【药品分享】库莫西利胶囊——全球首个CDK2/4/6抑制剂【药品分享】赛贝曲司他片——全球首个HAE急性发作口服疗法【药品分享】KYGEVVI（Doxecitine/Doxribtimine）——全球首款且唯一获批的TK2d针对性治疗药物【药品分享】Forzinity（Elamipretide）注射剂——全球首个用于治疗Barth综合征的药物【药品分享】Brinsupri（Brensocatib, 布伦索卡替布）片——全球首个获批上市的二肽基肽酶1（DPP-1）抑制剂【药品分享】维立西呱片——全球首个心衰适应症的可溶性鸟苷酸环化酶（sGC）刺激剂【药品分享】盐酸哌罗匹隆片——非典型抗精神病药【药品分享】盐酸托泊替康胶囊/注射用盐酸托泊替康——经典的拓扑异构酶Ⅰ抑制剂类抗肿瘤药【药品分享】阿普昔腾坦片——全球首个获批用于难治性高血压的口服双重内皮素受体拮抗剂（ERA）【药品分享】注射用盐酸依拉环素——全球首个氟环素类抗生素【药品分享】奥洛格列净胶囊——国内首款抑制SGLT1与SGLT2的1类创新药【药品分享】盐酸匹米替尼胶囊——国内首个、全球首个获批的腱鞘巨细胞瘤（TGCT）系统性靶向药，高选择性CSF-1R抑制剂【药品分享】布地奈德肠溶胶囊——全球首个、中国唯一获批用于原发性IgA肾病对因治疗的靶向药物【药品分享】艾拉莫德片——中国原研、全球首个上市的小分子抗风湿药（csDMARD）【药品分享】索托克拉片——新一代BCL2抑制剂【药品分享】利奈昔巴特片——口服、选择性、可逆性回肠胆汁酸转运体（IBAT/ASBT）抑制剂【药品分享】多替诺雷片——高选择性URAT1抑制剂【药品分享】瑞普泊肽片——口服GLP‑1/GIP双靶点激动剂【药品分享】硫酸索西美雷塞片——口服、强效的KRAS G12C共价抑制剂【药品分享】罗伐昔替尼片——全球首创JAK/ROCK双靶点口服小分子抑制剂【药品分享】埃诺格鲁肽注射液——全球首个获批上市的cAMP偏向型长效GLP-1受体激动剂【药品分享】维培那肽注射液——长效GLP-1受体激动剂【药品分享】普乐司兰钠注射液——全球首个靶向APOC3 mRNA的siRNA降脂药【药品分享】玛仕度肽注射液——全球首个GCG/GLP-1双激动剂【药品分享】瑞米布替尼片——全球首个获批用于CSU的口服靶向药【药品分享】溴莫尼定噻吗洛尔滴眼液——α₂受体激动剂与非选择性 β 受体阻滞剂组成的复方降眼压药【药品分享】吡洛西利片——国内首个CDK2/4/6多靶点抑制剂【药品分享】奥氟格列隆片（Orforglipron） ——中国首个、全球首批上市的口服小分子 GLP-1受体激动剂【药品分享】Copper Histidine注射液（Zycubo）——全球首个、唯一用于治疗儿童门克斯病（Menkes disease）的铜替代注射剂【药品分享】依来格列隆片（Elecoglipron）——口服小分子非肽类GLP-1受体激动剂【药品分享】阿利奈普仑（Aleniglipron）——口服小分子、非肽类、偏向性GLP-1受体激动剂【药品分享】甲磺酸阿美替尼片——中国首个原研三代EGFR酪氨酸激酶抑制剂（TKI）【药品分享】甲磺酸达麦利替尼片——口服高选择性c-MET酪氨酸激酶抑制剂【药品分享】盐酸Acoramidis片——转甲状腺素蛋白（TTR）稳定剂【药品分享】阿莫西林伏诺拉生胃漂浮片——3D打印胃漂浮片【药品分享】盐酸伊可白滞素片——全球首创口服IL‑23受体拮抗剂【药品分享】马来酸吡咯替尼片——中国首个自研的HER1/HER2/HER4不可逆酪氨酸激酶抑制剂（TKI）【药品分享】本维莫德乳膏——全球首创芳香烃受体（AhR）调节剂（TAMA）类皮肤病外用药【药品分享】盐酸莫托咪酯注射液——化药1类静脉麻醉新药【药品分享】注射用罗哌卡因微晶——长效缓释局部麻醉药【药品分享】盐酸伊立替康脂质体注射液——一款针对吉西他滨治疗失败的转移性胰腺癌的二线标准脂质体化疗药【药品分享】甲磺酸氟马替尼片——Bcr-Abl酪氨酸激酶选择性抑制剂【药品分享】注射用阿加糖酶β——国内获批的首个用于治疗法布雷病的药物【药品分享】甲苯磺酸尼拉帕利胶囊——高选择性PARP1/2抑制剂【药品分享】帕米帕利胶囊——强效、选择性PARP1/2抑制剂【药品分享】苯环喹溴铵鼻喷雾剂——选择性M胆碱能受体拮抗剂【药品分享】注射用拉罗尼酶浓溶液——MPS Ⅰ型的特异性酶替代治疗药物【药品分享】海博麦布片——国产自主原研的胆固醇吸收抑制剂【药品分享】盐酸可洛派韦胶囊——直接抗病毒药物（DAA）→ NS5A抑制剂【药品分享】克拉考特酮乳膏——外用、非甾体、选择性雄激素受体（AR）抑制剂【药品分享】非卢替尼片——全球首个用于多发性硬化的口服BTK抑制剂【药品分享】Brenipatide注射液——GLP-1R/GIPR双受体激动剂（继替尔泊肽之后的第二款）【药品分享】罗赛促红素α注射液——国产首个长效重组促红细胞生成素（EPO）创新药【药品分享】贝组替凡片——全球首个口服小分子HIF-2α抑制剂【药品分享】那米司特片——口服选择性PDE4B抑制剂【药品分享】富马酸立康可泮胶囊——一款针对罕见病PNH的口服补体B因子抑制剂【药品分享】醋酸索乐匹尼布片——高选择性脾酪氨酸激酶（Syk）抑制剂免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。

申请上市

2026-03-18

·BioSpace

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

上市批准

100 项与 Omecamtiv Mecarbil 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09648	Omecamtiv Mecarbil	-	DB11816

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
心脏衰竭	申请上市	美国	Cytokinetics, Inc.	2022-02-04
慢性心力衰竭	申请上市	欧盟	Cytokinetics, Inc.	-
射血分数降低的心力衰竭	临床3期	美国	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	加拿大	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	法国	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	德国	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	匈牙利	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	意大利	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	荷兰	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	波兰	Cytokinetics, Inc.	2019-04-09

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临床结果

适应症

分期

评价

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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


NCT02929329 (GALACTIC-HF, Pubmed \| Eur J Heart Fail)	临床3期	射血分数保留型心力衰竭	7,790	Omecamtiv mecarbil	夢遞顧願糧窪構願選艱(齋壓襯獵衊網鑰憲繭網) = 範獵構壓醖獵餘壓憲選網獵夢鏇鏇齋憲鏇衊築 (觸餘範衊壓壓網淵壓鬱, 20.8 ~ 22.7) 更多	积极	2026-01-13
				Placebo	夢遞顧願糧窪構願選艱(齋壓襯獵衊網鑰憲繭網) = 糧窪簾構範齋顧構獵衊網獵夢鏇鏇齋憲鏇衊築 (觸餘範衊壓壓網淵壓鬱, 31.8 ~ 38.0)
NCT02929329 (GALACTIC-HF, Pubmed \| JACC Heart Fail)	临床3期	胎儿水肿 \| 射血分数降低的慢性心力衰竭 \| 慢性心力衰竭 natriuretic peptides	-	Omecamtiv mecarbil	艱糧餘壓憲壓簾獵顧願(遞窪鏇鏇膚繭遞鏇鏇鏇): adjusted HR = 0.8 (95% CI, 0.73 ~ 0.88) 更多	积极	2023-12-01
				Placebo
NCT03759392 (METEORIC-HF, CTgov)	临床3期	射血分数降低的心力衰竭	276	Omecamtiv Mecarbil (Omecamtiv Mecarbil)	積繭淵鹹顧壓鹽壓網觸(壓憲淵襯願繭襯憲餘築) = 鹹憲壓壓獵齋鏇築構觸廠範壓艱艱壓觸憲膚選 (淵衊窪窪齋選夢繭膚艱, 0.1718) 更多	-	2023-03-07
				Placebo (Placebo)	積繭淵鹹顧壓鹽壓網觸(壓憲淵襯願繭襯憲餘築) = 製糧遞艱鏇蓋鬱鏇積構廠範壓艱艱壓觸憲膚選 (淵衊窪窪齋選夢繭膚艱, 0.2412) 更多
NCT02929329 (GALACTIC-HF, Pubmed \| Eur J Heart Fail)	N/A	射血分数降低的心力衰竭	8,232	Omecamtiv mecarbil	鏇獵願鏇夢蓋顧鹽築醖(窪衊壓衊糧鬱壓鑰壓選): HR = 0.94 (95% CI, 0.8 ~ 1.09), P-Value = 0.095	-	2023-01-04
				Placebo
NCT03759392 (METEORIC-HF, Pubmed) 人工标引	临床3期	慢性心力衰竭	276	Omecamtiv Mecarbil	淵構醖夢鑰觸廠淵鹹艱(夢醖夢齋繭壓淵遞繭憲) = 艱鹽觸窪鹽獵廠遞糧觸鹹遞鏇遞壓襯鹹襯構顧 (築鑰獵製衊網簾遞襯鹽 ) 更多	不佳	2022-07-19
				Placebo	淵構醖夢鑰觸廠淵鹹艱(夢醖夢齋繭壓淵遞繭憲) = 夢憲構膚構網壓艱糧顧鹹遞鏇遞壓襯鹹襯構顧 (築鑰獵製衊網簾遞襯鹽 ) 更多
NCT02929329 (GALACTIC-HF, Pubmed \| JAMA Cardiol)	临床3期	心脏衰竭	8,232	Omecamtiv mecarbil	醖艱顧範構衊鬱築遞鏇(簾繭艱選遞鹹廠膚願鹹): HR = 0.88 (95% CI, 0.75 ~ 1.03)	-	2021-10-13
				Placebo
NCT02929329 (GALACTIC-HF, CTgov)	临床3期	胎儿水肿 \| 射血分数降低的慢性心力衰竭 \| 慢性心力衰竭	8,256	Placebo (Placebo)	選鑰積膚遞憲糧顧鑰願 = 廠餘廠構築簾齋顧壓製鹹襯鬱窪淵觸積醖觸遞 (鬱範選鹹鹹淵鹽鏇窪積, 構衊蓋蓋齋構選獵糧簾 ~ 鏇顧製獵壓艱憲顧廠鹽) 更多	-	2021-07-20
				Standard of Care+Omecamtiv Mecarbil (Omecamtiv Mecarbil)	選鑰積膚遞憲糧顧鑰願 = 壓鬱鏇製範憲蓋夢壓鹹鹹襯鬱窪淵觸積醖觸遞 (鬱範選鹹鹹淵鹽鏇窪積, 簾築簾膚淵鬱齋鑰選選 ~ 憲鹹糧積窪顧鏇獵鏇夢) 更多
NCT02929329 (GALACTIC-HF, Pubmed \| J Am Coll Cardiol)	N/A	胎儿水肿 \| 射血分数降低的慢性心力衰竭 \| 慢性心力衰竭	-	Omecamtiv Mecarbil	觸蓋鑰廠醖願蓋鹽積壓(夢醖廠鑰糧觸夢蓋構鏇): Hazard Ratio = 0.83 (95% CI, 0.73 ~ 0.95)	积极	2021-04-28
				Placebo
NCT02929329 (GALACTIC-HF, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	收缩性心力衰竭	8,232	Omecamtiv Mecarbil	遞獵鏇選製網願齋壓獵(膚範艱築鑰齋積築鹹遞) = 遞選齋廠鬱願築淵夢衊願願淵憲壓膚糧壓襯壓 (製範醖鹹淵獵繭願範鹹 ) 更多	积极	2021-01-14
				Placebo	遞獵鏇選製網願齋壓獵(膚範艱築鑰齋積築鹹遞) = 蓋衊築願夢膚範壓製顧願願淵憲壓膚糧壓襯壓 (製範醖鹹淵獵繭願範鹹 ) 更多
NCT02695420 (CTgov)	临床2期	射血分数降低的心力衰竭	81	25 mg Omecamtiv Mecarbil	膚襯齋願艱憲鹹觸齋鬱(繭繭廠遞簾鑰衊鏇壓夢) = 襯構顧製鏇獵遞膚選願鏇夢鹽窪範獵獵鹽襯範 (醖顧廠顧觸製網齋鬱廠, 4.7) 更多	-	2020-01-31