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Last update 04 Sep 2025

Amiodarone Hydrochloride

Last update 04 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAmiodarone, also known as CORDARONE, is an antiarrhythmic drug developed in 1961 by chemists Tondeur and Binon. By 1980, it was commonly prescribed throughout Europe for the treatment of arrhythmias. In December 1985, due to the threat of a cut-off from European companies, amiodarone was approved by the FDA for the treatment of arrhythmias, even though it had not undergone rigorous randomized clinical trials. Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. It blocks sodium and myocardial potassium channels, contributing to slowing of conduction and prolongation of refractoriness. CORDARONE is indicated for the treatment of life-threatening ventricular fibrillation and unstable tachycardia in adults who have not responded to other antiarrhythmics.

Drug Type

Small molecule drug

Synonyms

2-Butyl-3-(3,5-diiodo-4-(2-diethylaminoethoxy)benzoyl)benzofuran, 2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone, 2-n-Butyl-3',5'-diiodo-4'-N-diethylaminoethoxy-3-benzoylbenzofuran

+ [15]

Target

Potassium channel x Sodium channels x VDCCs x β-adrenoceptors

Action

blockers, antagonists

Mechanism

Potassium channel blockers, Sodium channels blockers, VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Heart ArrestAtrial FibrillationTachycardia, Ventricular+ [3]

Inactive Indication

Heart Failure

Originator Organization

Labaz

Active Organization

Sanofi KKBaxter Healthcare Corp.

Libbs Farmacêutica Ltda.

+ [2]

Inactive Organization

Prism Pharmaceuticals, Inc.Wyeth ABWyeth Pharmaceuticals LLC

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 1983),

Arrhythmias, Cardiac

RegulationOrphan Drug (United States), Orphan Drug (Japan)

Structure/Sequence

Molecular FormulaC25H30ClI2NO3

InChIKeyITPDYQOUSLNIHG-UHFFFAOYSA-N

CAS Registry19774-82-4

161

Clinical Trials associated with Amiodarone Hydrochloride

CTR20252782

/ Active, not recruitingNot Applicable

盐酸胺碘酮片在中国健康受试者中空腹和餐后状态下单中心、随机、开放、单剂量、两周期、两序列、双交叉的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, double-crossover bioequivalence study of amiodarone hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions

主要目的：以珠海润都制药股份有限公司生产的盐酸胺碘酮片（规格：0.2g）为受试制剂，Sanofi-Aventis France持证的盐酸胺碘酮片（规格：0.2g，商品名：Cordarone®）为参比制剂，评价受试制剂和参比制剂在空腹及餐后条件下的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation and the reference preparation under fasting and postprandial conditions, using amiodarone hydrochloride tablets (specification: 0.2g) produced by Zhuhai Rundu Pharmaceutical Co., Ltd. as the test preparation and amiodarone hydrochloride tablets (specification: 0.2g, trade name: Cordarone®) certified by Sanofi-Aventis France as the reference preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Aug 2025

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

NCT01422148

/ Not yet recruitingPhase 2IIT

Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery (MINA)

. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs.
In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care of this disease.

Start Date01 Jul 2025

Sponsor / Collaborator

Baystate Medical Center

NCT06835491

/ Not yet recruitingPhase 3IIT

Prophylactic Anti-aRrhythmic Therapy with Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest with Initial Shockable Rhythm.

To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Start Date15 Jun 2025

Sponsor / Collaborator

Centre Hospitalier de Versailles

100 Clinical Results associated with Amiodarone Hydrochloride

100 Translational Medicine associated with Amiodarone Hydrochloride

100 Patents (Medical) associated with Amiodarone Hydrochloride

13,226

Literatures (Medical) associated with Amiodarone Hydrochloride

31 Dec 2025·REDOX REPORT

Artemisinin protected human bronchial epithelial cells from amiodarone-induced oxidative damage via 5′-AMP-activated protein kinase (AMPK) activation

Article

Author: Zhao, Xia ; Zheng, Wenhua ; Xiong, Wenjun ; Liang, Guang ; Yang, Chao ; Dong, Jiayi

BACKGROUND:

Amiodarone, a common antiarrhythmic drug, is known for its severe side effects, including pulmonary toxicity, which involves oxidative stress and apoptosis. Artemisinin, an antimalarial drug, has shown cytoprotective properties by inhibiting oxidative stress and apoptosis. This study investigated the protective effects of artemisinin against amiodarone-induced toxicity in human bronchial epithelial cells (BEAS-2B) and mouse models.

RESULTS:

In vitro experiments revealed that amiodarone decreased cell viability, increased LDH release, ROS generation, caspase 3 activation, and apoptosis in BEAS-2B cells. Artemisinin counteracted these effects by upregulating p-AMPK, CaMKK2, Nrf2, and SOD1 protein levels, thereby protecting the cells from oxidative damage. The protective effect of artemisinin was diminished by the AMPK inhibitor Compound C or AMPKα knockdown. In vivo experiments demonstrated that artemisinin increased p-AMPK and Nrf2 protein levels in lung tissues, protecting against amiodarone-induced apoptosis and bronchial epithelial cell shedding in mice.

CONCLUSION:

These findings suggest that artemisinin protects airway epithelial cells and lung tissue from amiodarone-induced oxidative stress and apoptosis through AMPK activation, offering potential new strategies for preventing and treating amiodarone-induced pulmonary toxicity.

31 Dec 2025·SCANDINAVIAN CARDIOVASCULAR JOURNAL

The use of antiarrhythmic drugs for atrial fibrillation in Finland 2007–2018

Article

Author: Marjamaa, Annukka ; Siponen, Rasmus ; Lehto, Mika ; Hartikainen, Juha ; Teppo, Konsta ; Putaala, Jukka ; Airaksinen, Juhani ; Aro, Aapo ; Mustonen, Pirjo ; Salmela, Birgitta ; Haukka, Jari ; Virrankorpi, Janne ; Linna, Miika ; Lappalainen, Antti ; Halminen, Olli

BACKGROUND:

Patients with atrial fibrillation (AF) are often treated with antiarrhythmic drugs (AADs) to maintain sinus rhythm and with heart rate-lowering drugs to achieve the optimal rate control. In this study, we investigated trends in the use of AADs and rate control drugs in Finnish patients with AF.

METHODS AND RESULTS:

The Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study is a nationwide study including all patients with AF in Finland from 2007 to 2018. The number of AAD purchases and the proportions of all prevalent AF patients in a certain year of interest were calculated. In total, 391030 AF patients were identified between 2007 and 2018, and 39,816 (10.2%) of them had purchased either class I or III AADs. The proportion of patients using classes I and III AADs decreased from 8.6% to 6.3%. Flecainide and amiodarone were the most often used AADs. The use of flecainide and amiodarone decreased from 4.9% to 3.9% and 1.9% to 1.5%, respectively. The proportion of patients on beta-blockers remained stable at 75%. Dronedarone became available in 2011 when it also was the most used (0.8% of patients), but the use decreased thereafter. The use of sotalol and digoxin decreased from 1.5% to 0.6% and 24.6% to 11.0% over the study period.

CONCLUSION:

The number of AAD purchases increased alongside with the increasing prevalence of AF, whereas the proportion of AF patients on classes I and III AADs and digoxin decreased between 2007 and 2018. Flecainide remained the most used AAD followed by amiodarone.

01 Dec 2025·TOXICOLOGY

A mechanistically-anchored and human stem cell-based in vitro test battery for assessing liver steatogenic potential of chemicals

Article

Author: De Kock, Joery ; Rodrigues, Robim M ; Sanz-Serrano, Julen ; Verhoeven, Anouk ; Vinken, Mathieu ; Gatzios, Alexandra ; Vanhaecke, Tamara

Fatty liver disease, which can result from various factors including chemical exposure, is an increasing clinical concern. A key event in its development is steatosis, referring to the accumulation of lipids within hepatocytes. To enable early detection of chemical-induced liver steatosis, we developed a mechanistically-anchored, human-relevant new approach methodology (NAM). This NAM consists of a 2-tiered in vitro test battery, aligned with the adverse outcome pathway (AOP) network for steatosis, and utilizes human skin-derived precursor cells differentiated into hepatic cells (hSKP-HPC), previously shown to be responsive to steatogenic triggers. In total, 6 well-known steatogenic compounds, including 3 pharmaceuticals (sodium valproate, tetracycline hydrochloride, amiodarone hydrochloride), a pesticide (cyproconazole), and 2 plasticizers (tricresyl phosphate and perfluorohexanesulfonic acid) alongside 2 non-steatogenic chemicals (minocycline hydrochloride and tartaric acid), were tested over a 72-hour period. Tier 1 evaluated transcriptional changes in key lipid metabolism pathways, and modulations were observed in nuclear receptors (peroxisome proliferator-activated receptor), fatty acid uptake (fatty acid translocase), de novo lipogenesis (diacylglycerol acyl transferase 2, fatty acid synthase and stearoyl-CoA desaturase 1), as well as in VLDL secretion (apolipoprotein B100). Tier 2 assays assessed and confirmed downstream functional disruptions in fatty acid uptake and lipid accumulation as ultimate specific key events for steatogenic chemicals. Overall, this human stem cell-based NAM offers a promising tool for supporting early hazard identification of steatogenic chemicals across diverse sectors, bridging mechanistic insights to outcomes relevant to the initiation of fatty liver disease.

News (Medical) associated with Amiodarone Hydrochloride

22 Jan 2025

·www.prnewswire.com

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalLicense out/in

16 Jan 2025

·www.prnewswire.com

Late-breaking data presented at AF Symposium 2025 highlight key Boston Scientific therapies for management of patients with atrial fibrillation

First phase of ADVANTAGE AF clinical trial achieves safety and effectiveness endpoints for treatment of drug-resistant, symptomatic, persistent atrial fibrillation with the FARAPULSE™ Pulsed Field Ablation System Sub-analysis from OPTION clinical trial highlights consistent safety and efficacy outcomes with the WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac ablation in both concomitant and sequential procedures MARLBOROUGH, Mass., Jan. 16, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced data supporting the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device, respectively, during a late-breaking science session at AF Symposium 2025. ADVANTAGE AF clinical study Currently, the FARAPULSE PFA System is approved for pulmonary vein isolation (PVI) in patients who have paroxysmal AF, an irregular heartbeat that occurs occasionally and typically spontaneously resolves back to normal rhythm. The ADVANTAGE AF study examined use of the FARAPULSE PFA System for both PVI and posterior wall ablation (PWA) in patients who have persistent AF, where individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represent 25% of all AF cases.1 The prospective, single arm trial included 260 patients enrolled at 43 global sites who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD). Key findings from the study through 12 months included: The primary safety endpoint – defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months – was met with a 2.3% event rate. The primary effectiveness endpoint – defined as freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AAD or amiodarone – was met at 63.5%. The symptomatic AF recurrence-free rate was 85.3% and observationally, among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to 91.8%. There were no reported incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications. "In addition to the positive safety and efficacy outcomes achieved in the ADVANTAGE AF study, a significant number of patients were able to discontinue AADs as well as see greater improvements in quality of daily life," said Vivek Reddy, M.D.**, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York and study principal investigator. "As the population of patients living with AF continues to grow, data from trials such as ADVANTAGE AF further support the paradigm shift to PFA as a treatment for patients who are living with persistent and other complex forms of AF." OPTION trial sub-analysis The late-breaking session also included a prespecified sub-analysis from the OPTION clinical trial that built upon the positive primary endpoint results presented at the American Heart Association 2024 meeting and published in The New England Journal of Medicine.2 In line with the overall 36-month outcomes from this first head-to-head study of the WATCHMAN FLX device and direct oral anticoagulants (95% DOAC, 5% warfarin), the sub-analysis of 1,600 patients with atrial fibrillation who underwent a device implantation either concomitantly or sequentially (90-180 days post ablation) demonstrated: Consistent with the previously presented primary safety and efficacy endpoint data presented in November 2024, concomitant LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 44% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.0% vs. 13.3%; p=0.02) and similar efficacy outcomes (7.0% vs. 6.7% p=0.91), with the primary efficacy endpoint defined as all-cause death, stroke or systemic embolism. Also consistent with the previously presented primary safety and efficacy endpoint data, sequential LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 62% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.8% vs. 21.5%; p<0.0001) and similar efficacy outcomes (4.2% vs. 5.3%; p=0.45). Similar stroke protection with the WATCHMAN FLX device compared to OAC irrespective of concomitant (2.3% vs. 2.5% rates of all stroke) or sequential (1.1% vs 1.6%) implantation. "These late-breaking studies provide valuable clinical evidence supporting our ablation and stroke prevention technologies that are designed to improve long-term outcomes for patients with atrial fibrillation," said Dr. Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific. "The positive findings support our focus on expanding the number of patients who can benefit from these life-changing therapies, which we will continue to advance through future clinical trials and product development." More information on the ADVANTAGE AF study is available here and on the OPTION trial here.*** About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and connect on LinkedIn and X, formerly Twitter. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, clinical trials, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document. CONTACTS: Becca Johnson Media Relations +1 (952) 994-8526 [email protected] Jon Monson Investor Relations +1 (508) 683-5450 [email protected] *CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation beyond pulmonary vein isolation is outside the use of labeled indication of the FARAWAVE PFA Catheter with the FARAPULSE PFA System. **Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release. *** The FARAPULSE PFA System was not commercially available at the time of the OPTION trial initiation and was not included in the trial design. 1Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220. doi: 10.2147/CLEP.S47385 2 Wazni OM, Saliba WI, Nair DG, et al. Left atrial appendage closure after ablation for atrial fibrillation. N Engl J Med. 2024 Nov 16. doi:10.1056/NEJMoa2408308 SOURCE Boston Scientific Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultClinical StudyAHA

22 Nov 2024

·www.drugs.com

AHA: Initial Catheter Ablation Beneficial for Ventricular Tachycardia

FRIDAY, Nov. 22, 2024 -- An initial strategy of catheter ablation leads to a lower risk for a composite primary end point than antiarrhythmic drug therapy among patients with ischemic cardiomyopathy and ventricular tachycardia, according to a study published online Nov. 16 in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2024, held from Nov. 16 to 18 in Chicago. John L. Sapp, M.D., from Dalhousie University in Halifax, Nova Scotia, Canada, and colleagues randomly assigned 416 patients with previous myocardial infarction and clinically significant ventricular tachycardia to receive antiarrhythmic drug therapy (sotalol or amiodarone) or to undergo catheter ablation, performed within 14 days after randomization. Patients were followed for a median of 4.3 years. The researchers found that a primary end point occurred in 50.7 percent of the 203 patients assigned to catheter ablation and 60.6 percent of the 213 assigned to drug therapy (hazard ratio, 0.75). Among patients in the catheter ablation group, adverse events within 30 days included death and nonfatal adverse events (1.0 and 11.3 percent, respectively). Among patients assigned to drug therapy, adverse events attributed to antiarrhythmic drug treatment included death from pulmonary toxic effects and nonfatal adverse events (0.5 and 21.6 percent, respectively). "Catheter ablation and antiarrhythmic drug therapy can reduce the risk of recurrent ventricular tachycardia and implantable cardioverter-defibrillator shock, but both approaches are associated with adverse events and have imperfect efficacy," the authors write. "Determining when to use these therapies is an important clinical decision." Several authors disclosed ties to pharmaceutical companies, including Johnson & Johnson and Abbott, which provided research grants.

AHAClinical Study

100 Deals associated with Amiodarone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00636	Amiodarone Hydrochloride	C01BD01	DB01118

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Arrest	Japan	Sanofi KK	31 May 2013
Atrial Fibrillation	Japan	Sanofi KK	03 Jul 1992
Tachycardia, Ventricular	United States	Wyeth Pharmaceuticals LLC	24 Dec 1985
Ventricular Fibrillation	United States	Wyeth Pharmaceuticals LLC	24 Dec 1985
Tachycardia, Supraventricular	Brazil	Libbs Farmacêutica Ltda.	15 Aug 1983
Arrhythmias, Cardiac	China	Guilin Pharmaceutical Co., Ltd.	01 Jan 1983

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	Phase 2	-	Prism Pharmaceuticals, Inc.	01 Aug 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01850277 (Pilot-CRAfT, Pubmed \| Clin Res Cardiol)	Phase 4	Atrial Fibrillation	43	cardiac resynchronization (Rhythm control group)	exnzcaouqo(rukucxmuty) = hbwshgltpi ajmfecrapw (ajaxrsyznk, 97.3 - 99.8) View more	Positive	10 Oct 2024
				cardiac resynchronization (Rate control group)	exnzcaouqo(rukucxmuty) = xssfunwoiv ajmfecrapw (ajaxrsyznk, 94.0 - 99.0) View more
NCT01722942 (CHAGASICS, Pubmed \| JAMA Cardiol) Manual	Not Applicable	Cardiomyopathies	323	Amiodarone	cxeeuhseze(cmbylgrnzn) = ysnswcerdb pbiwduiifu (fjuxhdjzjg ) View more	Negative	02 Oct 2024
				amiodarone	cxeeuhseze(cmbylgrnzn) = qxprlsvawi pbiwduiifu (fjuxhdjzjg ) View more
ESC2024	Not Applicable	Atrial Fibrillation	-	Amiodarone	trzbaphjrc(cxdmtjjzni) = avfpifapva yavtdwgurm (qachktglec ) View more	-	09 Apr 2024
				Propafenone	trzbaphjrc(cxdmtjjzni) = btltamxurm yavtdwgurm (qachktglec ) View more
NCT05004077 (RADICAL, CTgov)	Phase 4	Atrial Fibrillation	3	Amiodarone (Conventional Amiodarone Dosing Regimen (CDR))	yjaampgjzr(kfkpglyyre) = wwphiripik wjzjmgcdqx (wsfczciojv, gfklbxepjv - wuqrtnflcz) View more	-	18 Nov 2023
				Amiodarone (Repeated Amiodarone Bolus Dosing Regimen (RBDR))	yjaampgjzr(kfkpglyyre) = mpijytrfho wjzjmgcdqx (wsfczciojv, nzzbiqbnaj - prmpffwezj) View more
PSUN38 (ENDO2022)	Not Applicable	-	-	amiodarone (Thyrotoxicosis)	kqtoyviaer(amxkdjagun) = kdmwsijcza sviinwxlck (bnhalczmla ) View more	Positive	01 Nov 2022
				amiodarone (Hypothyroidism)	kqtoyviaer(amxkdjagun) = qihfcuzkvw sviinwxlck (bnhalczmla )
ESC2022	Not Applicable	Atrial Fibrillation	-	Amiodarone treatment	dtaxtdppne(knjgjndaum) = jbjqridbew cyzbdbtirq (elbddlqcso )	Positive	29 Aug 2022
				Control group (not exposed to amiodarone)	dtaxtdppne(knjgjndaum) = zzjsfdkftx cyzbdbtirq (elbddlqcso )
ASTRO2020	Not Applicable	Non-Small Cell Lung Cancer	-	Amiodarone	sfyeughawn(ophxfqfkib) = dggvsxcqhd rmltzccxgf (ucyujxsrav )	-	01 Nov 2020
NCT03221764 (CTgov)	Phase 2	Lung transplant rejection \| Atrial Fibrillation	20	amiodarone	hgajrgbkqy = qbubreukbb abkdypydnl (apknsayjnv, xrwfklljry - fldnberdud) View more	-	29 Jun 2020
NCT01097330 (CEASE-VT, CTgov)	Phase 3	Tachycardia, Ventricular	12	Ablation (Ablation)	fxsdessbnd = ppoicnpmtc mpwpadtxsh (msrqfgebei, fzaxdutzjc - wvxmmascfl) View more	-	29 Jan 2020
				Amiodarone (Amiodarone)	fxsdessbnd = eocirgybpp mpwpadtxsh (msrqfgebei, bovedtddsy - tbjnpdozzq) View more
NCT02301390 (INTERVENE, CTgov)	Not Applicable	Tachycardia, Ventricular	53	Amiodarone (Amiodarone Only)	awkpqbcnxv = nqpzfmlyaf wewusyywon (ozgutvaqxl, xgjhusonnv - vdomobeksl) View more	-	27 Jan 2020
				Catheter Ablation+Amiodarone (Amiodarone + Catheter Ablation)	awkpqbcnxv = podbtyovkl wewusyywon (ozgutvaqxl, ytzykypajg - zwcjmbmwqz) View more

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