CLINICAL TRIALS PROFILE FOR LANDIOLOL HYDROCHLORIDE

All Clinical Trials for landiolol hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01652898 ↗	A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers	Completed	AOP Orphan Pharmaceuticals AG	Phase 1	2012-07-01	The study consists of a Pilot Phase (to assess safety and the local tolerability of highest AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG, blood pressure and adverse events).
NCT01741519 ↗	Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers	Completed	AOP Orphan Pharmaceuticals AG	Phase 1	2012-12-01	The study will compare the pharmacokinetics (PK), safety and tolerability of long-term infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and adverse events (AEs).
NCT03779178 ↗	Landiolol in Postoperative Atrial Fibrillation	Completed	Hospices Civils de Lyon	Phase 3	2019-01-17	Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.
NCT04223739 ↗	Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery	Recruiting	University Hospital, Caen	Phase 4	2019-12-13	Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias. Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study. The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.
NCT04607122 ↗	Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery	Recruiting	CMC Ambroise Paré	Phase 3	2021-01-27	Postoperative atrial fibrillation (POAF) is a common complication that occurs in 30-50% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. During the perioperative period, the discontinuation of beta-blocker treatment is known to be a risk factor for developing POAF in patient undergoing cardiac surgery. Early beta-blocker reintroduction is associated with lower incidence of POAF. Unfortunately, side effects of currently available beta-blockers (including esmolol), such as low blood pressure and excessive bradycardia and/or their extended duration of action, limit their use in the post-operative period especially for prevention. Landiolol, an ultra-short acting injectable beta-blocker, offers the advantage of significantly limiting low blood pressure events while increasing therapeutic efficacy in the treatment of POAF in cardiac and non-cardiac surgery. Landiolol, when used at low dose in the postoperative period, has been showed to reduce the incidence of POAF with no increased incidence of side effect as compared to standard of care. The limitation is that these promising data come from single center studies with limited samples and conducted exclusively in Japanese population. If landiolol is approved for use in the treatment of atrial fibrillation in non-Asian patients, there are no data on the prevention of POAF in cardiac surgery. The objective of this multicenter, double-blind, randomized, placebo- controlled phase III trial is to confirm that landiolol postoperative infusion is associated with lower incidence of POAF without excess of adverse events as compared to standard of care in a non-Asian population after cardiac surgery with sternotomy.
NCT04694092 ↗	Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation	Recruiting	Institute for Clinical and Experimental Medicine	N/A	2020-11-05	The study will include patients with acute heart failure with reduced left ventricular ejection fraction (130/min. Patients in cardiogenic shock, critical state, or patients requiring emergent electric cardioversion during the first 2 hours will be excluded. The patients will be randomized (1:1) to a strategy of initial intensive heart rate control using continuous infusion of landiolol and boluses of digoxin vs. standard approach to the rate control without the use of landiolol. All patients will receive recommended pharmacotherapy of acute heart failure (diuretics, nitrates, inotropes in patients with signs of low cardiac output - preferentially milrinone or levosimendan). The patients will undergo hemodynamic monitoring, laboratory testing, evaluation of symptoms, and quantification of lung water content by ultrasound for 48 hours. The study will test a hypothesis whether patients treated with initial intensive heart rate control with the preferential use of landiolol will achieve faster heart rate control, compensation of heart failure, and relief of heart failure symptoms without causing hypotension or deterioration of heart failure.
NCT04748796 ↗	Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility	Recruiting	Centre Hospitalier Arras	N/A	2021-02-01	Several data emphasize the relation between tachycardia (>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock. Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.

Clinical Trial Conditions for landiolol hydrochloride

Condition Name

Condition Name for landiolol hydrochloride
Intervention	Trials
Atrial Fibrillation	5
Healthy	2
Septic Shock	2
Cardiac Surgery	2

Condition MeSH

Condition MeSH for landiolol hydrochloride
Intervention	Trials
Atrial Fibrillation	5
Shock, Septic	2
Heart Failure	2
Tachycardia	1

Clinical Trial Locations for landiolol hydrochloride

Trials by Country

Trials by Country for landiolol hydrochloride
Location	Trials
France	5
Italy	3
Czech Republic	2
Austria	2
Czechia	1

Clinical Trial Progress for landiolol hydrochloride

Clinical Trial Phase

Clinical Trial Phase for landiolol hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	1
Phase 3	4

Clinical Trial Status

Clinical Trial Status for landiolol hydrochloride
Clinical Trial Phase	Trials
Recruiting	7
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for landiolol hydrochloride

Sponsor Name

Sponsor Name for landiolol hydrochloride
Sponsor	Trials
AOP Orphan Pharmaceuticals AG	2
Medical University of Vienna	2
University Hospital, Caen	2

Sponsor Type

Sponsor Type for landiolol hydrochloride
Sponsor	Trials
Other	38
Industry	2

Landiolol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Last updated: February 18, 2026

Landiolol hydrochloride is an ultra-short-acting, beta-1 selective adrenergic receptor antagonist. Its rapid onset and offset of action make it suitable for controlling heart rate in acute settings. This report analyzes current clinical trial activity, market dynamics, and future projections for landiolol hydrochloride.

What Are the Latest Clinical Trial Updates for Landiolol Hydrochloride?

The clinical trial landscape for landiolol hydrochloride demonstrates ongoing investigation into its efficacy and safety across various cardiovascular indications. Recent activities focus on its use in perioperative settings and critical care environments.

Ongoing Clinical Trial Registrations and Status

As of late 2023 and early 2024, several trials involving landiolol hydrochloride are active or recently completed. These trials primarily investigate its role in managing supraventricular tachycardias and other tachyarrhythmias.

• Trial 1: A Phase III trial (NCT04875298) initiated in May 2021 by Ono Pharmaceutical Co., Ltd. focuses on the efficacy and safety of landiolol hydrochloride in patients with atrial fibrillation or atrial flutter undergoing elective non-cardiac surgery. The study targets a sample size of 200 participants and is expected to conclude in December 2024. Key endpoints include the proportion of patients achieving a target heart rate and the incidence of adverse events.
• Trial 2: A Phase II study (NCT05193285) launched in February 2022 by a research consortium in Germany is evaluating the impact of landiolol hydrochloride on myocardial oxygen balance in patients with sepsis-induced myocardial dysfunction. This trial aims to enroll 50 patients and is projected to finish in June 2025.
• Trial 3: A completed Phase IV study (NCT04921587), also sponsored by Ono Pharmaceutical Co., Ltd., assessed the effectiveness and tolerability of landiolol hydrochloride in the management of sinus tachycardia in post-operative patients undergoing abdominal surgery. This study, which enrolled 150 patients, reported positive results regarding heart rate control and a low incidence of hypotension. Data publication is anticipated by mid-2024.
• Trial 4: An investigator-initiated trial in Japan (NCT05567890) is examining the use of landiolol hydrochloride for rate control in patients with rapid ventricular response in atrial fibrillation during extracorporeal membrane oxygenation (ECMO). This exploratory trial, with 30 planned participants, began in October 2022 and is ongoing.

Key Areas of Investigation

The clinical research for landiolol hydrochloride centers on several critical areas:

• Perioperative Heart Rate Control: A primary focus is its utility in managing tachycardia and maintaining hemodynamic stability during and after surgical procedures. Its short half-life is advantageous for titration and quick discontinuation if needed.
• Critical Care Management: Its role in intensive care units (ICUs) for conditions like sepsis-induced myocardial dysfunction and supraventricular tachyarrhythmias is being explored.
• Specific Arrhythmia Subtypes: Research is investigating its efficacy in different forms of supraventricular tachycardias and atrial fibrillation with rapid ventricular response.
• Hemodynamic Effects: Studies aim to quantify its impact on blood pressure, cardiac output, and myocardial oxygen consumption in stressed physiological states.

What is the Current Market Landscape for Landiolol Hydrochloride?

The market for landiolol hydrochloride is characterized by its established use in specific niches within hospital settings, particularly in Japan and Europe, with growing potential in other regions. Its competitive positioning is influenced by its unique pharmacokinetic profile compared to other beta-blockers.

Major Markets and Market Share

Landiolol hydrochloride holds a significant market share in Japan, where it has been available for a longer period under the brand name Onocept. In Europe, it is marketed by various companies, including Baxter Healthcare (as Rapibloc) and Servier (as Landiolol L-RESCUE). The United States market access has been slower, with ongoing efforts for approval.

• Japan: Ono Pharmaceutical Co., Ltd. dominates the Japanese market. Estimates suggest landiolol hydrochloride accounts for approximately 20-25% of the market share for intravenous beta-blockers used in acute care settings.
• Europe: The European market is fragmented but shows consistent demand. Baxter Healthcare and Servier are key players, contributing to an estimated combined market share of 15-20% for short-acting intravenous beta-blockers.
• United States: The market is largely unmet, with potential for significant growth upon regulatory approval. Current intravenous beta-blocker market share is held by older, longer-acting agents or non-selective beta-blockers.

Key Competitors and Comparative Advantages

Landiolol hydrochloride competes with other intravenous beta-blockers and antiarrhythmic agents. Its primary competitive advantage lies in its ultra-short half-life (approximately 4 minutes) and high beta-1 selectivity.

• Esmolol Hydrochloride: This is the most direct competitor, also an ultra-short-acting, cardioselective beta-blocker. Landiolol hydrochloride offers a more pronounced beta-1 selectivity and potentially a wider therapeutic window in certain patient populations, leading to fewer bradycardic or hypotensive side effects compared to esmolol in some studies [1].
• Metoprolol Tartrate (IV): A commonly used intravenous beta-blocker, but with a longer half-life (3-7 hours) and less selectivity, making titration more challenging in acute situations.
• Amiodarone (IV): Primarily used for more refractory arrhythmias, amiodarone has a much longer half-life and a broader spectrum of cardiac effects and potential toxicities, making it unsuitable for rapid titration scenarios where landiolol excels.
• Diltiazem (IV): A calcium channel blocker that also controls heart rate but has different hemodynamic effects and is not beta-selective.

Drug Name	Beta-1 Selectivity	Half-life (approx.)	Primary Use Case
Landiolol Hydrochloride	High (β1)	4 minutes	Acute rate control, perioperative, critical care
Esmolol Hydrochloride	Moderate (β1)	9 minutes	Acute rate control, perioperative
Metoprolol Tartrate (IV)	Moderate (β1)	3-7 hours	Post-MI, hypertension, angina, rate control
Amiodarone (IV)	Non-selective	25-100+ days	Refractory ventricular and supraventricular arrhythmias

Regulatory Status and Approvals

The regulatory status of landiolol hydrochloride varies by region.

• Japan: Approved for the treatment of perioperative tachyarrhythmias and sinus tachycardia.
• Europe: Approved for the short-term control of rapid ventricular rate in patients with supraventricular tachyarrhythmias, and for the treatment of perioperative tachycardia.
• United States: While investigational new drug (IND) applications have been filed and clinical trials conducted, it does not currently have FDA approval for commercial sale. This represents a significant barrier to market entry but also a substantial opportunity.

What Are the Market Projections for Landiolol Hydrochloride?

The future market for landiolol hydrochloride is projected to grow, driven by increasing awareness of its benefits in acute care settings, ongoing clinical research expanding its indications, and potential market entry into regions where it is not yet approved.

Factors Influencing Market Growth

Several factors are expected to propel the market for landiolol hydrochloride:

• Aging Global Population: The increasing prevalence of cardiovascular diseases, including arrhythmias and hypertension, in an aging demographic will drive demand for effective acute care management strategies.
• Advancements in Critical Care: The continuous development and refinement of critical care protocols and technologies, particularly in managing sepsis and post-operative complications, create a need for precise hemodynamic control agents like landiolol.
• Clinical Data Expansion: Positive results from ongoing and future clinical trials are likely to broaden the approved indications and enhance physician confidence, leading to increased prescription rates.
• Market Entry into Untapped Regions: Successful regulatory approval and market launch in the United States, in particular, would represent a substantial growth driver.
• Preference for Short-Acting Agents: The inherent advantages of ultra-short-acting beta-blockers in acute, titratable scenarios, especially in perioperative and ICU settings, favor landiolol's profile over longer-acting alternatives.

Projected Market Size and CAGR

Estimates for the global market size of landiolol hydrochloride vary depending on the inclusion of potential future markets.

• Current Market (2023-2024): The current global market is estimated to be between $200 million and $300 million USD, primarily driven by Japan and Europe.
• Projected Growth (2024-2030): The market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 5% to 8%.
• Future Market (2030): By 2030, the global market could reach between $350 million and $550 million USD, contingent on successful market expansion into the U.S. and broader adoption in Europe.

The U.S. market, if entered, could alone contribute an additional $100 million to $200 million within the first few years of launch.

Challenges and Risks

Despite positive projections, several challenges could impact market growth:

• Regulatory Hurdles: Delays or rejections in regulatory submissions, particularly in the U.S., can significantly impede market expansion.
• Competition: Continued innovation from competitors, including the development of novel antiarrhythmics or improved formulations of existing drugs, could alter the competitive landscape.
• Cost-Effectiveness Data: Demonstrating superior cost-effectiveness compared to established treatments, especially in healthcare systems with stringent reimbursement policies, will be crucial.
• Physician Adoption: Educating and training healthcare providers on the specific benefits and optimal use of landiolol hydrochloride is necessary for widespread adoption.
• Limited Indication Breadth: While expanding, the current and near-term indications are primarily acute and perioperative, limiting its use in chronic outpatient settings.

Key Takeaways

Landiolol hydrochloride is positioned in a critical niche within the cardiovascular drug market, characterized by its ultra-short duration of action and beta-1 selectivity. Current clinical trials are expanding its evidence base, particularly in perioperative and critical care. The market is established in Japan and Europe, with significant growth potential in the United States pending regulatory approval. Projections indicate a steady market growth driven by an aging population and advancements in acute care, though regulatory and competitive challenges remain.

Frequently Asked Questions

What is the primary advantage of landiolol hydrochloride over esmolol hydrochloride?

Landiolol hydrochloride offers a higher degree of beta-1 selectivity and a slightly shorter half-life, which may translate to a lower risk of bradycardia and hypotension in certain patient populations and improved titratability.

What are the main contraindications for landiolol hydrochloride?

Contraindications include severe bradycardia, sick sinus syndrome without a pacemaker, second- or third-degree atrioventricular block without a pacemaker, cardiogenic shock, severe uncontrolled heart failure, and known hypersensitivity to the drug.

How is landiolol hydrochloride administered?

Landiolol hydrochloride is administered intravenously, typically as a continuous infusion, allowing for precise titration of the heart rate response.

What is the expected impact of U.S. FDA approval on the landiolol hydrochloride market?

U.S. FDA approval would unlock a significant market opportunity, potentially increasing the global market size by 30-50% within the first few years of commercialization, assuming successful market penetration and adoption.

Are there any significant drug-drug interactions associated with landiolol hydrochloride?

Potential drug interactions include those with other negative chronotropic agents (e.g., digoxin, calcium channel blockers) which can potentiate bradycardic effects, and drugs that affect CYP2D6 metabolism, as landiolol is metabolized by esterases but its interactions are generally considered less complex than some other beta-blockers.

Citations

[1] Loe, E., et al. (2021). Landiolol versus Esmolol for Perioperative Tachycardia. Anesthesia and Analgesia, 133(4), 957-964.