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.

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
Heart Failure	2
Shock, Septic	2
Heart Arrest	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

Last updated: May 22, 2026

Landiolol Hydrochloride Clinical Trials Update, Market Analysis, and Forecast (2026-2035)

Landiolol hydrochloride is a short-acting, ultra–short-acting IV beta-1 selective blocker positioned for perioperative heart-rate control and rhythm management, with the core commercial driver tied to postoperative atrial fibrillation risk reduction and acute cardiovascular rate control. Clinical development is still led by investigator-initiated and sponsor-led programs in perioperative and arrhythmia-adjacent settings, while market growth is constrained by geography-specific adoption patterns, hospital formulary inertia, and the need to demonstrate outcome value versus established rate-control and rhythm strategies.

Market sizing and forecasting requires anchored sales baselines (country-level uptake, tender pricing, and reimbursement). If those baseline data are not available in the source set, no defensible projection can be produced.

Regulatory and clinical reality check

• Landiolol hydrochloride has an established use case in Japan and specific markets where approvals exist.
• Near-term pipeline value depends on whether ongoing trials convert to broader label expansion (new indications, broader patient populations, and perioperative pathways).

Because you requested a “clinical trials update, market analysis and projection,” a complete answer must include: (1) trial-by-trial status with dates and endpoints, (2) revenue baseline and geographic segmentation, and (3) forecast methodology tied to those facts. No complete, accurate set of those inputs is available in the current context.

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What clinical trials are ongoing for landiolol hydrochloride, and what are their endpoints?

Perioperative atrial fibrillation and heart-rate control

Primary intent categories:

• Prevention or reduction of postoperative atrial fibrillation (POAF)
• Rate control in tachyarrhythmias with rapid offset due to drug’s short half-life
• Perioperative hemodynamic stabilization in high-risk surgical cohorts

Arrhythmia and acute cardiovascular settings

Secondary intent categories:

• Acute rate control where rapid titration and quick discontinuation are required
• Transition of care from IV to longer-acting agents without prolonged beta blockade

Development status data required for an “update”

A true clinical trials update must be grounded in:

• Trial registry IDs (e.g., NCT/UMIN/JPRN)
• Sponsor, phase, and primary/secondary endpoints
• Current recruitment and last update dates
• Results availability and subgroup findings

Those concrete trial facts are not present in the current context, so a complete update cannot be generated.

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Is landiolol hydrochloride approved for postoperative atrial fibrillation (POAF) and what does its label say?

Key label elements that drive commercial adoption

• Indication wording (prevention vs treatment; POAF timing window)
• Patient population definition (e.g., cardiac surgery vs non-cardiac surgery)
• Dosage and administration protocol (bolus/titration; infusion duration)
• Contraindications and safety monitoring requirements (bradycardia, hypotension)
• Claims around reversal/rapid offset as part of clinical pathway

Without approved label text and geography, the label analysis cannot be completed.

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What is the Orange Book status of landiolol hydrochloride (including listed patents and exclusivity)?

An Orange Book status analysis requires:

• Drug product listing(s) and strength/dosage form entries
• Patent numbers, expiration dates, and exclusivity indicators (e.g., 5-year NCE, 3-year new clinical investigation, 7-year orphan if applicable)
• Any listed changes (supplements) that shift expiration timelines

No Orange Book listing dataset is provided here, so a patent-and-exclusivity section would be incomplete.

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When does landiolol hydrochloride lose exclusivity in key markets (US/EU/JP), and can generics launch early?

To answer “when it loses exclusivity,” you need:

• Legal exclusivity triggers by country (NCE or indication exclusivity, data exclusivity, patent term)
• Patent expiration schedules by jurisdiction
• Regulatory pathway mapping (ANDA vs 505(b)(2); and for EU, Article 10/18)

No jurisdiction-specific exclusivity or patent schedule is available in the current context.

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How many patents protect landiolol hydrochloride, and what claims types dominate (formulation, method-of-use, manufacturing)?

A defensible IP strength count requires:

• Patent family aggregation
• Claim type classification
• Jurisdiction-by-jurisdiction status (granted, pending, lapsed)
• Expiration and term-adjustment/extension data

No patent corpus is supplied here, so coverage cannot be quantified.

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Which companies are developing or selling landiolol hydrochloride, and what is the competitive landscape?

A competitive landscape requires:

• Marketing authorization holders and distributors by country
• Tender/contract presence
• Competitor class positioning: other IV beta blockers (where used), rate-control agents, and rhythm-control strategies

No market roster or authorization holder data is included here.

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How does landiolol hydrochloride compare with alternative IV beta blockers for perioperative rate control?

A comparison must include:

• Clinical outcome endpoints (POAF incidence, time to rate control, hypotension/bradycardia rates)
• Pharmacokinetic profile claims (onset, offset)
• Dosing protocols and titration flexibility
• Evidence strength by trial quality and endpoints

Trial-specific comparative data is not available in the current context.

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What generic entry risks exist for landiolol hydrochloride (Paragraph IV and 505(b)(2) scenarios)?

This requires:

• Orange Book patent list mapping to ANDA grounds
• Identification of any “carve-out” patents vulnerable to Paragraph IV
• Regulatory history (prior 505(b)(2)/ANDA submissions)
• Settlement or litigation triggers

No Orange Book or litigation dataset is provided here.

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What litigation, settlements, or FDA regulatory disputes involve landiolol hydrochloride?

This requires:

• Court docket references (e.g., Hatch-Waxman litigations)
• Settlement dates and terms
• Any FDA correspondence affecting approvals, labeling, or patent certification

No litigation dataset is included here.

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Market analysis: where is landiolol hydrochloride sold, how fast is it growing, and who captures demand?

A market analysis with projection must quantify:

• Current revenue by geography (Japan first, then any approved markets elsewhere)
• Hospital adoption metrics (use-per-hospital, formulary penetration)
• Pricing and reimbursement drivers
• Procedure volumes: cardiac surgery and high-risk non-cardiac surgery cohorts
• Uptake of perioperative AF prevention pathways

None of the above quantified inputs are available in the current context, so a numeric market forecast cannot be produced.

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Market projection for landiolol hydrochloride through 2035: scenario model and key drivers

A proper projection needs:

• Starting-year sales baseline (units and value)
• CAGR assumptions tied to adoption curves and procedure growth
• Patent/exclusivity milestones
• Competitive pressure from alternative therapies and any generic erosion
• Sensitivity analysis for formulary changes

No sales baseline or exclusivity timeline is available here, so producing a projection would not meet “complete and accurate response” constraints.

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Key Takeaways

• Landiolol hydrochloride’s market potential depends on perioperative and arrhythmia-indication label reach and outcomes evidence in POAF and rate-control pathways.
• A complete clinical trials update requires trial-by-trial registry facts and current status timestamps.
• A defensible market analysis and projection requires starting-year sales baselines and geographic segmentation tied to adoption, pricing, and exclusivity/patent schedules.
• Those required inputs are not present in the current context, so a complete, accurate clinical-and-market forecast cannot be issued.

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FAQs

1. Which landiolol hydrochloride trials have results reported for postoperative atrial fibrillation?
2. What dosing regimens of landiolol hydrochloride are used in perioperative studies and how do they differ by indication?
3. In which countries is landiolol hydrochloride approved and what are the exact label indications?
4. What endpoints matter most for payer and guideline adoption of ultra-short-acting IV beta blockers?
5. How does potential generic entry risk typically affect hospital adoption of IV rate-control drugs?

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References (APA)

1. [No cited sources were provided in the current context.]