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Last Updated: January 11, 2025

CLINICAL TRIALS PROFILE FOR INDACATEROL MALEATE


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All Clinical Trials for INDACATEROL MALEATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00624702 ↗ Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma Completed Novartis Phase 1 2008-02-01 This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
NCT00605306 ↗ Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma Completed Merck Sharp & Dohme Corp. Phase 2 2008-01-01 This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
NCT00605306 ↗ Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma Completed Novartis Phase 2 2008-01-01 This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
NCT00556673 ↗ Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma Completed Merck Sharp & Dohme Corp. Phase 2 2007-10-01 This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.
NCT00556673 ↗ Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma Completed Novartis Phase 2 2007-10-01 This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.
NCT00403637 ↗ Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma Completed Novartis Phase 2/Phase 3 2006-11-01 The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week
NCT00396604 ↗ Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD) Completed Novartis Phase 2/Phase 3 2006-10-01 The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for INDACATEROL MALEATE

Condition Name

965300123456789AsthmaCOPDChronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease[disabled in preview]
Condition Name for INDACATEROL MALEATE
Intervention Trials
Asthma 9
COPD 6
Chronic Obstructive Pulmonary Disease (COPD) 5
Chronic Obstructive Pulmonary Disease 3
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Condition MeSH

1010980-101234567891011AsthmaPulmonary Disease, Chronic ObstructiveLung DiseasesLung Diseases, Obstructive[disabled in preview]
Condition MeSH for INDACATEROL MALEATE
Intervention Trials
Asthma 10
Pulmonary Disease, Chronic Obstructive 10
Lung Diseases 9
Lung Diseases, Obstructive 8
[disabled in preview] 0
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Clinical Trial Locations for INDACATEROL MALEATE

Trials by Country

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Trials by Country for INDACATEROL MALEATE
Location Trials
United States 102
Italy 61
Spain 33
United Kingdom 27
Germany 20
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Trials by US State

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Trials by US State for INDACATEROL MALEATE
Location Trials
North Carolina 7
Texas 6
Florida 5
California 5
New Jersey 4
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Clinical Trial Progress for INDACATEROL MALEATE

Clinical Trial Phase

25.0%20.8%12.5%41.7%0345678910Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for INDACATEROL MALEATE
Clinical Trial Phase Trials
Phase 4 6
Phase 3 5
Phase 2/Phase 3 3
[disabled in preview] 10
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Clinical Trial Status

91.7%0-2024681012141618202224CompletedTerminatedWithdrawn[disabled in preview]
Clinical Trial Status for INDACATEROL MALEATE
Clinical Trial Phase Trials
Completed 22
Terminated 1
Withdrawn 1
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Clinical Trial Sponsors for INDACATEROL MALEATE

Sponsor Name

trials0246810121416Novartis PharmaceuticalsNovartisMerck Sharp & Dohme Corp.[disabled in preview]
Sponsor Name for INDACATEROL MALEATE
Sponsor Trials
Novartis Pharmaceuticals 15
Novartis 6
Merck Sharp & Dohme Corp. 2
[disabled in preview] 5
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Sponsor Type

85.7%14.3%00510152025IndustryOther[disabled in preview]
Sponsor Type for INDACATEROL MALEATE
Sponsor Trials
Industry 24
Other 4
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INDACATEROL MALEATE Market Analysis and Financial Projection

Indacaterol Maleate: Clinical Trials, Market Analysis, and Projections

Introduction to Indacaterol Maleate

Indacaterol maleate, a selective beta 2-adrenergic agonist, is a key medication used in the management of chronic obstructive pulmonary disease (COPD) and, in some cases, mild persistent asthma. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Early Clinical Trials

The clinical development of indacaterol maleate involved a comprehensive series of trials to establish its efficacy and safety. Early dose-ranging studies (B2201, B2205, B2212, B1202) were conducted to determine the optimal dosing regimen. These studies used doses ranging from 50 mcg to 800 mcg and helped in selecting the doses of 150 mcg and 300 mcg for further evaluation[3].

Confirmatory Clinical Trials

Six confirmatory randomized, double-blind, placebo and active-controlled clinical trials were conducted, involving 2516 patients exposed to indacaterol maleate at doses of 75 mcg or greater for at least 12 weeks. These trials showed that indacaterol maleate significantly improved lung function, as measured by forced expiratory volume in one second (FEV1), and had a favorable safety profile. The mean age of patients was 64 years, and 47% were aged 65 years or older[1].

Real-World Evidence

A 52-week post-marketing surveillance in Japanese patients with COPD further reinforced the safety and efficacy of indacaterol maleate. This study, involving 1846 patients, reported improvements in lung function parameters (FVC, FEV1, and %FEV1) and a favorable safety profile, with no new safety signals observed[5].

Safety and Efficacy Findings

Adverse Events

In the clinical trials, the most common adverse reactions reported were cough, pneumonia, and COPD worsening. Serious adverse events, such as pneumonia, were relatively rare, occurring in about 1.04% of patients. The proportion of patients who discontinued treatment due to adverse reactions was similar between the indacaterol maleate and placebo groups[1][5].

Efficacy

Indacaterol maleate demonstrated significant improvements in lung function. The physician-reported global evaluation of treatment effectiveness (GETE) showed that 69.70% of patients achieved an excellent, good, or moderate response following treatment. The COPD assessment test (CAT) scores decreased, indicating an improvement in symptoms and quality of life[5].

Pharmacokinetics and Metabolism

Bioavailability and Elimination

Indacaterol maleate has approximately 43% bioavailability, resulting from both pulmonary and intestinal absorption. The drug is primarily eliminated through the fecal route, with over 90% of the dose recovered in a mass balance study. Approximately 54% of the drug is eliminated unchanged, and 23% is excreted as a hydroxylated indacaterol metabolite[3].

Market Analysis and Projections

Global Market Size and Growth

The global indacaterol maleate market is expected to grow significantly over the next few years. While exact figures are not provided in the available sources, the market is anticipated to expand due to the increasing prevalence of COPD and the drug's established efficacy and safety profile[2].

Key Producers and Supply Chain

The market for indacaterol maleate is dominated by key producers, with Novartis being the primary developer and marketer of the drug under the brand name ARCAPTA NEOHALER. The supply chain includes various manufacturing and distribution networks to ensure global availability[2].

Market Trends and Drivers

The growth of the indacaterol maleate market is driven by several factors, including the rising incidence of COPD, aging populations, and the need for effective maintenance treatments. Additionally, advancements in inhalation technologies and the preference for once-daily dosing regimens contribute to the market's expansion[2].

Future Projections

Market Growth

The global indacaterol maleate market is projected to continue its growth trajectory, driven by increasing demand for effective COPD treatments. The market is expected to reach significant revenue by 2029, although the exact figures are not specified in the available sources[2].

Research and Development

Ongoing research and post-marketing surveillance will continue to provide valuable insights into the long-term safety and efficacy of indacaterol maleate. This will help in further optimizing treatment regimens and potentially expanding the drug's indications.

Key Takeaways

  • Clinical Efficacy: Indacaterol maleate has demonstrated significant improvements in lung function and symptoms in patients with COPD.
  • Safety Profile: The drug has a favorable safety profile, with common adverse events being cough, pneumonia, and COPD worsening.
  • Market Growth: The global market for indacaterol maleate is expected to grow due to increasing demand for effective COPD treatments.
  • Pharmacokinetics: The drug has approximately 43% bioavailability and is primarily eliminated through the fecal route.
  • Real-World Evidence: Post-marketing surveillance has reinforced the safety and efficacy of indacaterol maleate in real-life settings.

FAQs

What is indacaterol maleate used for?

Indacaterol maleate is used as a maintenance treatment for chronic obstructive pulmonary disease (COPD) and, in some cases, for mild persistent asthma.

What are the common adverse events associated with indacaterol maleate?

Common adverse events include cough, pneumonia, and COPD worsening. Serious adverse events, such as pneumonia, are relatively rare.

How is indacaterol maleate administered?

Indacaterol maleate is administered via inhalation using the NEOHALER inhaler, typically once daily.

What is the bioavailability of indacaterol maleate?

The bioavailability of indacaterol maleate is approximately 43%, resulting from both pulmonary and intestinal absorption.

What are the key drivers of the indacaterol maleate market growth?

The market growth is driven by the increasing prevalence of COPD, aging populations, and the need for effective maintenance treatments.

Sources

  1. FDA Label for ARCAPTA NEOHALER: Accessdata.fda.gov
  2. Global Indacaterol Maleate Supply, Demand and Key Producers, 2023-2029: MarketResearchReports.com
  3. Clinical Pharmacology and Biopharmaceutics of Indacaterol Maleate: Accessdata.fda.gov
  4. Patient Summary for Indacaterol Maleate Trials: Novctrd.com
  5. Real-world Safety and Efficacy of Indacaterol Maleate in Japanese Patients: PubMed.ncbi.nlm.nih.gov

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