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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR ISORDIL


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All Clinical Trials for Isordil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00170183 ↗ Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure Completed Scios, Inc. Phase 3 2003-03-01 Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has not been fully defined. The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60 ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure Service who meet entrance criteria will be randomized to standard clinical practice with or without a 48 hour infusion of BNP. The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3 days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day readmission rate.
NCT00170183 ↗ Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure Completed Mayo Clinic Phase 3 2003-03-01 Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has not been fully defined. The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60 ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure Service who meet entrance criteria will be randomized to standard clinical practice with or without a 48 hour infusion of BNP. The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3 days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day readmission rate.
NCT00262470 ↗ Treatment of Orthostatic Intolerance Active, not recruiting National Institutes of Health (NIH) Phase 1/Phase 2 1997-04-01 This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isordil

Condition Name

Condition Name for Isordil
Intervention Trials
Fontan 1
Kidney Diseases 1
Left Ventricular Dysfunction 1
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Condition MeSH

Condition MeSH for Isordil
Intervention Trials
Heart Failure 2
Kidney Failure, Chronic 1
Cardiomyopathies 1
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Clinical Trial Locations for Isordil

Trials by Country

Trials by Country for Isordil
Location Trials
United States 4
South Africa 1
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Trials by US State

Trials by US State for Isordil
Location Trials
Ohio 1
Massachusetts 1
Tennessee 1
Minnesota 1
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Clinical Trial Progress for Isordil

Clinical Trial Phase

Clinical Trial Phase for Isordil
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Isordil
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Isordil

Sponsor Name

Sponsor Name for Isordil
Sponsor Trials
Scios, Inc. 1
Mayo Clinic 1
National Institutes of Health (NIH) 1
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Sponsor Type

Sponsor Type for Isordil
Sponsor Trials
Other 7
Industry 2
NIH 1
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Clinical Trials, Market Analysis, and Projections for Isosorbide Mononitrate (ISORDIL)

Introduction

Isosorbide mononitrate (ISMN), commonly known by the brand name ISORDIL, is a medication widely used for the treatment of angina pectoris and, more recently, has been investigated for its potential in managing cerebral small vessel disease (cSVD). This article will delve into the recent clinical trials, market analysis, and future projections for ISMN.

Clinical Trials: LACI-2 Trial

Objective and Design

The Lacunar Intervention Trial-2 (LACI-2) is a pivotal clinical trial that aimed to evaluate the feasibility, safety, and efficacy of ISMN and cilostazol in patients with lacunar ischemic stroke, a form of cSVD. This investigator-initiated, randomized clinical trial employed a 2 × 2 factorial design, recruiting 363 participants from 26 UK hospital stroke centers between February 2018 and May 2021[1][4].

Key Findings

  • Feasibility and Retention: The trial demonstrated high feasibility with 99% of patients retained at 1 year and good adherence to the study drugs.
  • Safety and Tolerability: ISMN and cilostazol were found to be well-tolerated and safe, with no significant safety concerns.
  • Efficacy: ISMN reduced recurrent stroke and cognitive impairment, while cilostazol reduced dependence. The combination of ISMN and cilostazol reduced the composite of adverse vascular, dependence, and cognitive outcomes[1][4].

Implications

These results suggest that ISMN and cilostazol may be effective in reducing adverse long-term outcomes of lacunar ischemic stroke. The findings support the need for larger phase 3 trials to confirm these results and potentially establish these medications as standard treatments for cSVD.

Market Analysis

Global Isosorbide Market

The global isosorbide market, which includes ISMN, was valued at USD 703.47 million in 2023 and is projected to grow at a CAGR of 9.4% during the forecast period from 2024 to 2032. This growth is driven by several factors:

  • Increasing Demand in Various Industries: The use of isosorbide in pharmaceuticals, cosmetics, and the construction industry is on the rise. The demand for bioplastics and eco-friendly products is particularly significant[2].
  • Rapid Growth in Emerging Economies: Countries like India and China are experiencing rapid growth in the construction sector, which is a major consumer of isosorbide-based products[2].
  • Sustainability and Regulatory Factors: The increasing focus on sustainability and strict environmental regulations are driving the adoption of isosorbide as a renewable building block in various industries[2].

Segment Dominance

The resins and polymers segment dominates the global isosorbide market, driven by the increasing use of isosorbide in the bio-based refinery industry and its versatile chemical properties. The additives segment is expected to grow at the fastest rate, driven by its use as a fuel additive and electrolyte additive for lithium-ion batteries[2].

Market Projections

Growth Opportunities

The global isosorbide market is expected to reach USD 1,577.75 million by 2032, with North America leading the market. Key growth drivers include:

  • Increasing Consumption in End-Use Industries: The demand for isosorbide in pharmaceuticals, cosmetics, and construction is expected to continue growing.
  • Rising Demand for Bioplastics: The shift towards bioplastics due to consumer preference for greener products will drive market growth.
  • Innovations and R&D: Significant R&D expenditures and innovations in bio-based chemicals are expected to generate new growth opportunities[2].

Regional Outlook

The market is segmented by region, with North America currently leading. However, emerging economies in Asia Pacific, such as India and China, are expected to contribute significantly to the market growth due to their expanding construction sectors and increasing demand for bioplastics[2].

Key Takeaways

  • Clinical Efficacy: ISMN has shown promising results in reducing recurrent stroke and cognitive impairment in patients with lacunar ischemic stroke.
  • Market Growth: The global isosorbide market is expected to grow significantly, driven by increasing demand in various industries and a shift towards sustainable products.
  • Future Prospects: Larger phase 3 trials are needed to confirm the efficacy of ISMN in cSVD, and the market is poised for growth with new applications and innovations.

FAQs

What is the primary use of Isosorbide Mononitrate (ISMN)?

ISMN is primarily used for the treatment of angina pectoris but has been investigated for its potential in managing cerebral small vessel disease (cSVD).

What were the key findings of the LACI-2 trial?

The LACI-2 trial found that ISMN reduced recurrent stroke and cognitive impairment, while cilostazol reduced dependence. The combination of ISMN and cilostazol reduced the composite of adverse vascular, dependence, and cognitive outcomes.

What is driving the growth of the global isosorbide market?

The growth is driven by increasing demand in pharmaceuticals, cosmetics, and the construction industry, along with a shift towards bioplastics and sustainable products.

Which segment dominates the global isosorbide market?

The resins and polymers segment currently dominates the market due to its widespread use in the bio-based refinery industry.

What is the projected market size of the global isosorbide market by 2032?

The global isosorbide market is expected to reach USD 1,577.75 million by 2032.

Which region is leading the global isosorbide market?

North America is currently leading the global isosorbide market, but emerging economies in Asia Pacific are expected to contribute significantly to future growth.

Sources

  1. JAMA Neurology: "Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease" - May 24, 2023
  2. Polaris Market Research: "Global Isosorbide Market Size, Share Analysis Report, 2024-2032"
  3. Merck: "Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection" - December 19, 2024
  4. PubMed: "The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial" - July 1, 2023

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