CLINICAL TRIALS PROFILE FOR ISORDIL

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.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	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.
NCT01822808 ↗	Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure	Unknown status	Momentum Research, Inc.	Phase 3	2013-01-01	To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.
NCT01822808 ↗	Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure	Unknown status	University of Cape Town	Phase 3	2013-01-01	To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.

Clinical Trial Conditions for ISORDIL

Condition Name

Condition Name for ISORDIL
Intervention	Trials
Kidney Diseases	1
Left Ventricular Dysfunction	1
Maternal Care for Late Fetal Death	1
Tachycardia	1

Condition MeSH

Condition MeSH for ISORDIL
Intervention	Trials
Heart Failure	2
Tachycardia	1
Stillbirth	1
Orthostatic Intolerance	1

Clinical Trial Locations for ISORDIL

Trials by Country

Trials by Country for ISORDIL
Location	Trials
United States	4
South Africa	1

Trials by US State

Trials by US State for ISORDIL
Location	Trials
Ohio	1
Massachusetts	1
Tennessee	1
Minnesota	1

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

Clinical Trial Status

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

Clinical Trial Sponsors for ISORDIL

Sponsor Name

Sponsor Name for ISORDIL
Sponsor	Trials
Satish R. Raj	1
Momentum Research, Inc.	1
University of Cape Town	1

Sponsor Type

Sponsor Type for ISORDIL
Sponsor	Trials
Other	7
Industry	2
NIH	1

ISORDIL Market Analysis and Financial Projection

Last updated: April 25, 2026

ISORDIL (Isosorbide Dinitrate): What the Clinical-Landscape Update and Market Projection Imply

ISORDIL is a branded nitrate for angina and related ischemic heart disease indications. It has a long commercial history, and the current development posture is best characterized as mature, with limited visibility into new, pivotal clinical programs. Public clinical trial signals for “ISORDIL” itself are sparse because the active ingredient is widely studied and marketed under multiple brand and generic configurations, which dilutes brand-specific trial discovery.

What is ISORDIL and what claims does it typically support?

ISORDIL is isosorbide dinitrate, an organic nitrate used to prevent and treat angina pectoris by reducing myocardial oxygen demand through vasodilation (primarily via venous pooling).

Common clinical use patterns in practice align with:

• Chronic angina prophylaxis (scheduled dosing)
• Breakthrough angina management (depending on formulation and prescriber approach)
• Combination therapy with other antianginal classes in multi-drug regimens

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Are there active brand-specific clinical trials for ISORDIL (isosorbide dinitrate)?

Brand-specific recruitment and results for “ISORDIL” are not consistently surfaced in major registries. When trial activity is visible, it is typically under:

• Generic ingredient labeling (isosorbide dinitrate rather than ISORDIL)
• Alternative nitrate comparators (isosorbide mononitrate, nitroglycerin)
• Formulation or bioequivalence studies rather than new clinical endpoint trials

Implication for R&D diligence: for investor-grade tracking, “ISORDIL” should be monitored at the API level (isosorbide dinitrate) and then mapped to brand/formulation, rather than relying on brand-name registry hits.

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What is the clinical-research landscape for isosorbide dinitrate right now?

The isosorbide dinitrate literature is dominated by historical efficacy and safety evidence, with ongoing activity concentrated in:

• Formulation optimization (immediate-release vs extended-release, tablet variants)
• Bioequivalence and generic quality studies
• Real-world evidence and adherence/titration observations in angina care

Because nitrates are established therapy with broad use, sponsor incentives for large, new superiority trials against modern standard-of-care are limited unless there is a clear differentiating mechanism (new delivery system, new dosing logic, or patient subgroup emphasis with a strong rationale).

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What does the market look like for ISORDIL and its class?

ISORDIL sits inside the antianginal nitrates market. The market is structurally influenced by:

• Long-term generic penetration
• Patent and exclusivity maturity for specific brand formulations
• Physician familiarity and formularies that favor low-cost stable options
• Competition from other nitrate molecules (isosorbide mononitrate) and from non-nitrate classes (beta blockers, calcium channel blockers, ranolazine, ivabradine, etc.)

Market structure (practical lens)

• Brand-level sales for long-established nitrates tend to be small relative to generics.
• Wholesale volume in nitrates is driven by stable incidence and chronic prescribing patterns for angina.
• Price compression is typical because multiple equivalent products exist and tend to be substituted at pharmacy level.

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How should investors project revenues for ISORDIL-like products?

Revenue projection for mature nitrate brands should be modeled as a function of (1) generic substitution pressure, (2) formulary retention of brand, (3) reimbursement dynamics, and (4) volume stability in angina care.

A projection framework that fits mature antianginal nitrates

Use three linked drivers:

1) Volume stability (Uptake and persistence)

• Angina prevalence and secondary care patterns support baseline prescription continuity.
• Nitrates remain a standard option, which supports non-zero demand even as specific products switch.

2) Share shift to generics

• If ISORDIL is no longer protected for its current formulation or strengths in major markets, share tends to migrate to low-cost entrants.
• Brand survival usually depends on remaining protections (where any exist) plus payer and pharmacy behavior.

3) Price erosion and net revenue mechanics

• Net prices typically compress faster than gross volume growth.
• Revenue growth usually does not track unit growth due to generic benchmarking.

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What does the clinical and market maturity mean for “new trial” expectations?

For ISORDIL, the practical expectation in near-term clinical development is:

• Low probability of novel phase 3 efficacy programs that materially change label scope for isosorbide dinitrate itself.
• Higher probability of “life-cycle” programs that do not generate new endpoint claims (formulation, bioequivalence, stability, comparability).

This means that value creation, where it exists, is more likely to come from:

• Market access tactics
• Formulation-level differentiation (if any)
• Operational manufacturing and supply reliability
• Potential niche indication expansion (only if supported by regulatory filings and evidence)

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What are the likely near-term business outcomes (base/bull/bear)?

Because ISORDIL is tied to an established API with heavy generic availability, scenario analysis should be anchored to share and net pricing, not to major clinical differentiation.

Scenario logic for ISORDIL brand-like revenues

Base case

• Flat-to-slightly declining net revenue
• Volume roughly stable or slowly down due to continued generic substitution
• Price drift downward with occasional payer-led promotions

Bull case

• Improved formulary positioning (or reduced competitive intensity)
• Better retention among institutions that prefer branded supply consistency
• Slower generic share shift than peers

Bear case

• Accelerated substitution due to new generics or stronger pharmacy switching programs
• Net price declines outpace unit stability
• Supply disruptions in niche markets or manufacturing constraints hit availability

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Where to focus monitoring for clinical signals

Even if brand-level trials are limited, investors should monitor:

• Ingredient-level registries for isosorbide dinitrate trials
• Formulation studies (bioequivalence) that can indicate ongoing product lifecycle investment
• New label or safety communications impacting nitrate scheduling and tolerance management
• Regulatory filings in major jurisdictions that might change market structure (new strengths, modified release, new dossier submissions)

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Key Takeaways

• ISORDIL is an established isosorbide dinitrate antianginal nitrate, and the clinical landscape is mature with limited visibility into brand-specific late-stage development.
• Active research is most often formulation, bioequivalence, or incremental clinical practice evidence, not new label-changing trials.
• Market prospects for ISORDIL are dominated by generic substitution and price compression, so revenue outcomes should be modeled primarily via share and net price, not via breakthrough clinical value.
• The most actionable diligence path is API-level monitoring mapped to brand/formulation, because brand-name trial discovery is incomplete for mature products.

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FAQs

1) Is ISORDIL still used for angina in clinical practice?

Yes. Isosorbide dinitrate remains part of standard antianginal management in many formularies, often alongside other therapies.

2) Will new clinical trials likely expand ISORDIL’s indication?

Near-term, the most likely trial activity is incremental and formulation-driven rather than indication-expanding, given the API’s long-standing clinical evidence base.

3) How does generic competition affect ISORDIL pricing?

Generic availability typically drives net price compression and pharmacy switching. Brand share often erodes unless remaining protections or access advantages persist.

4) What signals should be watched for lifecycle investment?

Bioequivalence studies, formulation changes (release profile or strength), and regulatory updates tied to product dossiers.

5) Is the value proposition for ISORDIL clinical or operational?

For a mature nitrate brand, value creation is usually driven more by market access, supply reliability, and net pricing strategy than by new clinical differentiation.

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References

[1] FDA. (n.d.). NDA/BLA drug product labeling and approval history (query portal and label retrieval). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. (n.d.). Studies on isosorbide dinitrate and nitrate antianginal therapies (registry search). National Library of Medicine. https://clinicaltrials.gov/
[3] EMA. (n.d.). European public assessment reports (EPAR) and product information (isosorbide dinitrate search). European Medicines Agency. https://www.ema.europa.eu/