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.

Clinical Trial Conditions for ISORDIL

Condition Name

Condition Name for ISORDIL
Intervention	Trials
Cardiomyopathy	1
Cervical Pregnancy	1
Chronic Hemodialysis (ESRD)	1

Condition MeSH

Condition MeSH for ISORDIL
Intervention	Trials
Heart Failure	2
Kidney Failure, Chronic	1
Cardiomyopathies	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
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for ISORDIL

Sponsor Name

Sponsor Name for ISORDIL
Sponsor	Trials
Children's Hospital Medical Center, Cincinnati	1
Scios, Inc.	1
Mayo Clinic	1

Sponsor Type

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

Last updated: July 29, 2026

Isordil (isosorbide dinitrate) clinical trials update, market analysis, and exclusivity outlook

Isordil (isosorbide dinitrate; sublingual tablets and oral formulations depending on market) is an older, off-patent nitrate therapy with no meaningful, current-era R&D pipeline typical of single-molecule blockbuster drugs. The competitive market is driven by generic isosorbide dinitrate and the broader antianginal class (other nitrates and antianginals), not by new branded patent-protected entries. Clinical-trial activity is limited and largely reflects formulation, bioequivalence, or secondary research rather than late-stage, registration-driving programs.

Because “Isordil” is a brand used in multiple jurisdictions and product presentations, a precise, current, trial-by-trial update and a quantified market forecast cannot be produced from the information provided.

What clinical trials exist for Isordil (isosorbide dinitrate) today?

No current, registration-relevant late-stage clinical program can be confirmed as associated with Isordil as a brand based solely on the drug name.

Are there ongoing Phase 2/3 trials for isosorbide dinitrate branded as Isordil?

Isosorbide dinitrate has clinical use history in angina and related nitrate-responsive indications, but modern clinical activity that is publicly attributable to “Isordil” branding is typically sparse. Where trials exist, they are usually:

• small pharmacokinetic or bioavailability studies
• comparator trials of generic products
• mechanistic or hemodynamic studies using isosorbide dinitrate as an active control

Do Isordil trials focus on angina, heart failure, or other indications?

Historically, isosorbide dinitrate is used for:

• stable angina and nitrate-responsive ischemic heart disease
• acute hemodynamic studies and chronic antianginal regimens

In practice, the newer development narrative for nitrate class therapies has shifted to combination regimens and disease-area pathways rather than brand-specific isosorbide dinitrate programs.

What is the current market for Isordil and generic isosorbide dinitrate?

The market for Isordil is structurally commercialized through generics in most major geographies. Branded share is constrained by:

• long elapsed product lifecycles
• extensive generic penetration
• substitution within the nitrate class

A quantified market sizing, branded vs generic share, and forward projection require current sales, procurement, and channel data by country and dosage form, which is not available in the provided context.

Which companies dominate sales of generic isosorbide dinitrate?

In mature API-driven markets, suppliers typically include multiple established generic manufacturers and distributors. The identity of “dominant” companies depends on:

• tender and hospital formularies
• dosage form (tablets, sublingual, extended-release)
• packaging strength and local regulatory status

Without country-level data, a defensible ranking cannot be produced.

How does isosorbide dinitrate compete versus isosorbide mononitrate and other antianginals?

Key competitive axes:

• dosing convenience and duration of effect (where extended-release products exist)
• cost per daily dose
• guideline positioning relative to beta blockers, calcium channel blockers, ranolazine, and revascularization pathways
• tolerability profile and nitrate-related side effects driving formulary preferences

Isordil exclusivity status: when would generics lose any remaining protection?

Isordil’s active ingredient isosorbide dinitrate is longstanding and widely generic. For a brand-level exclusivity timeline (patents, regulatory exclusivities, pediatric exclusivity, and listed exclusivities in the Orange Book), a specific US NDA/ANDA listing and patent family mapping are required.

No patent-expiration or exclusivity calendar can be produced from the drug name alone.

What patents protect Isordil (isosorbide dinitrate) in the US?

A meaningful “patents protecting Isordil” answer requires:

• the exact Orange Book product code
• NDA/ANDA number
• listed patent numbers and claims (composition, formulation, method of use, device, manufacturing)

That dataset is not provided.

What is the Orange Book status of Isordil?

Orange Book status is product-specific. A generic product may have no listed patents even if a brand exists historically. Without the correct product listing, no Orange Book status call is valid.

What generic entry risks exist for Isordil (Paragraph IV, ANDA readiness, and litigation)?

For Isordil, the generic entry risk profile is normally low in the sense that the active ingredient is mature, but the actual legal risk for any specific dosage form depends on:

• whether any formulation or process patents are still listed
• whether any active method-of-use or new formulation patents remain in force
• whether any recent litigation produced settlements delaying entry

No defensible Paragraph IV or litigation posture can be stated without the relevant patent and ANDA records.

What formulation patents or method-of-use patents could block Isordil generics?

Blocking IP in mature generics markets usually falls into one of these buckets:

• specific extended-release matrix technology
• sublingual or rapidly dissolving formulation IP
• manufacturing process or particle size control

But identifying what applies specifically to “Isordil” requires dossier-level patent mapping.

How does Isordil compare with other nitrate antianginal drugs in clinical use and competitive position?

Competitive comparison among nitrate therapies is primarily pharmacologic and formulary-driven:

• speed of onset (sublingual vs oral)
• duration of action (immediate vs sustained release)
• nitrate tolerance mitigation schedules
• compatibility with comorbid regimens

A market projection depends on the relative uptake of alternative antianginals and shifts in ischemic heart disease treatment patterns, none of which can be quantified without market data.

Key Takeaways

• Isordil (isosorbide dinitrate) is a legacy antianginal nitrate with a market structure dominated by generic substitution in most jurisdictions.
• A precise clinical trials update that names ongoing studies and phases cannot be produced from the drug name alone.
• A defensible market forecast and exclusivity timeline cannot be produced without product-specific regulatory identifiers (e.g., NDA/ANDA, Orange Book listing) and country-level sales data.

FAQs

1. Is Isordil still prescribed for stable angina in the US?
2. Are there any brand-specific clinical trials for isosorbide dinitrate products labeled “Isordil”?
3. What are the typical dosage forms of Isordil and how do they differ in onset?
4. How does isosorbide dinitrate compare with isosorbide mononitrate for chronic angina?
5. What drives formulary switching between nitrate generics and other antianginal classes?

References

1. FDA Orange Book. U.S. Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. ClinicalTrials.gov. Search results for isosorbide dinitrate (clinical studies). U.S. National Library of Medicine.
3. Guidelines on chronic coronary disease and antianginal therapy (e.g., ACC/AHA, ESC).