CLINICAL TRIALS PROFILE FOR ISOSORBIDE MONONITRATE

All Clinical Trials for isosorbide mononitrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00143195 ↗	Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina	Completed	Pfizer	Phase 4	2001-04-01	The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
NCT00143195 ↗	Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2001-04-01	The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
NCT00168519 ↗	Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes	Completed	Diabetes Australia	N/A	2002-10-01	The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00168519 ↗	Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes	Completed	Hoffmann-La Roche	N/A	2002-10-01	The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00168519 ↗	Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes	Completed	National Health and Medical Research Council, Australia	N/A	2002-10-01	The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00168519 ↗	Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes	Completed	Baker Heart Research Institute	N/A	2002-10-01	The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00252421 ↗	The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2005-10-01	Osteoporosis or "thinning of the bones" affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis. The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide.

Clinical Trial Conditions for isosorbide mononitrate

Condition Name

Condition Name for isosorbide mononitrate
Intervention	Trials
Hypertension	6
Healthy	5
Cerebral Small Vessel Diseases	3
Cervical Ripening	3

Condition MeSH

Condition MeSH for isosorbide mononitrate
Intervention	Trials
Hypertension	6
Cerebral Small Vessel Diseases	3
Headache	3
Malnutrition	2

Clinical Trial Locations for isosorbide mononitrate

Trials by Country

Trials by Country for isosorbide mononitrate
Location	Trials
United States	20
Egypt	12
Denmark	4
China	4
India	3

Trials by US State

Trials by US State for isosorbide mononitrate
Location	Trials
Pennsylvania	3
Texas	2
Ohio	2
Minnesota	1
Massachusetts	1

Clinical Trial Progress for isosorbide mononitrate

Clinical Trial Phase

Clinical Trial Phase for isosorbide mononitrate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	7

Clinical Trial Status

Clinical Trial Status for isosorbide mononitrate
Clinical Trial Phase	Trials
Completed	30
Unknown status	7
Withdrawn	4

Clinical Trial Sponsors for isosorbide mononitrate

Sponsor Name

Sponsor Name for isosorbide mononitrate
Sponsor	Trials
Cairo University	5
Danish Headache Center	3
Merck Sharp & Dohme Corp.	3

Sponsor Type

Sponsor Type for isosorbide mononitrate
Sponsor	Trials
Other	61
Industry	17
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Isosorbide Mononitrate

Last updated: April 28, 2026

What is isosorbide mononitrate and where is it positioned clinically?

Isosorbide mononitrate (IMN) is an oral nitrate used for angina prophylaxis and for prevention of ischemic episodes related to coronary artery disease. In clinical practice it competes in a crowded cardiovascular vasodilator and antianginal landscape that includes other nitrates (immediate- and extended-release forms, sublingual rescue products), beta-blockers, calcium channel blockers, ranolazine, and revascularization where appropriate.

IMN is widely used and typically evaluated clinically for:

• Antianginal efficacy (frequency of angina attacks)
• Exercise tolerance outcomes (time to angina or time to ischemic changes)
• Hemodynamic effects and tolerability (headache, hypotension)

What does the clinical trials landscape look like right now?

A complete, current “trials update” requires a live registry sweep. No registry query results were provided here, and no trial identifiers (e.g., NCT numbers, start dates, sponsors) were included in the prompt. Under the operating constraints, an accurate update cannot be produced.

How is the market defined for isosorbide mononitrate?

The IMN market is best modeled as a segment within:

• Cardiology antianginal therapies
• Oral nitrate therapy (prophylaxis)
• Chronic use settings (stable angina management)

Practical market drivers for IMN include:

• High prevalence of ischemic heart disease and stable angina
• Generic penetration across major markets, which compresses pricing and shifts growth to volume and mix
• Formulation strategy (extended-release vs immediate-release) that aims to smooth symptom control and improve adherence

What are the key competitive dynamics?

IMN competes on:

• Price-to-coverage in generic-heavy markets
• Form factor and dosing convenience (once-daily or multiple daily dosing schedules depending on formulation)
• Switchability with other antianginals, especially when payers and clinicians optimize combination therapy

Competitive pressure is strongest from:

• Other generic antianginal classes (beta-blockers, CCBs)
• Brand and generic antianginals with stronger perceived efficacy or guideline alignment in subpopulations
• Revascularization in appropriately selected patients, which can reduce medication burden

What is the current IP status relevance for new development?

Isosorbide mononitrate itself is an established active ingredient. Commercial differentiation in most markets typically depends on:

• Formulation IP (controlled release matrices, coating systems)
• Dosing regimens and bioequivalence-based product lifecycle management
• Local regulatory pathways for generics and follow-on versions

For investing in “new IMN” products, the decisive question is usually whether a party can secure enforceable IP around a specific formulation or delivery profile rather than the API.

What market projection is supportable?

A credible projection requires at least one of the following: a baseline market size, recent forecast sources, or registry-linked growth tied to specific pipeline products. None were provided, and no cited market-source inputs are available in the prompt. Under the operating constraints, an accurate numeric projection cannot be produced.

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Data tables (hard facts only)

No registry or market-size inputs were provided in the prompt. The following tables therefore cannot be populated without introducing unsourced numbers, which violates the constraint set.

Market sizing and forecast inputs

Item	Required input	Provided
Global market size (IMN)	2023/2024 revenue or units	No
Forecast methodology	CAGR assumption source	No
Segment split	oral controlled-release vs others; geography	No
Competitive pricing	ASP or reimbursement trends	No
Pipeline-driven uplift	trial- or approval-linked products	No

Clinical trials table

Field	Required data	Provided
NCT-linked studies	registry results	No
Trial phase distribution	phase counts by date	No
Enrollment status	recruited/active/completed	No
Endpoints	angina frequency, exercise tolerance	No
Safety findings	headache, hypotension rates	No

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Key Takeaways

• Isosorbide mononitrate is a mature, generic-heavy antianginal oral nitrate used for angina prophylaxis.
• A current “clinical trials update” cannot be produced from the information supplied; no trial registry data was included.
• A numeric market projection cannot be produced without baseline market figures and forecast source inputs; none were provided.

FAQs

1. What is isosorbide mononitrate used for?
   It is used for angina prophylaxis to prevent ischemic episodes in coronary artery disease patients.

2. Is the product differentiated by the API or formulation?
   In mature markets, differentiation is usually tied to formulation and release profile rather than new API development.

3. Who competes with isosorbide mononitrate?
   It competes with other nitrates and broad antianginal classes such as beta-blockers and calcium channel blockers, plus add-on options like ranolazine depending on patient profile.

4. Can you summarize ongoing trials right now?
   Not from the information provided in the prompt; no trial registry details were included.

5. Can you give a market CAGR forecast for isosorbide mononitrate?
   Not without a baseline and forecast-source inputs; none were provided.

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References

[1] World Health Organization. WHO Model List of Essential Medicines (for class context and established use of antianginal nitrates).