Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR NITROGLYCERIN


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All Clinical Trials for NITROGLYCERIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000503 ↗ Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1982-08-01 To assess the effect of non-surgical reperfusion on infarct size in patients with acute myocardial infarction.
NCT00001716 ↗ Effects of Nitric Oxide and Nitroglycerin in Patients With Sickle Cell Anemia Completed National Institutes of Health Clinical Center (CC) Phase 2 1998-07-01 Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels and cause pain and injury to organs. Some of the complications caused by the sticking of blood cells are called acute pain crisis and acute chest syndrome (ACS). Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle cell hemoglobin molecules, thereby improving blood flow through small vessels. This study is designed to evaluate the effects of NO, when taken in combination with a drug called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects of these two drugs only last while the patient is receiving them. Researchers hope the information learned from this study will help to develop new therapies for sickle cell anemia.
NCT00034060 ↗ The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 2002-04-01 This study has two phases. Phase 1 will examine the role of inflammatory mediators called cytokines on growth hormone levels in women with rheumatoid arthritis (RA). Phase 2 will evaluate the effect of etanercept on these growth hormone levels. Etanercept is approved for the treatment of RA. It lowers the levels of a key inflammatory mediator called tumor necrosis factor-alpha and is very effective in reducing arthritis symptoms. Growth hormone promotes bone and muscle growth. With aging, people lose muscle mass and bone strength, possibly because of decreased levels of growth hormone. People with RA have bone and muscle changes similar to those in older people, perhaps also due to decreased levels of growth hormone. The first part of this study will see if the inflammatory mediators responsible for joint inflammation (warmth, redness, pain, and swelling) in RA are related to the lowered growth hormone levels in this disease. The second part will evaluate the effect of etanercept treatment on muscle mass and bone density, in addition to growth hormone levels. Premenopausal women between 18 and 55 years of age with a recent diagnosis of rheumatoid arthritis (less than 3 years) are eligible for this study. Healthy volunteers will also be enrolled in the first phase of the study as control subjects. This study is conducted at two sites, the NIH and the Johns Hopkins Medical Center in Baltimore. Healthy volunteers enrolled in this study will be interviewed about their health status and will fill out questionnaires on diet and general physical function, including fatigue, energy and well being. In addition, they will be hospitalized once at the NIH Clinical Center for 24-hour blood sampling and will visit to Johns Hopkins Medical Center in Baltimore for a brachial artery reactivity study, as follows: - 24-hour blood sampling for growth hormone levels. Blood samples (1/2 teaspoon each) will be collected every 20 minutes from 8 AM one day until 8 AM the following day through a plastic tube in an arm vein. - Dual energy X-ray absorptiometry (DEXA) scan on a small area of the spine, hip and wrist to assess bone density and a total body DEXA scan to assess the amount and distribution of muscle and body fat. - Blood vessel (brachial artery reactivity) study to measure the ability of the brachial artery to dilate and increase its blood flow. For this procedure, the subject lies on a table with electrocardiogram leads attached to the chest. A blood pressure cuff is inflated for several minutes and a drop of nasal spray of nitroglycerin is given that may cause a headache. Blood pressure and headache are monitored and treated as needed. Patients with rheumatoid arthritis will be seen at the NIH clinic on six separate visits (weeks 0, 1, 6, 12, 18, and 26) over 26 weeks. Week 0 is a screening visit. At weeks 1 and 26, patients will be admitted to the hospital for 24-hour blood sampling, DEXA scans, and brachial artery reactivity tests, as described above, plus X-rays of the hand and feet. After the first visit, they will start taking etanercept, given by self-injection under the skin (like insulin shots) twice a week. Follow-up visits at weeks 6, 12, and 18 will involve evaluations of disease activity and drug side effects through joint examination, blood tests, and questionnaires.
NCT00043719 ↗ Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 2002-07-01 Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women. Study hypothesis: On average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.
NCT00076414 ↗ The Effect of Lopinavir/Ritonavir on Endothelial Function Completed National Institutes of Health Clinical Center (CC) Phase 1 2004-01-01 This study will examine how the anti-HIV protease inhibitor lopinavir/ritonavir (Kaletra® (Registered Trademark)) affects the function of the endothelium (lining of the arteries). Medications such as protease inhibitors can dramatically change the course of HIV infection in many patients; however, among their side effects is development of abnormal lipid levels resulting in high cholesterol and insulin resistance. These side effects may damage the lining of the arteries that supply blood to the heart, leading to premature coronary artery disease. The study will determine whether lopinavir/ritonavir directly affects endothelial function and whether it alters cholesterol levels, glucose tolerance, and markers of inflammation in people who take the drug for 4 weeks. Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates must be HIV-negative and have no history of heart disease, hypertension, or diabetes mellitus. They must not have smoked for at least 6 weeks before entering the study. Volunteers will be screened with a medical history, physical examination, blood tests (including a pregnancy test for women of childbearing potential), and electrocardiogram. In addition, candidates will have an oral glucose tolerance test (see description below). Participants will undergo the following procedures: - Lopinavir/ritonavir: 4 weeks (3 capsules twice a day) beginning study day 1 - Flow-mediated vasodilatation test (study days 0 and 29) - An ultrasound device for measuring the size of the brachial artery (artery in the upper arm) is placed just above the elbow. The size of the artery is measured before and 5 minutes after blood flow to the arm is stopped for 5 minutes, using a blood pressure cuff. The artery is also measured before and after taking nitroglycerin, a medicine that dilates blood vessels. These measurements tell how well the drug treatment works on the cells lining the brachial artery, which is an indicator of coronary artery function. This test takes about 1.5 hours. - Forearm blood-flow test (study days 1 and 30): Small tubes are inserted into an artery and vein in the forearm at the inside of the elbow. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm. When the blood pressure cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. When the devices are in place, a salt water solution is injected in the small tube in the artery. After 20 minutes, small doses of the following drugs are given through the catheter at various intervals: 1) L-NMMA (blocks production of nitric oxide, a substance produced by the blood vessels that causes them to dilate); 2) sodium nitroprusside (dilates blood vessels, increasing blood flow); 3) acetylcholine (lowers blood pressure); and 4) acetylcholine plus L-NMMA. The effect of the different drugs on blood flow in the forearm is measured. The study takes about 2 hours to complete. - Blood tests (screening and study days 1,15, 30, and 44) - Electrocardiogram (at screening and on study day 30) - Oral glucose tolerance test (at screening and on study day 30) - A blood sample is collected. Then, the subject drinks 300 milliliters of a glucose solution (a liquid that contains sugar dissolved in water). Two hours after drinking the solution, blood is drawn again to examine how the body responds to the increase blood sugar levels.
NCT00090558 ↗ Effect of Nitric Oxide Donor on Endothelial Progenitor Cells in Patients With Coronary Artery Disease Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2004-08-01 Regular exercise reduces the risk of heart problems, in part because it improves the work of the endothelium (the cells that line blood vessels). Exercise appears to release precursor cells from the bone marrow that will later become endothelial cells. A molecule called nitric oxide (NO) appears to be involved in this release. However, some heart patients do not improve their endothelial function despite regular exercise. The researchers believe that the heart disease in these patients may interfere with the normal relationship between exercise and endothelial function. This study is designed to test whether giving a patient nitroglycerin (which is converted to NO in the bloodstream) will increase the release of endothelial precursor cells from the bone marrow. If the study succeeds, it may lead to improved healing of arteries in heart disease patients. Adults may be eligible for this study if they have coronary artery disease and do not take nitroglycerin or nitroglycerin-like medication on a daily basis. Volunteers will be admitted to the Clinical Center on 2 separate nights at least 1 week apart. On the morning after each admission, volunteers will have blood drawn from an arm vein for laboratory tests, and then walk on a treadmill until fatigue or discomfort prevents further exercise, or until asked to stop. On one of their admissions, volunteers will receive 1 tablet of nitroglycerin under the tongue shortly before the treadmill test. Volunteers will be monitored by EKGs and blood pressure tests during the treadmill tests, and will have more blood drawn at about 15 minutes and 24 hours after each treadmill test. Researchers will examine the levels of endothelial precursor cells and nitric oxide in the blood samples taken before and after exercise.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NITROGLYCERIN

Condition Name

Condition Name for NITROGLYCERIN
Intervention Trials
Coronary Artery Disease 10
Hypertension 9
Heart Failure 5
Raynaud's Disease 5
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Condition MeSH

Condition MeSH for NITROGLYCERIN
Intervention Trials
Coronary Artery Disease 18
Myocardial Ischemia 15
Hypertension 13
Coronary Disease 12
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Clinical Trial Locations for NITROGLYCERIN

Trials by Country

Trials by Country for NITROGLYCERIN
Location Trials
United States 178
Egypt 22
Canada 16
China 14
Russian Federation 9
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Trials by US State

Trials by US State for NITROGLYCERIN
Location Trials
California 20
New York 11
Maryland 9
Tennessee 9
Massachusetts 9
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Clinical Trial Progress for NITROGLYCERIN

Clinical Trial Phase

Clinical Trial Phase for NITROGLYCERIN
Clinical Trial Phase Trials
PHASE4 8
PHASE3 1
PHASE2 4
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Clinical Trial Status

Clinical Trial Status for NITROGLYCERIN
Clinical Trial Phase Trials
Completed 115
Recruiting 28
Unknown status 26
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Clinical Trial Sponsors for NITROGLYCERIN

Sponsor Name

Sponsor Name for NITROGLYCERIN
Sponsor Trials
MediQuest Therapeutics 9
Vanderbilt University 6
Ain Shams University 5
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Sponsor Type

Sponsor Type for NITROGLYCERIN
Sponsor Trials
Other 232
Industry 45
NIH 12
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Nitroglycerin Clinical Trials Update, Market Analysis, and Regulatory Patent Landscape (US and Key Markets)

Last updated: July 23, 2026

Nitroglycerin remains an established cardiovascular drug class used for angina and acute ischemic episodes. Publicly available information on “nitroglycerin” clinical development is sparse because most current activity centers on formulation life-cycle management (e.g., sprays, sublingual tablets, transdermal systems) rather than new molecular entities. For market and competitive projections, the strongest signal comes from route-specific use patterns, guideline-relevant endpoints, payer formularies, and pricing/availability dynamics across brand and generic supply chains.

What clinical trials update exists for nitroglycerin in 2024–2026 (and what endpoints are being used)?

Answer: The current observable “trial” footprint for nitroglycerin in major registries tends to be formulation and device-adjacent studies (pharmacokinetics, bioequivalence, local tolerability, and rapidity of onset). Most large outcome trials in ischemic heart disease were conducted decades ago; contemporary activity typically measures time-to-therapeutic effect, exposure metrics, and patient-reported tolerability rather than hard cardiovascular outcomes.

What trial types are most common for nitroglycerin today?

  1. Pharmacokinetic and bioequivalence studies
    These compare absorption and systemic exposure across generic vs reference products, often for sublingual tablets, sprays, and transdermal patches or ointments.

  2. Onset and dose-consistency studies
    Studies evaluate how quickly nitroglycerin achieves target hemodynamic effects (e.g., blood pressure reduction) after sublingual dosing.

  3. Tolerability and local irritation studies
    For transdermal systems: dermatitis, headache incidence, and adherence. For oral mucosa products: irritation and taste effects.

  4. Drug-device integration studies (where applicable)
    For metered sprays and delivery systems that affect spray plume geometry, dosing consistency, and variability.

What are the most relevant endpoints to track?

  • PK: Cmax, Tmax, AUC, and variability metrics.
  • PD/clinical surrogates: time to onset of symptom relief, blood pressure response time, headache rates.
  • Safety: hypotension incidence, tachycardia, syncope, discontinuations.
  • Acceptability: tolerability at the application site (transdermal) and oral mucosa comfort (sublingual).

Where are trial updates most likely to surface?

  • US and EU bioequivalence networks where generic manufacturers run studies for ANDA/505(b)(2) and product revisions.
  • Transdermal product life-cycle updates that test new adhesive matrices or delivery layers for consistent skin permeation.

What patents protect nitroglycerin products, and how strong is the patent estate?

Answer: Nitroglycerin as an active ingredient is not meaningfully protected by primary composition-of-matter patents in major markets; protection today is primarily through formulation patents, manufacturing/controlled-release patents, and brand-specific method-of-use or delivery system IP. For market entrants, the barrier is typically not “nitroglycerin itself,” but product-specific Orange Book listings and any still-active patents tied to particular dosage forms and release profiles.

What patent categories matter for nitroglycerin life-cycle management?

  • Controlled-release delivery system patents
    Transdermal patches and ointment bases can be protected by polymers, layered structures, and release-rate control methods.
  • Formulation and stability patents
    Sublingual products may be protected by tablet matrix design or spray stability and excipient systems.
  • Manufacturing process patents
    Granulation, coating, mixing, and sterilization or aseptic steps for certain delivery formats.
  • Method-of-use patents
    Less common for a classic molecule with broad indications, but may exist for specific titration strategies or administration regimens.

How many patents cover nitroglycerin dosage forms?

Answer: Coverage is product-specific and varies by reference brand and jurisdiction. The patent estate count must be established via the Orange Book and associated patent registries for each reference listed drug (RLD) and dosage form.

Practical IP implication for development

  • If a company is developing a new nitroglycerin product in the US, the IP risk is typically evaluated at the RLD level (e.g., specific transdermal system or sublingual formulation), not at the molecule level.
  • In litigation, generic entry disputes usually focus on formulation equivalence and whether the generic product infringes or avoids specific claims.

What is the Orange Book status of nitroglycerin, and what is the Paragraph IV challenge risk?

Answer: Nitroglycerin has extensive generic penetration for many dosage forms. Where Orange Book patents remain listed for specific RLDs, the Paragraph IV risk exists at the product level. The most meaningful risk drivers are: (1) whether formulation/control-release patents remain active, (2) whether the generic is certifying “not infringed” or “invalid,” and (3) whether any settlement agreements have been reached that limit launch timing.

How to interpret Orange Book listings for nitroglycerin

  • Patent terms differ by jurisdiction and type: some formulation patents may last longer than older composition claims due to later filing dates and patent family structure.
  • Multiple listed patents per RLD are common in reformulated generics and delivery system updates.

What generic entry risks exist for nitroglycerin?

  • Infringement allegations on transdermal release mechanisms and excipient interactions.
  • “Design-around” complexity: to avoid a claim, generic formulators may need material changes that affect release kinetics and bioequivalence.

How does nitroglycerin market dynamics look now (brands vs generics, pricing, and supply)?

Answer: Nitroglycerin pricing and supply are shaped by (1) generic availability, (2) frequency of use in acute care and outpatient angina management, (3) cold-chain or storage constraints for some formats, and (4) pharmacy-level stocking and substitution policies. Transdermal systems and sublingual formulations dominate different segments based on onset needs and adherence.

Key commercial segments by route

  1. Sublingual (rapid onset, rescue therapy)

    • Use is episodic but clinically critical.
    • Substitution rates are high when reference products are no longer exclusive.
  2. Oral spray and metered-dose formats

    • Competitive with sublingual tablets where patient preference supports spray delivery.
    • Formulation differences can affect dosing consistency and tolerability.
  3. Transdermal delivery (maintenance or intermittent symptom control)

    • Higher product design complexity and life-cycle IP risk.
    • Demand is sensitive to headache/skin tolerability and wear-time convenience.
  4. Intravenous formulations (hospital setting)

    • Procurement-driven market with strict quality and supply requirements.
    • Competition depends on manufacturing scale, sterility assurance, and stability in infusion.

Supply chain and utilization drivers

  • Hospital formularies favor stocked, reliable supply for acute settings.
  • Outpatient prescriptions respond to co-pay structures and local substitution rules.

What is the revenue projection for nitroglycerin globally by route and geography?

Answer: A defensible projection requires product-level aggregation (by NDC/RLD and dosage form), which cannot be reconstructed from limited public clinical-trials-only inputs. The correct forecasting model for nitroglycerin must be built from route-level utilization trends, generic unit growth, and price erosion assumptions by region.

What drives near-term growth vs decline?

  • Growth drivers
    • Continued guideline-aligned use in angina care and acute ischemia protocols.
    • Expansion of hospital utilization for chest pain pathways, depending on regional practice.
  • Downward forces
    • Ongoing generic price erosion and substitution.
    • Patent-limited brand maintenance offset by generic share gains.

What is the most investable angle?

For nitroglycerin, the “investable” opportunities typically come from:

  • Transdermal innovation (better adherence and lower headache rates) that can justify payer preference even in generic-dense markets.
  • Hospital channel execution for IV or emergency kits where supply reliability and packaging matter more than novel IP.

Which companies sell nitroglycerin and where is competition most intense?

Answer: Competition is intense in US generics across most oral and transdermal formats. In hospitals, competition is channel-specific by procurement contracts and manufacturer qualification status. The competitive landscape is best mapped by NDC-level distribution and procurement rosters, not by company-level branding alone.

How competition usually splits

  • US outpatient: many generic entrants for sublingual tablets, sprays, and patches.
  • Hospital: fewer qualified suppliers, but those suppliers can maintain share via contracts.
  • Retail adoption: driven by pharmacy stocking and payer switching policies.

When do nitroglycerin product exclusivities end, and what timing matters for launches?

Answer: For nitroglycerin, exclusivity timing is product-specific and depends on the last active listed patent for each RLD dosage form plus any US-specific exclusivity (e.g., 505(b)(2), orphan, new clinical investigation, etc.). For generics, the timing question is whether Orange Book patents have expired and whether any litigation stayed launch via settlement.

What timing factors determine generic launch windows?

  • Orange Book patent expiration dates for each RLD and formulation/delivery system patent.
  • “Automatic stay” and litigation triggers in US Paragraph IV scenarios.
  • Settlement agreements that may include agreed launch dates or market-entry restrictions.

What litigation affects nitroglycerin generics?

Answer: Litigation in nitroglycerin is generally concentrated around still-listed formulation patents for specific RLDs rather than the molecule. When disputes occur, they usually involve whether the generic’s formulation or delivery kinetics infringe.

What to look for in litigation records

  • Claim construction around controlled release technologies or adhesive matrices.
  • Settlement terms that specify launch dates, labeling carve-outs, or product modifications.

How does nitroglycerin compare with other antianginal routes (isosorbide, ranolazine, calcium channel blockers)?

Answer: Nitroglycerin is different in role and pharmacodynamics. It is used for rapid relief (sublingual) and maintenance symptom control (transdermal in some regimens) and is not a direct substitute for chronic antianginals like ranolazine or long-acting calcium channel blockers. This drives a market where nitroglycerin demand persists even as other agents gain chronic control share.

Substitution and switching reality

  • Acute rescue therapy: nitroglycerin has entrenched use.
  • Long-term disease control: other agents may reduce frequency of nitroglycerin rescue dosing, affecting unit growth but not eliminating demand.

What does the future regulatory outlook mean for nitroglycerin products?

Answer: Regulatory pressure focuses on:

  • bioequivalence and manufacturing quality for generics,
  • labeling consistency (adverse reactions, contraindications, and administration instructions),
  • stability and delivery performance for reformulated systems.

For most nitroglycerin products, the regulatory pathway is established; the competitive differentiator becomes product performance and compliance readiness rather than clinical innovation.


Key Takeaways

  • Nitroglycerin clinical activity in 2024–2026 is mostly formulation, PK, and tolerability work rather than new outcome-driven trials.
  • Patent protection is primarily product- and delivery-system-specific, with Orange Book and formulation patents shaping generic launch risk.
  • Market demand persists due to entrenched roles in rescue and maintenance use, but pricing and growth are dominated by generic substitution and route-level utilization.
  • For accurate revenue projections, the forecasting baseline must be built from dosage-form-specific units and pricing, then layered with patent/settlement timing for each RLD.

FAQs

  1. Do nitroglycerin transdermal patches face higher patent or litigation risk than sublingual tablets?
  2. What bioequivalence metrics are typically required for generic nitroglycerin sublingual sprays or tablets?
  3. How do FDA labeling requirements for nitroglycerin affect generic product differentiation?
  4. Which nitroglycerin delivery systems tend to have the highest discontinuation rates due to headache or local irritation?
  5. How does hospital procurement contracting influence nitroglycerin IV market share compared with retail outpatient channels?

References

  1. FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).” U.S. Food and Drug Administration. (Database). https://www.accessdata.fda.gov/scripts/cder/daf/
  2. ClinicalTrials.gov. “Nitroglycerin” (search results). U.S. National Library of Medicine. https://clinicaltrials.gov/

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