NITROMIST (nitroglycerin)
Nitromist is a nitrate vasodilator indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. It is used for the immediate management of active angina symptoms and as a preventive measure when administered shortly before activities that may trigger an attack.
How NITROMIST Works
Nitroglycerin forms free radical nitric oxide (NO), which activates the enzyme guanylate cyclase, resulting in increased levels of cyclic guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle. These events lead to the dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, resulting in vasodilation.
Details
- Status
- Prescription
- First Approved
- 2006-11-02
- Routes
- SUBLINGUAL
- Dosage Forms
- AEROSOL, METERED
NITROMIST Approval History
What NITROMIST Treats
2 indicationsNITROMIST is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Angina Pectoris
- Coronary Artery Disease
NITROMIST Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NITROMIST
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02425566 | 141218 | Ph 1 | active not recruiting | Role of Sympathetic Activity and Splanchnic Capacitance in Hypertension |
| NCT03689946 results posted | 54274 | Ph 3 | completed | Effect of Evolocumab on Coronary Atherosclerosis |
| NCT02209636 results posted | CLNB-006-13F CX001030 | Ph 4 | completed | Phosphate Lowering in CKD Trial |
| NCT02617550 VENICE | 17849 2015-001444-11 | Ph 1 | completed | Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients |
| NCT03716050 results posted | IRB00038262 | Ph 2, Ph 3 | terminated | The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems |
| NCT03809065 | N53-2016 | Ph 4 | completed | Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension |
| NCT03296670 | LSG1501104 | Ph 4 | completed | Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP |
| NCT04220281 prop | RGAbusinna | Ph 1, Ph 2 | terminated | Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery |
| NCT02961946 results posted | 2016P002417 | Ph 4 | completed | Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality |
| NCT03622060 NONERAO | HerminaHCK | Ph 3 | completed | Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion |
| NCT02343276 results posted | ICSC-2015 | Ph 3 | completed | Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs |
| NCT02327793 PATIS | PATIS Version 1.0 | Ph 2 | completed | Perfusion and Antihypertensive Therapy in Acute Ischemic Stroke |
| NCT02254252 results posted | 12604 | Ph 4 | completed | Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NITROMIST FDA Label Details
Indications & Usage
FDA Label (PDF)NITROMIST is indicated for the treatment of Angina Pectoris; Coronary Artery Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.