Nitroglycerin
Nitro-dur, Nitroglycerin, Nitrolingual Pumpspray, Nitromist, Nitrostat, Rectiv (nitroglycerin) is a small molecule pharmaceutical. Nitroglycerin was first approved as Nitroglycerin on 1982-01-01. It is used to treat angina pectoris, diffuse esophageal spasm, eclampsia, fissure in ano, and heart failure amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Nitro-dur, Nitroglycerin, Nitrolingual pumpspray, Nitromist, Nitrostat, Rectiv (discontinued: Gonitro, Minitran, Nitro, Nitro-bid, Nitroglycerin, Nitrol, Nitrolingual pumpspray, Nitrostat, Transderm-nitro, Tridil)
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nitroglycerin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RECTIV | AbbVie | N-021359 RX | 2011-06-21 | 1 products, RLD, RS |
| NITROGLYCERIN IN DEXTROSE 5% | Baxter | N-019970 RX | 1989-12-29 | 3 products, RLD, RS |
| NITROMIST | Evus Health Solutions | N-021780 RX | 2006-11-02 | 1 products, RLD, RS |
| NITROLINGUAL PUMPSPRAY | Pohl-Boskamp | N-018705 RX | 1997-01-10 | 1 products, RLD, RS |
| NITRO-DUR | USpharma | N-020145 RX | 1995-04-04 | 6 products, RLD, RS |
| NITROSTAT | Viatris | N-021134 RX | 2000-05-01 | 3 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| basic dental emergency kit | unapproved drug other | 2024-10-03 |
| deluxe dental emergency kit | unapproved drug other | 2024-10-03 |
| gonitro | New Drug Application | 2018-06-20 |
| minitran | Export only | 2025-01-15 |
| nitro-bid | ANDA | 2024-09-04 |
| nitro-dur | New Drug Application | 2023-05-30 |
| nitro-time | unapproved drug other | 2018-10-09 |
| nitroglycerin | ANDA | 2025-09-02 |
| nitroglycerin in dextrose | New Drug Application | 2022-12-09 |
| nitroglycerin in dextrose | New Drug Application | 2016-08-22 |
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Indications
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5416 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 3 | 4 | — | — | 7 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | 5 | 1 | — | — | 7 |
| Lymphoma | D008223 | — | C85.9 | 3 | 5 | 1 | — | — | 7 |
| Leukemia | D007938 | — | C95 | 1 | 2 | 4 | — | — | 6 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 2 | 4 | — | — | 6 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 3 | 1 | — | — | 4 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | 4 | — | — | — | 4 |
| B-cell lymphoma | D016393 | — | — | 2 | 3 | — | — | — | 3 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 2 | — | — | — | 2 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Hairy cell leukemia | D007943 | — | C91.4 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 1 | — | — | — | 1 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 1 | 1 | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nitroglycerin |
| INN | — |
| Description | Nitroglycerin is a nitroglycerol that is glycerol in which the hydrogen atoms of all three hydroxy groups are replaced by nitro groups. It acts as a prodrug, releasing nitric oxide to open blood vessels and so alleviate heart pain. It has a role as a vasodilator agent, a nitric oxide donor, an explosive, a prodrug, a tocolytic agent, a muscle relaxant and a xenobiotic. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-] |
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Nitroglycerin
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Safety
Black-box Warning
Black-box warning for: Nitro-dur, Nitroglycerin transdermal infusion system
Adverse Events
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10,550 adverse events reported
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