Nitroglycerin
Nitro-dur, 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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| digestive system diseases | D004066 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Nitro-dur, Nitrolingual pumpspray, Nitromist, Nitrostat, Rectiv (generic drugs available since 1988-05-24, discontinued: Gonitro, Minitran, Nitro, Nitro-bid, Nitrol, Nitrolingual, Nitronal, Transderm-nitro, Tridil)
Drug Products
FDA
EMA
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 |
Show 10 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gonitro | New Drug Application | 2019-07-01 |
| minitran | Export only | 2023-01-25 |
| nitro-bid | ANDA | 2020-04-11 |
| nitro-dur | New Drug Application | 2019-12-17 |
| nitroglycerin | ANDA | 2023-06-05 |
| nitrolingual | New Drug Application | 2019-07-01 |
| nitromist | New Drug Application | 2020-06-08 |
| nitrostat | New Drug Application | 2023-02-23 |
| rectiv | New Drug Application | 2016-11-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| angina pectoris | EFO_0003913 | D000787 | I20 |
| diffuse esophageal spasm | EFO_1001785 | D015155 | K22.4 |
| eclampsia | HP_0100601 | D004461 | O15 |
| fissure in ano | HP_0012390 | D005401 | K60.2 |
| heart failure | EFO_0003144 | D006333 | I50 |
| intraoperative complications | — | D007431 | — |
| myocardial infarction | EFO_0000612 | D009203 | I21 |
| pulmonary hypertension | EFO_0001361 | D006976 | I27.20 |
Agency Specific
FDA
EMA
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
206 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | 1 | 1 | 2 | 6 |
| Fissure in ano | D005401 | HP_0012390 | K60.2 | — | — | 1 | 2 | 2 | 5 |
| Coronary artery disease | D003324 | I25.1 | 1 | 1 | — | 3 | — | 5 | |
| Coronary disease | D003327 | — | — | 1 | 3 | — | 4 | ||
| Stable angina | D060050 | I20.8 | — | — | — | 4 | — | 4 | |
| Chronic renal insufficiency | D051436 | N18 | 1 | 1 | — | 1 | 1 | 3 | |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 1 | 2 | 3 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 2 | 1 | 1 | — | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 1 | 1 | 3 |
| Retained placenta | D018457 | O72.0 | — | — | — | 2 | — | 2 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | — | 4 | 4 | — | — | 8 | |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | 2 | 2 | 5 | — | — | 8 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 4 | — | 2 | 6 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | 1 | — | 1 | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 1 | — | 1 | 3 |
| Vasodilation | D014664 | — | — | 1 | — | 2 | 3 | ||
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 1 | 3 | — | — | 3 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 2 | — | — | 2 |
| Cardiac catheterization | D006328 | — | 1 | 2 | — | — | 2 | ||
| Neonatal sepsis | D000071074 | HP_0040187 | — | — | 1 | — | — | 1 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | 1 | — | — | 6 | 9 | ||
| Mycosis fungoides | D009182 | C84.0 | — | 5 | — | — | 2 | 7 | |
| T-cell lymphoma cutaneous | D016410 | C84.A | — | 2 | — | — | 1 | 3 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 2 | — | — | 1 | 3 | |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 2 | 1 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | 2 | — | — | — | 2 | ||
| Cerebral hemorrhage | D002543 | — | 1 | — | — | 1 | 2 | ||
| Hodgkin disease | D006689 | C81 | — | 2 | — | — | — | 2 | |
| Chest pain | D002637 | HP_0100749 | R07.9 | — | 1 | — | — | 1 | 2 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 1 | — | — | 1 | 2 |
Show 19 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | 1 | — | — | — | — | 1 | ||
| Inflammation | D007249 | 1 | — | — | — | — | 1 | ||
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | 1 | — | — | — | — | 1 | |
| Rectal neoplasms | D012004 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 5 | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 2 | 2 |
| Controlled hypotension | D007023 | — | — | — | — | 2 | 2 | ||
| Vascular access devices | D062666 | — | — | — | — | 2 | 2 | ||
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | — | 2 | 2 |
| Pregnancy complications | D011248 | — | — | — | — | 2 | 2 | ||
| Breech presentation | D001946 | HP_0001623 | — | — | — | — | 2 | 2 | |
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | 2 | 2 | |
| Glucose metabolism disorders | D044882 | — | — | — | — | 1 | 1 |
Show 33 more
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-] |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000018390 | ALDH2, 1510G>A, Glu504Lys | drug response | 2021-03-24 | 2B |
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Nitro-dur
Adverse Events
Top Adverse Reactions
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16,902 adverse events reported
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