Overview
Nitroglycerin, also known as glyceryl trinitrate, is an organic nitrate and a vasodilating agent that was first discovered in 1847. Originally used to dynamite, its antianginal effects were identified in the late 1860s after it produced headaches in factory workers while workers with angina pectoris or heart failure experienced relief from chest pain. Its use as a treatment for angina dates back to 1879 and is still used to treat and prevent angina. Nitroglycerin causes vasodilation in both arteries and veins. Nitroglycerin is used in a variety of different conditions, including angina pectoris due to coronary artery disease, peri-operative hypertension, congestive heart failure, and chronic anal fissure. It is also used to induce intraoperative hypotension.
Background
Nitroglycerin, also known as glyceryl trinitrate, is an organic nitrate and a vasodilating agent that was first discovered in 1847. Originally used to dynamite, its antianginal effects were identified in the late 1860s after it produced headaches in factory workers while workers with angina pectoris or heart failure experienced relief from chest pain. Its use as a treatment for angina dates back to 1879 and is still used to treat and prevent angina. Nitroglycerin causes vasodilation in both arteries and veins. Nitroglycerin is used in a variety of different conditions, including angina pectoris due to coronary artery disease, peri-operative hypertension, congestive heart failure, and chronic anal fissure. It is also used to induce intraoperative hypotension.
Indication
Sublingual nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. Intravenous nitroglycerin is indicated for the treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and beta (β)-blockers; and for induction of intraoperative hypotension. Topical nitroglycerin ointment is used to treat moderate to severe pain associated with chronic anal fissure.
Associated Conditions
- Angina Attacks
- Angina Pectoris
- Congestive Heart Failure (CHF)
- Perioperative Hypertension
- Moderate to severe pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/04 | Phase 1 | Not yet recruiting | |||
2025/04/13 | Not Applicable | Not yet recruiting | Minia University | ||
2025/04/04 | Phase 3 | Completed | University of Medicine and Pharmacy "Victor Babes" Timisoara | ||
2024/11/11 | Phase 4 | Not yet recruiting | Copenhagen University Hospital, Hvidovre | ||
2024/10/11 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2024/05/24 | Phase 4 | Recruiting | |||
2024/03/04 | Phase 2 | Not yet recruiting | |||
2024/02/20 | Not Applicable | Not yet recruiting | |||
2024/02/14 | N/A | Recruiting | |||
2023/10/30 | Phase 2 | ENROLLING_BY_INVITATION |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Sigmapharm Laboratories, LLC | 42794-213 | SUBLINGUAL | 0.6 mg in 1 1 | 5/15/2018 | |
Zydus Pharmaceuticals (USA) Inc. | 70710-1019 | SUBLINGUAL | 0.4 mg in 1 1 | 3/29/2022 | |
HF Acquisition Co LLC, DBA HealthFirst | 51662-1386 | INTRAVENOUS | 5 mg in 1 mL | 2/19/2024 | |
Espero Pharmaceuticals, Inc. | 70007-400 | SUBLINGUAL | 400 ug in 1 1 | 6/30/2016 | |
Dr. Reddys Laboratories Inc | 43598-436 | SUBLINGUAL | 0.4 mg in 1 1 | 2/10/2017 | |
Glenmark Pharmaceuticals Inc., USA | 68462-639 | SUBLINGUAL | 0.4 mg in 1 1 | 10/21/2021 | |
Henry Schein, Inc. | 0404-9928 | INTRAVENOUS | 5 mg in 1 mL | 11/13/2023 | |
Cosette Pharmaceuticals, Inc. | 0713-0564 | RECTAL | 4 mg in 1 g | 2/21/2024 | |
Aurobindo Pharma Limited | 59651-659 | SUBLINGUAL | 0.6 mg in 1 1 | 11/1/2023 | |
Graceway Pharmaceuticals, LLC | 29336-322 | TRANSDERMAL | 5 mg in 1 d | 11/23/2009 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
RECTOGESIC OINTMENT 0.2% w/w | SIN12240P | OINTMENT | 0.2% w/w | 3/27/2003 | |
GLYTRIN SPRAY | SIN09161P | SPRAY | 400 mcg/spray | 1/21/1997 | |
GLYCERYL TRINITRATE-HAMELN INJECTION 1MG/ML | SIN15105P | INFUSION, SOLUTION | 1.000 MG/ML | 10/20/2016 | |
MYONIT INSTA NITROGLYCERIN SUBLINGUAL TABLETS USP 0.5MG | SIN15702P | TABLET | 0.5mg | 5/31/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Nitroglycerin Injection | 国药准字H20234379 | 化学药品 | 注射剂 | 10/27/2023 | |
Nitroglycerin Injection | 国药准字H20253571 | 化学药品 | 注射剂 | 3/11/2025 | |
Nitroglycerin Injection | 国药准字H20253838 | 化学药品 | 注射剂 | 4/8/2025 | |
Nitroglycerin Injection | 国药准字H20253572 | 化学药品 | 注射剂 | 3/11/2025 | |
Nitroglycerin Injection | 国药准字H20253839 | 化学药品 | 注射剂 | 4/8/2025 | |
Nitroglycerin Injection | 国药准字H20234396 | 化学药品 | 注射剂 | 10/27/2023 | |
Nitroglycerin Injection | 国药准字H20058649 | 化学药品 | 注射剂 | 7/12/2020 | |
Nitroglycerin Injection | 国药准字H20247124 | 化学药品 | 注射剂 | 6/12/2024 | |
Nitroglycerin Injection | 国药准字H11020290 | 化学药品 | 注射剂(小容量注射剂) | 9/16/2020 | |
Nitroglycerin Injection | 国药准字H14022197 | 化学药品 | 注射剂 | 8/5/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ANGININE glyceryl trinitrate 600microgram tablet bottle | 227783 | Medicine | A | 2/19/2015 | |
RECTOGESIC glyceryl trinitrate 0.2% w/w ointment tube. | 108254 | Medicine | A | 9/9/2004 | |
GLYCERYL TRINITRATE CONCENTRATED INJECTION PHEBRA glyceryl trinitrate 50 mg/10 mL concentrated injection vial | 453908 | Medicine | A | 5/22/2025 | |
GLYCERYL TRINITRATE WKT glyceryl trinitrate 50 mg/50 mL concentrated solution for injection vial | 301499 | Medicine | A | 5/7/2019 | |
TRANSIDERM-NITRO 50 glyceryl trinitrate 50 mg transdermal drug delivery system sachet | 17105 | Medicine | A | 10/2/1991 | |
DBL GLYCERYL TRINITRATE 50mg/10mL Injection | 16341 | Medicine | A | 10/8/1991 | |
MINITRAN 15 glyceryl trinitrate 15mg/24 hour transdermal drug delivery system, sachet | 52030 | Medicine | A | 8/8/1995 | |
RECTOGESIC OINTMENT glyceryl trinitrate 0.2% w/w ointment tube | 66382 | Medicine | A | 10/13/1998 | |
MINITRAN 10 glyceryl trinitrate 10mg/24 hour transdermal drug delivery system, sachet | 52029 | Medicine | A | 8/8/1995 | |
Anginine Tablets | 11086 | Medicine | A | 8/2/1991 |