MedPath

Nitroglycerin

Generic Name
Nitroglycerin
Brand Names
Gonitro, Minitran, Mylan-nitro, Nitro-bid, Nitro-dur, Nitroject, Nitrolingual, Nitromist, Nitrostat, Rectiv, Trinipatch
Drug Type
Small Molecule
Chemical Formula
C3H5N3O9
CAS Number
55-63-0
Unique Ingredient Identifier
G59M7S0WS3

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.
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