nitroglycerin
Trade name: transderm-nitro
Approved
May 28, 1981
Nitroglycerin was first invented in 1847 and has been used as an active ingredient in the manufacture of explosives, mostly dynamite. Nitroglycerin came into medical use in 1878 as as a potent vasodilator (dilation of the vascular system) to treat heart conditions, such as angina pectoris and chronic heart failure. Upon administration, nitroglycerin is converted to nitric oxide (NO) by mitochondrial aldehyde dehydrogenase. NO is a potent activator of guanylyl cyclase (GC) by heme-dependent mechanisms. — NCATS
Clinical trial activity
186 trials · 187 clinical orgs · 47 marketing orgs
Earliest trial started Aug 1, 1982 (NCT00000503)
Timeline
1870s
- Jun 1, 1878
Evidence of US Marketing
1980s
- May 28, 1981
Earliest FDA Approval
- May 28, 1981
Fougera — Marketing Organization
- Sep 30, 1981
Hospira — NDA Secondary Org
- Oct 19, 1981
Novartis — First NDA Organization
- Oct 19, 1981
Novartis — NDA Secondary Org
- Oct 19, 1981
Novartis — NDA Organization
- Jan 1, 1982
Earliest Phase 3 Sponsor(trial)
- Jan 5, 1982
Sanofi-Aventis — NDA Secondary Org
- Jan 19, 1983
Rorer — NDA Secondary Org
- Oct 31, 1985
Pohl Boskamp — NDA Secondary Org
- Dec 10, 1985
US Pharma — NDA Secondary Org
- Jun 19, 1986
Smith & Nephew — Marketing Organization
- Jan 8, 1987
Parke-Davis — Marketing Organization
- Jan 8, 1987
Warner Lambert — Marketing Organization
- May 24, 1988
Sankyo — Marketing Organization
- May 24, 1988
Lutipold — Marketing Organization
- Nov 28, 1988
Bausch Health Companies — Marketing Organization
- Nov 28, 1988
Medicis — Marketing Organization
- Dec 29, 1989
Baxalta — NDA Secondary Org
- Dec 29, 1989
Baxter — NDA Secondary Org
1990s
- Feb 28, 1990
Sanofi-Aventis — Marketing Organization
- Aug 31, 1990
Hospira — Marketing Organization
- Aug 30, 1996
Mylan — Marketing Organization
- Nov 26, 1996
Noven Therapeutics — Marketing Organization
- Jan 1, 1998
Earliest Phase 2 Sponsor(trial)
- Oct 30, 1998
Hercon Pharmaceuticals — Marketing Organization
2000s
- May 1, 2000
Viatris — Marketing Organization
- May 1, 2000
Pfizer — NDA Secondary Org
- May 1, 2000
Upjohn — Marketing Organization
- May 1, 2000
Viatris — NDA Secondary Org
- Jan 1, 2001
Earliest Phase 1 Sponsor(trial)
- Aug 10, 2004
Lannett Company, Inc. — Marketing Organization
- Nov 2, 2006
Mist Pharmaceuticals — NDA Secondary Org
- Nov 2, 2006
Evus — Marketing Organization
- Nov 2, 2006
Evus — NDA Secondary Org
2010s
- Jun 21, 2011
Allergan — NDA Secondary Org
- Jun 21, 2011
Allergan — Marketing Organization
- Jun 21, 2011
AbbVie — Marketing Organization
- Jun 21, 2011
AbbVie — NDA Secondary Org
- Sep 20, 2013
Padagis Us — Marketing Organization
- Sep 20, 2013
Perrigo — Marketing Organization
- Aug 26, 2016
Dr. Reddy's Laboratories — Marketing Organization
- Sep 19, 2017
Glenmark Pharmaceuticals — Marketing Organization
- Oct 16, 2017
Actavis — Marketing Organization
- Oct 16, 2017
Allergan PLC (2015) — Marketing Organization
- May 7, 2018
Sigmapharm Laboratories — Marketing Organization
- Apr 30, 2019
Natco Pharma — Marketing Organization
- Apr 30, 2019
Alvogen — Marketing Organization
2020s
- May 3, 2021
Rubicon Research — Marketing Organization
- Mar 8, 2022
Zydus Discovery DMCC — Marketing Organization
- Oct 26, 2023
Aurobindo Pharma — Marketing Organization
- Dec 5, 2023
Mankind Pharma — Marketing Organization
- Feb 16, 2024
Cosette — Marketing Organization
- Oct 15, 2024
Viwit Pharm — Marketing Organization
- Nov 29, 2024
Acrux Ltd — Marketing Organization
- Dec 16, 2024
Encube Ethicals Pvt. Ltd. — Marketing Organization
Indications
Approved for
Studied for
- Anemia, Sickle Cell · Phase 2
- Anesthesia · Phase 1/Phase 2
- Angina Pectoris · Phase 4
- Angina, Stable · Phase 4
- Angina, Unstable · Phase 4
- Arterial Occlusive Diseases · Phase 3
- Arteries · Early Phase 1
- Arthritis, Rheumatoid · Phase 3
- Atherosclerosis · Phase 3
- Autoimmune Diseases · Phase 3
- Autonomic Dysreflexia · Phase 2
- Biliary Tract Diseases · Phase 2
- Bone Diseases, Metabolic · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Cardiac Catheterization · Phase 3
- Cardiopulmonary Bypass · Phase 4
- Cardiovascular Diseases · Phase 4
- Catheter-Related Infections · Phase 1/Phase 2
- Cerebral Hemorrhage · Phase 2
- Chest Pain · Phase 2
- Cholangiopancreatography, Endoscopic Retrograde · Phase 2/Phase 3
- Colic · Phase 2
- Colonic Polyps · Early Phase 1
- Colorectal Neoplasms · Early Phase 1
- Contraception · Phase 4
- Coronary Artery Bypass · Phase 4
- Coronary Disease · Phase 4
- Diabetes Mellitus · Phase 2
- Erectile Dysfunction · Phase 3
- Escherichia coli Infections · Phase 4
- Esophageal Diseases · Phase 4
- Extracorporeal Membrane Oxygenation · Phase 2
- Fissure in Ano · Phase 4
- Fractures, Bone · Phase 1
- General Surgery · Phase 4
- Gynecomastia · Phase 3
- Hand Injuries · Phase 3
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 3
- Heart Failure · Phase 4
- Heart Transplantation · Phase 4
- Hemorrhage · Phase 4
- Hypertension, Pulmonary · Phase 1
- Hypertrophy, Left Ventricular · Phase 2
- Hypotension · Phase 4
- Inflammation · Phase 1
- Intrauterine Devices · Phase 4
- Ischemic Stroke · Phase 3
- Kidney Diseases · Phase 4
- Labor, Obstetric · Phase 4
- Lung Neoplasms · Phase 2
- Medicine, Chinese Traditional · Phase 4
- Menopause · Phase 2
- Microcirculation · Phase 4
- MINOCA · Phase 4
- Myocardial Infarction · Phase 4
- Myocardial Ischemia · Phase 3
- Myocardial Reperfusion Injury · Phase 3
- Osteoporosis · Phase 3
- Pain · Phase 3
- Pancreatitis · Phase 4
- Percutaneous Coronary Intervention · Phase 4
- Perfusion · Phase 4
- Peripheral Arterial Disease · Early Phase 1
- Pharmacokinetics · Early Phase 1
- Phlebitis · Phase 1/Phase 2
- Placenta, Retained · Phase 4
- Platelet-Rich Plasma · Phase 4
- Pre-Eclampsia · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 2/Phase 3
- Pulmonary Edema · Phase 2/Phase 3
- Radial Artery · Phase 4
- Raynaud Disease · Phase 3
- Rectal Diseases · Phase 4
- Rectal Neoplasms · Phase 1
- Regional Blood Flow · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Retina · Phase 4
- Scleroderma, Systemic · Phase 3
- Sepsis · Phase 4
- Shock · Early Phase 1
- Shock, Hemorrhagic · Phase 2
- Shock, Septic · Phase 3
- Sleep Apnea, Obstructive · Early Phase 1
- Small Cell Lung Carcinoma · Phase 2
- Spasm · Phase 2/Phase 3
- Spinal Cord Injuries · Phase 2
- ST Elevation Myocardial Infarction · Phase 4
- Stroke · Phase 3
- Surgical Wound Dehiscence · Phase 1
- Tendinopathy · Phase 2
- Vascular Diseases · Phase 1/Phase 2
- Vasodilation · Phase 3
- Vasospasm, Intracranial · Phase 4
- Version, Fetal · Phase 2/Phase 3
- Wound Healing · Phase 3
- Wound Infection · Phase 1
Mechanism of action
- Soluble guanylate cyclaseACTIVATOR
Soluble guanylate cyclase activator
Heterodimer, beta (1 or 2) is binding site
Approval history
- approvedMay 28, 1981
- approvedJun 1, 1878
Chemistry & pharmacology
SMILES
[O-][N+](=O)OCC(CO[N+]([O-])=O)O[N+]([O-])=O- Mol. weight
- 227.0865 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral, Topical
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
Yes
Sources
- WikipediaNitroglycerin ↗
- NCATSG59M7S0WS3 ↗
- ChEMBLCHEMBL730 ↗
Also known as
- 1,2,3-propanetrioltrinitrate
- 1,2,3-propanetrioltrinitrate
- 1,2,3-propanetriyl nitrate
- 1,2,3-propanetriyl nitrate
- amphimatrix
- coro-nitro
- coro-nitro
- deponit 10
- deponit 5
- deponit 5
- glycerine trinitrate
- glycerine trinitrate
- glycerin trinitrate
- glycerin trinitrate
- glyceroli trinitratis
- glyceroli trinitratis
- glycerol, nitric acid triester
- glycerol, nitric acid triester
- glyceroltrinitrat
- glyceroltrinitrat
- glycerol trinitrate
- glycerol trinitrate
- glycerol trinitrate
- glyceryl nitrate
- glyceryl nitrate
- glyceryl trinitate
- glyceryl trinitrate
- glyceryl trinitrate
- glyceryl trinitrate
- glyceryl trinitrate
- glyceryl trinitrate
- glyceryl trinitrate
- glyceryl trinitrate
- glytrin
- glytrin
- hcp1302
- imx-150
- imx-150
- lenitral 7.5
- minitran
- minitran
- minitran 10
- minitran 15
- minitran 5
- natirose
- natispray
- natispray
- ng
- ng
- nitriderm tts
- nitriderm tts
- nitro-bid
- nitro-bid
- nitrocine
- nitrocine
- nitrocontin continus
- nitrocontin continus
- nitro-dur
- nitro-dur
- nitroglicerina
- nitroglicerina
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerin
- nitroglycerine
- nitroglycerine
- nitroglycerine
- nitroglycerine
- nitroglycerol
- nitroglycerol
- nitroglycerol
- nitro iv
- nitro iv
- nitrol
- nitrol
- nitrolingual
- nitrolingual
- nitrolingual pumpspray
- nitrolingual pumpspray
- nitro-mack ret
- nitromed
- nitromed
- nitromin
- nitromin
- nitromist
- nitromist
- nitronal
- nitronal
- nitrostat
- nitrostat
- nitrostat
- percutol
- percutol
- propane-1,2,3-triyl trinitrate
- propane-1,2,3-triyl trinitrate
- propanetriol trinitrate
- rectiv
- rectiv
- rectogesic
- rectogesic
- rectogesic
- suscard buccal
- sustac
- sustac
- transderm-nitro
- transderm-nitro
- transiderm-nitro 10
- transiderm-nitro 5
- tridil
- tridil
- trinitrine
- trinitrine
- trinitrin tablets
- trinitrin tablets
- trinitroglycerin
- trinitroglycerin
- trinitroglycerin
- trinitroglycerol
- trinitroglycerol
- trinitroglycerol
- trintek 10
- trintek 15
- trintek 5
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07004764 | Phase 1 | Dec 31, 2025 | Johns Hopkins University, Orthopaedic Trauma Association |
| NCT07197463 | N/A | Oct 10, 2025 | Shandong University |
| NCT07044232 | Phase 4 | Oct 1, 2025 | Aarhus University |
| NCT07159334 | N/A | Aug 2, 2025 | King Edward Medical University |
| NCT07083063 | Phase 4 | Aug 1, 2025 | National Cheng Kung University |
| NCT06925763 | N/A | Apr 1, 2025 | Minia University |
| NCT06859554 | Phase 4 | Mar 17, 2025 | Lahore Medical and Dental college |
| NCT06787066 | Early Phase 1 (Phase 1) | Feb 28, 2025 | University of Missouri |
| NCT06785337 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2025 | Beni Suef University |
| NCT06682260 | Phase 4 | Jan 1, 2025 | University of Copenhagen |
| NCT06265415 | N/A | Mar 30, 2024 | Sohag University |
| NCT06289946 | Phase 2 | Mar 1, 2024 | Thomas Jefferson University |
| NCT06637956 | N/A | Jan 1, 2024 | RESnTEC, Institute of Research |
| NCT06107465 | Phase 2/Phase 3 (Phase 3) | Nov 10, 2023 | Alexandria University |
| NCT05952011 | N/A | Aug 8, 2023 | Ain Shams University |
| NCT05741229 | N/A | May 20, 2023 | Alexandria University |
| NCT06912139 | Phase 3 | Apr 1, 2023 | University of Medicine and Pharmacy Victor Babes Timisoara |
| NCT05635851 | Phase 2 | Feb 28, 2023 | Simon Fraser University, University of British Columbia |
| NCT06238882 | N/A | Feb 23, 2023 | Government of Mexico |
| NCT05687669 | Phase 4 | Jan 12, 2023 | Assiut University |
Organizations
Research & Development (187)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| MediQuest Therapeutics | For profit | 9 | 9 | 3 | 2004 |
| Ain Shams University | Academic/Hospital | 6 | 6 | 4 | 2016 |
| University of Copenhagen | Academic/Hospital | 6 | 6 | 3 | 2004 |
| Cairo University | Academic/Hospital | 5 | 5 | 3 | 2016 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 5 | 3 | 3 | 1982 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 5 | 2 | 3 | 1982 |
| Mansoura University | Academic/Hospital | 4 | 4 | 1 | 2016 |
| University of California, San Francisco | Academic/Hospital | 4 | 4 | 4 | 2008 |
| Assiut University | Academic/Hospital | 3 | 3 | 2 | 2016 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 3 | 3 | 1 | 2019 |
| Futura Medical Developments Ltd. | For profit | 3 | 3 | 3 | 2015 |
| Miguel Hernández University | Academic/Hospital | 3 | 3 | 1 | 2009 |
| Seoul National University | Academic/Hospital | 3 | 3 | 1 | 2019 |
| Thomas Jefferson University | Academic/Hospital | 3 | 2 | 3 | 2016 |
| University of British Columbia | Academic/Hospital | 3 | 1 | 2 | 2009 |
| University of Vienna | Academic/Hospital | 3 | 3 | 3 | 1999 |
| Vanderbilt University | Academic/Hospital | 3 | 3 | 2 | 2001 |
| Aarhus University | Academic/Hospital | 2 | 2 | 2 | 2014 |
| Alexandria University | Academic/Hospital | 2 | 2 | 2 | 2023 |
| Bayer | For profit | 2 | 1 | 2 | 2011 |
Marketing (60)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Jun 21, 2011 |
| AbbVie | For profit | NDA2 | Jun 21, 2011 |
| Abraxis | For profit | MKTG | — |
| Acrux Ltd | For profit | MKTG | Nov 29, 2024 |
| Actavis | For profit | MKTG | Oct 16, 2017 |
| Allergan | For profit | NDA2 | Jun 21, 2011 |
| Allergan | For profit | MKTG | Jun 21, 2011 |
| Allergan PLC (2015) | For profit | MKTG | Oct 16, 2017 |
| Alvogen | For profit | MKTG | Apr 30, 2019 |
| Athenex, Inc. | For profit | MKTG | — |
| Aurobindo Pharma | For profit | MKTG | Oct 26, 2023 |
| Bausch Health Companies | For profit | MKTG | Nov 28, 1988 |
| Bausch Health Companies | For profit | SYN | Nov 28, 1988 |
| Bausch Health Companies | For profit | SYN | Nov 28, 1988 |
| Baxalta | For profit | NDA2 | Dec 29, 1989 |
| Baxter | For profit | NDA2 | Dec 29, 1989 |
| Cosette | For profit | MKTG | Feb 16, 2024 |
| Dr. Reddy's Laboratories | For profit | SYN | Aug 26, 2016 |
| Dr. Reddy's Laboratories | For profit | MKTG | Aug 26, 2016 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Dec 16, 2024 |
| Evus | For profit | MKTG | Nov 2, 2006 |
| Evus | For profit | NDA2 | Nov 2, 2006 |
| Fougera | For profit | MKTG | May 28, 1981 |
| Glenmark Pharmaceuticals | For profit | SYN | Sep 19, 2017 |
| Glenmark Pharmaceuticals | For profit | MKTG | Sep 19, 2017 |
| Hercon Pharmaceuticals | For profit | MKTG | Oct 30, 1998 |
| Hospira | For profit | NDA2 | Sep 30, 1981 |
| Hospira | For profit | MKTG | Aug 31, 1990 |
| International Medication | For profit | MKTG | — |
| Lannett Company, Inc. | For profit | MKTG | Aug 10, 2004 |
| Lutipold | For profit | MKTG | May 24, 1988 |
| Mankind Pharma | For profit | MKTG | Dec 5, 2023 |
| Medicis | For profit | MKTG | Nov 28, 1988 |
| Mist Pharmaceuticals | For profit | NDA2 | Nov 2, 2006 |
| Mylan | For profit | MKTG | Aug 30, 1996 |
| Natco Pharma | For profit | MKTG | Apr 30, 2019 |
| Novartis | For profit | NDA2 | Oct 19, 1981 |
| Novartis | For profit | NDA | Oct 19, 1981 |
| Noven Therapeutics | For profit | MKTG | Nov 26, 1996 |
| Padagis Us | For profit | MKTG | Sep 20, 2013 |
| Parke-Davis | For profit | MKTG | Jan 8, 1987 |
| Parke-Davis | For profit | NDA2 | — |
| Perrigo | For profit | MKTG | Sep 20, 2013 |
| Pfizer | For profit | NDA2 | May 1, 2000 |
| Pohl Boskamp | For profit | NDA2 | Oct 31, 1985 |
| Rorer | For profit | NDA2 | Jan 19, 1983 |
| Rubicon Research | For profit | MKTG | May 3, 2021 |
| Rubicon Research | For profit | SYN | May 3, 2021 |
| Sankyo | For profit | MKTG | May 24, 1988 |
| Sanofi-Aventis | For profit | NDA2 | Jan 5, 1982 |
| Sanofi-Aventis | For profit | MKTG | Feb 28, 1990 |
| Sigmapharm Laboratories | For profit | MKTG | May 7, 2018 |
| Smith & Nephew | For profit | MKTG | Jun 19, 1986 |
| US Pharma | For profit | NDA2 | Dec 10, 1985 |
| Upjohn | For profit | MKTG | May 1, 2000 |
| Viatris | For profit | MKTG | May 1, 2000 |
| Viatris | For profit | NDA2 | May 1, 2000 |
| Viwit Pharm | For profit | MKTG | Oct 15, 2024 |
| Warner Lambert | For profit | MKTG | Jan 8, 1987 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 8, 2022 |