nitroglycerin

Trade name: transderm-nitro

Small moleculeapproved

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

Phase 1
28
Phase 2
55
Phase 3
38
Phase 4
40

Earliest trial started Aug 1, 1982 (NCT00000503)

Timeline

1870s

  1. Jun 1, 1878

    Evidence of US Marketing

1980s

  1. May 28, 1981

    Earliest FDA Approval

  2. May 28, 1981

    Fougera — Marketing Organization

  3. Sep 30, 1981

    Hospira — NDA Secondary Org

  4. Oct 19, 1981

    Novartis — First NDA Organization

  5. Oct 19, 1981

    Novartis — NDA Secondary Org

  6. Oct 19, 1981

    Novartis — NDA Organization

  7. Jan 1, 1982

    Earliest Phase 3 Sponsor(trial)

  8. Jan 5, 1982

    Sanofi-Aventis — NDA Secondary Org

  9. Jan 19, 1983

    Rorer — NDA Secondary Org

  10. Oct 31, 1985

    Pohl Boskamp — NDA Secondary Org

  11. Dec 10, 1985

    US Pharma — NDA Secondary Org

  12. Jun 19, 1986

    Smith & Nephew — Marketing Organization

  13. Jan 8, 1987

    Parke-Davis — Marketing Organization

  14. Jan 8, 1987

    Warner Lambert — Marketing Organization

  15. May 24, 1988

    Sankyo — Marketing Organization

  16. May 24, 1988

    Lutipold — Marketing Organization

  17. Nov 28, 1988

    Bausch Health Companies — Marketing Organization

  18. Nov 28, 1988

    Medicis — Marketing Organization

  19. Dec 29, 1989

    Baxalta — NDA Secondary Org

  20. Dec 29, 1989

    Baxter — NDA Secondary Org

1990s

  1. Feb 28, 1990

    Sanofi-Aventis — Marketing Organization

  2. Aug 31, 1990

    Hospira — Marketing Organization

  3. Aug 30, 1996

    Mylan — Marketing Organization

  4. Nov 26, 1996

    Noven Therapeutics — Marketing Organization

  5. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  6. Oct 30, 1998

    Hercon Pharmaceuticals — Marketing Organization

2000s

  1. May 1, 2000

    Viatris — Marketing Organization

  2. May 1, 2000

    Pfizer — NDA Secondary Org

  3. May 1, 2000

    Upjohn — Marketing Organization

  4. May 1, 2000

    Viatris — NDA Secondary Org

  5. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  6. Aug 10, 2004

    Lannett Company, Inc. — Marketing Organization

  7. Nov 2, 2006

    Mist Pharmaceuticals — NDA Secondary Org

  8. Nov 2, 2006

    Evus — Marketing Organization

  9. Nov 2, 2006

    Evus — NDA Secondary Org

2010s

  1. Jun 21, 2011

    Allergan — NDA Secondary Org

  2. Jun 21, 2011

    Allergan — Marketing Organization

  3. Jun 21, 2011

    AbbVie — Marketing Organization

  4. Jun 21, 2011

    AbbVie — NDA Secondary Org

  5. Sep 20, 2013

    Padagis Us — Marketing Organization

  6. Sep 20, 2013

    Perrigo — Marketing Organization

  7. Aug 26, 2016

    Dr. Reddy's Laboratories — Marketing Organization

  8. Sep 19, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  9. Oct 16, 2017

    Actavis — Marketing Organization

  10. Oct 16, 2017

    Allergan PLC (2015) — Marketing Organization

  11. May 7, 2018

    Sigmapharm Laboratories — Marketing Organization

  12. Apr 30, 2019

    Natco Pharma — Marketing Organization

  13. Apr 30, 2019

    Alvogen — Marketing Organization

2020s

  1. May 3, 2021

    Rubicon Research — Marketing Organization

  2. Mar 8, 2022

    Zydus Discovery DMCC — Marketing Organization

  3. Oct 26, 2023

    Aurobindo Pharma — Marketing Organization

  4. Dec 5, 2023

    Mankind Pharma — Marketing Organization

  5. Feb 16, 2024

    Cosette — Marketing Organization

  6. Oct 15, 2024

    Viwit Pharm — Marketing Organization

  7. Nov 29, 2024

    Acrux Ltd — Marketing Organization

  8. Dec 16, 2024

    Encube Ethicals Pvt. Ltd. — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedMay 28, 1981
  • approvedJun 1, 1878

Chemistry & pharmacology

Loading structure…

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

Black box warningProdrug

Sources

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 IDPhaseStart dateSponsor(s)
NCT07004764Phase 1Dec 31, 2025Johns Hopkins University, Orthopaedic Trauma Association
NCT07197463N/AOct 10, 2025Shandong University
NCT07044232Phase 4Oct 1, 2025Aarhus University
NCT07159334N/AAug 2, 2025King Edward Medical University
NCT07083063Phase 4Aug 1, 2025National Cheng Kung University
NCT06925763N/AApr 1, 2025Minia University
NCT06859554Phase 4Mar 17, 2025Lahore Medical and Dental college
NCT06787066Early Phase 1 (Phase 1)Feb 28, 2025University of Missouri
NCT06785337Phase 2/Phase 3 (Phase 3)Feb 1, 2025Beni Suef University
NCT06682260Phase 4Jan 1, 2025University of Copenhagen
NCT06265415N/AMar 30, 2024Sohag University
NCT06289946Phase 2Mar 1, 2024Thomas Jefferson University
NCT06637956N/AJan 1, 2024RESnTEC, Institute of Research
NCT06107465Phase 2/Phase 3 (Phase 3)Nov 10, 2023Alexandria University
NCT05952011N/AAug 8, 2023Ain Shams University
NCT05741229N/AMay 20, 2023Alexandria University
NCT06912139Phase 3Apr 1, 2023University of Medicine and Pharmacy Victor Babes Timisoara
NCT05635851Phase 2Feb 28, 2023Simon Fraser University, University of British Columbia
NCT06238882N/AFeb 23, 2023Government of Mexico
NCT05687669Phase 4Jan 12, 2023Assiut University
Showing 20 of 186 trials
Page 1 / 10

Organizations

Research & Development (187)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MediQuest TherapeuticsFor profit9932004
Ain Shams UniversityAcademic/Hospital6642016
University of CopenhagenAcademic/Hospital6632004
Cairo UniversityAcademic/Hospital5532016
Icahn School of Medicine at Mount SinaiAcademic/Hospital5331982
National Heart, Lung, and Blood Institute (NHLBI)Government5231982
Mansoura UniversityAcademic/Hospital4412016
University of California, San FranciscoAcademic/Hospital4442008
Assiut UniversityAcademic/Hospital3322016
China Academy of Chinese Medical SciencesAcademic/Hospital3312019
Futura Medical Developments Ltd.For profit3332015
Miguel Hernández UniversityAcademic/Hospital3312009
Seoul National UniversityAcademic/Hospital3312019
Thomas Jefferson UniversityAcademic/Hospital3232016
University of British ColumbiaAcademic/Hospital3122009
University of ViennaAcademic/Hospital3331999
Vanderbilt UniversityAcademic/Hospital3322001
Aarhus UniversityAcademic/Hospital2222014
Alexandria UniversityAcademic/Hospital2222023
BayerFor profit2122011
187 organizations
Page 1 / 10

Marketing (60)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJun 21, 2011
AbbVieFor profitNDA2Jun 21, 2011
AbraxisFor profitMKTG
Acrux LtdFor profitMKTGNov 29, 2024
ActavisFor profitMKTGOct 16, 2017
AllerganFor profitNDA2Jun 21, 2011
AllerganFor profitMKTGJun 21, 2011
Allergan PLC (2015)For profitMKTGOct 16, 2017
AlvogenFor profitMKTGApr 30, 2019
Athenex, Inc.For profitMKTG
Aurobindo PharmaFor profitMKTGOct 26, 2023
Bausch Health CompaniesFor profitMKTGNov 28, 1988
Bausch Health CompaniesFor profitSYNNov 28, 1988
Bausch Health CompaniesFor profitSYNNov 28, 1988
BaxaltaFor profitNDA2Dec 29, 1989
BaxterFor profitNDA2Dec 29, 1989
CosetteFor profitMKTGFeb 16, 2024
Dr. Reddy's LaboratoriesFor profitSYNAug 26, 2016
Dr. Reddy's LaboratoriesFor profitMKTGAug 26, 2016
Encube Ethicals Pvt. Ltd.For profitMKTGDec 16, 2024
EvusFor profitMKTGNov 2, 2006
EvusFor profitNDA2Nov 2, 2006
FougeraFor profitMKTGMay 28, 1981
Glenmark PharmaceuticalsFor profitSYNSep 19, 2017
Glenmark PharmaceuticalsFor profitMKTGSep 19, 2017
Hercon PharmaceuticalsFor profitMKTGOct 30, 1998
HospiraFor profitNDA2Sep 30, 1981
HospiraFor profitMKTGAug 31, 1990
International MedicationFor profitMKTG
Lannett Company, Inc.For profitMKTGAug 10, 2004
LutipoldFor profitMKTGMay 24, 1988
Mankind PharmaFor profitMKTGDec 5, 2023
MedicisFor profitMKTGNov 28, 1988
Mist PharmaceuticalsFor profitNDA2Nov 2, 2006
MylanFor profitMKTGAug 30, 1996
Natco PharmaFor profitMKTGApr 30, 2019
NovartisFor profitNDA2Oct 19, 1981
NovartisFor profitNDAOct 19, 1981
Noven TherapeuticsFor profitMKTGNov 26, 1996
Padagis UsFor profitMKTGSep 20, 2013
Parke-DavisFor profitMKTGJan 8, 1987
Parke-DavisFor profitNDA2
PerrigoFor profitMKTGSep 20, 2013
PfizerFor profitNDA2May 1, 2000
Pohl BoskampFor profitNDA2Oct 31, 1985
RorerFor profitNDA2Jan 19, 1983
Rubicon ResearchFor profitMKTGMay 3, 2021
Rubicon ResearchFor profitSYNMay 3, 2021
SankyoFor profitMKTGMay 24, 1988
Sanofi-AventisFor profitNDA2Jan 5, 1982
Sanofi-AventisFor profitMKTGFeb 28, 1990
Sigmapharm LaboratoriesFor profitMKTGMay 7, 2018
Smith & NephewFor profitMKTGJun 19, 1986
US PharmaFor profitNDA2Dec 10, 1985
UpjohnFor profitMKTGMay 1, 2000
ViatrisFor profitMKTGMay 1, 2000
ViatrisFor profitNDA2May 1, 2000
Viwit PharmFor profitMKTGOct 15, 2024
Warner LambertFor profitMKTGJan 8, 1987
Zydus Discovery DMCCFor profitMKTGMar 8, 2022