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ipratropium

Trade name: atrovent

Small moleculeapproved

Approved

Dec 29, 1986

Ipratropium (ipratropium bromide, ATROVENT® HFA) is a muscarinic antagonist structurally related to atropine but often considered safer and more effective for inhalation use. It is indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Ipratropium (ipratropium bromide, ATROVENT® HFA) is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. Anticholinergics prevent the increases in intracellular concentration of Ca2+ which is caused by interaction of acetylcholine with the muscarinic receptors on bronchial smooth muscle. — NCATS

Clinical trial activity

99 trials · 96 clinical orgs · 27 marketing orgs

Phase 1
10
Phase 2
40
Phase 3
21
Phase 4
32

Earliest trial started Sep 1, 1984 (NCT00000568)

Timeline

1980s

  1. Jan 1, 1984

    Earliest Phase 3 Sponsor(trial)

  2. Dec 29, 1986

    Boehringer Ingelheim — Earliest FDA Approval

  3. Dec 29, 1986

    Boehringer Ingelheim — NDA Secondary Org

  4. Dec 29, 1986

    Boehringer Ingelheim — NDA Organization

1990s

  1. Jan 10, 1997

    Mylan — Marketing Organization

  2. Jan 10, 1997

    PHARMOBEDIENT — NDA Secondary Org

  3. Jan 1, 1998

    Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 1999

    Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)

  5. Apr 22, 1999

    Actavis — Marketing Organization

2000s

  1. Jan 19, 2001

    Zennova — Marketing Organization

  2. Jan 19, 2001

    Pharmasciences — Marketing Organization

  3. Jan 26, 2001

    Ritedose — Marketing Organization

  4. Mar 21, 2001

    Mylan — NDA Secondary Org

  5. Mar 28, 2001

    Apotex — Marketing Organization

  6. Sep 27, 2001

    Nephron Pharmaceuticals Corporation — Marketing Organization

  7. Oct 15, 2001

    Bausch Health Companies — Marketing Organization

  8. Jul 22, 2002

    Roxane Laboratories — Marketing Organization

  9. Jul 22, 2002

    Boehringer Ingelheim — Marketing Organization

  10. Mar 31, 2003

    Bausch & Lomb — Marketing Organization

  11. Nov 5, 2003

    Hikma — Marketing Organization

  12. Nov 5, 2003

    West-Ward Pharmaceutical — Marketing Organization

  13. May 9, 2005

    Watson Pharmaceuticals — Marketing Organization

  14. Jul 19, 2005

    Landela Pharmaceutical — Marketing Organization

  15. Dec 21, 2006

    Fosun — Marketing Organization

  16. Dec 21, 2006

    AiPing Pharm Inc — Marketing Organization

  17. Dec 31, 2007

    Cipla — Marketing Organization

  18. Dec 31, 2007

    Teva — Marketing Organization

2010s

  1. Oct 27, 2016

    Aurobindo Pharma — Marketing Organization

  2. Oct 27, 2016

    Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. — Marketing Organization

  3. Jan 3, 2017

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Aug 16, 2022

    Amneal Pharmaceuticals — Marketing Organization

  2. Nov 15, 2024

    Rubicon Research — Marketing Organization

  3. Jan 27, 2025

    Lupin — Marketing Organization

  4. Feb 23, 2026

    Armstrong Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • combivent

    with albuterol

    Also known as combivent respimat, duoneb

Approval history

  • approvedPriority reviewDec 29, 1986

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[N+]1(C)[C@@H]2CC[C@H]1C[C@@H](OC(=O)C(CO)c1ccccc1)C2
Mol. weight
332.46 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 3α-hydroxy-8-isopropyl-1αh,5αh-tropanium bromide (±)-tropate
  • 3α-hydroxy-8-isopropyl-1αh,5αh-tropanium bromide (±)-tropate
  • 8-isopropylnoratropine methobromide
  • 8-isopropylnoratropine methobromide
  • aer 001
  • albuterol sulfate mixture with ipratropium bromide
  • atrovent
  • atrovent
  • atrovent
  • atrovent
  • atrovent aerocaps
  • atrovent fte
  • atrovent hfa
  • atrovent hfa
  • atrovent udvs
  • bromure d'ipratropium
  • bromure d'ipratropium
  • bromuro de ipratropio
  • bromuro de ipratropio
  • (endo,syn)-(±)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane bromide
  • (endo,syn)-(±)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane bromide
  • ipratrop
  • ipratropii bromidum
  • ipratropii bromidum
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropium
  • ipratropiumbromid
  • ipratropiumbromid
  • ipratropium bromide
  • ipratropium bromide
  • ipratropium bromide
  • ipratropium bromide
  • ipratropium bromide
  • ipratropium bromide
  • ipratropium bromide
  • ipratropium bromide anhydrous
  • ipratropium bromide anhydrous
  • ipratropium bromide (anhydrous)
  • ipratropium bromide (anhydrous)
  • ipratropium bromide hydrate
  • ipratropium bromide hydrate
  • ipratropium bromide hydrate
  • ipratropium bromide monohydrate
  • ipratroprium
  • ipratrop steripoule
  • n-isopropylnoratropinium bromomethylate
  • n-isopropylnoratropinium bromomethylate
  • respontin
  • respontin
  • rinatec
  • rinatec
  • sch-1000-br-
  • sch-1000-br-
  • sch-1000-br monohydrate
  • sch-1000-br monohydrate
  • tropiovent
  • tropiovent
  • tv46017

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06657079Phase 1/Phase 2 (Phase 2)May 1, 2024Badr University, Damanhour University
NCT06376942Phase 2/Phase 3 (Phase 3)Apr 24, 2024Postgraduate Institute of Medical Education and Research
NCT06918418Phase 4Jan 1, 2024The Children Complex & The Institute of Child Health, Multan
NCT06074185Phase 2Jan 1, 2024Oregon Health and Science University, University at Buffalo, University of Utah, Wake Forest University
NCT05550402Phase 3Jan 1, 2023Hatyai Hospital, Hat Yai Medical Education Center
NCT05183841N/AMar 31, 2022University of Sao Paulo
NCT04446637Phase 3Sep 30, 2020Cukurova University, Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital, NeuTec Pharma
NCT04315558Phase 2Apr 30, 2020Mylan, Theravance, University of California, Los Angeles
NCT04167280Phase 4Nov 5, 2019University of Saskatchewan
NCT03910985Phase 4Apr 23, 2019CHU Mont-Godinne
NCT04101500Phase 4Apr 1, 2019Huazhong University of Science and Technology
NCT03738917Phase 4Feb 1, 2019Catalan Institute of Health, Jordi Gol i Gurina Foundation, Spanish Clinical Research Network
NCT03747536Phase 2Jan 1, 2019University of Western Ontario
NCT03296579N/AJun 30, 2018Postgraduate Institute of Medical Education and Research, University of British Columbia
NCT03219866Phase 4Oct 3, 2017Wake Forest University
NCT03405090Phase 4Sep 20, 2017Canadian Lung Association, Queen's University, Belfast
NCT03031093N/AJun 1, 2017Federal University of Pernambuco, Universidade Federal do Rio Grande do Norte
NCT03271905N/AApr 10, 2017Universidade Federal do Rio Grande do Norte
NCT03480997Phase 1Dec 27, 2016Advanced Respiratory and Sleep Medicine, PLLC, Pneuma Pharmaceuticals Incorporated
NCT04617015Early Phase 1 (Phase 1)Sep 9, 2016State University of New York, Buffalo
Showing 20 of 99 trials
Page 1 / 5

Organizations

Research & Development (96)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit302951998
GlaxoSmithKlineFor profit5332005
Aerovance, Inc.For profit3322005
AstraZenecaFor profit3122007
IQVIAFor profit3022005
National Heart, Lung, and Blood Institute (NHLBI)Government3121984
Queen's University, BelfastAcademic/Hospital3312005
Case Western Reserve UniversityAcademic/Hospital2222004
Laval UniversityAcademic/Hospital2212008
NovartisFor profit2112007
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital2122018
SunovionFor profit2122004
TheravanceFor profit2112011
Universidade Federal do Rio Grande do NorteAcademic/Hospital2212017
University of MonastirAcademic/Hospital2212005
University of SaskatchewanAcademic/Hospital2212008
University of TorontoAcademic/Hospital2222004
Wake Forest UniversityAcademic/Hospital2122017
Advanced Respiratory and Sleep Medicine, PLLCAcademic/Hospital1012016
AerogenFor profit1012016
96 organizations
Page 1 / 5

Marketing (36)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGApr 22, 1999
AiPing Pharm IncFor profitMKTGDec 21, 2006
Amneal PharmaceuticalsFor profitMKTGAug 16, 2022
ApotexFor profitMKTGMar 28, 2001
Armstrong PharmaceuticalsFor profitMKTGFeb 23, 2026
Aurobindo PharmaFor profitSYNMar 31, 2003
Aurobindo PharmaFor profitMKTGOct 27, 2016
Bausch & LombFor profitMKTGMar 31, 2003
Bausch & LombFor profitSYNOct 15, 2001
Bausch Health CompaniesFor profitMKTGOct 15, 2001
Boehringer IngelheimFor profitNDA2Dec 29, 1986
Boehringer IngelheimFor profitNDADec 29, 1986
Boehringer IngelheimFor profitMKTGJul 22, 2002
CiplaFor profitMKTGDec 31, 2007
FosunFor profitMKTGDec 21, 2006
HikmaFor profitMKTGNov 5, 2003
HikmaFor profitMKTGNov 5, 2003
Landela PharmaceuticalFor profitMKTGJul 19, 2005
LupinFor profitMKTGJan 27, 2025
MylanFor profitMKTGJan 10, 1997
MylanFor profitNDA2Mar 21, 2001
Nephron Pharmaceuticals CorporationFor profitMKTGSep 27, 2001
PHARMOBEDIENTFor profitNDA2Jan 10, 1997
PharmasciencesFor profitMKTGJan 19, 2001
RitedoseFor profitMKTGJan 26, 2001
Roxane LaboratoriesFor profitMKTGJul 22, 2002
Rubicon ResearchFor profitMKTGNov 15, 2024
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.For profitMKTGOct 27, 2016
Sun PharmaceuticalsFor profitSYNJan 3, 2017
Sun PharmaceuticalsFor profitMKTGJan 3, 2017
TevaFor profitMKTGDec 31, 2007
TevaFor profitSYNFeb 7, 2000
TevaFor profitSYNApr 13, 2007
Watson PharmaceuticalsFor profitMKTGMay 9, 2005
West-Ward PharmaceuticalFor profitMKTGNov 5, 2003
ZennovaFor profitMKTGJan 19, 2001