CDEK
← All drugs Report issue

glycopyrronium

Trade name: robinul

Small moleculeapproved

Approved

Aug 11, 1961

Glycopyrrolate is a synthetic anticholinergic agent with a quaternary ammonium structure. Glycopyrrolate is a muscarinic competitive antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics. Glycopyrrolate binds competitively to the muscarinic acetylcholine receptor. Like other anticholinergic (antimuscarinic) agents, it inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily. Glycopyrrolate is marketed under the brand names Robinul, Robinul Forte, Cuvposa. In October 2015, glycopyrrolate was approved by the FDA for use as a standalone treatment for Chronic obstructive pulmonary disease (COPD), as Seebri Neohaler. — NCATS

Clinical trial activity

250 trials · 123 clinical orgs · 66 marketing orgs

Phase 1
37
Phase 2
130
Phase 3
95
Phase 4
60

Earliest trial started Oct 1, 2005 (NCT00242333)

Timeline

1960s

  1. Aug 11, 1961

    American Home Products — Earliest FDA Approval

  2. Aug 11, 1961

    American Home Products — NDA Organization

  3. Aug 11, 1961

    Casper Pharma LLC — NDA Secondary Org

1970s

  1. Feb 6, 1975

    West-Ward Pharmaceutical — NDA Secondary Org

  2. Feb 6, 1975

    Hikma — NDA Secondary Org

  3. Dec 17, 1975

    AH Robins — NDA Secondary Org

1980s

  1. Aug 25, 1981

    Watson Pharmaceuticals — Marketing Organization

  2. Jul 23, 1986

    Lutipold — Marketing Organization

  3. Jul 23, 1986

    Sankyo — Marketing Organization

  4. Jun 15, 1988

    Hospira — Marketing Organization

1990s

  1. Sep 10, 1991

    Teva — Marketing Organization

2000s

  1. Dec 22, 2004

    Renata — Marketing Organization

  2. Dec 22, 2004

    Chartwell Pharmaceuticals — Marketing Organization

  3. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  4. Aug 31, 2006

    Par Pharmaceuticals — Marketing Organization

  5. Jan 1, 2007

    Novartis — Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

  7. Mar 21, 2008

    Dr. Reddy's Laboratories — Marketing Organization

  8. Dec 29, 2008

    Rising Pharmaceuticals — Marketing Organization

  9. Dec 29, 2008

    ANDA Repository — Marketing Organization

  10. Aug 18, 2009

    Sun Pharmaceuticals — Marketing Organization

2010s

  1. Jul 28, 2010

    Merz — NDA Secondary Org

  2. Sep 21, 2011

    Hikma — Marketing Organization

  3. Oct 19, 2011

    Oxford Pharmaceuticals — Marketing Organization

  4. Mar 12, 2012

    LGM Pharma — Marketing Organization

  5. Mar 12, 2012

    Nexgen Pharma, Inc — Marketing Organization

  6. Sep 21, 2012

    Leading Pharma Llc — Marketing Organization

  7. Feb 3, 2014

    Boscogen — Marketing Organization

  8. Feb 3, 2014

    Kenton — Marketing Organization

  9. Oct 29, 2015

    Sunovion — NDA Secondary Org

  10. Oct 29, 2015

    Novartis — NDA Secondary Org

  11. Apr 25, 2016

    AstraZeneca — Marketing Organization

  12. Jun 20, 2016

    Natco Pharma — Marketing Organization

  13. Jan 3, 2017

    Heritage Pharma — Marketing Organization

  14. Jan 3, 2017

    Emcure — Marketing Organization

  15. Jun 15, 2017

    Amneal Pharmaceuticals — Marketing Organization

  16. Jun 23, 2017

    Somerset Pharmaceuticals — Marketing Organization

  17. Jun 23, 2017

    Mylan — Marketing Organization

  18. Oct 27, 2017

    Fresenius — Marketing Organization

  19. Dec 5, 2017

    Sumitomo — Marketing Organization

  20. Dec 5, 2017

    Sumitomo Dainippon — NDA Secondary Org

  21. Jun 28, 2018

    Fortress Biotech — Marketing Organization

  22. Jun 28, 2018

    Dermira, Inc. — NDA Secondary Org

  23. Jun 28, 2018

    Fortress Biotech — NDA Secondary Org

  24. Jul 11, 2018

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  25. Jul 11, 2018

    Exela Pharma Sciences, LLC. — Marketing Organization

  26. Oct 25, 2018

    Piramal — Marketing Organization

  27. Oct 31, 2018

    Prinston Inc — Marketing Organization

  28. Nov 28, 2018

    Aurobindo Pharma — Marketing Organization

  29. Nov 28, 2018

    Eugia Pharma — Marketing Organization

  30. Nov 30, 2018

    Alembic — Marketing Organization

  31. Nov 30, 2018

    Orit Labs Llc — Marketing Organization

  32. Mar 20, 2019

    Caplin Point Laboratories — Marketing Organization

  33. May 14, 2019

    Sandoz — Marketing Organization

  34. May 14, 2019

    Novartis — Marketing Organization

  35. Sep 30, 2019

    Gland Pharma Ltd — Marketing Organization

  36. Sep 30, 2019

    Fosun — Marketing Organization

  37. Oct 29, 2019

    Apotex — Marketing Organization

2020s

  1. Feb 21, 2020

    RiconPharma — Marketing Organization

  2. Feb 21, 2020

    Athenex, Inc. — Marketing Organization

  3. Jul 8, 2020

    Accord Research — Marketing Organization

  4. Jul 23, 2020

    AstraZeneca — NDA Secondary Org

  5. Nov 27, 2020

    Suven Life Sciences Limited — Marketing Organization

  6. Mar 4, 2021

    Exeltis — Marketing Organization

  7. Jul 6, 2021

    Meitheal — Marketing Organization

  8. Aug 9, 2021

    Bristol-Myers Squibb — Marketing Organization

  9. Oct 13, 2021

    Nivagen Pharmaceuticals Inc. — Marketing Organization

  10. Nov 9, 2021

    Zydus Discovery DMCC — Marketing Organization

  11. Dec 16, 2021

    Edenbridge Pharms — Marketing Organization

  12. Dec 16, 2021

    Edenbridge Pharms — NDA Secondary Org

  13. Apr 21, 2022

    Fresenius — NDA Secondary Org

  14. Jul 5, 2022

    Annora Pharma — Marketing Organization

  15. Nov 28, 2022

    Aspen Pharmaceuticals — Marketing Organization

  16. Feb 7, 2023

    Lupin — Marketing Organization

  17. Feb 23, 2023

    Slayback Pharma Llc — NDA Secondary Org

  18. Feb 27, 2023

    Mankind Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedAug 11, 1961

Chemistry & pharmacology

Loading structure…

SMILES

C[N+]1(C)CC[C@@H](C1)OC(=O)[C@@](O)(C2CCCC2)C3=CC=CC=C3
Mol. weight
318.4305 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • ad 237
  • ad 237
  • ahr-504
  • ahr-504
  • beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium
  • beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium bromide
  • copyrrolate
  • cuvposa
  • cuvposa
  • drm04
  • drm04
  • drm04
  • drm04b
  • gastrodyn
  • glycopyrrolate
  • glycopyrrolate
  • glycopyrrolate
  • glycopyrrolate
  • glycopyrrolate
  • glycopyrrolate
  • glycopyrrolate bromide
  • glycopyrrolate bromide
  • glycopyrrolate bromide
  • glycopyrrolate cation
  • glycopyrrolate cation
  • glycopyrrolate ion
  • glycopyrrolate ion
  • glycopyrrolate mixture with indacaterol
  • glycopyrrone bromide
  • glycopyrrone bromide
  • glycopyrronium
  • glycopyrronium
  • glycopyrronium
  • glycopyrronium
  • glycopyrronium
  • glycopyrronium
  • glycopyrronium bromide
  • glycopyrronium bromide
  • glycopyrronium bromide
  • glycopyrronium bromide
  • glycopyrronium bromide
  • glycopyrronium bromide
  • glycopyrronium bromide / indacaterol maleate
  • glycopyrronium cation
  • glycopyrronium cation
  • glycopyrronium ion
  • glycopyrronium ion
  • glycopyrronium tosylate
  • glycopyrronium tosylate
  • indacaterol / glycopyrronium bromide
  • nva237
  • qvm149
  • robanul
  • robinul
  • robinul
  • robinul
  • robinul forte
  • robinul forte
  • robinul fte
  • seebri breezhaler
  • sialanar
  • sialanar
  • sialanar
  • sialanar
  • sialanar
  • sialanar
  • sun-101

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06234345Phase 3Feb 28, 2026Eurofarma Laboratorios S.A.
NCT07073950Phase 4Nov 14, 2025AstraZeneca, Parexel
NCT07132983Phase 2Oct 6, 2025Verona Pharma plc
NCT07016412Phase 2Jul 31, 2025Verona Pharma plc
NCT06723756Phase 1Jan 23, 2025AstraZeneca, Parexel
NCT05776927Phase 3Dec 23, 2024Novartis
NCT06340581Phase 1Oct 17, 2024AstraZeneca, Parexel
NCT06545500Phase 2Aug 16, 2024Verona Pharma plc
NCT06398899N/AMay 1, 2024National Taiwan University
NCT06297668Phase 1Apr 29, 2024AstraZeneca, Parexel
NCT06376942Phase 2/Phase 3 (Phase 3)Apr 24, 2024Postgraduate Institute of Medical Education and Research
NCT06283966Phase 3Feb 21, 2024AstraZeneca
NCT06075095Phase 3Jan 15, 2024AstraZeneca
NCT06643078Phase 3Dec 11, 2023Haisco Pharmaceutical
NCT06228092Phase 4Dec 4, 2023University of Copenhagen
NCT05985343Phase 4Dec 1, 2023The Cleveland Clinic
NCT06035393Phase 2Oct 27, 2023Hengrui Therapeutics, Inc.
NCT06067828Phase 3Oct 24, 2023AstraZeneca
NCT06041984Phase 1/Phase 2 (Phase 2)Oct 8, 2023Chongqing Medical University
NCT06045364Phase 1/Phase 2 (Phase 2)Oct 1, 2023Chongqing Medical University
Showing 20 of 250 trials
Page 1 / 13

Organizations

Research & Development (123)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit666242005
ChiesiFor profit262442009
Pearl TherapeuticsFor profit212132009
AstraZenecaFor profit191652017
MerckFor profit12622011
University of ManchesterAcademic/Hospital9032009
Department of Veteran AffairsGovernment8832012
ParexelFor profit8032017
SunovionFor profit8842009
Dermira, Inc.For profit6622013
Chongqing Medical UniversityAcademic/Hospital4422022
Dr. August Wolff GmbH & Co. KG ArzneimittelFor profit4432016
Ajou UniversityAcademic/Hospital3312018
B.P. Koirala Institute of Health SciencesAcademic/Hospital3322014
The Cleveland ClinicAcademic/Hospital3312017
The University of Texas, DallasAcademic/Hospital3322010
University of GroningenAcademic/Hospital3222011
Verona Pharma plcFor profit3312024
Kangbuk Samsung HospitalAcademic/Hospital2212017
Klinikum Vest - Knappschaftskrankenhaus, RecklinghausenAcademic/Hospital2022018
123 organizations
Page 1 / 7

Marketing (88)

OrganizationOrg typeRelationshipDate
AH RobinsFor profitNDA2Dec 17, 1975
ANDA RepositoryFor profitMKTGDec 29, 2008
AbraxisFor profitMKTG—
Accord ResearchFor profitMKTGJul 8, 2020
AlembicFor profitMKTGNov 30, 2018
AlembicFor profitSYNNov 30, 2018
American Home ProductsFor profitNDAAug 11, 1961
Amneal PharmaceuticalsFor profitSYNJun 15, 2017
Amneal PharmaceuticalsFor profitMKTGJun 15, 2017
Annora PharmaFor profitMKTGJul 5, 2022
ApotexFor profitMKTGOct 29, 2019
Aspen PharmaceuticalsFor profitMKTGNov 28, 2022
AstraZenecaFor profitSYNApr 25, 2016
AstraZenecaFor profitMKTGApr 25, 2016
AstraZenecaFor profitNDA2Jul 23, 2020
Athenex, Inc.For profitMKTGFeb 21, 2020
Aurobindo PharmaFor profitMKTGNov 28, 2018
Aurobindo PharmaFor profitSYNApr 15, 2013
Aurobindo PharmaFor profitSYNApr 15, 2013
BoscogenFor profitMKTGFeb 3, 2014
Bristol-Myers SquibbFor profitMKTGAug 9, 2021
Caplin Point LaboratoriesFor profitMKTGMar 20, 2019
Casper Pharma LLCFor profitNDA2Aug 11, 1961
Chartwell PharmaceuticalsFor profitMKTGDec 22, 2004
Dermira, Inc.For profitNDA2Jun 28, 2018
Dr. Reddy's LaboratoriesFor profitMKTGMar 21, 2008
Edenbridge PharmsFor profitMKTGDec 16, 2021
Edenbridge PharmsFor profitNDA2Dec 16, 2021
EmcureFor profitMKTGJan 3, 2017
Eugia PharmaFor profitMKTGNov 28, 2018
Exela Pharma Sciences, LLC.For profitNDA2Jul 11, 2018
Exela Pharma Sciences, LLC.For profitMKTGJul 11, 2018
ExeltisFor profitMKTGMar 4, 2021
Fortress BiotechFor profitMKTGJun 28, 2018
Fortress BiotechFor profitNDA2Jun 28, 2018
FosunFor profitMKTGSep 30, 2019
FreseniusFor profitMKTGOct 27, 2017
FreseniusFor profitNDA2Apr 21, 2022
Gland Pharma LtdFor profitMKTGSep 30, 2019
Heritage PharmaFor profitMKTGJan 3, 2017
HikmaFor profitMKTGSep 21, 2011
HikmaFor profitSYNMar 5, 2009
HikmaFor profitSYNFeb 6, 1975
HikmaFor profitSYNFeb 6, 1975
HikmaFor profitNDA2Feb 6, 1975
HospiraFor profitMKTGJun 15, 1988
KentonFor profitMKTGFeb 3, 2014
LGM PharmaFor profitMKTGMar 12, 2012
Leading Pharma LlcFor profitMKTGSep 21, 2012
Leading Pharma LlcFor profitSYNSep 21, 2012
LupinFor profitMKTGFeb 7, 2023
LutipoldFor profitMKTGJul 23, 1986
Mankind PharmaFor profitMKTGFeb 27, 2023
MeithealFor profitMKTGJul 6, 2021
MerzFor profitNDA2Jul 28, 2010
MylanFor profitMKTGJun 23, 2017
Natco PharmaFor profitMKTGJun 20, 2016
Natco PharmaFor profitMKTGJun 20, 2016
Nexgen Pharma, IncFor profitMKTGMar 12, 2012
Nivagen Pharmaceuticals Inc.For profitMKTGOct 13, 2021
NovartisFor profitNDA2Oct 29, 2015
NovartisFor profitMKTGMay 14, 2019
Orit Labs LlcFor profitMKTGNov 30, 2018
Oxford PharmaceuticalsFor profitMKTGOct 19, 2011
Par PharmaceuticalsFor profitMKTGAug 31, 2006
Par PharmaceuticalsFor profitSYNAug 9, 2021
PiramalFor profitMKTGOct 25, 2018
Prinston IncFor profitMKTGOct 31, 2018
RenataFor profitMKTGDec 22, 2004
RiconPharmaFor profitMKTGFeb 21, 2020
Rising PharmaceuticalsFor profitSYNDec 29, 2008
Rising PharmaceuticalsFor profitMKTGDec 29, 2008
SandozFor profitMKTGMay 14, 2019
SandozFor profitSYNMay 14, 2019
SankyoFor profitMKTGJul 23, 1986
Slayback Pharma LlcFor profitNDA2Feb 23, 2023
Somerset PharmaceuticalsFor profitMKTGJun 23, 2017
SumitomoFor profitMKTGDec 5, 2017
Sumitomo DainipponFor profitNDA2Dec 5, 2017
Sun PharmaceuticalsFor profitMKTGAug 18, 2009
SunovionFor profitNDA2Oct 29, 2015
SunovionFor profitSYNDec 5, 2017
Suven Life Sciences LimitedFor profitSYNJul 5, 2022
Suven Life Sciences LimitedFor profitMKTGNov 27, 2020
TevaFor profitMKTGSep 10, 1991
Watson PharmaceuticalsFor profitMKTGAug 25, 1981
West-Ward PharmaceuticalFor profitNDA2Feb 6, 1975
Zydus Discovery DMCCFor profitMKTGNov 9, 2021