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atropine

Small moleculeapproved

Approved

Sep 15, 1960

Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses to injected (exogenous) choline esters. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically. Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors. — NCATS

Clinical trial activity

197 trials · 184 clinical orgs · 66 marketing orgs

Phase 1
27
Phase 2
61
Phase 3
42
Phase 4
52

Earliest trial started Dec 1, 1996 (NCT00748059)

Timeline

1960s

  1. Sep 15, 1960

    Pfizer — Earliest FDA Approval

  2. Sep 15, 1960

    G D Searle — Marketing Organization

  3. Sep 15, 1960

    Pfizer — NDA Secondary Org

  4. Sep 15, 1960

    Pfizer — NDA Organization

  5. Oct 19, 1961

    G D Searle — NDA Secondary Org

1970s

  1. May 15, 1973

    Meridien Medical Technologies, Inc. — NDA Secondary Org

  2. May 15, 1973

    MMT — NDA Secondary Org

  3. Apr 18, 1977

    MD Pharma — Marketing Organization

  4. Jun 3, 1977

    Sun Pharmaceuticals — Marketing Organization

  5. Jun 7, 1977

    Fosun — Marketing Organization

  6. Jul 5, 1977

    R&S Pharma — Marketing Organization

  7. Jan 27, 1978

    Lumara Health — Marketing Organization

  8. Feb 13, 1978

    Medpointe — Marketing Organization

  9. Feb 21, 1978

    Lannett Company, Inc. — Marketing Organization

  10. Mar 9, 1978

    Inwood Laboratories — Marketing Organization

  11. Jun 22, 1978

    Watson Pharmaceuticals — Marketing Organization

  12. Jul 14, 1978

    Sebela Pharmaceuticals — Marketing Organization

  13. Jul 14, 1978

    Sebela Pharmaceuticals — NDA Secondary Org

  14. Dec 22, 1978

    Mylan — Marketing Organization

  15. Oct 29, 1979

    Ani Pharmaceuticals — Marketing Organization

1980s

  1. Apr 6, 1981

    R.P. Scherer — Marketing Organization

  2. Jul 17, 1981

    Parke-Davis — Marketing Organization

  3. Jul 17, 1981

    Warner Lambert — Marketing Organization

  4. Mar 15, 1982

    Hikma — Marketing Organization

  5. May 3, 1982

    West-Ward Pharmaceutical — Marketing Organization

  6. Sep 9, 1982

    Lederle — Marketing Organization

  7. Sep 9, 1982

    American Cyanamid — Marketing Organization

  8. Mar 25, 1983

    Vanguard — Marketing Organization

  9. May 10, 1985

    Superpharm — Marketing Organization

  10. Jan 30, 1987

    AbbVie — Marketing Organization

1990s

  1. Sep 19, 1990

    United States Army — NDA Secondary Org

  2. Nov 6, 1991

    Mylan — NDA Secondary Org

  3. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

  4. Mar 5, 1997

    Bausch Health Companies — Marketing Organization

  5. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. May 2, 2000

    Strides Pharma Science — Marketing Organization

  2. May 2, 2000

    Par Pharmaceuticals — Marketing Organization

  3. Nov 27, 2000

    Able Laboratories — Marketing Organization

  4. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  5. Jul 9, 2001

    Hospira — NDA Secondary Org

  6. Sep 28, 2006

    Meridien Medical Technologies, Inc. — Marketing Organization

2010s

  1. Jul 18, 2014

    Akorn, Inc. — NDA Secondary Org

  2. Jul 18, 2014

    Rising Pharmaceuticals — Marketing Organization

  3. Dec 1, 2016

    Alcon — NDA Secondary Org

  4. Dec 1, 2016

    Nestle — NDA Secondary Org

  5. Jan 26, 2018

    Fresenius — NDA Secondary Org

  6. Jul 9, 2018

    Rafa Laboratories — NDA Secondary Org

  7. Aug 31, 2018

    Upsher-Smith Laboratories — Marketing Organization

  8. Nov 13, 2018

    Bayshore Pharms Llc — Marketing Organization

  9. Nov 13, 2018

    IPCA Laboratories Ltd. — Marketing Organization

2020s

  1. Feb 20, 2020

    Leading Pharma Llc — Marketing Organization

  2. Jun 3, 2020

    Mayne Pharma — Marketing Organization

  3. Jun 3, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  4. Sep 29, 2020

    Accord Research — Marketing Organization

  5. Sep 29, 2020

    Accord Research — NDA Secondary Org

  6. Oct 6, 2020

    Specgx Llc — Marketing Organization

  7. Oct 6, 2020

    International Medication — Marketing Organization

  8. Oct 6, 2020

    Mallinckrodt (2013) — Marketing Organization

  9. Oct 21, 2020

    Pharma Life Sciences LLC — Marketing Organization

  10. Oct 21, 2020

    Eci Pharmaceuticals Llc — Marketing Organization

  11. Oct 21, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  12. Jan 27, 2021

    Winder Labs Llc — Marketing Organization

  13. Nov 26, 2021

    Apotex — Marketing Organization

  14. Jan 26, 2022

    Amneal Pharmaceuticals — Marketing Organization

  15. Mar 15, 2022

    Bausch & Lomb — Marketing Organization

  16. Mar 15, 2022

    Bausch Health Companies — NDA Secondary Org

  17. May 26, 2022

    Sankyo — Marketing Organization

  18. May 26, 2022

    Daiichi Sankyo — Marketing Organization

  19. Nov 4, 2022

    Medefil — Marketing Organization

  20. Jan 8, 2024

    Mankind Pharma — Marketing Organization

  21. Apr 29, 2024

    Somerset Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • atnaa

    with pralidoxime

    Also known as duodote

  • atropine and demerol

    with meperidine

    Also known as meperidine and atropine sulfate

  • enlon-plus

    with tension

  • lomotil

    with diphenoxylate

    Also known as colonai, di-atro, logen, lonox, lo-trol

  • motofen

    with difenoxin

    Also known as motofen half-strength

Approval history

  • approvedPriority reviewSep 15, 1960

Chemistry & pharmacology

Loading structure…

SMILES

CN1[C@@H]2CC[C@H]1C[C@@H](OC(=O)C(CO)c1ccccc1)C2
Mol. weight
289.38 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

  • [(1s,5r)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl] 3-hydroxy-2-phenyl-propanoate
  • [(1s,5r)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl] 3-hydroxy-2-phenyl-propanoate
  • (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
  • (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
  • 8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
  • 8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
  • 8-methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
  • 8-methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
  • anaspaz
  • anaspaz
  • atroject
  • atropen
  • atropen
  • atropen
  • atrophate
  • atropin
  • atropin
  • atropin
  • atropina
  • atropina
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • atropine
  • (+-)-atropine
  • (+-)-atropine
  • (+/-)-atropine
  • (±)-atropine
  • (±)-atropine
  • (−)-atropine
  • (−)-atropine
  • atropine sulfate
  • atropine sulfate
  • atropine sulfate
  • atropine sulfate
  • atropine sulfate
  • atropine sulfate ansyr plastic syringe
  • atropine sulfate ansyr plastic syringe
  • atropine sulfate monohydrate
  • atropine sulphate
  • atropine sulphate
  • atropinum
  • atropinum
  • atropinum sulphuricum
  • dl-hyoscyamine
  • dl-hyoscyamine
  • dl-hyoscyamine
  • dl-tropyltropate
  • dl-tropyltropate
  • (+-)-hyoscyamine
  • (+-)-hyoscyamine
  • (±)-hyoscyamine
  • (±)-hyoscyamine
  • isopto atropine
  • isopto atropine
  • l-tropine tropate
  • l-tropine tropate
  • mydriasine
  • mydriasine
  • (r)-atropine
  • (+,-)-tropyl tropate
  • (+,-)-tropyl tropate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07271875Phase 3Jan 1, 2026Xijing Hospital
NCT07095894Phase 3Jan 1, 2026Jaeb Center for Health Research, Vanderbilt University
NCT07253428N/AOct 30, 2025Ain Shams University
NCT07164092Phase 2/Phase 3 (Phase 3)Sep 30, 2025Mansoura University
NCT07268586Phase 4Aug 1, 2025Ain Shams University
NCT07028827Phase 3Jul 1, 2025Consorzio per Valutazioni Biologiche e Farmacologiche, Ocus Innovation Ireland Limited
NCT07176949N/AJun 1, 2025Shanghai Eye Disease Prevention and Treatment Center
NCT06922097N/AApr 7, 2025University of Hamburg
NCT06765603Phase 2Feb 1, 2025Singapore National Eye Centre
NCT06389110Phase 3Dec 30, 2024Laboratorios Sophia S.A de C.V.
NCT06667037N/ANov 30, 2024Tianjin Medical University
NCT06794450Phase 1/Phase 2 (Phase 2)Nov 5, 2024Padjadjaran University
NCT06265454Phase 2Sep 1, 2024Ain Shams University
NCT06579287Phase 2Aug 31, 2024Sunhawk Vision Biotech, Inc.
NCT06200194Phase 2Aug 1, 2024National Yang Ming Chiao Tung University Hospital
NCT06450132Phase 4Aug 1, 2024Ohio State University
NCT06493838Phase 4Jul 15, 2024Minia University
NCT06358755Phase 2Jul 1, 2024The Hong Kong Polytechnic University, The University of Hong Kong
NCT06708156Phase 3Jun 15, 2024Capital Medical University, Government of China, Seefunge Pharmaceutical Technology Co., Ltd.
NCT06366087Phase 1Apr 15, 2024Allucent, Department of Health and Human Services, Rho, Inc.
Showing 20 of 197 trials
Page 1 / 10

Organizations

Research & Development (184)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jaeb Center for Health ResearchAcademic/Hospital9921999
National Eye Institute (NEI)Government9121999
Shanghai Eye Disease Prevention and Treatment CenterAcademic/Hospital9922019
Jiao Tong UniversityAcademic/Hospital7232014
MerckFor profit7522008
Assiut UniversityAcademic/Hospital6632016
Ain Shams UniversityAcademic/Hospital5542021
Capital Medical UniversityAcademic/Hospital5132022
Ohio State UniversityAcademic/Hospital5542016
The Hong Kong Polytechnic UniversityAcademic/Hospital5522016
The University of Hong KongAcademic/Hospital5022016
Magna Pharmaceuticals, Inc.For profit4432009
Seoul National UniversityAcademic/Hospital4432008
Vanderbilt UniversityAcademic/Hospital4331996
Johns Hopkins UniversityAcademic/Hospital3021999
Laboratorios Sophia S.A de C.V.For profit3322022
Mansoura UniversityAcademic/Hospital3332016
Mayo ClinicAcademic/Hospital3232002
Singapore National Eye CentreAcademic/Hospital3322006
State University of New YorkAcademic/Hospital3222017
184 organizations
Page 1 / 10

Marketing (81)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJan 30, 1987
Able LaboratoriesFor profitMKTGNov 27, 2000
Accord ResearchFor profitMKTGSep 29, 2020
Accord ResearchFor profitNDA2Sep 29, 2020
Akorn, Inc.For profitNDA2Jul 18, 2014
AlconFor profitNDA2Dec 1, 2016
AlpharmaFor profitMKTG—
American CyanamidFor profitMKTGSep 9, 1982
American Home ProductsFor profitMKTG—
Amneal PharmaceuticalsFor profitMKTGJan 26, 2022
Ani PharmaceuticalsFor profitMKTGOct 29, 1979
Ani PharmaceuticalsFor profitMKTGOct 29, 1979
ApotexFor profitMKTGNov 26, 2021
ApotexFor profitSYNNov 26, 2021
Ascot PharmaceuticalsFor profitMKTG—
Bausch & LombFor profitMKTGMar 15, 2022
Bausch Health CompaniesFor profitMKTGMar 5, 1997
Bausch Health CompaniesFor profitNDA2Mar 15, 2022
Bayshore Pharms LlcFor profitMKTGNov 13, 2018
Chartwell PharmaceuticalsFor profitMKTGOct 21, 2020
Daiichi SankyoFor profitMKTGMay 26, 2022
Dr. Reddy's LaboratoriesFor profitMKTGJun 3, 2020
Eci Pharmaceuticals LlcFor profitMKTGOct 21, 2020
FosunFor profitMKTGJun 7, 1977
FreseniusFor profitNDA2Jan 26, 2018
G D SearleFor profitMKTGSep 15, 1960
G D SearleFor profitNDA2Oct 19, 1961
HalseyFor profitMKTG—
Heather PharmaFor profitMKTG—
HikmaFor profitSYNMay 3, 1982
HikmaFor profitMKTGMar 15, 1982
HospiraFor profitNDA2Jul 9, 2001
IPCA Laboratories Ltd.For profitMKTGNov 13, 2018
International MedicationFor profitMKTGOct 6, 2020
Inwood LaboratoriesFor profitMKTGMar 9, 1978
Lannett Company, Inc.For profitMKTGFeb 21, 1978
Leading Pharma LlcFor profitMKTGFeb 20, 2020
Leading Pharma LlcFor profitSYNFeb 20, 2020
LederleFor profitMKTGSep 9, 1982
Lumara HealthFor profitMKTGJan 27, 1978
MD PharmaFor profitMKTGApr 18, 1977
MMTFor profitNDA2May 15, 1973
Mallinckrodt (2013)For profitMKTGOct 6, 2020
Mankind PharmaFor profitMKTGJan 8, 2024
Mayne PharmaFor profitMKTGJun 3, 2020
MedefilFor profitMKTGNov 4, 2022
MedpointeFor profitMKTGFeb 13, 1978
Meridien Medical Technologies, Inc.For profitNDA2May 15, 1973
Meridien Medical Technologies, Inc.For profitMKTGSep 28, 2006
MylanFor profitSYNNov 17, 1977
MylanFor profitSYNNov 6, 1991
MylanFor profitMKTGDec 22, 1978
MylanFor profitNDA2Nov 6, 1991
NestleFor profitNDA2Dec 1, 2016
Par PharmaceuticalsFor profitMKTGMay 2, 2000
Parke-DavisFor profitMKTGJul 17, 1981
PfizerFor profitNDA2Sep 15, 1960
PfizerFor profitNDASep 15, 1960
Pharma Life Sciences LLCFor profitMKTGOct 21, 2020
R&S PharmaFor profitMKTGJul 5, 1977
R.P. SchererFor profitMKTGApr 6, 1981
Rafa LaboratoriesFor profitNDA2Jul 9, 2018
Rising PharmaceuticalsFor profitMKTGJul 18, 2014
Roxane LaboratoriesFor profitMKTG—
SankyoFor profitMKTGMay 26, 2022
Sebela PharmaceuticalsFor profitMKTGJul 14, 1978
Sebela PharmaceuticalsFor profitNDA2Jul 14, 1978
Somerset PharmaceuticalsFor profitMKTGApr 29, 2024
Somerset PharmaceuticalsFor profitSYNJul 1, 2024
Specgx LlcFor profitMKTGOct 6, 2020
Strides Pharma ScienceFor profitMKTGMay 2, 2000
Sun PharmaceuticalsFor profitMKTGJun 3, 1977
SuperpharmFor profitMKTGMay 10, 1985
United States ArmyGovernmentNDA2Sep 19, 1990
Upsher-Smith LaboratoriesFor profitMKTGAug 31, 2018
Upsher-Smith LaboratoriesFor profitSYNMar 29, 1982
VanguardFor profitMKTGMar 25, 1983
Warner LambertFor profitMKTGJul 17, 1981
Watson PharmaceuticalsFor profitMKTGJun 22, 1978
West-Ward PharmaceuticalFor profitMKTGMay 3, 1982
Winder Labs LlcFor profitMKTGJan 27, 2021