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benzatropine

Trade name: cogentin

Small moleculeapproved

Approved

Mar 5, 1954

Benztropine is an anticholinergic used in the symptomatic treatment of all etiologic groups of parkinsonism and drug-induced extrapyramidal reactions (except tardive dyskinesia). Benztropine possesses both anticholinergic and antihistaminic effects, although only the former has been established as therapeutically significant in the management of parkinsonism. Benztropine's anticholinergic activity is about equal to that of atropine. Benztropine also inhibits dopamine reuptake via the dopamine transporter at nerve terminals. Benztropine is a selective M1 muscarinic acetylcholine receptor antagonist. It is able to discriminate between the M1 (cortical or neuronal) and the peripheral muscarinic subtypes (cardiac and glandular). Benztropine partially blocks cholinergic activity in the CNS, which is responsible for the symptoms of Parkinson's disease. It is also thought to increase the availability of dopamine, a brain chemical that is critical in the initiation and smooth control of voluntary muscle movement. Used as an adjunct in the therapy of all forms of parkinsonism and also for use in the control of extrapyramidal disorders due to neuroleptic drugs. — NCATS

Clinical trial activity

7 trials · 11 clinical orgs · 23 marketing orgs

Phase 1
0
Phase 2
4
Phase 3
0
Phase 4
2

Earliest trial started Apr 1, 1999 (NCT00018200)

Timeline

1950s

  1. Mar 5, 1954

    Merck — Earliest FDA Approval

  2. Mar 5, 1954

    Merck — NDA Secondary Org

  3. Mar 5, 1954

    Merck — NDA Organization

  4. Dec 21, 1959

    Akorn, Inc. — NDA Secondary Org

  5. Dec 21, 1959

    Akorn, Inc. — Marketing Organization

1980s

  1. Apr 11, 1985

    Lannett Company, Inc. — Marketing Organization

  2. Aug 10, 1988

    Pliva — Marketing Organization

  3. Feb 27, 1989

    Epic Pharma Llc — Marketing Organization

1990s

  1. Jan 23, 1992

    Chartwell Pharmaceuticals — Marketing Organization

  2. Dec 12, 1996

    Upsher-Smith Laboratories — Marketing Organization

  3. Dec 12, 1996

    AiPing Pharm Inc — Marketing Organization

  4. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Aug 27, 2007

    Endo Pharmaceuticals — Marketing Organization

  2. Aug 27, 2007

    Vintage — Marketing Organization

  3. Aug 27, 2007

    PH HEALTH — Marketing Organization

  4. Feb 14, 2008

    Oxford Pharmaceuticals — Marketing Organization

  5. Jul 28, 2009

    Fresenius — Marketing Organization

  6. Aug 31, 2009

    Hikma — Marketing Organization

2010s

  1. Mar 29, 2010

    Invagen Pharms — Marketing Organization

  2. Mar 29, 2010

    Lutipold — Marketing Organization

  3. Mar 29, 2010

    Daiichi Sankyo — Marketing Organization

  4. Nov 28, 2012

    Leading Pharma Llc — Marketing Organization

  5. Feb 5, 2013

    Navinta — Marketing Organization

  6. Apr 14, 2015

    Nuvo Research Inc. — Marketing Organization

  7. Apr 14, 2015

    Aspen Pharmaceuticals — Marketing Organization

2020s

  1. Feb 11, 2025

    Quagen Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 5, 1954

Chemistry & pharmacology

Loading structure…

SMILES

CN1[C@@H]2CC[C@H]1C[C@@H](OC(c1ccccc1)c1ccccc1)C2
Mol. weight
307.44 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 3alpha-benzhydryloxy-8-methyl-8-azabicyclo[3.2.1]octane
  • 3alpha-benzhydryloxy-8-methyl-8-azabicyclo[3.2.1]octane
  • 3alpha-(diphenylmethoxy)-1alphah,5alphah-tropane
  • 3alpha-(diphenylmethoxy)-1alphah,5alphah-tropane
  • 3-alpha-(diphenylmethoxy)tropane
  • 3-alpha-(diphenylmethoxy)tropane
  • 3alpha-(diphenylmethoxy)tropane
  • 3alpha-(diphenylmethoxy)tropane
  • 3endo-benzhydryloxytropane
  • 3endo-benzhydryloxytropane
  • 3α-benzhydryloxy-8-methyl-8-azabicyclo[3.2.1]octane
  • 3α-benzhydryloxy-8-methyl-8-azabicyclo[3.2.1]octane
  • 3α-(diphenylmethoxy)-1αh,5αh-tropane
  • 3α-(diphenylmethoxy)-1αh,5αh-tropane
  • 3α-(diphenylmethoxy)tropane
  • 3α-(diphenylmethoxy)tropane
  • benzatropina
  • benzatropina
  • benzatropine
  • benzatropine
  • benzatropine
  • benzatropine
  • benzatropine
  • benzatropine
  • benzatropine mesilate
  • benzatropine mesilate
  • benzatropinum
  • benzatropinum
  • benzhydryl 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ether
  • benzhydryl 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ether
  • benztropine
  • benztropine
  • benztropine
  • benztropine
  • benztropine
  • benztropine
  • benztropine mesilate
  • benztropine mesilate
  • benztropine mesilate
  • benztropine mesylate
  • benztropine mesylate
  • benztropine mesylate
  • benztropine mesylate
  • benztropine mesylate
  • cogentin
  • cogentin
  • cogentin
  • cogentin
  • cogentin
  • cogentin
  • cogentin
  • cogentin
  • tropine benzohydryl ether
  • tropine benzohydryl ether
  • tropine benzohydryl ether

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT00964886Phase 2Jan 1, 2010Department of Veteran Affairs, University of California, San Diego
NCT00802100Phase 4Dec 1, 2008Duke University, National Institute of Mental Health (NIMH), University of North Carolina at Chapel Hill
NCT00715377N/AJun 1, 2007University of Toronto
NCT00457366Phase 4May 1, 2006AstraZeneca, University of Southern California
NCT00000333Phase 2May 1, 2001Department of Veteran Affairs, National Institute on Drug Abuse (NIDA)
NCT00000793Phase 2Nov 2, 1999Boehringer Ingelheim, National Institute of Allergy and Infectious Diseases (NIAID)
NCT00018200Phase 2Apr 1, 1999Department of Veteran Affairs
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Department of Veteran AffairsGovernment3211999
AstraZenecaFor profit1012006
Boehringer IngelheimFor profit1011999
Duke UniversityAcademic/Hospital1012008
National Institute of Allergy and Infectious Diseases (NIAID)Government1111999
National Institute of Mental Health (NIMH)Government1112008
National Institute on Drug Abuse (NIDA)Government1112001
University of California, San DiegoAcademic/Hospital1012010
University of North Carolina at Chapel HillAcademic/Hospital1012008
University of Southern CaliforniaAcademic/Hospital1112006
University of TorontoAcademic/Hospital1112007
11 organizations
Page 1 / 1

Marketing (28)

OrganizationOrg typeRelationshipDate
AiPing Pharm IncFor profitMKTGDec 12, 1996
Akorn, Inc.For profitNDA2Dec 21, 1959
Akorn, Inc.For profitMKTGDec 21, 1959
Aspen PharmaceuticalsFor profitMKTGApr 14, 2015
Chartwell PharmaceuticalsFor profitMKTGJan 23, 1992
Daiichi SankyoFor profitMKTGMar 29, 2010
Endo PharmaceuticalsFor profitMKTGAug 27, 2007
Epic Pharma LlcFor profitMKTGFeb 27, 1989
FreseniusFor profitMKTGJul 28, 2009
HikmaFor profitMKTGAug 31, 2009
HikmaFor profitSYNOct 14, 2021
Invagen PharmsFor profitMKTGMar 29, 2010
Lannett Company, Inc.For profitMKTGApr 11, 1985
Leading Pharma LlcFor profitMKTGNov 28, 2012
Leading Pharma LlcFor profitSYNNov 28, 2012
LutipoldFor profitMKTGMar 29, 2010
MerckFor profitNDA2Mar 5, 1954
MerckFor profitNDAMar 5, 1954
NavintaFor profitMKTGFeb 5, 2013
Nuvo Research Inc.For profitMKTGApr 14, 2015
Oxford PharmaceuticalsFor profitMKTGFeb 14, 2008
PH HEALTHFor profitMKTGAug 27, 2007
PlivaFor profitMKTGAug 10, 1988
Quagen PharmaFor profitMKTGFeb 11, 2025
Quantum PharmaceuticalFor profitMKTG—
Upsher-Smith LaboratoriesFor profitMKTGDec 12, 1996
Upsher-Smith LaboratoriesFor profitSYNDec 12, 1996
VintageFor profitMKTGAug 27, 2007