trihexyphenidyl

Small moleculeapproved

Approved

May 13, 1949

Trihexyphenidyl (Artane, Apo-Trihex, Parkin, Pacitane), also known as benzhexol and trihex has been in clinical usage for decades.It is an anticholinergic used in the symptomatic treatment of all etiologic groups of parkinsonism and drug induced extrapyramidal reactions (except tardive dyskinesia). Trihexyphenidyl possesses both anticholinergic and antihistaminic effects, although only the former has been established as therapeutically significant in the management of parkinsonism. Trihexyphenidyl 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). Trihexyphenidyl 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. Trihexyphenidyl is indicated for the treatment of parkinson's disease and extrapyramidal reactions caused by drugs. — NCATS

Clinical trial activity

3 trials · 7 clinical orgs · 13 marketing orgs

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

Earliest trial started Jan 1, 2003 (NCT00122044)

Timeline

1940s

  1. May 13, 1949

    Lederle — Earliest FDA Approval

  2. May 13, 1949

    Lederle — NDA Organization

  3. May 13, 1949

    American Cyanamid — NDA Secondary Org

1970s

  1. Nov 26, 1974

    Watson Pharmaceuticals — Marketing Organization

1980s

  1. Jul 30, 1982

    Vanguard — Marketing Organization

  2. Apr 7, 1989

    Pharm Ventures, Ltd. — Marketing Organization

1990s

  1. Apr 17, 1997

    Pharmaceutical Associates — Marketing Organization

  2. Dec 24, 1998

    Novitium Pharma — Marketing Organization

  3. Sep 27, 1999

    Mikart — Marketing Organization

  4. Sep 27, 1999

    Chartwell Pharmaceuticals — Marketing Organization

2000s

  1. Feb 16, 2000

    Hikma — Marketing Organization

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Nov 17, 2010

    Natco Pharma — Marketing Organization

  2. Jan 1, 2018

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedMay 13, 1949

Chemistry & pharmacology

Loading structure…

SMILES

OC(CCN1CCCCC1)(c1ccccc1)C1CCCCC1
Mol. weight
301.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • agitane
  • apo-trihex
  • apo-trihex
  • artane
  • artane
  • artane
  • artane
  • bentex
  • benzhexol
  • benzhexol
  • benzhexol
  • benzhexol hcl
  • benzhexol hydrochloride
  • benzhexol hydrochloride
  • benzhexol hydrochloride
  • broflex
  • (rs)-1-cyclohexyl-1-phenyl-3-(1-piperidyl)propan-1-ol
  • (rs)-1-cyclohexyl-1-phenyl-3-(1-piperidyl)propan-1-ol
  • tremin
  • tremin
  • trihexifenidilo
  • trihexifenidilo
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphenidyl
  • trihexyphénidyle
  • trihexyphénidyle
  • trihexyphenidyl hcl
  • trihexyphenidyl hcl
  • trihexyphenidyl hcl
  • trihexyphenidyl hydrochloride
  • trihexyphenidyl hydrochloride
  • trihexyphenidyl hydrochloride
  • trihexyphenidyl hydrochloride
  • trihexyphenidyl hydrochloride
  • trihexyphenidylum
  • trihexyphenidylum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03430596Early Phase 1 (Phase 1)Feb 28, 2018Jiao Tong University
NCT04523935Phase 4Dec 7, 2005Sathbhavana Brain Clinic
NCT00122044Phase 2Jan 1, 2003Crowley Carter Foundation, Don and Linda Carter Foundation, Stanford University, United Cerebral Palsy Foundation, University of Southern California
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Crowley Carter FoundationAcademic/Hospital1012003
Don and Linda Carter FoundationAcademic/Hospital1012003
Jiao Tong UniversityAcademic/Hospital1112018
Sathbhavana Brain ClinicAcademic/Hospital1112005
Stanford UniversityAcademic/Hospital1012003
United Cerebral Palsy FoundationAcademic/Hospital1012003
University of Southern CaliforniaAcademic/Hospital1112003
7 organizations
Page 1 / 1

Marketing (14)

OrganizationOrg typeRelationshipDate
American CyanamidFor profitNDA2May 13, 1949
Chartwell PharmaceuticalsFor profitMKTGSep 27, 1999
HikmaFor profitMKTGFeb 16, 2000
HikmaFor profitSYNFeb 16, 2000
LederleFor profitNDAMay 13, 1949
MikartFor profitMKTGSep 27, 1999
NYLOSFor profitMKTG
Natco PharmaFor profitMKTGNov 17, 2010
Novitium PharmaFor profitMKTGDec 24, 1998
Pharm Ventures, Ltd.For profitMKTGApr 7, 1989
Pharmaceutical AssociatesFor profitMKTGApr 17, 1997
ScheringFor profitMKTG
VanguardFor profitMKTGJul 30, 1982
Watson PharmaceuticalsFor profitMKTGNov 26, 1974