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Data updated: Mar 29, 2026

TRIHEXYPHENIDYL HYDROCHLORIDE

TRIHEXYPHENIDYL HYDROCHLORIDE
Neurology Approved 1974-11-26

Trihexyphenidyl hydrochloride is indicated as an adjunct for the treatment of all forms of parkinsonism, including postencephalitic, arteriosclerotic, and idiopathic types. It is frequently utilized as adjuvant therapy in patients being treated for these conditions with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

Source: FDA Label โ€ข NOVITIUM PHARMA

How TRIHEXYPHENIDYL HYDROCHLORIDE Works

Trihexyphenidyl is a synthetic tertiary amine anticholinergic agent. It exerts its effect by competitively inhibiting muscarinic acetylcholine receptors in the central nervous system and peripheral parasympathetic nervous system. In parkinsonism and drug-induced extrapyramidal symptoms, the drug works primarily by blocking cholinergic transmission in the striatum, thereby helping to restore the functional balance between dopaminergic and cholinergic neurotransmission. It also exhibits a direct inhibitory effect on smooth muscle.

10
Indications
--
Phase 3 Trials
51
Years on Market

Details

Status
Prescription
First Approved
1974-11-26
Routes
ORAL
Dosage Forms
TABLET, ELIXIR

TRIHEXYPHENIDYL HYDROCHLORIDE Approval History

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What TRIHEXYPHENIDYL HYDROCHLORIDE Treats

1 indications

TRIHEXYPHENIDYL HYDROCHLORIDE is approved for 1 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Parkinsonism
Source: FDA Label
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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TRIHEXYPHENIDYL HYDROCHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Trihexyphenidyl is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.