Overview
Trihexyphenidyl is a centrally acting muscarinic antagonist used for treatment of parkinsonism and drug-induced extrapyramidal disorders. Its discovery was published in 1949 in a study looking for drugs with antispasmodic activity. Trihexyphenidyl is rarely used in the treatment of parkinsonism, and is not a first line treatment due to significant adverse effects. It has largely been replaced by drugs such as levodopa. Trihexyphenidyl was granted FDA approval on 13 May 1949.
Indication
Tihexyphenidyl is indicated as an adjunct in the treatment of parkinsonism, an adjuvant in the treatment of parkinsonism with levodopa, and in the control of extrapyramidal disorders caused by central nervous system drugs.
Associated Conditions
- Extrapyramidal disorder
- Extrapyramidal symptoms caused by butyrophenones
- Extrapyramidal symptoms caused by dibenzoxazepines
- Extrapyramidal symptoms caused by phenothiazines
- Extrapyramidal symptoms caused by thioxanthenes
- Idiopathic Parkinson's Disease
- Parkinsonism post encephalitic
- Arteriosclerotic Parkinsonism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/15 | Phase 1 | Recruiting | Children's Mercy Hospital Kansas City | ||
2018/02/13 | Early Phase 1 | Completed | |||
2005/07/21 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| TYA Pharmaceuticals | 64725-0161 | ORAL | 5 mg in 1 1 | 5/3/2011 | |
| State of Florida DOH Central Pharmacy | 53808-0634 | ORAL | 5 mg in 1 1 | 10/1/2013 | |
| REMEDYREPACK INC. | 70518-2409 | ORAL | 5 mg in 1 1 | 2/28/2024 | |
| A-S Medication Solutions | 50090-5205 | ORAL | 5 mg in 1 1 | 1/28/2019 | |
| State of Florida DOH Central Pharmacy | 53808-0633 | ORAL | 2 mg in 1 1 | 10/1/2013 | |
| Akorn | 61748-054 | ORAL | 2 mg in 5 mL | 6/21/2022 | |
| Richmond Pharmaceuticals, Inc. | 54738-555 | ORAL | 5 mg in 1 1 | 8/19/2016 | |
| Natco Pharma Limited | 63850-0021 | ORAL | 2 mg in 1 1 | 10/29/2019 | |
| PAI Holdings, LLC | 0121-0658 | ORAL | 2 mg in 5 mL | 3/2/2023 | |
| Richmond Pharmaceuticals, Inc. | 54738-554 | ORAL | 2 mg in 1 1 | 8/19/2016 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AA PHARMA TRIHEXYPHENIDYL TABLET 2 mg | SIN05827P | TABLET | 2 mg | 5/21/1991 | |
| BENZHEXOL TABLETS 2 mg | SIN06043P | TABLET | 2 mg | 5/8/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ARTANE 5mg trihexyphenidyl (benzhexol) hydrochloride 5mg tablet bottle | 15126 | Medicine | A | 9/9/1991 | |
| ARTANE 2mg trihexyphenidyl (benzhexol) hydrochloride 2mg tablet bottle | 15125 | Medicine | A | 9/9/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PMS-TRIHEXYPHENIDYL | 00726265 | Tablet - Oral | 2 MG | 12/31/1987 | |
| PMS-TRIHEXYPHENIDYL ELX 0.4MG/ML | 00885398 | Elixir - Oral | 0.4 MG / ML | 10/16/1996 | |
| NOVO-HEXIDYL 2MG | novopharm limited | 00021911 | Tablet - Oral | 2 MG | 12/31/1968 |
| ARTANE TAB 2MG | lederle cyanamid canada inc. | 00015040 | Tablet - Oral | 2 MG | 12/31/1951 |
| TRIHEXYPHEN TAB 2MG | PRO DOC LIMITEE | 00572802 | Tablet - Oral | 2 MG | 12/31/1982 |
| ARTANE TAB 5MG | lederle cyanamid canada inc. | 00015059 | Tablet - Oral | 5 MG | 12/31/1951 |
| APARKANE TAB 2MG | icn canada ltd. | 00280445 | Tablet - Oral | 2 MG | 12/31/1973 |
| ARTANE ELX 2MG/5ML | lederle cyanamid canada inc. | 00014656 | Elixir - Oral | 2 MG / 5 ML | 12/31/1967 |
| APARKANE TAB 5MG | icn canada ltd. | 00271314 | Tablet - Oral | 5 MG | 12/31/1973 |
| NU-TRIHEXYPHENIDYL | nu-pharm inc | 02239236 | Tablet - Oral | 5 MG / TAB | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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