Overview
Tolcapone is a drug that inhibits the enzyme catechol-O-methyl transferase (COMT). It is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa medication. It is a yellow, odorless, non-hygroscopic, crystalline compound. Tolcapone is associated with a risk of hepatotoxicity.
Indication
Used as an adjunct to levodopa/carbidopa therapy for the symptomatic treatment of Parkinson's Disease. This drug is generally reserved for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies.
Associated Conditions
- Idiopathic Parkinson's Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/29 | Phase 2 | Recruiting | Clinica Universidad de Navarra, Universidad de Navarra | ||
2022/11/22 | Phase 2 | Recruiting | |||
2021/10/04 | Phase 1 | Recruiting | |||
2019/12/20 | Early Phase 1 | Completed | |||
2019/04/05 | Phase 2 | Recruiting | |||
2018/08/16 | Phase 1 | Completed | |||
2018/07/19 | Early Phase 1 | Completed | |||
2017/11/21 | Phase 2 | Completed | |||
2017/09/06 | Phase 2 | UNKNOWN | Sheppard Pratt Health System | ||
2016/10/31 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch Health US LLC | 0187-0938 | ORAL | 100 mg in 1 1 | 10/2/2020 | |
| Ingenus Pharmaceuticals, LLC | 50742-193 | ORAL | 100 mg in 1 1 | 11/28/2018 | |
| Oceanside Pharmaceuticals | 68682-938 | ORAL | 100 mg in 1 1 | 10/1/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/27/1997 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tolcapone Tablets | 国药准字H20050206 | 化学药品 | 片剂 | 3/18/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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