Overview
Levodopa is a prodrug of dopamine that is administered to patients with Parkinson's due to its ability to cross the blood-brain barrier. Levodopa can be metabolised to dopamine on either side of the blood-brain barrier and so it is generally administered with a dopa decarboxylase inhibitor like carbidopa to prevent metabolism until after it has crossed the blood-brain barrier. Once past the blood-brain barrier, levodopa is metabolized to dopamine and supplements the low endogenous levels of dopamine to treat symptoms of Parkinson's. The first developed drug product that was approved by the FDA was a levodopa and carbidopa combined product called Sinemet that was approved on May 2, 1975.
Background
Levodopa is a prodrug of dopamine that is administered to patients with Parkinson's due to its ability to cross the blood-brain barrier. Levodopa can be metabolised to dopamine on either side of the blood-brain barrier and so it is generally administered with a dopa decarboxylase inhibitor like carbidopa to prevent metabolism until after it has crossed the blood-brain barrier. Once past the blood-brain barrier, levodopa is metabolized to dopamine and supplements the low endogenous levels of dopamine to treat symptoms of Parkinson's. The first developed drug product that was approved by the FDA was a levodopa and carbidopa combined product called Sinemet that was approved on May 2, 1975.
Indication
Levodopa on its own is formulated as an oral inhalation powder indicated for intermittent treatment of off episodes in Parkinson's patients who are already being treated with carbidopa and levodopa. Levodopa is most commonly formulated as an oral tablet with a peripheral dopa decarboxylase inhibitor indicated for treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism following carbon monoxide intoxication or manganese intoxication.
Associated Conditions
- Paralysis agitans
- Parkinson's Disease (PD)
- Parkinsonism
- Parkinsonism post encephalitic
- Restless Legs Syndrome (RLS)
- Advanced Motor fluctuations
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/15 | Not Applicable | Recruiting | |||
2024/02/23 | Not Applicable | Completed | University Hospital Bispebjerg and Frederiksberg | ||
2024/01/31 | Phase 4 | Recruiting | |||
2023/06/13 | Not Applicable | Completed | |||
2022/06/28 | Phase 1 | Completed | |||
2022/02/22 | Phase 1 | Completed | |||
2020/09/22 | Phase 2 | Recruiting | |||
2020/07/14 | Phase 2 | Recruiting | |||
2019/08/13 | Not Applicable | UNKNOWN | Western University, Canada | ||
2019/06/27 | Phase 2 | Suspended | Jessica M D'Amico |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 71610-579 | ORAL | 100 mg in 1 1 | 8/5/2021 | |
| Major Pharmaceuticals | 0904-7257 | ORAL | 100 mg in 1 1 | 5/17/2022 | |
| Rising Pharma Holdings, Inc. | 16571-691 | ORAL | 100 mg in 1 1 | 2/1/2022 | |
| Actavis Pharma, Inc. | 0228-2540 | ORAL | 250 mg in 1 1 | 9/1/2020 | |
| Almatica Pharma LLC | 52427-842 | ORAL | 200 mg in 1 1 | 12/31/2019 | |
| Sun Pharmaceutical Industries, Inc. | 47335-001 | ORAL | 50 mg in 1 1 | 3/1/2019 | |
| Sun Pharmaceutical Industries, Inc. | 47335-005 | ORAL | 150 mg in 1 1 | 3/1/2019 | |
| Physicians Total Care, Inc. | 54868-2866 | ORAL | 100 mg in 1 1 | 2/2/2012 | |
| Sandoz Inc | 0781-5637 | ORAL | 100 mg in 1 1 | 2/1/2016 | |
| Almatica Pharma LLC | 52427-827 | ORAL | 125 mg in 1 1 | 12/31/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/11/2013 | ||
Authorised | 10/17/2003 | ||
Authorised | 8/23/2011 | ||
Authorised | 9/19/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Stalevo Film Coated Tablets 150/37.5/200 mg | SIN13141P | TABLET, FILM COATED | 150 mg | 8/29/2005 | |
| MADOPAR 250 TABLET 250 mg | SIN06119P | TABLET | 200 mg | 5/17/1991 | |
| MADOPAR HBS 125 CAPSULE | SIN05195P | CAPSULE | 100 mg | 1/17/1990 | |
| MADOPAR 125 CAPSULE 125 mg | SIN06121P | CAPSULE | 100mg | 5/17/1991 | |
| MADOPAR DISPERSIBLE TABLETS 125 mg | SIN11075P | TABLET | 100 mg | 8/17/1999 | |
| SINEMET CR 50/200 TABLET | SIN07202P | TABLET | 200 mg | 10/12/1992 | |
| TIDOMET FORTE TABLET | SIN12575P | TABLET | 250 mg | 7/31/2004 | |
| Stalevo Film Coated Tablets 100/25/200 mg | SIN13142P | TABLET, FILM COATED | 100 mg | 8/29/2005 | |
| Stalevo Film Coated Tablets 50/12.5/200 mg | SIN13143P | TABLET, FILM COATED | 50 mg | 8/29/2005 | |
| CREDANIL 25/100 TABLET | SIN10285P | TABLET | 100 mg | 10/14/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Levodopa Capsules | 国药准字H44023481 | 化学药品 | 胶囊剂 | 5/14/2024 | |
| Levodopa Capsules | 国药准字H45020056 | 化学药品 | 胶囊剂 | 8/20/2020 | |
| Levodopa Injection | 国药准字H31022793 | 化学药品 | 注射剂 | 3/9/2020 | |
| Levodopa Injection | 国药准字H45021481 | 化学药品 | 注射剂 | 9/27/2020 | |
| Levodopa Tablets | 国药准字H11021055 | 化学药品 | 片剂 | 8/13/2020 | |
| Levodopa Tablets | 国药准字H32022244 | 化学药品 | 片剂 | 8/21/2020 | |
| Levodopa Tablets | 国药准字H44023063 | 化学药品 | 片剂 | 5/11/2021 | |
| Levodopa Tablets | 国药准字H44020067 | 化学药品 | 片剂 | 5/6/2020 | |
| Levodopa Tablets | 国药准字H53020598 | 化学药品 | 片剂 | 6/15/2020 | |
| Levodopa Tablets | 国药准字H20103627 | 化学药品 | 片剂 | 5/29/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MADOPAR HBS CAP "125" CONTROLLED RELEASE | N/A | N/A | N/A | 9/20/1988 | |
| MADOPAR DISP 125 TAB | N/A | N/A | N/A | 7/31/1998 | |
| MADOPAR '250' TAB | N/A | N/A | N/A | 5/25/1981 |