Overview
Droxidopa is a precursor of noradrenaline that is used in the treatment of Parkinsonism. It is approved for use in Japan and is currently in trials in the U.S. The racaemic form (dl-threo-3,4-dihydroxyphenylserine) has also been used, and has been investigated in the treatment of orthostatic hypotension. There is a deficit of noradrenaline as well as of dopamine in Parkinson's disease and it has been proposed that this underlies the sudden transient freezing seen usually in advanced disease. Though L-DOPS has been used in Japan and Southeast Asia already for some time, it is also currently in clinical trials at the phase III point in the United States (U.S.), Canada, Australia, and throughout Europe. Provided L-DOPS successfully completes clinical trials, it could be approved for the treatment of neurogenic orthostatic hypotension (NOH) as early as 2011. Additionally, phase II clinical trials for intradialytic hypotension are also underway. Chelsea Therapeutics obtained orphan drug status (ODS) for L-DOPS in the U.S. for NOH, and that of which associated with Parkinson's disease , pure autonomic failure, and multiple system atrophy, and is the pharmaceutical company developing it in that country.
Indication
For treatment of neurogenic orthostatic hypotension (NOH) associated with various disorders including Multiple System Atrophy, Familial Amyloid Polyneuropathy, hemodialysis induced hypotension and Parkinson's Disease. Also investigated for use/treatment in neurologic disorders, nephropathy, blood (blood forming organ disorders, unspecified), and dizzy/fainting spells.
Associated Conditions
- Symptomatic Neurogenic Orthostatic Hypotension (NOH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/22 | Phase 2 | Recruiting | Giuseppe Cullaro, MD | ||
2021/07/26 | Phase 1 | Completed | Stephen G. Kaler, MD | ||
2020/08/12 | Phase 4 | Completed | Alberto Espay, MD, MSc | ||
2018/07/26 | Phase 4 | Completed | James J. Peters Veterans Affairs Medical Center | ||
2018/06/25 | Phase 2 | UNKNOWN | St. Joseph's Hospital and Medical Center, Phoenix | ||
2018/02/27 | Phase 2 | Withdrawn | |||
2017/07/25 | Phase 4 | Completed | William Ondo, MD | ||
2017/06/02 | Not Applicable | Completed | Colorado Springs Neurological Associates | ||
2017/04/14 | Phase 4 | Completed | |||
2017/03/06 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ajanta Pharma USA Inc. | 27241-199 | ORAL | 100 mg in 1 1 | 11/23/2021 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1389 | ORAL | 100 mg in 1 1 | 9/18/2023 | |
| Golden State Medical Supply, Inc. | 51407-765 | ORAL | 100 mg in 1 1 | 6/13/2023 | |
| ScieGen Pharmaceuticals Inc | 50228-431 | ORAL | 300 mg in 1 1 | 2/19/2021 | |
| Slate Run Pharmaceuticals, LLC | 70436-142 | ORAL | 300 mg in 1 1 | 3/28/2023 | |
| Slate Run Pharmaceuticals, LLC | 70436-141 | ORAL | 200 mg in 1 1 | 3/28/2023 | |
| Upsher-Smith Laboratories, LLC | 0832-0721 | ORAL | 200 mg in 1 1 | 11/7/2019 | |
| MSN LABORATORIES PRIVATE LIMITED | 69539-146 | ORAL | 100 mg in 1 1 | 1/23/2019 | |
| Novadoz Pharmaceuticals LLC | 72205-073 | ORAL | 200 mg in 1 1 | 11/20/2020 | |
| Sun Pharmaceutical Industries, Inc. | 63304-112 | ORAL | 300 ug in 1 1 | 2/18/2021 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
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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