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Droxidopa

Generic Name
Droxidopa
Brand Names
Northera
Drug Type
Small Molecule
Chemical Formula
C9H11NO5
CAS Number
23651-95-8
Unique Ingredient Identifier
J7A92W69L7

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.

Background

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

FDA Approved Products

Droxidopa
Manufacturer:Golden State Medical Supply, Inc.
Route:ORAL
Strength:300 mg in 1 1
Approved: 2023/06/13
NDC:51407-767
Droxidopa
Manufacturer:Golden State Medical Supply, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/06/13
NDC:51407-766
Droxidopa
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:100 mg in 1 1
Approved: 2021/08/17
NDC:31722-014
Northera
Manufacturer:Lundbeck Pharmaceuticals LLC
Route:ORAL
Strength:300 mg in 1 1
Approved: 2019/07/01
NDC:67386-822
Droxidopa
Manufacturer:MSN LABORATORIES PRIVATE LIMITED
Route:ORAL
Strength:300 mg in 1 1
Approved: 2019/01/23
NDC:69539-089

Singapore Approved Products

No Singapore products found for this drug

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