DROXIDOPA
Droxidopa is indicated for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in adult patients. It is used to manage symptoms such as orthostatic dizziness, lightheadedness, and the sensation of an impending blackout. The medication is specifically approved for patients with nOH caused by primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Because effectiveness beyond two weeks of treatment has not been established, the continued benefit of the drug must be assessed periodically.
How DROXIDOPA Works
Droxidopa is a synthetic amino acid analog that is metabolized directly into norepinephrine by the enzyme dopa-decarboxylase. This conversion occurs extensively throughout the body, resulting in small and transient rises in plasma norepinephrine levels. The resulting norepinephrine increases blood pressure by inducing vasoconstriction in the peripheral arteries and veins. The drug is believed to exert its therapeutic effects through these norepinephrine levels rather than through the parent molecule itself.
Details
- Status
- Prescription
- First Approved
- 2021-02-18
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
DROXIDOPA Approval History
What DROXIDOPA Treats
4 indicationsDROXIDOPA is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neurogenic Orthostatic Hypotension
- Parkinson's Disease
- Multiple System Atrophy
- Dopamine Beta-Hydroxylase Deficiency
DROXIDOPA Boxed Warning
SUPINE HYPERTENSION WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue droxidopa [see Warnings and Precautions (5.1) ]....
WARNING: SUPINE HYPERTENSION WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue droxidopa [see Warnings and Precautions (5.1) ].
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DROXIDOPA FDA Label Details
ProIndications & Usage
Droxidopa capsules indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically. Droxidopa capsules are indicated for the...
WARNING: SUPINE HYPERTENSION WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blo...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.