DROXIDOPA
DROXIDOPA is indicated for the treatment of Neurogenic Orthostatic Hypotension; Parkinson's Disease; Multiple System Atrophy; Dopamine Beta-Hydroxylase Deficiency.
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
- Discontinued
- 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) ].
DROXIDOPA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DROXIDOPA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04977388 results posted | 00001113 | Ph 1, Ph 2 | completed | NORTHERA (DROXIDOPA) for Dysautonomia in Adult Survivors of Menkes Disease and Occipital Horn Syndrome |
| NCT02897063 | 160255 | Ph 1 | recruiting | Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure |
| NCT01370512 | 10-008810 P01NS044233 | Ph 2 | enrolling by invitation | Droxidopa / Pyridostigmine in Orthostatic Hypotension |
| NCT01323374 FMS201 | Droxidopa FMS201 | Ph 2 | completed | Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia |
| NCT01132326 NOH304 results posted | Droxidopa NOH304 | Ph 3 | completed | Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) |
| NCT03229174 | Pro00013931 | Ph 4 | completed | Brain Perfusion & Oxygenation in Parkinson's Disease With NOH |
| NCT03446807 | 5170406 | Ph 2 | withdrawn | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism |
| NCT03115827 results posted | VUMC54580 | Ph 4 | completed | Norepinephrine-targeted Therapy for Action Control in Parkinson Disease |
| NCT03070730 results posted | 2011P000246 R01HL059459 | Ph 1, Ph 2 | terminated | Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist |
| NCT01927055 results posted | NOH401 | Ph 3 | terminated | A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy |
| NCT00977171 CFS201 results posted | Droxidopa CFS201 | Ph 2 | terminated | Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome |
| NCT01176240 306A/306B results posted | Droxidopa NOH306 (306A / 306B) | Ph 3 | completed | A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease |
| NCT00633880 NOH302 results posted | Droxidopa NOH302 | Ph 3 | completed | Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) |
| NCT00738062 NOH303 results posted | Droxidopa NOH303 | Ph 3 | completed | Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) |
| NCT00782340 NOH301 results posted | Droxidopa NOH301 | Ph 3 | completed | A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa |
| NCT01354158 | 01272 | Ph 1 | completed | A Dose Titration of Droxidopa in Patients With Spinal Cord Injury |
| NCT01331122 | Droxidopa FOG201 | Ph 1, Ph 2 | withdrawn | Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease |
| NCT01468259 | Droxidopa NOH103 | Ph 1 | withdrawn | A Multi-Center, Open-Label Study |
| NCT01149629 | Droxidopa NOH101 | Ph 1 | completed | Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa |
| NCT01612078 OH | TSHDX1101 | Ph 3 | terminated | Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients |
| NCT01327066 | Droxidopa QTc102 | Ph 1 | completed | Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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
Indications & Usage
DROXIDOPA is indicated for the treatment of Neurogenic Orthostatic Hypotension; Parkinson's Disease; Multiple System Atrophy; Dopamine Beta-Hydroxylase Deficiency.
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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NORTHERA
Full clinical data, patents, trials, and competitive landscape for droxidopa.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.