NDAORALCAPSULEPriority Review
Approved
Feb 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
Priority Review
NORTHERA (droxidopa) by Lundbeck is unknown. First approved in 2014.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NORTHERA (droxidopa) is a synthetic amino acid analog that is metabolized to norepinephrine, which increases blood pressure through peripheral vasoconstriction. It is indicated for treating neurogenic orthostatic hypotension (nOH) in patients with autonomic dysfunction. The drug works by directly elevating norepinephrine levels to counteract blood pressure drops upon standing.
$0.028BPart D
PeakNORTHERA is in peak commercial phase with established nOH market presence, suggesting stable team operations and focused optimization efforts rather than aggressive expansion.
Mechanism of Action
unknown. NORTHERA is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body. NORTHERA is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism
Started Dec 2021
0Parkinson DiseaseMultiple System AtrophyProgressive Supranuclear Palsy
Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease
Started Apr 2016
21 enrolled
Parkinson's Disease
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
Started Feb 2016
453 enrolled
Symptomatic Neurogenic Orthostatic Hypotension
Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)
Started Sep 2015
30 enrolled
Postural Tachycardia Syndrome (POTS)Vasovagal Syncope (VVS)Fainting
Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients
Started Jun 2012
25 enrolled
Orthostatic Hypotension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.