CLINICAL TRIALS PROFILE FOR NORTHERA

All Clinical Trials for NORTHERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00547911 ↗	Augmenting Effects of L-DOPS With Carbidopa and Entacapone	Terminated	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2	2007-10-01	An experimental drug called L-DOPS increases production in the body of a messenger chemical called norepinephrine. Cells in the brain that make norepinephrine are often gone in Parkinson disease. The exact consequences of this loss are unknown, but they may be related to symptoms such as fatigue, depression, or decreased attention that occur commonly in Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the effects are of increasing norepinephrine production in the brain and whether carbidopa and entacapone augment those effects. Volunteers for this study must be at least 18 years of age and able to give consent to participate in the study. To participate in the study, volunteers must discontinue use of alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or discontinue certain kinds of medications that might interfere with the results of the study. Candidates will be screened with a medical history and physical exam. Participants will be admitted to the National Institutes of Health Clinical Center for two weeks of testing. The study will have three testing phases in a randomly chosen order for each participant: - Single dose of L-DOPS - Single dose of L-DOPS in conjunction with carbidopa - Single dose of L-DOPS in conjunction with entacapone Each phase will last two days, with a washout day between each phase in which no drugs will be given and no testing will be performed. In each phase, participants will undergo a series of tests and measurements, including blood pressure and electrocardiogram tests. Participants who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture (also known as a spinal tap) to obtain spinal fluid for chemical tests.
NCT00633880 ↗	Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)	Completed	Chiltern International Inc.	Phase 3	2008-01-01	The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
NCT00633880 ↗	Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)	Completed	Chelsea Therapeutics	Phase 3	2008-01-01	The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
NCT01176240 ↗	A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease	Completed	Chelsea Therapeutics	Phase 3	2010-06-01	This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug. Symptoms of NOH may include any of the following: - Dizziness, light-headedness, feeling faint or feeling like you may blackout - Problems with vision (blurring, seeing spots, tunnel vision, etc.) - Weakness - Fatigue - Trouble concentrating - Head & neck discomfort (the coat hanger syndrome) - Difficulty standing for a short time or a long time - Trouble walking for a short time or a long time The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.
NCT01327066 ↗	Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose	Completed	Chelsea Therapeutics	Phase 1	2011-03-01	The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin in healthy male and female subjects.

Clinical Trial Conditions for NORTHERA

Condition Name

Condition Name for NORTHERA
Intervention	Trials
Parkinson Disease	7
Multiple System Atrophy	3
Parkinson's Disease	2
Orthostatic Hypotension	2

Condition MeSH

Condition MeSH for NORTHERA
Intervention	Trials
Parkinson Disease	10
Hypotension, Orthostatic	7
Hypotension	7
Multiple System Atrophy	3

Clinical Trial Locations for NORTHERA

Trials by Country

Trials by Country for NORTHERA
Location	Trials
United States	92
Canada	4
Australia	3
New Zealand	2

Trials by US State

Trials by US State for NORTHERA
Location	Trials
New York	5
Arizona	5
Texas	5
Tennessee	4
Ohio	4

Clinical Trial Progress for NORTHERA

Clinical Trial Phase

Clinical Trial Phase for NORTHERA
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for NORTHERA
Clinical Trial Phase	Trials
Recruiting	5
Completed	5
Unknown status	3

Clinical Trial Sponsors for NORTHERA

Sponsor Name

Sponsor Name for NORTHERA
Sponsor	Trials
Chelsea Therapeutics	4
H. Lundbeck A/S	4
St. Joseph's Hospital and Medical Center, Phoenix	2

Sponsor Type

Sponsor Type for NORTHERA
Sponsor	Trials
Other	16
Industry	12
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Northera (Droxidopa)

Last updated: October 28, 2025

Introduction

Northera (Droxidopa) is a prescription medication developed by Lundbeck and Arbor Pharmaceuticals, approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with diseases such as Parkinson's disease, multiple system atrophy, and pure autonomic failure. As a prodrug of norepinephrine, Droxidopa enhances sympathetic nervous system activity to alleviate dizziness, lightheadedness, and falls characteristic of nOH. The evolving clinical landscape, coupled with regulatory and market dynamics, necessitates comprehensive updates on Northera’s clinical development status, market performance, and future projections.

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Clinical Trials Update

Recent Clinical Efficacy and Safety Studies

Since its initial approval, Nejhera has remained under continuous clinical evaluation. Notably, in 2021, Arbor Pharmaceuticals announced ongoing post-marketing studies and real-world evidence collection to assess long-term safety and effectiveness. While no large-scale phase III trials are currently registered, several examine the optimal dosing strategies and combination therapies with other autonomic dysfunction treatments.

Key Clinical Trials and Findings

• Post-Approval Observational Studies: These studies focus on real-world effectiveness and tolerability across diverse patient populations, confirming the drug’s safety profile consistent with initial trials [1].

• Long-term Safety Monitoring: Data from post-marketing surveillance, consolidated annually, suggests that adverse events remain manageable, with orthostatic hypotension-related symptoms improving significantly in the majority of patients.

• Innovative Trial Initiatives: Recently, there is renewed interest in investigating Droxidopa’s potential benefits in other autonomic failure conditions, such as diabetic autonomic neuropathy, although these trials are at preliminary stages.

Regulatory and Market Expansion Trials

While no recent pivotal trials have significantly altered Northera's approved indications, ongoing investigations involve its off-label potential, especially for conditions sharing autonomic dysfunction features—a strategic focus for future expansion.

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Market Analysis

Market Size and Segmentation

The global market for autonomic failure treatments, primarily centered on nOH, has demonstrated steady growth. In 2022, the market was estimated at approximately USD 350 million, with projections reaching USD 500 million by 2028, driven by increasing aging populations and awareness of nOH.

Key segments include:

• Neurodegenerative disease patients: Parkinson’s disease accounts for roughly 60% of nOH cases, representing the primary diagnosed cohort using Northera.

• Clinical settings: Outpatient neurology clinics and specialty centers are primary distribution points.

Competitive Landscape

Despite Northera’s FDA approval, market presence faces competition from:

• Non-pharmacological interventions: Lifestyle adjustments and physical therapy.

• Other pharmacological agents:MDMA-like agents or off-label drugs such as pyridostigmine, which lack formal approval for nOH but are occasionally used off-label.

• Emerging therapies: New drugs targeting autonomic dysfunction are in experimental phases, potentially impacting Northera’s market share [2].

Market Penetration and Challenges

Though Northera holds a notable market position, challenges include:

• Limited indication breadth: Approved solely for nOH, restricting utilization scope.

• Side-effect profile: Risks of supine hypertension, headaches, and nausea require careful management, potentially limiting broader acceptance.

• Pricing and reimbursement constraints: Market access varies globally, with cost-effectiveness analyses influencing prescribing patterns.

Regional Market Dynamics

The U.S. remains the dominant market, accounting for over 70% of total sales. Emerging markets in Europe and Asia are gradually adopting Northera, attributable to increased autonomic disorder diagnoses and healthcare infrastructure improvements, though regulatory approvals vary.

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Market Projection

Short- and Long-term Outlook

Based on current trends and pipeline activity, Northera’s market is projected to grow at a CAGR of approximately 7% through 2028. This growth hinges on factors including:

• Enhanced awareness of nOH: Increased screening and diagnosis.

• Regulatory approvals in additional indications: Pending submissions for off-label conditions like diabetic autonomic neuropathy.

• Expanded clinical data: Demonstrating broader efficacy and safety.

Potential Market Drivers

• Aging demographics: As populations age, the prevalence of Parkinson’s disease and other neurodegenerative conditions will elevate the demand for Northera.

• Advances in diagnostics: Better detection of autonomic dysfunction enhances treatment opportunities.

• Strategic collaborations: Partnerships with healthcare providers and payers could improve market access and patient adherence.

Risks and Limitations

• Emergence of competing therapies: More effective or safer agents could steal market share.

• Regulatory hurdles: Approval delays in new indications or regions.

• Pricing pressures: Reimbursement cutbacks may restrict access.

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Conclusion

Northera remains a vital therapeutic option for neurogenic orthostatic hypotension, with ongoing clinical data reaffirming its efficacy and safety. Market growth prospects are positive, underpinned by demographic trends and increased disease awareness, despite competitive pressures and regulatory challenges. Strategic expansion into broader indications and regional markets, supported by compelling clinical evidence, will be crucial for sustaining and enhancing Northera's market position.

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Key Takeaways

• Clinical stability: Northera demonstrates a consistent safety and efficacy profile, supported by post-marketing data.

• Market growth potential: The autonomic failure treatment market is projected to expand markedly, driven by demographic and diagnostic advancements.

• Expansion opportunities: Off-label research and regulatory filings could broaden Northera’s approved indications, fueling future demand.

• Competitive landscape: Continuous monitoring of emerging therapies and market dynamics is vital for strategic positioning.

• Regulatory and reimbursement environment: Success depends on navigating approval processes and demonstrating value to payers.

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FAQs

1. What are the main indications for Northera?
Northera is approved for symptomatic neurogenic orthostatic hypotension in conditions like Parkinson’s disease, multiple system atrophy, and pure autonomic failure.

2. Are there ongoing clinical trials exploring Northera’s use in other conditions?
Yes, preliminary research is investigating its potential benefits in diabetic autonomic neuropathy and other autonomic dysregulation disorders, though these are at early stages.

3. What are common side effects associated with Northera?
Adverse events include headache, nausea, dizziness, and the risk of supine hypertension, requiring careful monitoring.

4. How does market growth for Northera compare to other autonomic disorder treatments?
While Northera’s growth is steady, overall market expansion is driven by increased disease prevalence and diagnosis rather than rapid innovation, with competition from off-label and emerging therapies.

5. What strategic moves could enhance Northera’s market share?
Expanding indications, improving clinician awareness, optimizing reimbursement strategies, and conducting key validation trials are critical pathways.

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Sources

1. Lundbeck. Northera (Droxidopa) Post-Marketing Experience Reports. 2021.
2. Market Research Future. Autonomic Dysfunction Treatment Market Analysis. 2022.