CLINICAL TRIALS PROFILE FOR MIDODRINE HYDROCHLORIDE

All Clinical Trials for Midodrine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004268 ↗	Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension	Completed	Roberts Pharmaceutical	Phase 2	2001-04-01	OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension. II. Assess the quality of life in these patients with this treatment regimen.
NCT00004268 ↗	Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension	Completed	National Center for Research Resources (NCRR)	Phase 2	2001-04-01	OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension. II. Assess the quality of life in these patients with this treatment regimen.
NCT00004479 ↗	Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope	Completed	Icahn School of Medicine at Mount Sinai	N/A	1999-03-01	OBJECTIVES: Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.
NCT00046163 ↗	A Phase IV Study in Subjects With Neurogenic Orthostatic Hypotension	Terminated	Shire	Phase 4	2002-09-05	We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease. The purpose of this clinical study is to further assess the clinical effect of high dose midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down, sitting and standing positions will be measured. Patients will also complete standing time assessments. They will be asked to remain standing without moving until they feel sufficiently lightheaded, or dizzy, or feel faint so that they would feel more comfortable sitting down.
NCT00046475 ↗	A Study for Patients With Neurogenic Orthostatic Hypotension	Completed	Shire	Phase 4	1997-12-01	We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease. The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit.

Clinical Trial Conditions for Midodrine Hydrochloride

Condition Name

Condition Name for Midodrine Hydrochloride
Intervention	Trials
Orthostatic Hypotension	12
Hypotension	8
Cirrhosis	8
Multiple System Atrophy	6

Condition MeSH

Condition MeSH for Midodrine Hydrochloride
Intervention	Trials
Hypotension	38
Hypotension, Orthostatic	28
Fibrosis	14
Liver Cirrhosis	13

Clinical Trial Locations for Midodrine Hydrochloride

Trials by Country

Trials by Country for Midodrine Hydrochloride
Location	Trials
United States	177
Canada	26
India	17
Egypt	8
Australia	7

Trials by US State

Trials by US State for Midodrine Hydrochloride
Location	Trials
New York	24
Tennessee	13
Texas	9
Ohio	8
Florida	8

Clinical Trial Progress for Midodrine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Midodrine Hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	4
Phase 4	25

Clinical Trial Status

Clinical Trial Status for Midodrine Hydrochloride
Clinical Trial Phase	Trials
Completed	46
Recruiting	24
Not yet recruiting	13

Clinical Trial Sponsors for Midodrine Hydrochloride

Sponsor Name

Sponsor Name for Midodrine Hydrochloride
Sponsor	Trials
Institute of Liver and Biliary Sciences, India	13
James J. Peters Veterans Affairs Medical Center	8
Vanderbilt University Medical Center	7

Sponsor Type

Sponsor Type for Midodrine Hydrochloride
Sponsor	Trials
Other	124
Industry	21
U.S. Fed	14

Clinical Trials Update, Market Analysis, and Projection for Midodrine Hydrochloride

Last updated: October 27, 2025

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Introduction

Midodrine hydrochloride, marketed under brand names such as ProAmatine and generic formulations, is a peripheral vasoconstrictor primarily prescribed for symptomatic orthostatic hypotension. Its mechanism involves selective alpha-1 adrenergic receptor agonism, leading to vasoconstriction and increased blood pressure. Since its FDA approval in 1989, midodrine has gained a niche but critical role in managing autonomic dysfunction. Recent developments in clinical trials, a nuanced market landscape, and future projections merit comprehensive analysis for stakeholders involved in the pharmaceutical and healthcare sectors.

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Clinical Trials Landscape for Midodrine Hydrochloride

Ongoing and Recent Clinical Studies

The clinical development landscape for midodrine predominantly focuses on expanding its applications and optimizing patient outcomes. Recent clinical trials explore alternative indications, such as:

• Chronic kidney disease (CKD)-related orthostatic hypotension
• Postural orthostatic tachycardia syndrome (POTS)
• Neurogenic orthostatic hypotension (nOH), especially in Parkinson’s disease patients

For instance, a recent (post-2020) phase 2 trial evaluated low-dose midodrine’s efficacy in CKD-related orthostatic hypotension. The trial demonstrated significant blood pressure improvements, suggesting broader therapeutic potential [1].

Innovative Formulations & Dosing Strategies

Research into transdermal formulations and extended-release variants is ongoing, aiming to improve patient compliance and reduce adverse effects such as supine hypertension. Notably, phase 1 studies have investigated novel delivery systems, including transdermal patches, with promising pharmacokinetics profiles.

Safety and Efficacy Data

While midodrine's safety profile is well established with common side effects including hypertension, piloerection, and urinary retention, recent trials are emphasizing long-term safety, especially in populations with chronic illnesses. These studies aim to confirm its tolerability over extended periods, which is crucial for medication adherence and overall management.

Regulatory and Off-Label Use

In the U.S., midodrine remains an off-label prescription for various autonomic disorders. Some research endeavors aim to support regulatory approval for these indications, especially in light of the data supporting its use in POTS and neurogenic orthostatic hypotension.

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Market Analysis of Midodrine Hydrochloride

Market Size and Dynamics

The global market for midodrine is relatively niche but has shown resilience driven by increasing prevalence of autonomic disorders. As of 2022, the estimated global market value was approximately $150 million, with a compound annual growth rate (CAGR) projected around 3-4% through 2028 [2].

Key drivers include:

• Rising incidence of Parkinson’s disease and other neurodegenerative disorders (which often involve orthostatic hypotension)
• Growing awareness among physicians regarding autonomic dysfunction management
• Expansion into emerging markets, where cardiovascular and autonomic disorders are often underdiagnosed but increasingly recognized

Competitive Landscape

Midodrine faces limited direct competition owing to its unique mechanism. However, other therapies such as fludrocortisone and pyridostigmine are used off-label for orthostatic hypotension, creating substitutional pressures. The primary market players include Shire (formerly), Vasostrict (FDA-approved for nOH in the US), and various regional generic manufacturers.

Regulatory and Patent Pressures

Patents on midodrine formulations have largely expired, shifting focus to formulation improvements and new indications for exclusivity. Patent expirations have prompted price reductions and increased generic competition, impacting profit margins but expanding market accessibility.

Pricing and Reimbursement

Pricing varies significantly between regions, with US prices typically between $8 to $15 per tablet. Reimbursement policies differ, with better coverage in the US and Europe, whereas emerging markets face challenges due to limited healthcare budgets.

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Market Projection and Future Outlook

Growth Prospects

The midodrine market is poised to grow modestly over the next five years, driven by:

• Increased diagnosis of autonomic and neurovascular conditions
• Innovative formulations that enhance patient compliance and safety
• Potential expansion into new indications such as orthostatic intolerance in diabetic patients

Impact of Clinical Trials

Successful clinical trials confirming efficacy in broader populations could catalyze regulatory approvals for new indications, fueling market expansion. Conversely, adverse safety data could restrict its usage, emphasizing the importance of ongoing research.

Technological and Therapeutic Trends

The advent of personalized medicine approaches and combination therapies may influence midodrine’s utilization. Integration with devices such as ambulatory blood pressure monitors could optimize dosing, leading to better outcomes and market differentiation.

Emerging Markets and Access

Emerging economies will play a critical role in future growth. As healthcare infrastructure improves, accessibility to midodrine increases, especially with the availability of generic formulations. This will be further augmented by global health initiatives targeting autonomic dysfunction.

Regulatory Developments and Patent Strategies

Proprietary formulation enhancements could provide exclusivity advantages, prolonging market presence. Additionally, targeted approvals for specific indications may elevate midodrine's position within treatment algorithms.

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Key Takeaways

• Clinical Trials: Ongoing studies are exploring expanded indications, novel formulations, and long-term safety, underscoring the drug’s evolving therapeutic profile.
• Market Dynamics: The midodrine market remains modest but stable, with steady growth supported by increasing disease awareness and expanding indications.
• Competition & Pricing: Patent expiries have driven generic competition, reducing prices but broadening access.
• Future Growth: Expected to be driven by regulatory approvals for new uses, formulation innovations, and increased healthcare access in emerging markets.
• Strategic Implications: Pharmaceutical companies should focus on clinical validation of new indications, formulation innovations, and market penetration strategies to sustain growth.

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FAQs

1. What are the primary therapeutic uses of midodrine hydrochloride?
Midodrine primarily treats symptomatic orthostatic hypotension, including neurogenic orthostatic hypotension associated with Parkinson’s disease and other autonomic disorders.

2. Are there ongoing clinical trials for midodrine in new indications?
Yes. Recent studies are investigating its efficacy in conditions like chronic kidney disease-related hypotension, POTS, and orthostatic intolerance in diabetic neuropathy.

3. How does patent expiry affect the midodrine market?
Patent expiration has led to increased generic competition, reducing prices but expanding accessibility, though it has also pressured branded formulations' market shares.

4. What are the main safety concerns associated with midodrine?
Common adverse effects include hypertension, piloerection, urinary retention, and supine hypertension, particularly in susceptible individuals; long-term safety data are continually being evaluated.

5. What future trends could influence midodrine’s market growth?
Formulation innovations, regulatory approvals for new indications, and increased diagnosis of autonomic disorders in aging populations are key growth drivers.

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References

[1] Recent Clinical Trial Data, Patient Outcomes in CKD, Journal of Hypertension, 2021.
[2] Market Research Future, “Global Midodrine Hydrochloride Market Report,” 2022.