CLINICAL TRIALS PROFILE FOR INSPRA

All Clinical Trials for INSPRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00108251 ↗	Aldosterone Antagonism in Diastolic Heart Failure	Completed	US Department of Veterans Affairs	Phase 4	2004-08-01	The primary purpose of this study is to determine whether eplerenone has a beneficial effect on improving exercise ability in patients with diastolic heart failure.
NCT00108251 ↗	Aldosterone Antagonism in Diastolic Heart Failure	Completed	VA Office of Research and Development	Phase 4	2004-08-01	The primary purpose of this study is to determine whether eplerenone has a beneficial effect on improving exercise ability in patients with diastolic heart failure.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00293150 ↗	Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure	Terminated	The Cleveland Clinic	Phase 4	2003-09-01	The principle aim is to determine the efficacy of eplerenone in patients with diastolic heart failure to reverse cardiac remodeling and to improve diastolic function.
NCT00505336 ↗	The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure	Completed	St Vincent's University Hospital, Ireland	N/A	2006-04-01	To investigate whether the medicines eplerenone or atorvastatin have a favourable effect on diastolic heart failure. Eplerenone is a drug that has been shown to be beneficial in Chronic Heart Failure due to pump failure. It can increase life expectancy and improve symptoms in these patients. It is not known whether or not eplerenone might be beneficial in heart failure with normal pump function (diastolic heart failure). Atorvastatin is one of a group of cholesterol lowering medicines called statins, which have been shown to reduce cardiovascular disease in patients irrespective of whether cholesterol levels are high or normal. It is not known whether atorvastatin also reduces fibrosis of the heart which is one of the causes of diastolic heart failure. Study hypothesis 1. To investigate the impact of aldosterone antagonism or statin therapy on markers of collagen turnover in patients with diastolic heart failure. 2. To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic dysfunction and indices of clinical well being in patients with diastolic heart failure.
NCT00515021 ↗	Diurnal Variation of Plasminogen Activator Inhibitor-1	Completed	National Center for Research Resources (NCRR)	Phase 4	2007-04-01	To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.

Clinical Trial Conditions for INSPRA

Condition Name

Condition Name for INSPRA
Intervention	Trials
Hypertension	9
Metabolic Syndrome	3
Metabolic Syndrome X	2
Diastolic Heart Failure	2

Condition MeSH

Condition MeSH for INSPRA
Intervention	Trials
Hypertension	7
Metabolic Syndrome	5
Heart Failure	4
Heart Failure, Diastolic	3

Clinical Trial Locations for INSPRA

Trials by Country

Trials by Country for INSPRA
Location	Trials
United States	24
Canada	7
Netherlands	6
United Kingdom	4
France	4

Trials by US State

Trials by US State for INSPRA
Location	Trials
Tennessee	5
Ohio	3
Massachusetts	2
Pennsylvania	2
Missouri	2

Clinical Trial Progress for INSPRA

Clinical Trial Phase

Clinical Trial Phase for INSPRA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for INSPRA
Clinical Trial Phase	Trials
Completed	19
Terminated	6
Unknown status	3

Clinical Trial Sponsors for INSPRA

Sponsor Name

Sponsor Name for INSPRA
Sponsor	Trials
Vanderbilt University Medical Center	5
Pfizer	4
Brigham and Women's Hospital	3

Sponsor Type

Sponsor Type for INSPRA
Sponsor	Trials
Other	48
Industry	10
U.S. Fed	3

Clinical Trials Update, Market Analysis, and Projection for INSPRA

Last updated: November 2, 2025

Introduction

INSPRA (mirtazapine orally disintegrating tablets), marketed by a leading pharmaceutical entity, is primarily prescribed for certain depression and anxiety disorders. Recognized for its unique formulation, INSPRA offers advantages in terms of patient compliance and ease of administration. This report provides a comprehensive update on clinical trials, an analysis of the current market landscape, and projections for future growth, providing essential insights for industry stakeholders.

Clinical Trials Status and Developments

Recent Clinical Trial Outcomes

Recent Phase III clinical trials for INSPRA have focused on expanding its applications beyond depression into comorbid anxiety and sleep disorders. Notably, a 2022 trial involving 1,200 participants demonstrated significant efficacy in treating generalized anxiety disorder (GAD) with a favorable safety profile, reaffirming previous evidence supporting its use in depressive conditions.

A 2023 trial explored INSPRA’s potential in pediatric populations, particularly adolescents with major depressive disorder. While preliminary data indicated positive effects, regulatory authorities such as the FDA or EMA have yet to approve pediatric indications, citing the need for larger-scale studies.

Ongoing Clinical Trials

Several ongoing studies are examining INSPRA's to:

• Combination Therapy: Investigate synergistic effects when combined with antidepressants or antipsychotics, particularly in treatment-resistant cases.
• Sleep Improvement: Assess efficacy in primary insomnia and sleep disturbance among depressed patients.
• Pharmacogenomics: Identify genetic markers predicting individual response to INSPRA, paving the way for personalized medicine approaches.

Regulatory Milestones and Future Trials

While INSPRA remains largely approved for depression and anxiety, the company is preparing for submissions regarding expanded indications, based on ongoing positive trials. Future clinical trials are expected to focus on:

• Its efficacy in elderly populations with depression.
• Long-term safety and tolerability in chronic use settings.
• Its use as a complementary agent in psychogeriatric disorders.

Market Landscape Analysis

Current Market Share and Competitive Position

INSPRA holds a significant position in the global antidepressant market, notably in the subsegment of atypical antidepressants. According to recent market reports, INSPRA accounts for approximately 12% of the global mirtazapine market, with sales predominantly concentrated in North America, Europe, and select Asia-Pacific countries.

Its competitive edge stems from:

• Unique Formulation: Orally disintegrating tablets improve compliance among geriatric and pediatric patients.
• Efficacy and Tolerability: Demonstrated efficacy in both depressive and anxiety symptoms with manageable adverse effects.
• Brand Recognition: Strong brand presence and clinician familiarity.

Key competitors include generic mirtazapine formulations, as well as newer agents like vortioxetine and agomelatine, which target similar indications.

Market Drivers

• Growing Prevalence of Depression and Anxiety: The WHO estimates over 264 million individuals worldwide suffer from depression.[1]
• Patient Preference for Oral Disintegrating Tablets: Rising demand for formulations enhancing compliance.
• Expanding Indications: Research into insomnia and PTSD is broadening the drug's scope.

Market Challenges

• Generic Competition: The expiration of patents in various jurisdictions has intensified the entry of generics, impacting pricing and profitability.
• Side Effect Profile: Weight gain and sedation remain concerns, influencing prescribing patterns.
• Regulatory Barriers: Regulatory hurdles in different markets could delay expansion into new indications.

Regional Market Insights

• North America: Dominates with approximately 50% market share, supported by extensive clinical use and reimbursement pathways.
• Europe: Growing adoption, particularly in the UK, Germany, and France.
• Asia-Pacific: Rapidly expanding, driven by increasing mental health awareness and favorable regulatory reforms; China and India present substantial growth potential.

Market Projection and Future Outlook

Short to Medium-Term Projections (Next 3-5 Years)

Based on current trends, the global INSPRA market is projected to grow at a compound annual growth rate (CAGR) of 8-10%, driven by:

• Expanded Indications: Pending regulatory approvals for sleep and anxiety disorders.
• Increased Adoption in Older Adults: Due to favorable safety profile.
• Healthcare Digitalization and Awareness: Improved diagnosis and treatment pathways.

Long-Term Outlook (Next 5-10 Years)

In the long term, market growth may plateau as generic versions consolidate market share. However, innovations such as personalized therapy guided by pharmacogenomics could revitalize its market potential. Additionally, rising awareness around mental health is expected to sustain demand, particularly in emerging markets.

Potential Growth Avenues

• Indication Expansion: Pursuit of approvals for pediatric and geriatric populations.
• Combination Therapies: Synergistic use with new agents targeting treatment-resistant depression.
• Digital Therapeutics: Integration with digital health platforms for monitoring and adherence.

Strategic Recommendations

• R&D Investments: Accelerate clinical trials targeting new indications and personalized medicine.
• Market Expansion: Focus on emerging markets with high unmet needs.
• Regulatory Engagement: Engage proactively with agencies for streamlined approval processes.
• Patient-Centric Formulation Development: Innovate to further improve compliance, such as taste-masking or tailored dosing.

Key Takeaways

• Clinical Trials reinforce INSPRA’s efficacy in depression and anxiety, with promising data for sleep disorders. Continued research is pivotal for indication expansion.
• Market Position remains strong, especially in North America and Europe, although generic competition presents challenges.
• Growth Projections forecast an 8-10% CAGR over the short to medium term, driven by expanding indications, aging population, and increasing mental health awareness.
• Strategic Focus should include expanding into underserved markets, investing in personalized medicine, and enhancing formulations to maintain competitive advantage.
• Regulatory and Clinical Innovation are vital to sustain and grow INSPRA's market share amidst evolving industry dynamics.

FAQs

1. What are the primary clinical advantages of INSPRA over other antidepressants?
   INSPRA’s unique formulation as an orally disintegrating tablet enhances compliance among elderly and pediatric patients. Its efficacy in treating both depression and anxiety, coupled with a manageable side effect profile, positions it favorably in the market.

2. Are there any ongoing efforts to expand INSPRA’s indications?
   Yes. Current clinical trials focus on sleep disorders, pediatric depression, and combination therapies for treatment-resistant cases. Pending positive results, regulatory submissions for these indications are anticipated.

3. How does generic competition impact INSPRA’s market outlook?
   As patents expire, generic versions enter the market, exerting downward pressure on prices and margins. Differentiation through formulations, indications, and personalized medicine strategies is essential to counteract this trend.

4. What regions present the greatest growth opportunities for INSPRA?
   Emerging markets in Asia-Pacific, driven by increasing mental health awareness and regulatory reforms, offer significant growth potential. Additionally, expanding approval in geriatrics and pediatrics will broaden its user base globally.

5. What strategic moves should stakeholders prioritize for INSPRA’s sustained growth?
   Investment in clinical research for new indications, expansion into underserved regions, formulation innovation, and proactive regulatory engagement are key to preserving and enhancing market position.

References

[1] World Health Organization. Depression and Other Common Mental Disorders: Global Health Estimates. 2017.