CLINICAL TRIALS PROFILE FOR ORVATEN

All Clinical Trials for ORVATEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02379156 ↗	Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia	Active, not recruiting	The Craig H. Neilsen Foundation	Phase 4	2015-04-01	The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.
NCT02379156 ↗	Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia	Active, not recruiting	James J. Peters Veterans Affairs Medical Center	Phase 4	2015-04-01	The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.

Clinical Trial Conditions for ORVATEN

Condition Name

Condition Name for ORVATEN
Intervention	Trials
Hypothermia	1
Mild Cognitive Impairment	1
Tetraplegia	1

Condition MeSH

Condition MeSH for ORVATEN
Intervention	Trials
Quadriplegia	1
Mild Cognitive Impairment	1
Hypothermia	1
Cognitive Dysfunction	1

Clinical Trial Locations for ORVATEN

Trials by Country

+

−

Trials by Country for ORVATEN
Location	Trials
United States	1

Trials by US State

+

−

Trials by US State for ORVATEN
Location	Trials
New York	1

Clinical Trial Progress for ORVATEN

Clinical Trial Phase

Clinical Trial Phase for ORVATEN
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for ORVATEN
Clinical Trial Phase	Trials
Active, not recruiting	1

Clinical Trial Sponsors for ORVATEN

Sponsor Name

Sponsor Name for ORVATEN
Sponsor	Trials
The Craig H. Neilsen Foundation	1
James J. Peters Veterans Affairs Medical Center	1

Sponsor Type

Sponsor Type for ORVATEN
Sponsor	Trials
U.S. Fed	1
Other	1

Clinical Trials Update, Market Analysis, and Projections for Lorundrostat (ORVATEN)

Introduction

Lorundrostat, also known as ORVATEN, is a novel drug under investigation for its potential in managing uncontrolled hypertension. This article provides an update on the clinical trials, market analysis, and projections for this promising therapeutic agent.

Clinical Trials Overview

The clinical trials for lorundrostat have been conducted to evaluate its efficacy and safety in patients with uncontrolled hypertension.

Target-HTN Trial

The Target-HTN trial was a multicenter, prospective, randomized, placebo-controlled, dose-ranging clinical trial. It involved 200 participants across 43 sites in the United States. The trial included a prescreening period, a placebo run-in period, and an 8-week treatment period followed by a final visit 2-4 weeks after treatment completion.

• Dosing and Randomization: Participants were randomized to receive either placebo or one of several doses of lorundrostat (12.5 mg, 25 mg, 50 mg, or 100 mg once daily or 12.5 mg twice daily). An interim analysis led to the discontinuation of the two lowest doses due to insufficient blood pressure reduction[1].

• Efficacy End Points: The primary efficacy end point was the change in systolic automated office blood pressure (AOBP) from baseline to the end of week 8. Secondary end points included changes in diastolic AOBP, 24-hour ambulatory blood pressure monitoring, and the proportion of participants achieving an AOBP less than 130/80 mm Hg[1].

• Safety and Biomarkers: The trial also monitored safety parameters such as hyperkalemia, hypotension, and adrenal insufficiency, as well as pharmacodynamic biomarkers like plasma renin activity (PRA), serum aldosterone, cortisol, potassium, and estimated glomerular filtration rate (eGFR)[1].

Key Findings

The trial demonstrated that lorundrostat significantly reduced blood pressure compared to placebo, particularly at the 50 mg and 100 mg once-daily doses. This reduction was evident in both systolic and diastolic blood pressure measurements[1].

Market Analysis

Market Context

The global market for hypertension treatments is substantial and growing, driven by the increasing prevalence of hypertension and related cardiovascular diseases.

• Prevalence of Hypertension: Hypertension is a widespread condition affecting millions worldwide, with a significant impact on public health and healthcare systems. The need for effective and safe treatments is paramount[3].

• Competitive Landscape: The market for antihypertensive drugs is highly competitive, with various classes of medications such as ACE inhibitors, beta-blockers, and calcium channel blockers. Lorundrostat, as an aldosterone synthase inhibitor, offers a unique mechanism of action that could differentiate it from existing treatments[2].

Market Potential

Given the positive results from the clinical trials, lorundrostat has significant market potential.

• Unmet Need: Despite the availability of numerous antihypertensive medications, many patients remain uncontrolled, highlighting an unmet need for new and effective treatments. Lorundrostat's ability to reduce blood pressure in patients who are not adequately controlled by current therapies positions it well to address this gap[1].

• Market Size and Growth: The global antihypertensive drug market is expected to grow due to increasing prevalence of hypertension and the aging population. Lorundrostat, if approved, could capture a substantial share of this growing market[3].

Projections and Future Outlook

Regulatory Approval

The successful completion of the Target-HTN trial and the positive efficacy and safety data will likely support regulatory submissions for lorundrostat.

• Future Trials: Additional trials may be conducted to further establish the long-term safety and efficacy of lorundrostat, as well as to explore its use in combination with other antihypertensive medications[1].

Market Penetration

If approved, lorundrostat is expected to penetrate the market quickly due to its unique mechanism of action and the unmet need for effective hypertension treatments.

• Prescription Trends: Physicians may prefer lorundrostat for patients who have not responded adequately to current treatments, driving prescription rates and market share[3].

• Patient Compliance: The once-daily dosing regimen of lorundrostat could enhance patient compliance, further contributing to its market success[1].

Competitive Assessment

Key Players

The antihypertensive market is dominated by several major pharmaceutical companies. Lorundrostat's entry will need to compete with established brands.

• Market Leaders: Companies like Novartis, Pfizer, and Merck & Co. have a strong presence in the cardiovascular disease treatment market. Lorundrostat's unique mechanism and clinical data will be crucial in differentiating it from existing products[2].

Differentiation

Lorundrostat's mechanism as an aldosterone synthase inhibitor offers a distinct advantage.

• Mechanism of Action: By inhibiting aldosterone synthesis, lorundrostat targets a key component of the renin-angiotensin-aldosterone system (RAAS), which is central to blood pressure regulation. This differentiation could attract both physicians and patients seeking alternative treatments[1].

Key Takeaways

• Clinical Trials: Lorundrostat has demonstrated significant blood pressure reduction in clinical trials, particularly at higher doses.
• Market Potential: The drug has substantial market potential due to the unmet need for effective hypertension treatments.
• Regulatory Approval: Successful trial outcomes support future regulatory submissions.
• Market Penetration: Lorundrostat is expected to penetrate the market quickly due to its unique mechanism and once-daily dosing.
• Competitive Assessment: The drug will compete with established brands but can differentiate itself through its mechanism of action.

FAQs

What is lorundrostat (ORVATEN), and how does it work?

Lorundrostat is an aldosterone synthase inhibitor, which means it works by reducing the production of aldosterone, a hormone involved in blood pressure regulation.

What were the key findings of the Target-HTN trial?

The Target-HTN trial showed that lorundrostat significantly reduced systolic and diastolic blood pressure compared to placebo, particularly at the 50 mg and 100 mg once-daily doses.

What is the market potential for lorundrostat?

Given the positive clinical trial results and the unmet need for effective hypertension treatments, lorundrostat has significant market potential and could capture a substantial share of the growing antihypertensive drug market.

How does lorundrostat differentiate itself from other antihypertensive medications?

Lorundrostat differentiates itself through its unique mechanism of action as an aldosterone synthase inhibitor, targeting a key component of the RAAS system.

What are the next steps for lorundrostat after the successful completion of the Target-HTN trial?

The next steps include potential additional trials to establish long-term safety and efficacy and regulatory submissions for approval.

Who are the key players in the antihypertensive market that lorundrostat will compete with?

Lorundrostat will compete with established brands from companies like Novartis, Pfizer, and Merck & Co.

Sources

1. JAMA Network: Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension.
2. Business Insider: Global Statin Market Analysis to 2025.
3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
4. Foundation for Prader-Willi Research: PWS Clinical Trials.
5. GlobeNewswire: Skeletal Dysplasia Treatment Market Analysis by Type, End-User, Region, and Company Forecast to 2030.