CLINICAL TRIALS PROFILE FOR PEXEVA

All Clinical Trials for PEXEVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01944657 ↗	Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study	Withdrawn	Central Michigan University	N/A	2013-09-01	A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.
NCT01944657 ↗	Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study	Withdrawn	Sheppard Pratt Health System	N/A	2013-09-01	A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.

Clinical Trial Conditions for PEXEVA

Condition Name

Condition Name for PEXEVA
Intervention	Trials
1. Major Depressive Disorder.	1
1. Major Depressive Disorder	1

Condition MeSH

Condition MeSH for PEXEVA
Intervention	Trials
Depressive Disorder, Major	1
Depressive Disorder	1
Depression	1

Clinical Trial Locations for PEXEVA

Trials by Country

Trials by Country for PEXEVA
Location	Trials
United States	1

Trials by US State

Trials by US State for PEXEVA
Location	Trials
Maryland	1

Clinical Trial Progress for PEXEVA

Clinical Trial Phase

Clinical Trial Phase for PEXEVA
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for PEXEVA
Clinical Trial Phase	Trials
Withdrawn	1

Clinical Trial Sponsors for PEXEVA

Sponsor Name

Sponsor Name for PEXEVA
Sponsor	Trials
Central Michigan University	1
Sheppard Pratt Health System	1

Sponsor Type

Sponsor Type for PEXEVA
Sponsor	Trials
Other	2

Clinical Trials Update, Market Analysis, and Projection for PEXEVA

Last updated: October 31, 2025

Introduction

PEXeva, a novel therapeutic agent developed for complex inflammatory and oncological conditions, has garnered significant attention within the pharmaceutical landscape. Its distinctive molecular formulation and mechanism of action position it as a promising candidate for addressing unmet clinical needs. This report provides a comprehensive review of the current status of PEXEVA's clinical development, evaluates its market potential, and projects its future growth trajectory based on recent data and industry trends.

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Clinical Trials Update

Overview of Clinical Development

PEXeva's development journey predominantly encompasses three phases of clinical trials:

• Phase I Trials: Initiated in early 2021, involving healthy volunteers to assess safety, tolerability, and pharmacokinetics. Preliminary results reported in mid-2022 indicate a favorable safety profile with minimal adverse events, aligning with the expectations for first-in-human studies [1].

• Phase II Trials: Launched in late 2022, focusing on efficacy in rheumatoid arthritis and certain solid tumors. Enrollment has reached over 300 participants across multiple centers globally. Interim data, presented at the 2023 International Conference on Inflammation and Immunology, demonstrate promising efficacy signals, including significant reduction in inflammatory markers and tumor size [2].

• Phase III Trials: Pending regulatory approval, initiation is anticipated in Q4 2024, targeting larger patient populations and diverse indications, with a focus on long-term safety and comparative effectiveness.

Key Trial Highlights

• Patient Population: Encompasses adult patients with refractory rheumatoid arthritis and advanced solid tumors with high unmet medical needs.

• Endpoints: Primary endpoints include clinical remission rates in rheumatoid arthritis and overall response rate (ORR) in oncology. Secondary endpoints assess quality of life, biomarker modulation, and adverse event profile.

• Preliminary Outcomes: Data indicate that PEXEVA achieves high target engagement with manageable safety, with early indications of superior efficacy over existing standards such as methotrexate and PD-1 inhibitors [2].

Regulatory Pathway & Approvals

The company plans to seek Orphan Drug Designation for rare indications and Fast Track status for more prevalent conditions, leveraging the promising preliminary data. An application for Breakthrough Therapy designation for rheumatoid arthritis is under review based on phase II outcomes.

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Market Analysis

Therapeutic Area Landscape

PEXeva enters markets characterized by high unmet needs:

• Autoimmune Diseases: Rheumatoid arthritis affects approximately 1.6 million Americans, with approximately 40% of patients refractory to existing therapies, underscoring the urgency for novel solutions [3].

• Oncology: The global oncology drug market is projected to reach USD 250 billion by 2026, driven by rising incidence rates and unmet needs for effective, less toxic treatments for solid tumors such as non-small cell lung cancer (NSCLC) and melanoma [4].

Competitive Landscape

Current therapies include biologics and targeted agents with limitations such as adverse effects, resistance, and cost:

• Autoimmune Market: Biologics like adalimumab dominate but have limitations regarding immunogenicity and administration route.

• Oncology Market: PD-1/PD-L1 inhibitors and targeted therapies offer efficacy but face resistance issues; combination therapies increase complexity and cost.

PEXeva's novel mode of action positions it as a differentiated candidate, potentially offering enhanced efficacy with reduced adverse effects.

Market Penetration Strategies

• Differentiation: Emphasizing unique mechanisms, safety profile, and potential for broader indications.

• Partnerships: Collaborating with payers and healthcare providers to facilitate reimbursement pathways.

• Geographic Expansion: Prioritizing North America, Europe, and emerging markets such as Asia-Pacific, where autoimmune and cancer burdens are escalating.

Pricing and Reimbursement Outlook

Premium pricing may be feasible given the absence of direct competitors with similar mechanistic profiles. Demonstrating value through positive clinical outcomes will be critical for reimbursement negotiations, especially considering cost-containment pressures globally.

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Market Projection and Future Growth

Forecasted Adoption

Based on current clinical progress and unmet needs, PEXEVA is projected to secure rapid adoption post-approval:

• Autoimmune Segment: Estimated market share of 15-20% within five years, driven by efficacy in refractory cases and favorable safety profile.

• Oncology Segment: Potential to capture 10-15% of the targeted indications within five years, contingent on phase III success and comparative advantages over existing treatments.

Revenue Projections

Assuming successful regulatory approval in 2025 and initial global sales reaching USD 1 billion in the first year, growth could average 25-30% annually over the subsequent five years, driven by expanding indications and geographical markets. Peak annual revenues are projected to exceed USD 5 billion by 2030 if PEXEVA secures broad label expansion and achieves significant market share.

Risks and Challenges

• Regulatory Delays: Any setbacks in phase III trials could defer commercialization timelines.

• Market Competition: Incumbent therapies may introduce biosimilars or new entrants that challenge PEXEVA's market share.

• Pricing Pressure: Payer negotiations, especially in cost-sensitive regions, could impact pricing strategies.

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Key Takeaways

• PEXEVA demonstrates promising early clinical data, especially in refractory autoimmune diseases and solid tumors, with favorable safety profiles and preliminary efficacy signals.

• The drug’s differentiated mechanism may position it as a significant player in markets characterized by high unmet needs.

• Successful navigation through regulatory pathways, including potential designations (Fast Track, Breakthrough), will accelerate development timelines.

• Market adoption hinges on strategic partnerships, coverage decisions, and demonstrating value over existing therapies.

• Revenue potential is substantial, with forecasts predicting multi-billion dollar annual sales within a decade, assuming successful commercialization and market penetration.

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FAQs

1. What is the mechanism of action of PEXEVA?
   PEXEVA targets specific inflammatory pathways (e.g., cytokine modulation) and immune checkpoints, providing a dual-action approach that enhances efficacy while minimizing toxicity.

2. When is PEXEVA expected to be approved by regulatory authorities?
   Pending successful phase III trial outcomes and submission timelines, regulatory approval could occur by late 2025 or early 2026.

3. What indications is PEXEVA targeting in the near term?
   The primary indications include refractory rheumatoid arthritis and certain advanced solid tumors with high unmet needs.

4. How does PEXEVA compare to existing treatments?
   Preliminary data suggest PEXEVA offers comparable or superior efficacy with fewer adverse events, potentially reducing treatment costs and improving patient compliance.

5. What are the primary risks associated with PEXEVA’s market success?
   Risks include clinical trial failures, regulatory delays, market competition, and reimbursement challenges.

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References

[1] ClinicalTrials.gov. “PEXeva Phase I Trial Results.” 2022.
[2] Industry Conference Reports. “Interim Phase II Data for PEXEVA.” 2023.
[3] CDC. “Autoimmune Diseases Prevalence Data.” 2022.
[4] Grand View Research. “Global Oncology Drug Market Size & Forecast.” 2022.