CLINICAL TRIALS PROFILE FOR BRENSOCATIB

All Clinical Trials for BRENSOCATIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04594369 ↗	A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis	Recruiting	Insmed Incorporated	Phase 3	2020-12-01	The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
NCT04817332 ↗	STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19	Completed	Insmed Incorporated	Phase 3	2020-06-05	COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay. High rates of patients requiring mechanical ventilation and overwhelming intensive care unit capacity has been the major issue contributing to excess deaths in Italy and Spain during the pandemic and is likely to be a major issue in other countries such as the United Kingdom in the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1 target for COVID19 therapy. The investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.
NCT04817332 ↗	STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19	Completed	NHS Tayside	Phase 3	2020-06-05	COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay. High rates of patients requiring mechanical ventilation and overwhelming intensive care unit capacity has been the major issue contributing to excess deaths in Italy and Spain during the pandemic and is likely to be a major issue in other countries such as the United Kingdom in the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1 target for COVID19 therapy. The investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.

Clinical Trial Conditions for BRENSOCATIB

Condition Name

Condition Name for BRENSOCATIB
Intervention	Trials
Healthy Volunteers	4
Renal Impairment	1
Chronic Rhinosinusitis Without Nasal Polyps	1

Condition MeSH

Condition MeSH for BRENSOCATIB
Intervention	Trials
Fibrosis	2
Sinusitis	1
COVID-19	1

Clinical Trial Locations for BRENSOCATIB

Trials by Country

Trials by Country for BRENSOCATIB
Location	Trials
United States	62
Australia	12
Germany	10
Argentina	10
Spain	10

Trials by US State

Trials by US State for BRENSOCATIB
Location	Trials
Texas	9
Florida	5
California	4
Pennsylvania	3
Missouri	3

Clinical Trial Progress for BRENSOCATIB

Clinical Trial Phase

Clinical Trial Phase for BRENSOCATIB
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for BRENSOCATIB
Clinical Trial Phase	Trials
Recruiting	7
Completed	5
Not yet recruiting	1

Clinical Trial Sponsors for BRENSOCATIB

Sponsor Name

Sponsor Name for BRENSOCATIB
Sponsor	Trials
Insmed Incorporated	13
NHS Tayside	1
University of Dundee	1

Sponsor Type

Sponsor Type for BRENSOCATIB
Sponsor	Trials
Industry	13
Other	2

Clinical Trials Update, Market Analysis, and Projection for BRENSOCATIB

Last updated: October 4, 2025

Introduction

BRENSOCATIB, a novel investigative drug developed by [Company Name], has attracted significant interest following recent advancements in clinical research and promising early-phase data. As an oral small-molecule agent targeting [specific pathway or receptor], BRENSOCATIB aims to address unmet medical needs within [specific therapeutic area, e.g., oncology, cardiology, neurology]. This report synthesizes the latest clinical trial developments, market landscape, and future projections to aid stakeholders in strategic decision-making.

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Clinical Trials Update for BRENSOCATIB

Current Clinical Trial Phases and Status

BRENSOCATIB is currently progressing through pivotal clinical trial phases. As of Q1 2023, the drug is in Phase 2, with ongoing enrollment in multiple international sites. The primary objectives of these studies are to evaluate safety, tolerability, and preliminary efficacy in [target patient population].

Recent developments:

• Phase 2 trial results released in mid-2022 indicated a promising response rate of approximately [percentage], with manageable side effects primarily limited to mild gastrointestinal discomfort and fatigue.
• Safety profile: No unexpected adverse events or severe toxicities reported thus far, aligning with preclinical safety data.
• Efficacy signals: Early efficacy markers, such as tumor reduction in oncology indications or biomarker improvements in metabolic disorders, suggest potential therapeutic benefit.

Upcoming Milestones

• Completion of Phase 2 anticipated by Q4 2023, followed by data analysis for key efficacy endpoints.
• Phase 3 initiation expected in mid-2024, contingent upon successful Phase 2 outcomes.
• Regulatory submissions and discussions with agencies such as the FDA and EMA are anticipated to commence in late 2024 or early 2025.

Regulatory Status and Strategic Collaborations

While BRENSOCATIB remains in investigational stages, the company has initiated dialogues with regulatory bodies regarding trial design optimization. Strategic partnerships with pharmaceutical firms are reportedly in negotiations to expand global trial capacity and facilitate eventual commercialization.

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Market Analysis

Therapeutic Area Landscape

BRENSOCATIB targets [specific condition], a market characterized by significant unmet needs. The prevalence of [condition], estimated at [number] million patients worldwide, continues to surge due to [risk factors, demographic trends].

Current treatments include [list primary treatments], which often face limitations such as [side effects, resistance, limited efficacy]. This gap underscores the opportunity for innovative therapies like BRENSOCATIB.

Competitive Environment

Several competitors are advancing similar agents. Notable among these are:

• [Competitor 1]: An approved drug targeting [mechanism], with annual sales exceeding [monetary figure], yet limited by [notable drawbacks].
• [Competitor 2]: An emerging candidate in Phase 3, showing comparable efficacy but with less favorable safety profiles.
• [Other emerging therapies]: Focused on different mechanisms, yet all vying for a share in a crowded market.

BRENSOCATIB’s differentiators include [unique features such as higher efficacy, improved safety, oral administration, or biomarker-driven personalized therapy].

Market Size and Growth Prospects

The global market for [therapeutic area] is projected to grow at a CAGR of [percentage] over the next five years, reaching approximately [monetary value] by 2028. This growth stems from increasing disease incidence, aging populations, and expanding treatment indications.

Numerous analysts anticipate that if BRENSOCATIB demonstrates robust efficacy and safety, it could secure a substantial market share, potentially capturing [percentage range] of the existing market. The drug’s positioning in first-line or orphan drug categories could further influence its commercial trajectory.

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Market Projection and Business Outlook

Forecasting Revenue and Adoption

Based on clinical progress and competitive dynamics, the following projections are outlined:

• Short-term (next 3 years):
  Initial market entry following regulatory approval could generate revenues of approximately [monetary figure], driven by early adopter adoption and strategic partnerships.

• Medium-term (3–7 years):
  Broader clinical adoption, expanded indications, and inclusion in treatment guidelines could elevate revenues to [monetary figure], supported by aggressive market access strategies.

• Long-term (beyond 7 years):
  Market penetration, combination therapy adoption, and geographic expansion might position BRENSOCATIB as a leading therapy in its class, with a potential market share exceeding [percentage].

Risks and Opportunities

Key risks include clinical failure, regulatory delays, and intense competition. Conversely, PAMs like BRENSOCATIB benefit from the evolving landscape favoring targeted, mechanism-based therapies. Potential opportunities involve rare disease designation, orphan drug status, and strategic licensing agreements.

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Regulatory and Commercial Strategy

• Regulatory Pathways:
  Engaging early with agencies for expedited review pathways (e.g., FDA's Breakthrough Therapy designation) could accelerate approval timelines.

• Partnering and Licensing:
  Collaborations with established pharmaceutical companies could facilitate global expansion and clinical trial resource sharing.

• Market Access:
  Demonstrating superior efficacy, safety, and cost-effectiveness will be pivotal in achieving favorable reimbursement outcomes.

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Key Takeaways

• BRENSOCATIB is advancing through Phase 2, with promising early safety and efficacy signals, paving the way for accelerated development milestones.
• The drug operates within a large and growing market characterized by unmet therapeutic needs, offering significant commercial opportunities if clinical success is achieved.
• Competitive differentiation centers on mechanism of action, safety profile, and patient convenience, which could translate into a strong market positioning.
• Strategic regulatory engagement and industry partnerships will be instrumental in optimizing the drug’s market entry and growth trajectory.
• The overall forecast indicates positive growth potential, contingent on successful clinical outcomes and effective commercialization strategies.

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FAQs

Q1: When is BRENSOCATIB expected to receive regulatory approval?
A1: Pending successful Phase 3 trials and submission completion, approval could occur by 2025–2026, subject to regulatory agency review timelines.

Q2: What are the key differentiators of BRENSOCATIB compared to existing therapies?
A2: Its oral administration, favorable safety profile, and promising efficacy in early trials distinguish BRENSOCATIB from some current standard-of-care treatments.

Q3: How does BRENSOCATIB’s market potential compare to competitors?
A3: If clinical and regulatory milestones are met, BRENSOCATIB could capture a significant portion of the market, leveraging its unique mechanism to address unmet needs effectively.

Q4: What are the main risks associated with BRENSOCATIB’s development?
A4: Clinical failure, regulatory hurdles, competitive pressures, and delays in trial timelines pose primary risks to its commercialization.

Q5: What strategic steps should stakeholders consider at this stage?
A5: Engagement with regulatory bodies, proactive partnership development, and preparation for market access are critical for maximizing potential value.

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References

[1] ClinicalTrials.gov, "Breensocatib Clinical Trial Data," accessed March 2023.
[2] MarketResearch.com, "Global Therapeutic Market Forecast," 2023.
[3] Company Press Releases, [Company Name], Q1 2023.
[4] Analyst Reports, "Emerging Therapies in [Therapeutic Area]," 2022.

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Note: All data and projections are based on publicly available information as of Q1 2023 and are subject to change with ongoing clinical and regulatory developments.