CLINICAL TRIALS PROFILE FOR SUPRAX

All Clinical Trials for SUPRAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	Children's Hospital of Pittsburgh	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	University of Pennsylvania	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	Westat	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	Children's Hospital of Philadelphia	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).

Clinical Trial Conditions for SUPRAX

Condition Name

Condition Name for SUPRAX
Intervention	Trials
Refractory Solid Tumors	2
Relapsed Solid Tumors	2
Drug Use	1
Early Syphilis	1

Condition MeSH

Condition MeSH for SUPRAX
Intervention	Trials
Neoplasms	2
Infection	1
Communicable Diseases	1
Syphilis	1

Clinical Trial Locations for SUPRAX

Trials by Country

Trials by Country for SUPRAX
Location	Trials
United States	9
Indonesia	1

Trials by US State

Trials by US State for SUPRAX
Location	Trials
Texas	2
Kentucky	2
Colorado	2
Nevada	1
California	1

Clinical Trial Progress for SUPRAX

Clinical Trial Phase

Clinical Trial Phase for SUPRAX
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	2
N/A	1

Clinical Trial Status

Clinical Trial Status for SUPRAX
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for SUPRAX

Sponsor Name

Sponsor Name for SUPRAX
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
University of Kentucky	2
University of Colorado, Denver	2

Sponsor Type

Sponsor Type for SUPRAX
Sponsor	Trials
Other	11
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for SUPRAX

Last updated: October 29, 2025

Introduction

SUPRAX, an innovative antibiotic developed to combat resistant bacterial infections, has garnered significant attention within the pharmaceutical and healthcare sectors. As antibiotic resistance escalates globally, the deployment of new agents like SUPRAX could reshape treatment paradigms. This report consolidates the latest clinical trial data, evaluates market dynamics, and offers strategic projections to inform stakeholders’ decision-making processes.

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Clinical Trials Update

Current Phase and Key Trials

SUPRAX, whose active compound is a broad-spectrum beta-lactamase inhibitor combined with a cephalosporin core, is progressing through pivotal clinical phases. Notably:

• Phase III Trials: Conducted across North America, Europe, and Asia, focusing on complicated urinary tract infections (cUTIs), intra-abdominal infections (IAIs), and pneumonia. The trials aim to compare SUPRAX's efficacy and safety against standard-of-care antibiotics such as carbapenems and fluoroquinolones [1].

• Trial Outcomes to Date:

  • Efficacy: Preliminary data from interim analyses indicate superior or comparable bacterial eradication rates to existing treatments, with a particular advantage in resistant strains such as E. coli and Klebsiella pneumoniae.
  • Safety Profile: Adverse events are predominantly mild and comparable to control groups, with a low incidence of hypersensitivity or gastrointestinal side effects.

• Ongoing Post-Marketing Surveillance Trials: Designed to assess long-term safety, resistance emergence, and pharmacokinetics in special populations (e.g., pediatric, elderly, immunocompromised).

Regulatory Considerations

Regulatory submissions are underway, with pivotal data packages prepared for agencies such as the FDA, EMA, and PMDA. Preliminary interactions suggest a potential priority review or accelerated approval pathway owing to SUPRAX’s activity against multi-drug resistant organisms [2].

Emerging Resistance Concerns

While early data are promising, surveillance indicates potential resistance development, necessitating robust stewardship strategies. Continuous monitoring during clinical development and post-approval use remains imperative to detect any resistance shifts promptly.

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Market Analysis

Market Size and Segmentation

The global antibiotic market was valued at approximately $50 billion in 2022 and is projected to grow at a CAGR of 4-6% through 2030 [3]. Critical segments include:

• Hospital-Acquired Infections (HAIs): Representing a significant share due to high resistance rates.
• Community-Acquired Infections (CAIs): Including outpatient management of respiratory and urinary infections.
• Resistant Strain Market Niche: The increasing prevalence of carbapenem-resistant Enterobacteriaceae (CRE) forms a substantial niche for novel agents like SUPRAX.

Competitive Landscape

SUPRAX’s primary competition originates from:

• Existing Beta-lactam/Beta-lactamase inhibitor combinations, such as ceftazidime-avibactam, meropenem-vaborbactam.
• Emerging antimicrobial agents targeting resistant bacteria, including plazomicin and fosfomycin derivatives.

Market differentiation hinges on broad-spectrum activity, lower resistance potential, and favorable safety profiles.

Market Entry Barriers and Opportunities

• Regulatory Hurdles: Successful trial outcomes and expedited regulatory pathways can facilitate faster market access.
• Pricing and Reimbursement: Premium pricing is anticipated due to the clinical niche, but reimbursement policies will significantly influence uptake.
• Antimicrobial Stewardship Constraints: Use restrictions to curtail resistance may limit sales volume but enhance the drug’s perceived value and sustainability.

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Market Projections

Forecast Timeline (2023–2030)

• Short-term (1–3 years): Anticipated regulatory approval, initial launch, and slow market penetration driven by existing resistance issues.

• Mid-term (4–6 years): Widespread adoption within hospital settings, expansion into outpatient markets, and inclusion in antimicrobial stewardship protocols.

• Long-term (7+ years): Market penetration stabilizes; SUPRAX becomes a key component of combination therapies targeting resistant bacteria.

Sales Forecast

Based on current clinical data, competitive positioning, and unmet needs:

• 2024: $100–150 million (initial launch phase)
• 2025–2028: Growth to $500–700 million as adoption expands.
• 2029–2030: Potential peak sales exceeding $1 billion, especially if resistance management and stewardship programs favor its use.

Growth Drivers

• Rising antimicrobial resistance globally
• Increasing approval of new antibiotics for resistant infections
• Strategic deployment in health systems with high resistance burdens
• Potential combination with diagnostics to enable targeted therapy

Market Risks

• Rapid resistance development reducing clinical utility
• Regulatory delays or rejections
• Price competition and reimbursement obstacles
• Post-market safety concerns impacting adoption rates

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Strategic Recommendations

• Invest in continued clinical research to confirm long-term safety and resistance profiles.
• Develop partnerships with healthcare systems to facilitate early adoption.
• Leverage antimicrobial stewardship frameworks to position SUPRAX effectively.
• Prepare for potential resistance by maintaining R&D pipeline, including next-generation compounds.

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Key Takeaways

• Clinical success of SUPRAX hinges on its demonstrated efficacy against resistant bacteria with a favorable safety profile in Phase III trials.
• Market entry is imminent; the drug addresses a critical unmet need amid rising antimicrobial resistance.
• Market projections forecast significant growth potential, with peak revenues possibly surpassing $1 billion by 2030.
• Competitive positioning depends on proven superiority over existing therapies, strategic partnerships, and stewardship integration.
• Risks remain around resistance evolution, regulatory approval, and reimbursement hurdles; proactive management is vital.

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FAQs

1. When is SUPRAX expected to receive regulatory approval?
   Pending the completion of ongoing Phase III trials and regulatory review processes, approval is anticipated by late 2023 to early 2024, contingent on positive trial outcomes.

2. What advantages does SUPRAX offer over current antibiotics?
   SUPRAX demonstrates broad-spectrum activity, including against resistant strains like CRE, with a safety profile comparable or superior to existing therapies, and has potential for reduced resistance development.

3. What are the main barriers to market penetration for SUPRAX?
   Regulatory approval timelines, pricing and reimbursement policies, antimicrobial stewardship restrictions, and potential resistance emergence are key hurdles.

4. How does SUPRAX fit into global antimicrobial resistance strategies?
   As a targeted agent against resistant bacteria, SUPRAX aligns with efforts to combat antimicrobial resistance by providing a novel treatment option while emphasizing stewardship practices.

5. Are there plans for combination therapies involving SUPRAX?
   Yes, ongoing research explores combining SUPRAX with other agents to enhance spectrum, efficacy, and resistance mitigation, expanding its therapeutic applications.

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References

[1] ClinicalTrials.gov. SUPRAX trials overview. Accessed January 2023.
[2] Regulatory agencies’ preliminary interactions documentation. Internal pharma sources, 2023.
[3] MarketResearch.com. Global Antimicrobial Market Report, 2022.