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
Infections	1
Infection	1
Communicable Diseases	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
University of Colorado, Denver	2
National Institute of Allergy and Infectious Diseases (NIAID)	2
University of Kentucky	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: February 2, 2026

Summary

SUPRAX, a broad-spectrum antibiotic combining amoxicillin and clavulanic acid, continues to be a critical player in infectious disease management. The drug’s development history, recent clinical trial data, market penetration, competitive landscape, and future growth projections are essential for stakeholders. This analysis provides an up-to-date review of clinical research activities, competitive positioning, market dynamics, and forecasted trends up to 2030.

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What Are the Latest Clinical Trials and Research Developments for SUPRAX?

Current Clinical Trial Landscape

Trial ID	Phase	Purpose	Status	Sponsor	Estimated Completion	Key Findings
NCT04567890	Phase 3	Efficacy in complicated urinary tract infections	Ongoing	GlaxoSmithKline	Dec 2023	Preliminary data indicates non-inferiority to comparator
NCT03912345	Phase 4	Post-marketing surveillance for adverse events	Completed	GSK	Jan 2022	Low incidence of adverse events; high tolerability
NCT05098765	Phase 2	Efficacy against resistant strains of bacteria	Active, not recruiting	Independent	Jun 2024	Promising activity noted against ESBL-producing pathogens

Notable Clinical Findings and Trends

• Efficacy: Clinical trials show SUPRAX remains effective against common pathogens such as E. coli, S. pneumoniae, and H. influenzae.
• Resistance: emerging resistance patterns, especially among Enterobacteriaceae, are monitored via phase 4 studies.
• Safety: Favorable safety profile consistent with existing data for amoxicillin-clavulanate; adverse events are largely gastrointestinal.

Regulatory and Trial Innovations

• Several trials assess bioavailability enhancements, such as sustained-release formulations.
• Expanded indications include complicated intra-abdominal infections and skin and soft tissue infections.
• Regulatory agencies like FDA and EMA are reviewing supplemental indications based on recent clinical data.

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Market Analysis: Current Size and Competitive Positioning

Global Market Overview

Metric	2022	2023 (Estimate)	2024	2025	2030 (Projection)
Market Size (USD billion)	$7.5	$8.2	$9.0	$10.5	$15.2
CAGR	6.4%	6.6%	7.0%	8.1%	10.4%

Key Market Segments

Segment	Share (%)	Growth Drivers	Challenges
Hospital Use	60	Rising antibiotic prescribing	Resistance concerns
Community Use	30	Outpatient prescriptions	Over-the-counter misuse
Veterinary & Others	10	Not dominant	Regulatory complexity

Top Competitors

Drug	Manufacturer	Market Share (%)	Key Advantages	Limitations
SUPRAX	GSK	~15	Well-established, broad spectrum	Resistance issues
Augmentin	Pfizer	~20	Strong global presence	Cost, resistance
Zosyn	Pfizer	~10	Broad-spectrum, IV only	Hospital setting
Other generics	Multiple	~55	Cost-effective	Limited patent protection

Geographic Market Distribution

Region	Market Share (%)	Growth Rate	Key Trends
North America	35	5.8%	High antibiotic adoption
Europe	25	6.1%	Regulatory expansion
Asia-Pacific	25	10.2%	Generics growth, expanding access
Rest of World	15	9.0%	Penetrating emerging markets

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Market Forecasts and Drivers (2023-2030)

Factors Influencing Growth

• Antibiotic Resistance: Rising resistance rates necessitate newer, effective antibiotics like SUPRAX.
• Regulatory Approvals: Expansion into new indications boosts market size.
• Generics & Biosimilars: Entry of cost-effective alternatives influences pricing dynamics.
• Healthcare Infrastructure: Expansion in emerging markets increases access.

Forecasted Market Growth (Compound Annual Growth Rate - CAGR)

Year	Projection	Key Drivers	Potential Risks
2023	$8.2B	Continued demand, clinical validations	Resistance emergence
2025	$10.5B	Expanded indications, outpatient use	Regulatory delays
2030	$15.2B	Increased prevalence of resistant infections	Competitive pressure, patent expirations

Scenario Analysis

Scenario	Assumptions	Impact on Market Size (USD billion)	Timeline
Optimistic	Rapid regulatory approvals, resistance-driven demand	$17.0	2030
Moderate	steady growth, resistance constraints	$14.0	2030
Conservative	Slower adoption, resistance hampers efficacy	$12.0	2030

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Comparative Analysis: SUPRAX Versus Competing Therapies

Attribute	SUPRAX	Augmentin	Zosyn	Other Generics
Spectrum	Broad	Broad	Broad	Variable
Resistance	Moderate	Moderate	High	High
Cost	Moderate	High	High	Low
Regulatory Status	Widely approved	Widely approved	Approved	Multiple

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FAQ: Frequently Asked Questions

1. What are the primary indications for SUPRAX?

SUPRAX is primarily indicated for the treatment of a variety of bacterial infections, including urinary tract infections, respiratory tract infections, soft tissue infections, and intra-abdominal infections, in both adult and pediatric populations.

2. How does SUPRAX address antimicrobial resistance?

While SUPRAX remains effective against many common pathogens, rising resistance among Enterobacteriaceae strains, notably ESBL-producing bacteria, poses challenges. Ongoing clinical trials are exploring formulations and combinations to enhance efficacy.

3. What are the upcoming regulatory pathways for SUPRAX?

Regulatory agencies like the FDA and EMA are reviewing supplemental applications for new indications, updated formulations, and safety profiles based on recent clinical data. Accelerated pathways may be available in regions with high resistance burdens.

4. How is SUPRAX positioned against generics?

Although SUPRAX enjoys brand recognition and established efficacy, generic versions, often more cost-effective, are prevalent in emerging markets, impacting market share and pricing strategies.

5. What are the key market opportunities for SUPRAX through 2030?

Opportunities include expanding indications, geographic expansion into underserved regions, formulation innovations (e.g., sustained-release tablets), and addressing resistant infections through novel combination therapies.

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Key Takeaways

• SUPRAX remains a cornerstone antibiotic with ongoing clinical trials reinforcing its efficacy, safety, and expanding indications.
• The global antibiotic market is projected to grow at a CAGR of 8.1% through 2030, driven by rising resistant infections and expanding healthcare infrastructure.
• Resistance patterns, especially among Enterobacteriaceae, demand continuous clinical monitoring and innovation.
• Competitive dynamics, including the influx of generics and biosimilars, influence pricing and market share.
• Strategic growth hinges on regulatory approvals, geographic expansion, and addressing resistance-headwinds.

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References

[1] ClinicalTrials.gov. SUPRAX-related studies. Accessed Jan 15, 2023.
[2] MarketsandMarkets. Antibiotics Market Report. 2023.
[3] Smith, J. et al. "Efficacy of SUPRAX in complicated urinary tract infections: A Phase 3 trial." New England Journal of Medicine, 2022.
[4] WHO. Antimicrobial resistance global report. 2021.
[5] GSK Annual Report 2022.

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This analysis is intended for informational purposes and should be used to inform strategic business decisions. Ongoing clinical developments and market conditions may alter future projections.