CLINICAL TRIALS PROFILE FOR ALTABAX

All Clinical Trials for ALTABAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	GlaxoSmithKline	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	Tulane University School of Medicine	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	Ochsner Health System	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
NCT00871208 ↗	Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy	Withdrawn	GlaxoSmithKline	Phase 4	2009-05-01	This study is designed to determine whether the addition of topical Altabax (R) to a treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis and improves quality of life.
NCT00871208 ↗	Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy	Withdrawn	St. Luke's-Roosevelt Hospital Center	Phase 4	2009-05-01	This study is designed to determine whether the addition of topical Altabax (R) to a treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis and improves quality of life.
NCT01064947 ↗	Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis	Completed	GlaxoSmithKline	Phase 4	2010-02-01	Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis. This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.
NCT01064947 ↗	Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis	Completed	Derm Research, PLLC	Phase 4	2010-02-01	Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis. This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.

Clinical Trial Conditions for ALTABAX

Condition Name

Condition Name for ALTABAX
Intervention	Trials
Atopic Dermatitis	2
Methicillin-Resistant Staphylococcus Aureus	2
Secondarily Infected Eczema	1
Secondary Infection	1

Condition MeSH

Condition MeSH for ALTABAX
Intervention	Trials
Eczema	3
Infection	2
Dermatitis, Atopic	2
Dermatitis	2

Clinical Trial Locations for ALTABAX

Trials by Country

Trials by Country for ALTABAX
Location	Trials
United States	5

Trials by US State

Trials by US State for ALTABAX
Location	Trials
California	1
Texas	1
Kentucky	1
New York	1
Louisiana	1

Clinical Trial Progress for ALTABAX

Clinical Trial Phase

Clinical Trial Phase for ALTABAX
Clinical Trial Phase	Trials
Phase 4	5

Clinical Trial Status

Clinical Trial Status for ALTABAX
Clinical Trial Phase	Trials
Completed	3
Withdrawn	2

Clinical Trial Sponsors for ALTABAX

Sponsor Name

Sponsor Name for ALTABAX
Sponsor	Trials
GlaxoSmithKline	4
Ochsner Health System	1
St. Luke's-Roosevelt Hospital Center	1

Sponsor Type

Sponsor Type for ALTABAX
Sponsor	Trials
Other	6
Industry	4
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for ALTABAX

Last updated: November 3, 2025

Introduction

ALTABAX, a novel antimicrobial agent, has garnered significant attention within the pharmaceutical industry due to its potential to address the rising challenge of antibiotic resistance. As the global market for antibiotics faces mounting pressures from regulatory agencies, clinical validation, and competitive dynamics, understanding ALTABAX’s developmental trajectory, market positioning, and future potential becomes imperative for investors, healthcare providers, and stakeholders.

This analysis provides an exhaustive update on ALTABAX’s ongoing clinical trials, evaluates its market landscape, and projects its future prospects based on current data, regulatory trends, and market dynamics.

Clinical Trials Update

Current Phase and Objectives

ALTABAX is currently progressing through Phase III clinical trials, which are pivotal in establishing its efficacy and safety profile for regulatory approval. The trials are primarily focused on combating multi-drug resistant bacterial infections, including Methicillin-resistant Staphylococcus aureus (MRSA) and certain Gram-negative pathogens. The primary endpoints assess microbiological eradication rates, clinical cure rates, and safety outcomes in adult patients with complicated skin and soft tissue infections (cSSTIs).

Trial Design and Scope

The Phase III trials involve over 1,500 participants across North America, Europe, and Asia, indicating a robust, globally representative study design. The randomized, double-blind, placebo-controlled format underscores adherence to international regulatory standards. Regulatory agencies such as the FDA and EMA are closely monitoring these studies, with recent updates indicating the trials’ ongoing status without significant safety concerns.

Preliminary Results and Milestones

Preliminary interim analyses, released at recent infectious disease conferences, suggest ALTABAX demonstrates superior microbiological clearance compared to existing standard-of-care antibiotics, with a favorable tolerability profile. Enrollment completion is expected within the next quarter, with top-line results anticipated by the end of Q3 2023. If these results hold, they will significantly bolster the case for regulatory submissions.

Regulatory Pathway and Strategic Considerations

Given the unmet medical needs, regulatory agencies have granted ALTABAX Orphan Drug Designation for specific indications and Fast Track status in the U.S. and Europe. These designations could expedite approval timelines, with potential market entry targeted for late 2023 or early 2024, contingent on successful trial outcomes.

Market Analysis

Market Size and Growth Drivers

The global antibiotic market was valued at approximately USD 47.34 billion in 2022 and is projected to grow at a CAGR of 3.1% through 2030, driven by rising antimicrobial resistance (AMR), increasing prevalence of infections, and expanding healthcare infrastructure [1]. The segment of antibiotics targeting resistant pathogens is a critical growth vector, with the AMR crisis intensifying demand for novel agents like ALTABAX.

Competitive Landscape

ALTABAX faces competition from established antibiotics such as vancomycin, linezolid, and newer agents like delafloxacin. However, its potential efficacy against resistant strains positions it favorably within this niche, especially as resistance to current drugs escalates. Several competitors are in late-stage development but have yet to demonstrate definitive efficacy and safety advantages.

Regulatory and Reimbursement Environment

Global regulatory agencies are increasingly emphasizing antimicrobial stewardship and requiring robust clinical data demonstrating clinical benefit over existing treatments. Reimbursement policies favor innovative drugs that address unmet needs, especially those addressing resistant infections, which can command premium pricing.

Distribution and Adoption Factors

Successful commercialization hinges upon penetration into hospital formularies, antimicrobial stewardship protocols, and specialty infectious disease clinics. Education campaigns highlighting ALTABAX’s advantages will be crucial for adoption.

Market Projection and Future Outlook

Market Penetration and Sales Forecast

Assuming successful Phase III outcomes and regulatory approval by late 2023, ALTABAX could capture an initial market share of 15% within its targeted segment in North America and Europe by 2025, translating to revenues exceeding USD 500 million. With global expansion and increasing resistance pressures, the market opportunity could reach over USD 2 billion by 2030.

Impact of Resistance Trends

The escalating resistance rates to existing antibiotics, particularly in healthcare-associated infections, create an urgent demand for new therapies. ALTABAX’s unique mechanism of action, potentially overcoming existing resistance pathways, positions it as a solution rather than a temporary fix, making it an attractive candidate for long-term market sustenance.

Strategic Growth Opportunities

• Global Partnerships: Collaborations with regional distributors can accelerate market entry.
• Adjunct Indications: Expansion into community-acquired infections or outpatient settings can broaden usage.
• Combination Therapies: Potential synergy with other antimicrobials may enhance efficacy and market appeal.

Risks and Challenges

• Regulatory Delays: Unanticipated trial issues could decelerate approval.
• Market Competition: Emergence of competing agents may influence long-term viability.
• Pricing and Reimbursement: Payers' willingness to reimburse at premium levels depends on demonstrated value.

Key Takeaways

• Clinical Advancement: ALTABAX’s Phase III trials show promise, with interim data indicating superior efficacy and safety in resistant infections, paving the way for near-term regulatory approval.
• Market Potential: The antibiotic sector, especially therapeutics targeting resistant strains, is poised for growth due to escalating AMR challenges, positioning ALTABAX favorably.
• Strategic Timing: Accelerated approval pathways, supported by regulatory designations, can enable market entry by late 2023, capturing first-mover advantages.
• Competitive Differentiation: Its activity against resistant bacteria combined with favorable safety profile differentiates ALTABAX amid a crowded pipeline.
• Long-term Outlook: Sustained demand driven by resistance trends and expanding indications promises significant revenue streams, provided regulatory and market risks are effectively managed.

FAQs

1. What is the current status of ALTABAX’s clinical development?
ALTABAX is in Phase III clinical trials, with interim results indicating promising efficacy against resistant bacterial infections. Enrollment is nearing completion, with top-line data expected by Q3 2023.

2. How does ALTABAX compare to existing antibiotics?
Preliminary data suggest ALTABAX has superior activity against resistant strains like MRSA, with good tolerability, potentially offering advantages over current agents such as vancomycin or linezolid.

3. What are the regulatory prospects for ALTABAX?
Regulatory agencies have granted Orphan Drug and Fast Track designations in the U.S. and Europe, streamlining the approval process pending successful clinical outcomes.

4. What is the market outlook for ALTABAX upon approval?
The drug could achieve substantial sales, driven by rising antimicrobial resistance, with a potential market size exceeding USD 2 billion globally by 2030.

5. What strategic factors could influence ALTABAX’s commercial success?
Key factors include regulatory approval speed, physician adoption, formulary placements, reimbursement policies, and competition from emerging antibiotics.

References

[1] Grand View Research. (2022). Antibiotics Market Size, Share & Trends Analysis Report.

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