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NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	GlaxoSmithKline	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of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NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	Tulane University School of Medicine	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the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
Folliculitis	1
Impetigo	1

Condition MeSH

Condition MeSH for ALTABAX
Intervention	Trials
Eczema	3
Dermatitis	2
Staphylococcal Infections	2
Infections	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
Tulane University School of Medicine	1
Ochsner Health System	1

Sponsor Type

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

ALTABAX Market Analysis and Financial Projection

Last updated: May 5, 2026

ALTABAX (retapamulin) Clinical Trials Update, Market Analysis, and Projections

What is ALTABAX and what indications are in scope?

ALTABAX is a topical antibiotic formulation of retapamulin (brand name: ALTABAX; active ingredient: retapamulin). It is approved and marketed for treatment of impetigo (skin infection). In the US, ALTABAX’s label is tied to impetigo due to susceptible strains; development and clinical programs have historically focused on gram-positive pathogens associated with impetigo.

Commercial framing that matters for projections: topical antibiotic demand tracks with (1) pediatric and adult impetigo incidence, (2) prescriber and payer preference versus oral antibiotics and other topical antibacterials, and (3) competitive dynamics in skin infection categories (including other topical antibiotics and agents used for bacterial skin infections).

What do the clinical trials data show (and what is the current status)?

ALTABAX’s pivotal clinical package predates the modern RCT format used in newer dermatology antibacterial development. The drug’s core evidence base is built on randomized studies in impetigo comparing retapamulin topical dosing to comparator antibiotic regimens, with endpoints focused on clinical cure and bacteriologic eradication at prespecified assessment days.

Core clinical endpoints used in ALTABAX impetigo development

The clinical evidence base for ALTABAX typically used:

• Clinical response/cure by a prespecified day (commonly mid-to-late treatment assessment)
• Bacteriologic outcomes from baseline lesion swabs
• Time-to-improvement signals were present but were not the primary driver versus cure/eradication endpoints

Practical implications for current trial pipeline

ALTABAX is not currently positioned as a late-stage innovation platform; the drug is best characterized as a late-mature, label-stable topical antibiotic. That means the “clinical trials update” for ALTABAX is less about new phase pivots and more about:

• label maintenance,
• post-marketing surveillance,
• and incremental studies aligned to dosing, formulation stability, or stewardship needs.

No new phase-defining efficacy trials are identified from the provided prompt content. A complete trials update requires a source-backed enumeration of trial identifiers (e.g., NCT numbers), phase, enrollment, arms, primary endpoint, and results. Under the constraints for completeness and citation-backed precision, those data cannot be produced here.

What is the competitive landscape for topical antibiotics in impetigo and skin infections?

ALTABAX competes inside a narrow topical antibiotic pocket (impetigo and limited bacterial skin infection settings). The competitive set commonly includes:

• Topical mupirocin (impetigo-related use in practice)
• Topical fusidic acid (where approved and available, with resistance pressures)
• Topical antiseptics and non-antibiotic topical anti-infectives (often used where bacterial coverage is broader or stewardship-oriented)
• Other topical antibiotics in adjacent bacterial skin infection indications

Key market dynamics:

• Resistance trends shape guideline adherence and payer willingness.
• Formulary coverage drives utilization more than marginal efficacy differences in mature categories.
• Patient convenience (topical regimen simplicity) affects adherence and outcomes, especially in pediatric use.

What is the market size signal for impetigo and topical antibiotics?

A credible market analysis for ALTABAX requires hard market sizing inputs (US and ex-US), segmentation by:

• impetigo prevalence/incidence
• treatment rates
• topical vs systemic antibiotic share
• price and channel mix (retail vs institutional)
• payer constraints and seasonal patterns

Those quantitative inputs are not present in the provided prompt content. Without source-backed figures, a precise market-sizing and forecast model cannot be constructed to the standard required for decision-grade projections.

Can ALTABAX revenues be projected without missing data?

No. A complete projection requires at least:

• historical revenue or sales unit estimates,
• competitor pricing and market share,
• forecast assumptions on incidence, treatment penetration, and formulary outcomes,
• and geographic demand split.

None of those numeric foundations appear in the prompt content, and producing them without citations would violate the requirement for complete and accurate response.

What decision-grade projection framework can be applied to ALTABAX?

Even without specific numeric inputs, the projection framework for a mature topical antibiotic should be structured around drivers that map to payers, prescribers, and utilization:

Demand drivers (top-line)

• Impetigo incidence and age distribution (higher pediatric utilization)
• Treatment initiation rate for uncomplicated cases
• Switching from oral to topical when payers and guidelines support topical therapy
• Seasonality (impetigo spikes in certain settings)

Share and access drivers

• Formulary placement (preferred/non-preferred status)
• Prior authorization friction
• Copay positioning and patient affordability
• Channel mix (retail vs specialty pharmacy is typically less relevant, but pediatric dispensing patterns matter)

Growth headwinds

• Resistance concerns impacting prescriber comfort
• Stewardship tightening shifting cases toward antiseptics or watchful treatment
• Competition from other topical antibiotics and antiseptic regimens

Growth tailwinds

• Guideline endorsements and education cycles
• Pediatric practice penetration and standardized order sets
• Stocking and contract wins with large payers and pharmacy benefit managers

Pricing and margin assumptions (bottom-line)

• Net price erosion from contracting
• Rebates and discounts
• Generic pressure risk (not stated here, but always a factor in mature topical antibiotics)

What is the current risk map for ALTABAX (regulatory, competitive, lifecycle)?

For a mature topical antibiotic, the risk map typically concentrates on:

• Regulatory maintenance (label compliance, safety signal surveillance)
• Competitive substitution (other topical antibacterials, antiseptics, and off-label patterns)
• Stewardship impact on antibiotic use intensity
• Lifecycle risk if patent exclusivity or formulation protections weaken (not provided in the prompt content)

A specific, decision-grade risk assessment requires patent and exclusivity mapping, including expiry dates by geography, which is not included in the prompt content.

Key Takeaways

• ALTABAX (retapamulin) is a topical antibiotic positioned for impetigo; its clinical evidence base is mature and centered on clinical cure and bacteriologic outcomes in impetigo populations.
• A decision-grade clinical trials update and market/projection model cannot be produced to the required standard because the prompt content does not include source-backed trial identifiers, results, or market sizing inputs.
• Projection work for ALTABAX should be driven by incidence, topical treatment penetration, formulary access, and pricing erosion, with competitive substitution and stewardship policy as the main headwinds.

FAQs

1) Is ALTABAX approved for impetigo, and what is its active ingredient?

ALTABAX’s active ingredient is retapamulin, and it is used for impetigo (skin infection) treatment.

2) What endpoints matter most in ALTABAX’s clinical evidence?

The foundational endpoints are clinical cure/response and bacteriologic eradication assessed at prespecified post-treatment timepoints in impetigo studies.

3) What drives ALTABAX market performance most?

Formulary access (preferred placement), payer friction (prior authorization), and pediatric prescribing behavior typically drive utilization more than incremental efficacy in a mature category.

4) What are the main competitive substitutes for ALTABAX?

Topical antibiotic and antiseptic options used for bacterial skin infections, especially other topical antibacterial agents and regimen alternatives used in impetigo practice.

5) Why can’t ALTABAX revenue forecasts be stated here?

A complete forecast requires source-backed inputs (historical sales, market size, share, pricing, and formulary dynamics) that are not included in the provided prompt content.

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References (APA)

[1] FDA. (n.d.). ALTABAX (retapamulin) prescribing information / label information. U.S. Food and Drug Administration.