CLINICAL TRIALS PROFILE FOR AMOXIL

All Clinical Trials for AMOXIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00377403 ↗	Treatment of Acute Sinusitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	2006-10-01	This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
NCT00377403 ↗	Treatment of Acute Sinusitis	Completed	Washington University School of Medicine	Phase 4	2006-10-01	This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
NCT00778050 ↗	Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-10-01	This study compared the relative bioavailability (rate and extent of absorption) of amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited with that of Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals following single oral dose (600 mg) in healthy, adult, subjects under fasting conditions using a randomized two-way crossover design.
NCT01431989 ↗	Amoxicillin Bioequivalence Study Brazil - Fast	Completed	GlaxoSmithKline	Phase 1	2011-05-27	This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.
NCT01530009 ↗	The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children	Active, not recruiting	Nationwide Children's Hospital	N/A	2012-01-01	The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable effect on upper gastrointestinal motility compared to placebo. In particular, induction of phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular contractions that pass through the walls of the stomach and intestinal tract during the fasting state. It is characterized by an initial period where there is a minimal electrical activity and muscular contraction (phase I), followed by a gradual increase in the frequency of contractions (phase III) that often leads to a characteristic cluster of contractions (phase III). This cycle occurs only in the fasting state in normal individuals and the frequency of phase III is quite varied, dependent on age and the presence of any underlying abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics of the MMC, patient demographics in responders and non-responders, and the safety profile of AMX at the intervention dose.

Clinical Trial Conditions for AMOXIL

Condition Name

Condition Name for AMOXIL
Intervention	Trials
Community-acquired Pneumonia	3
Helicobacter Pylori Infection	3
Bariatric Surgery Candidate	1
Severe Acute Malnutrition	1

Condition MeSH

Condition MeSH for AMOXIL
Intervention	Trials
Infections	3
Communicable Diseases	3
Respiratory Tract Infections	3
Pneumonia	3

Clinical Trial Locations for AMOXIL

Trials by Country

Trials by Country for AMOXIL
Location	Trials
Brazil	5
United States	4
Canada	3
Pakistan	2
Egypt	1

Trials by US State

Trials by US State for AMOXIL
Location	Trials
New York	1
Ohio	1
North Dakota	1
Missouri	1

Clinical Trial Progress for AMOXIL

Clinical Trial Phase

Clinical Trial Phase for AMOXIL
Clinical Trial Phase	Trials
Phase 4	11
Phase 2/Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for AMOXIL
Clinical Trial Phase	Trials
Completed	13
Unknown status	2
Withdrawn	2

Clinical Trial Sponsors for AMOXIL

Sponsor Name

Sponsor Name for AMOXIL
Sponsor	Trials
Washington University School of Medicine	2
Children's Hospital of Eastern Ontario	2
Hamilton Health Sciences Corporation	2

Sponsor Type

Sponsor Type for AMOXIL
Sponsor	Trials
Other	30
Industry	3
NIH	1

Amoxil (amoxicillin) Clinical Trials Update, Market Analysis and Projection

Last updated: April 28, 2026

Amoxil is the brand name for amoxicillin, a widely used oral aminopenicillin antibiotic. The product’s clinical development is mature and ongoing evidence largely consists of post-approval studies (comparative effectiveness, resistance surveillance, pediatric use, pharmacokinetics, and safety monitoring) rather than new pivotal phase programs. The commercial outlook is driven by generic penetration, widespread baseline demand for acute bacterial infections, and pricing pressure in mature antibiotic markets.

What is Amoxil and what does the clinical evidence look like now?

Amoxil = amoxicillin (aminopenicillin antibiotic). It targets bacteria with susceptible cell-wall synthesis and is used for infections where clinicians select amoxicillin based on spectrum, local susceptibility patterns, and allergy history.

Clinical trial landscape: pre-approval vs. current

1. Pre-approval era
   • Amoxicillin’s key development milestones occurred decades ago when regulatory standards centered on establishing basic safety and efficacy against labeled infections.
2. Current era
   • Updates are dominated by:
     • Comparative studies (amoxicillin vs. other beta-lactams, or different dosing regimens)
     • Pediatric and weight-based dosing trials
     • Pharmacokinetic and formulation studies (bioequivalence, suspension performance, adherence-focused regimens)
     • Resistance and susceptibility surveillance that informs prescribing and label use

What is being studied in the “real world” evidence stream?

Across mature antibiotic classes, current evidence is commonly focused on:

• Treatment success by pathogen susceptibility
• Microbiological failure linked to beta-lactamase-mediated resistance
• Safety in pediatrics (diarrhea, rash, hypersensitivity)
• Pharmacokinetics in special populations (renal impairment, pediatrics)

However, no specific, current “active pivotal Phase 3” Amoxil program is identifiable from the information provided in this request. As a result, this update is framed at the level of the drug’s market and evidence posture: mature, label-driven, and dependent on resistance trends and stewardship.

How big is the amoxicillin market and what portion is economically relevant to Amoxil?

Amoxil’s addressable revenue depends on how much of branded amoxicillin remains versus generic share in each geography. In most major markets, amoxicillin is largely generic and branded share is typically limited to:

• Contracted channel placements
• Pediatric formulation preferences where branded packaging or distribution is maintained
• Regions with less aggressive generic penetration

Market structure that governs Amoxil performance

Core drivers

• High baseline incidence of labeled acute infections (ENT, some dental infections, respiratory infections in susceptible cases)
• Low cost elasticity that pressures pricing downward as generics expand
• Antibiotic stewardship rules that reduce unnecessary use

Key constraints

• Resistance (particularly beta-lactamase producers) that shifts clinicians toward alternatives or combination therapies
• Safety scrutiny that can affect prescribing patterns in settings with high reported allergy history

Competitive positioning

For most buyers and prescribers, amoxicillin competes against:

• Other beta-lactams (amoxicillin-clavulanate, cephalosporins)
• Narrow-spectrum choices based on susceptibility and guidelines
• Broader empiric regimens in higher-resistance settings

In a generic-heavy market, differentiation is primarily commercial and formulation-related, not mechanism innovation.

What is the market outlook for amoxicillin through the next 5 years?

A reasonable projection for amoxicillin demand typically follows:

• Stable to modest growth in volume driven by persistent infection incidence and pediatric prescribing
• Declining or flat branded pricing driven by generics
• Market share shifts toward the most guideline-concordant formulations (including combinations when resistance increases)

Amoxil-specific outlook (branded)

For Amoxil as a brand, the typical branded trajectory in mature antibiotic categories is:

• Volume is largely stable where brand distribution persists
• Revenue growth is limited by generic price floors
• Upside can come from pediatric-focused dosing/formulations and channel-specific contracts
• Downside can come from stewardship tightening and resistance-led regimen changes

What are plausible revenue and share scenarios for Amoxil?

Because branded amoxicillin faces structurally lower pricing power than generics, projections are best expressed as scenario ranges tied to market price erosion and channel retention.

Scenario model (directional)

Scenario	Generic price erosion	Branded channel retention	Expected Amoxil revenue direction
Base case	Moderate continued erosion	Stable	Flat to low single-digit decline
Downside	Faster erosion + stewardship-driven downshift in antibiotic use	Weaker	Low to mid single-digit decline
Upside	Slower erosion + stronger pediatric/formulation channel	Improved	Low single-digit growth

Are there any new patents or defensible IP drivers for Amoxil?

Amoxil is an old small-molecule antibiotic with broad generic availability. Brand-level defensibility depends on:

• Formulation-specific protections (e.g., certain pediatric presentations)
• Manufacturing/packaging trademarks and trade dress
• Regulatory exclusivities only if tied to specific new formulations or combinations

In practice, for classic amoxicillin brands, primary patent estates have long expired, making future growth reliant on commercial execution rather than new IP-driven market creation.

Clinical development and regulatory status: what does “update” mean for Amoxil now?

For drugs at this stage, “updates” typically include:

• Label refinements based on updated susceptibility breakpoints
• New dosing guidance for pediatric and special populations
• Safety updates from pharmacovigilance
• Evidence synthesis informing stewardship and guideline alignment

No discrete phase-by-phase “trial pipeline” for Amoxil is the dominant narrative in the current evidence environment; the activity is mostly post-marketing and regulatory lifecycle management.

Market projection: summary numbers by horizon

Given the constraints of the request (no market sizing inputs or geography specified), the only defensible projection structure is directional. The projection below is expressed in terms of branded performance characteristics rather than hard revenue values.

Projection by horizon

Horizon	Branded amoxicillin behavior	Market forces that dominate
12-24 months	Pricing pressure remains the key driver; volume depends on channel	Generics, reimbursement, stewardship
3-5 years	Likely flat-to-declining branded revenue; substitution toward combinations in higher-resistance settings	Susceptibility patterns, guideline updates
5+ years	Brand share tends to consolidate into niche channels	Channel contracting, pediatric formulation preferences

What should investors and R&D planners watch next for Amoxil?

Clinical and guideline signals

• Label updates tied to susceptibility and dosing optimization
• Stewardship policy changes that reduce unnecessary antibiotic exposure
• Evidence on tolerability in pediatrics that affects prescribing

Market and commercial signals

• Generic price trajectory and regional inventory cycles
• Formulary status changes driven by payer policies
• Substitution rates to amoxicillin-clavulanate or cephalosporins in resistant cohorts

Key Takeaways

• Amoxil (amoxicillin) is in a mature, post-approval evidence cycle; updates are mainly label lifecycle refinements, PK/formulation studies, and comparative effectiveness work.
• Branded Amoxil faces structural pricing pressure from widespread generics, so branded revenue outlook is typically constrained to stable volume with declining pricing.
• Market performance is driven by infection incidence, stewardship intensity, and resistance-driven substitution toward combination regimens.
• A realistic projection for branded Amoxil is flat to modest decline in base case, with upside only if channel retention and pediatric/formulation placement counter generic erosion.
• The strategic focus for brand holders is commercial execution and formulation/channel defense, not new mechanism innovation.

FAQs

1) Is Amoxil still undergoing major Phase 3 trials?
The current lifecycle for amoxicillin is dominated by post-marketing studies and regulatory updates rather than new pivotal Phase 3 programs.

2) What drives Amoxil demand most?
The incidence of labeled acute bacterial infections and guideline-concordant prescribing decisions in pediatrics and ENT settings.

3) How does antibiotic resistance affect Amoxil?
Resistance, especially beta-lactamase mediated mechanisms, reduces susceptibility in some cohorts and pushes clinicians toward alternative regimens or combinations.

4) Why does Amoxil branded performance struggle versus generics?
Because amoxicillin is heavily generic, branded products experience ongoing pricing pressure and formulary competition.

5) What is the most credible way to grow branded Amoxil?
Pediatric-focused formulation and channel contracting that preserves share, rather than expecting mechanism-based IP expansion.

References

No sources were provided in the prompt, and none are cited above.