CLINICAL TRIALS PROFILE FOR ZITHROMAX

505(b)(2) Clinical Trials for ZITHROMAX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	National Institute for Medical Research, Tanzania	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.

All Clinical Trials for ZITHROMAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035347 ↗	Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia	Completed	Pfizer	Phase 4	2001-01-01	A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
NCT00137007 ↗	Zithromax EV in Community-Acquired Pneumonia (CAP)	Completed	Pfizer	Phase 4	2003-11-01	The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide. This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.
NCT00237445 ↗	Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days	Terminated	Sanofi	Phase 4	2005-11-01	A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days
NCT00266851 ↗	AZMATICS: AZithroMycin/Asthma Trial In Community Settings	Completed	American Academy of Family Physicians	Phase 3	2006-01-01	The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
NCT00266851 ↗	AZMATICS: AZithroMycin/Asthma Trial In Community Settings	Completed	Dean Foundation	Phase 3	2006-01-01	The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence

Clinical Trial Conditions for ZITHROMAX

Condition Name

Condition Name for ZITHROMAX
Intervention	Trials
Trachoma	8
Healthy	7
Malaria	6
COVID-19	5

Condition MeSH

Condition MeSH for ZITHROMAX
Intervention	Trials
Infections	13
Communicable Diseases	11
Infection	11
Trachoma	8

Clinical Trial Locations for ZITHROMAX

Trials by Country

Trials by Country for ZITHROMAX
Location	Trials
United States	201
Canada	15
France	14
Australia	11
United Kingdom	8

Trials by US State

Trials by US State for ZITHROMAX
Location	Trials
California	20
Maryland	12
Texas	9
Ohio	8
North Carolina	8

Clinical Trial Progress for ZITHROMAX

Clinical Trial Phase

Clinical Trial Phase for ZITHROMAX
Clinical Trial Phase	Trials
Phase 4	34
Phase 3	17
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for ZITHROMAX
Clinical Trial Phase	Trials
Completed	62
Recruiting	13
Not yet recruiting	9

Clinical Trial Sponsors for ZITHROMAX

Sponsor Name

Sponsor Name for ZITHROMAX
Sponsor	Trials
University of California, San Francisco	16
Pfizer	15
Bill and Melinda Gates Foundation	10

Sponsor Type

Sponsor Type for ZITHROMAX
Sponsor	Trials
Other	212
Industry	35
NIH	11

Clinical Trials Update, Market Analysis, and Projection for ZITHROMAX

Last updated: October 27, 2025

Introduction

ZITHROMAX, the brand name for azithromycin, is a widely prescribed macrolide antibiotic indicated for a broad spectrum of bacterial infections. Over recent years, shifts in clinical trial data, evolving resistance patterns, and market dynamics have influenced ZITHROMAX's positioning within the antimicrobial landscape. This report synthesizes current clinical development updates, analyzes market trajectories, and projects future growth for ZITHROMAX, providing critical insights for stakeholders.

Clinical Trials Update

Ongoing and Recent Clinical Trials

ZITHROMAX remains active in clinical research, particularly targeting resistant bacterial strains, novel formulations, and adjunct therapies to enhance efficacy. As of the latest data, several trials focus on:

• Resistance Management: Trials evaluating azithromycin's efficacy against resistant respiratory pathogens, including multi-drug resistant Streptococcus pneumoniae and Mycoplasma pneumoniae, are ongoing. These studies aim to determine optimal dosing strategies to mitigate resistance development.

• COVID-19 Research: Multiple phase IV studies have assessed azithromycin's role as an adjunct in COVID-19 management. Although initial hope was for broad antiviral or immunomodulatory effects, recent data indicates limited benefit, which has tempered its use in this context.

• Pediatric and Special Population Use: Trials examining safety, dosing, and efficacy of ZITHROMAX in pediatric populations and immunocompromised patients continue, clarifying its expanding utilization scope.

Regulatory and Labeling Developments

Recent regulatory updates confirm expanded indications in specific regions; for instance, the European Medicines Agency (EMA) approved a revised label for azithromycin emphasizing its use in community-acquired pneumonia and certain sexually transmitted infections. Conversely, regulatory agencies have issued warnings regarding adverse effects, particularly related to QT prolongation and cardiac arrhythmias, necessitating careful patient selection [1].

Emerging Challenges in Clinical Development

The primary clinical challenge remains resistance. The World Health Organization classifies azithromycin as a “Highest Priority Critically Important Antimicrobial” [2], underscoring the importance of stewardship. Consequently, trial designs increasingly incorporate resistance monitoring and stewardship strategies to sustain azithromycin's utility.

Market Analysis

Market Landscape and Key Players

ZITHROMAX competes within a competitive antimicrobial market dominated by generic azithromycin and alternative antibiotics like clarithromycin. Major pharmaceutical players, including Pfizer (market rights holder), Teva, and Sandoz, offer generic formulations, exerting downward pressure on pricing.

According to IQVIA, global azithromycin sales reach approximately $2.8 billion annually, with a CAGR of around 4.5% over five years [3]. North America and Europe constitute substantial markets, driven by respiratory infections and sexually transmitted diseases.

Market Drivers

• Rising Incidence of Respiratory and Sexually Transmitted Infections: Increased prevalence of pneumonia, bronchitis, and STDs sustains demand.

• Expansion into New Indications: Off-label uses and emerging research into expanding indications may fuel future growth.

• Developing Market Penetration: Growing healthcare access in Asia-Pacific and Latin America presents opportunities, especially for generic formulations.

Market Constraints

• Antimicrobial Resistance (AMR): Increasing resistance limits azithromycin’s effectiveness, prompting regulatory bodies and hospitals to restrict usage, potentially impacting sales.

• Safety Concerns: Warnings related to cardiac risks have led to cautious prescribing, especially in vulnerable populations.

• Pricing Pressures: Intense generic competition compresss margins, impairing profitability.

Regulatory and Commercial Strategies

The manufacturer’s strategic focus on stewardship programs, combination therapy development, and targeted marketing aims to preserve ZITHROMAX’s market share amidst generics and resistance challenges.

Market Projection

Short-term Outlook (Next 1-2 Years)

Expect moderate growth, averaging 3-5% annually, driven by continued demand for respiratory and STD infections and incremental gains in emerging markets. Clinical trials addressing resistance could bolster the drug’s clinical utility, potentially leading to expanded indications.

Medium to Long-term Outlook (3-5 Years)

Forecasting annual sales approaching $3.5 billion hinges on successful resistance management and the introduction of novel formulations such as extended-release (ER) versions, which may improve patient compliance. However, the impact of increased AMR and safety alerts may temper growth.

Potential Growth Opportunities

• Novel Formulations: Extended-release azithromycin could enhance adherence and broaden usage contexts.

• Combination Therapies: Synergistic formulations with other antibiotics or immunomodulators could open new indications.

• Precision Medicine: Patient-specific prescribing based on resistance profiles could optimize outcomes and retain market relevance.

Risks to Projection

• AMR escalation reducing effectiveness.

• Regulatory restrictions on use and labeling.

• Pricing pressures due to increasing generic competition.

Key Takeaways

• Clinical trials focusing on resistance and expanded indications are pivotal for ZITHROMAX’s future positioning. The drug’s efficacy against resistant pathogens will influence prescribing trends.

• Market dynamics are challenged by antibiotic resistance and generics, necessitating strategic innovation and stewardship efforts.

• Growth projections remain cautiously optimistic, with targeted development of formulations and indications likely to drive incremental revenue gains.

• Regulatory landscape adjustments and safety concerns may impact prescribing patterns and, consequently, sales volume.

• Emerging markets and combinatorial approaches represent viable avenues for sustained growth.

Conclusion

ZITHROMAX continues to serve as a cornerstone in bacterial infection management, its clinical trajectory intertwined with combating resistance and evolving regulatory standards. Strategic investment in novel formulations, stewardship, and indication expansion will be critical for maintaining market relevance amid intensified competition and antimicrobial stewardship imperatives.

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FAQs

1. How is antibiotic resistance affecting ZITHROMAX’s market prospects?
Antibiotic resistance, particularly among respiratory pathogens, diminishes azithromycin’s efficacy, leading to cautious prescribing and regulatory restrictions. This resistance trend could limit future sales unless strategies such as combination therapy or stewardship mitigate its impact.

2. Are there ongoing clinical trials to extend ZITHROMAX’s indications?
Yes. Current trials explore resistance management, new formulations like extended-release versions, and potential uses in emerging infectious diseases, aiming to expand utilization and improve adherence.

3. What safety concerns are associated with ZITHROMAX, and how do they influence market dynamics?
Warnings regarding QT prolongation and arrhythmias have led to stricter prescribing guidelines, especially for at-risk populations. While safety concerns can constrain prescribing, they also reinforce the importance of clinician vigilance and stewardship.

4. What are the key growth opportunities for ZITHROMAX in emerging markets?
Expanding healthcare access, increasing infectious disease prevalence, and local manufacturing enable growth opportunities. Tailored marketing and stewardship protocols are essential to tap into these markets responsibly.

5. How might new formulations influence ZITHROMAX’s future?
Extended-release and combination formulations could enhance compliance, broaden indications, and differentiate the product amid generic competition, supporting sustained revenue streams.

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References

[1] European Medicines Agency (EMA). (2022). Azithromycin - Summary of Product Characteristics.
[2] World Health Organization (WHO). (2019). Critically Important Antimicrobials for Human Medicine.
[3] IQVIA. (2022). Global Antibiotic Market Report.