Zithromax

(Azithromycin)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Azithromycin is an antibiotic used to treat bacterial infections such as respiratory infections, ear infections, and sexually transmitted infections. It works by stopping bacteria from growing and multiplying.[2] Zithromax is currently approved and in use across 94 indications[4].[1]

Zithromax is one of 1008 small molecule programs targeting Asthma. It is currently in Approved.

Indications

377

Total Trials

Active Trials

1,007

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AsthmaCompleted

Typhoid FeverUnknown status

Mycoplasma Pneumoniae PneumoniaApproved

OsteomyelitisApproved

Eye DiseaseApproved

SepsisApproved

TuberculosisApproved

Bronchial DiseaseApproved

Inclusion ConjunctivitisApproved

Coronavirus Infectious DiseaseApproved

AsthmaApproved

Completed

Typhoid FeverApproved

Unknown status

Mycoplasma Pneumoniae PneumoniaApproved

Approved

OsteomyelitisApproved

Approved

Eye DiseaseApproved

Approved

SepsisApproved

Approved

TuberculosisApproved

Approved

Bronchial DiseaseApproved

Approved

Inclusion ConjunctivitisApproved

Approved

Coronavirus Infectious DiseaseApproved

Approved

Showing 10 of 89 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Zithromax

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

35 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

PPROM

NCT06396078

Q4 2027

Phase 3Recruiting

Sinusitis

NCT05157685

Phase 3Recruiting

Cesarean Delivery

NCT06605118

Q4 2028

Phase 2Recruiting

Complication

NCT06488781

Post-ApprovalRecruiting

Mycobacterium Avium Complex Pulmonary Disease

NCT07213765

Q1 2029

Phase 3Recruiting

Mycobacterium Avium Complex

NCT03236987

Clinical

Trials by Indication[1]

Azithromycin34 trials

A Study of Azithromycin in HIV-Infected Patients

Completed· Pfizer logo

Pfizer·Phase 1·NCT00002344·12 enrolled

Efficacy of Azithromycin as an Adjunct to Non-Surgical Periodontal Treatment

Completed·—·N/A·NCT03629288·18 enrolled

Improving Care Through Azithromycin Research for Infants in Africa

Active, not recruiting·BBarcelona Institute for Global Health·Phase 3·NCT04235816·20,560 enrolled

Show 31 more trials

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT02344628·583 enrolled

Cefixime / Azithromycin pK Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02708992·10 enrolled

A Single and Repeat Dose PK/PD Study to Characterise Biomarker Response in Healthy Subjects Treated With Azithromycin

Completed· GSK logo

GSK·Phase 1·NCT01416350·20 enrolled

Effect of Azithromycin in Preventing Premature Labour

Completed·—··NCT05465304·200 enrolled

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Completed·HHubert Ballard·Phase 2·NCT00319956·220 enrolled

Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Completed·LLaboratoires Thea·Phase 1·NCT00356772

Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire

Completed·FFHI 360·N/A·NCT04617626·1,735 enrolled

Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

Completed·UUniversity of California, San Francisco·Phase 4·NCT03682653·21,832 enrolled

Azithromycin Reduction to Reach Elimination of Trachoma

Completed·UUniversity of California, San Francisco·Phase 4·NCT04185402·3,931 enrolled

Gut and Azithromycin Mechanisms in Infants and Children II

Completed·UUniversity of California, San Francisco·Phase 4·NCT04315272·449 enrolled

Effect of Azithromycin on Oesophageal Hypomotility

Completed·JJAFAR JAFARI·Phase 2·NCT01448993·26 enrolled

A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS

Completed· Pfizer logo

Pfizer·Phase 1·NCT00000966·45 enrolled

Azithromycin for Preterm Pre-labor Rupture of Membranes

Completed·—·N/A·NCT04202380·300 enrolled

A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000947·850 enrolled

Community Health Azithromycin Trial in Burkina Faso

Completed·UUniversity of California, San Francisco·Phase 4·NCT03676764·77,664 enrolled

Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Unknown status·—·N/A·NCT03831269·30 enrolled

Cefixime Plus Doxycycline Compared to Ceftriaxone Plus Azithromycin for Treatment of Gonorrhoea

Completed·—·Phase 4·NCT06090565·161 enrolled

Azithromycin 600 Mg Tablets, Fed

Completed· Teva logo

Teva·Phase 1·NCT00834132·24 enrolled

Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes

Completed·—·Phase 4·NCT05118984·324 enrolled

Azithromycin 600 Mg Tablets, Fasting

Completed· Teva logo

Teva·Phase 1·NCT00834756·36 enrolled

Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy

Unknown status·WWaihong Chung·Phase 2·NCT03840057·435 enrolled

Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649935·54 enrolled

Azithromycin for Meibomian Gland Disease

Terminated·UUniversity of California, San Francisco·Phase 4·NCT03953118·2 enrolled

Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650273·54 enrolled

Comparing Efficacy of Tea Tree Oil Versus Topical Azithromycin in Treating Dry Eye

Not yet recruiting·EEhab Mohamed Elsayed Mohamed Saad·Phase 1/2·NCT06921525·44 enrolled

An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00879983·24 enrolled

Drug-Drug Interaction Study of Colchicine and Azithromycin

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983294·24 enrolled

Azithromycin and Coronary Events Study (ACES)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000617

Effect Of Azithromycin in Women at Risk of Preterm Labour

Unknown status·—·Phase 2/3·NCT05971654·200 enrolled

Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.

Unknown status·—·Phase 1/2·NCT03502356·400 enrolled

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Completed· Pfizer logo

Pfizer··NCT01227395·476 enrolled

COVID-1917 trials

Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO

Suspended·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT04341870·27 enrolled

Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19

Terminated·CChronic Obstructive Pulmonary Disease Trial Network, Denmark·Phase 2·NCT04322396·117 enrolled

Proactive Care of Ambulatory COVID19 Patients

Suspended·—·Phase 3·NCT04371107·11 enrolled

Show 14 more trials

Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

Completed·IIntermountain Health Care, Inc.·Phase 2·NCT04329832·85 enrolled

Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial

Terminated·—·Phase 3·NCT04339816·3 enrolled

International ALLIANCE Study of Therapies to Prevent Progression of COVID-19

Unknown status·NNational Institute of Integrative Medicine, Australia·Phase 2·NCT04395768·200 enrolled

Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)

Withdrawn·IInstitut de cancérologie Strasbourg Europe·Phase 2·NCT04392128

Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe COVID-19

Suspended·AAzidus Brasil·Phase 1·NCT04329572·400 enrolled

Effectiveness of Hydroxychloroquine in Covid-19 Patients

Unknown status·PProf. Dr. Umar Farooq·Phase 3·NCT04328272·75 enrolled

Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

Suspended·AAzidus Brasil·Phase 1·NCT04348474·200 enrolled

Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04358068·20 enrolled

Hydroxychloroquine, Azithromycin in the Treatment of Covid-19

Unknown status·CCentre Hôpital Universitaire Farhat Hached·Phase 3·NCT04405921·200 enrolled

Treatment for COVID-19 in High-Risk Adult Outpatients

Terminated·UUniversity of Washington·Phase 2/3·NCT04354428·289 enrolled

Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

Completed·SSt. Francis Hospital, New York·Phase 4·NCT04370782·18 enrolled

Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Unknown status·IIndonesia University·Phase 1·NCT04457609·40 enrolled

Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora

Unknown status·—·Phase 2·NCT04366089·152 enrolled

Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

Completed·SSouth Valley University·N/A·NCT04622891·300 enrolled

Pneumonia10 trials

Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia

Unknown status·JJiangxi Qingfeng Pharmaceutical Co. Ltd.·N/A·NCT04296383·450 enrolled

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 logo

Sanofi·Phase 4·NCT00237445·110 enrolled

Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients

Unknown status·FFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana·Phase 4·NCT02600806·500 enrolled

Show 7 more trials

Zithromax EV in Community-Acquired Pneumonia (CAP)

Completed· Pfizer logo

Pfizer·Phase 4·NCT00137007·151 enrolled

The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00809328·102 enrolled

Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19

Unknown status·GGrupo de Investigación Clínica en Oncología Radioterapia·N/A·NCT04380818·106 enrolled

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00643734·468 enrolled

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 logo

Pfizer·Phase 4·NCT00035347·219 enrolled

An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia

Completed· Pfizer logo

Pfizer·Phase 3·NCT00648726·139 enrolled

Treatment of Macrolide-resistant Mycoplasma Pneumoniae

Unknown status·NNational Taiwan University Hospital·N/A·NCT03530319·100 enrolled

Asthma8 trials

Personalized Treatment Algorithms for Difficult-to-treat Asthma

Completed·—·Phase 2·NCT04179461·21 enrolled

ASTHMA (AntibioticS To Help Manage Asthma) Pilot Study

Completed·WWisconsin Research Network·Phase 3·NCT00245908·100 enrolled

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.

Unknown status·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT01224977·20 enrolled

Show 5 more trials

Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Active, not recruiting·CCopenhagen Studies on Asthma in Childhood·Phase 2·NCT01233297·70 enrolled

AZISAST Study: AZIthromycin in Severe ASThma Study

Completed·UUniversity Hospital, Ghent·Phase 4·NCT00760838·109 enrolled

Azithromycin for Children Hospitalized With Asthma

Terminated·MMontefiore Medical Center·Phase 4·NCT02003911·159 enrolled

Azithromycin Treatment for Non-eosinophilic Chest Tightness Variant Asthma

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05596721·248 enrolled

Individualizing Treatment for Asthma in Primary Care (Full Study)

Recruiting·DDARTNet Institute·Phase 4·NCT07052942·3,200 enrolled

Mortality6 trials

Infant Mortality Reduction by the Mass Administration of Azithromycin

Active, not recruiting·UUniversity of California, San Francisco·Phase 4·NCT04716712·694,400 enrolled

Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali

Completed·TTampere University·Phase 3·NCT04424511·149,201 enrolled

Mortality Reduction After Oral Azithromycin: Morbidity Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT02048007·72,000 enrolled

Show 3 more trials

Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children

Unknown status·UUniversity of Washington·Phase 4·NCT02414399·1,400 enrolled

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

Recruiting·PPopulation Health Research Institute·Phase 3·NCT05580666·8,000 enrolled

Mortality Reduction After Oral Azithromycin: Mortality Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT02047981·190,238 enrolled

93 more indications

Cystic Fibrosis5 trials

Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

Completed·HHospices Civils de Lyon··NCT02803944·2,055 enrolled

Prevention of Bronchiectasis in Infants With Cystic Fibrosis

Completed·TThe University of Queensland·Phase 3·NCT01270074·130 enrolled

Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)

Completed·SSeattle Children's Hospital·Phase 4·NCT02677701·119 enrolled

Show 2 more trials

Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis

Completed·UUniversity of Colorado, Denver·N/A·NCT02372383·31 enrolled

Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa

Completed·CCF Therapeutics Development Network Coordinating Center·Phase 4·NCT00431964·263 enrolled

Mycobacterium Avium Complex4 trials

A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00002122·720 enrolled

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Completed·IInsmed Incorporated·Phase 3·NCT04677543·99 enrolled

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

Recruiting·—·Phase 3·NCT03236987·424 enrolled

Show 1 more trial

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Completed·IInsmed Incorporated·Phase 3·NCT04677569·425 enrolled

Cesarean Delivery4 trials

Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

Completed·—·Phase 4·NCT04062175·144 enrolled

The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Completed·UUniversity of Alabama at Birmingham··NCT01464840·30 enrolled

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Recruiting·TThe George Washington University Biostatistics Center·Phase 3·NCT06605118·8,000 enrolled

Show 1 more trial

Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean Delivery

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·N/A·NCT05647993·172 enrolled

Respiratory tract infection4 trials

Outpatient Registry Trial of Respiratory Tract Infections in Adults

Withdrawn·CCPL Associates·Phase 4·NCT00245453

Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

Terminated·MMaisonneuve-Rosemont Hospital·Phase 2·NCT01432080·12 enrolled

KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00132951·2,051 enrolled

Show 1 more trial

Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

Completed· Pfizer logo

Pfizer··NCT00939185·400 enrolled

Sinusitis4 trials

Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis

Terminated·CCPL Associates·Phase 4·NCT00245440·192 enrolled

Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

Completed·MMahidol University·N/A·NCT00944515·40 enrolled

Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults

Recruiting·—·Phase 3·NCT05157685·230 enrolled

Show 1 more trial

Zmax Compared to Augmentin in Sinusitis

Completed· Pfizer logo

Pfizer·Phase 4·NCT00367120·762 enrolled

Pregnant Women3 trials

Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage

Completed·—·Phase 4·NCT04278937·50 enrolled

Transplacental Transfer of Drugs Used in Pregnant Women

Completed·UUniversity Hospital, Gasthuisberg·N/A·NCT02622802·250 enrolled

Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial

Unknown status·VVital Pakistan Trust·N/A·NCT04012177·1,884 enrolled

Chronic Obstructive Pulmonary Disease3 trials

Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy

Terminated·UUniversity of Milan·Phase 2·NCT00323986·30 enrolled

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Completed·NNYU Langone Health·Phase 1·NCT02557958·19 enrolled

Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease

Completed·RR.S. Djamin·N/A·NCT00985244·92 enrolled

Acne Vulgaris3 trials

Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris

Active, not recruiting·HHayatabad Medical Complex·Phase 4·NCT07384793·60 enrolled

the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 2·NCT00419848·100 enrolled

Vitamin A and Azithromycin for Acne Vulgaris

Unknown status·MManchanda Medical Clinic·Phase 1·NCT03090048·30 enrolled

TED2 trials

Zoliflodacin in Uncomplicated Gonorrhoea

Completed·GGlobal Antibiotics Research and Development Partnership·Phase 3·NCT03959527·1,011 enrolled

Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Completed·LLaboratoires Thea·Phase 1·NCT00357383

Gonorrhea2 trials

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Completed· GSK logo

GSK·Phase 3·NCT04010539·628 enrolled

Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

Completed·MMelinta Therapeutics, Inc.·Phase 3·NCT02210325·264 enrolled

Chronic Rhinosinusitis2 trials

Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT01825408·40 enrolled

Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy

Completed·—·Phase 4·NCT02307825·129 enrolled

Bronchiolitis2 trials

Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis

Completed·WWashington University School of Medicine·Phase 2·NCT01486758·40 enrolled

Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II

Completed·WWashington University School of Medicine·Phase 2/3·NCT02911935·200 enrolled

Lung Disease2 trials

Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

Completed·TThe University of Texas Health Science Center at Tyler·Phase 4·NCT00598962·58 enrolled

Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

Unknown status·OOdense University Hospital·Phase 4·NCT00132860·800 enrolled

Antibiotics2 trials

Antibiotics for Children With Severe Diarrhoea

Completed·WWorld Health Organization·Phase 3·NCT03130114·8,268 enrolled

Intrapulmonary Pharmacokinetics of Antibiotics

Terminated·UUniversity of Illinois at Chicago·Phase 4·NCT00315601·35 enrolled

Blepharitis2 trials

Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

Completed·LLaboratoires Thea·Phase 2·NCT01089608·93 enrolled

Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

Completed·TTehran University of Medical Sciences·Phase 2·NCT01783860·100 enrolled

Diarrhea2 trials

Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct

Recruiting·HHenry M. Jackson Foundation for the Advancement of Military Medicine·Phase 4·NCT05677282·150 enrolled

Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00359970·176 enrolled

Clinical Trial2 trials

A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery

Completed· Pfizer logo

Pfizer·Phase 2·NCT00644176·66 enrolled

A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)

Completed·UUniversity of Oxford·Phase 3·NCT04381962·298 enrolled

Abortion1 trial

A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions

Completed·MMedstar Health Research Institute·N/A·NCT02756403·181 enrolled

Bacterial Infections1 trial

A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000811·690 enrolled

Mycobacterium Avium Complex Pulmonary Disease1 trial

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

Recruiting·BBin Cao·Phase 4·NCT07213765·188 enrolled

Chronic Graft Versus Host Disease1 trial

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT04294641·10 enrolled

Mycobacterium1 trial

An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy

Completed· Pfizer logo

Pfizer·N/A·NCT00002089

Corticosteroids1 trial

Eosinophil-guided Reduction of Inhaled Corticosteroids

Completed·CChronic Obstructive Pulmonary Disease Trial Network, Denmark·Phase 4·NCT04481555·444 enrolled

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Recruiting·OOhio State University·Phase 4·NCT06396078·56 enrolled

Mycoplasma pneumoniae pneumonia1 trial

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Terminated·—·N/A·NCT01217099·47 enrolled

Malnutrition1 trial

Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

Completed·WWashington University School of Medicine·N/A·NCT03079388·1,489 enrolled

Bone Marrow Transplantation1 trial

Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation

Completed·HHospital Authority, Hong Kong·N/A·NCT00563251·30 enrolled

Recruiting·UUniversity of Oklahoma·Phase 2·NCT06488781·787 enrolled

Allergic Contact Dermatitis1 trial

Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides

Not yet recruiting·—··NCT06574204·30 enrolled

Immune Deficiency1 trial

An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)

Completed· Pfizer logo

Pfizer·N/A·NCT00002090

Conjunctivitis1 trial

The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Completed·NNational Taiwan University Hospital·N/A·NCT01178762·42 enrolled

Sickle Cell Disease1 trial

Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease

Withdrawn·VVanderbilt University·Phase 1/2·NCT02960503

Inflammation1 trial

Preschool Wheeze: Inflammation/Infection Guided Management

Completed·IImperial College London·Phase 2·NCT02517099·60 enrolled

SARS CoV 2 Infection1 trial

Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

Terminated·—·Phase 2·NCT04335552·11 enrolled

Cardiovascular1 trial

Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients With Increased CD4 Cells Counts Following Anti-HIV Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000883·636 enrolled

Bronchiectasis1 trial

Bronchiectasis and Long Term Azithromycin Treatment

Completed·WW.G.Boersma·Phase 3·NCT00415350·72 enrolled

Ciprofloxacin1 trial

Ciprofloxacin Multiple Dose for Adult Cholera

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00741052·218 enrolled

Abscess1 trial

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Lung Transplantation1 trial

Peri-operative Azithromycin to Improve Early Allograft Function and Outcome After Lung Transplantation

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01915082·70 enrolled

HIV-Infected Individuals1 trial

A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000641·90 enrolled

Lymphatic Filariasis1 trial

Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis

Withdrawn·EEmory University·Phase 4·NCT01903057

Cryptosporidiosis1 trial

Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

Completed· Pfizer logo

Pfizer·N/A·NCT00002328

Idiopathic Pulmonary Fibrosis1 trial

Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Recruiting·—·N/A·NCT05842681·30 enrolled

Ventilator-Associated Pneumonia1 trial

Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia

Terminated·AAnbics Management-Services Ag·Phase 2·NCT00610623·92 enrolled

Chronic Lung Disease1 trial

The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT02544984·60 enrolled

Mycobacterium avium complex disease1 trial

A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

Completed· Pfizer logo

Pfizer·N/A·NCT00002309

Multiple Sclerosis1 trial

Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00043264·40 enrolled

Mycoplasma Genitalium1 trial

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

Completed·UUniversity of Washington·Phase 3·NCT00358462·606 enrolled

Respiratory Failure1 trial

Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02707523·48 enrolled

Adult Subject1 trial

A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01100060·40 enrolled

Neonatal Infection1 trial

Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

Not yet recruiting·—·Phase 4·NCT06958146·400 enrolled

Pulmonary Tuberculosis1 trial

Azithromycin as Host-directed Therapy for Pulmonary Tuberculosis

Completed·UUniversity Medical Center Groningen·Phase 2·NCT03160638·24 enrolled

Antibiotic Prophylaxis1 trial

Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

Unknown status·RRWJ Barnabas Health at Jersey City Medical Center·Phase 2·NCT03960970·800 enrolled

Tolerance1 trial

Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

Completed·LLaboratoires Thea·Phase 1·NCT00357292

Heart Disease1 trial

Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease

Terminated·CCadrock Pty. Ltd.·Phase 2·NCT03618108·20 enrolled

Plasmodium Falciparum1 trial

Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis

Withdrawn·RRadboud University Medical Center·Phase 1/2·NCT01783340

Fluoroquinolone1 trial

Fluoroquinolone Associated Disability

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT03535558·239,306 enrolled

Double-blind1 trial

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

Completed· Pfizer logo

Pfizer·Phase 3·NCT00644293·598 enrolled

Growth1 trial

Protein Plus: Improving Infant Growth Through Diet and Enteric Health

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 2/3·NCT03683667·5,283 enrolled

Typhoid Fever1 trial

Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children

Completed·ZZiauddin University·Phase 4·NCT04154722·126 enrolled

Tics1 trial

Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers

Completed·LLaboratoires Thea·Phase 1·NCT00357539

Pertussis1 trial

Bordetella Pertussis Colonisation Challenge Study

Unknown status·UUniversity of Southampton·N/A·NCT03751514·80 enrolled

Pre-Term1 trial

The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant

Completed·IIndonesia University·Phase 4·NCT05311228·120 enrolled

Child Health1 trial

Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia

Withdrawn·—·Phase 4·NCT04171388

Bacterial Conjunctivitis1 trial

Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis

Completed·LLaboratoires Thea·Phase 3·NCT00357773

Familial adenomatous polyposis1 trial

Azithromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 4·NCT04454151·10 enrolled

Randomized Controlled Trial1 trial

Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

Completed·TThomas Jefferson University·Phase 4·NCT04294069·6 enrolled

Nausea and vomiting1 trial

Effect of Using Azithromycin Versus Placebo With Dexamethasone in Prevention of Post-spinal Nausea and Vomiting.

Unknown status·—·Phase 4·NCT03165123·160 enrolled

Skin Inflammation1 trial

Skin Inflammation and PK of Azithromycin

Not yet recruiting·MMedical University of Vienna·N/A·NCT06170983·36 enrolled

Enteric Fever1 trial

Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever

Recruiting·IIndus Hospital and Health Network·Phase 4·NCT07314281·40 enrolled

Neonatal sepsis1 trial

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT03199547·11,985 enrolled

Antibiotic Therapy1 trial

Influence of Short-Term Antibiotic Therapy on Exercise

Recruiting·RRutgers, The State University of New Jersey·Phase 1·NCT05961189·40 enrolled

Chronic Periodontitis1 trial

The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Completed·IIsfahan University of Medical Sciences·Phase 2·NCT01921738·80 enrolled

Injury1 trial

Azithromycin in the Prevention of Lung Injury in Premature Newborn

Completed·HHospital de Clinicas de Porto Alegre·Phase 4·NCT03485703·80 enrolled

Bronchiolitis Obliterans1 trial

Azithromycin in Bronchiolitis Obliterans Syndrome

Completed·KKU Leuven·Phase 4·NCT01009619·83 enrolled

Severe Acute Respiratory Syndrome1 trial

Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Withdrawn·IInternational Brain Research Foundation·Phase 1·NCT04590274

Bacterial Disease1 trial

A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

Completed· Pfizer logo

Pfizer·N/A·NCT00002085

Infection1 trial

TINN2: Treat Infection in NeoNates 2

Withdrawn·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT02282176

Fasting Conditions1 trial

A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00830336·80 enrolled

Pediatric Patients1 trial

PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients

Terminated· Pfizer logo

Pfizer·Phase 2·NCT01919996·8 enrolled

Chronic Bronchitis1 trial

A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT00649831·250 enrolled

Premature rupture of membranes1 trial

Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes

Withdrawn·IIndiana University·Phase 3·NCT01556334

Otitis media1 trial

TELI COM - Telithromycin in Children With Otitis Media

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00315003·1,500 enrolled

Malaria1 trial

Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)

Unknown status·UUnknown Sponsor·N/A·NCT03944317·168 enrolled

Pulmonary Sarcoidosis1 trial

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

Completed·VVanderbilt University·Phase 2·NCT02024555·97 enrolled

Antibiotic1 trial

A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

Completed·AAbbott·Phase 4·NCT00644774·157 enrolled

HIV infection1 trial

A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000895·85 enrolled

Preoperative1 trial

The Effect of Preoperative Antibiotics on Peri-implant Healing

Unknown status·UUniversité de Montréal·Phase 1·NCT04280406·50 enrolled

Immunology1 trial

Chlamydia Trachomatis Immunology and Vaccinology Study

Completed·HHarold Wiesenfeld··NCT01150747·347 enrolled

Meibomian Gland Dysfunction1 trial

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

Completed·MMedical University of Vienna·Phase 4·NCT03162497·23 enrolled

Unspecified2 trials

International Milk Composition (IMiC) Consortium

Active, not recruiting·UUniversity of Manitoba··NCT05119166·1,000 enrolled

Hypertonic Saline for MAC

Recruiting·OOregon Health and Science University·Phase 4·NCT04921943·50 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 1, 1991

ZITHROMAX

NDA NDA050670

Sep 28, 1994

ZITHROMAX

NDA NDA050693

Oct 19, 1995

ZITHROMAX

NDA NDA050710

Jun 12, 1996

ZITHROMAX

NDA NDA050730

Jul 18, 1996

ZITHROMAX

NDA NDA050711

Jan 30, 1997

ZITHROMAX

NDA NDA050733

May 24, 2002

ZITHROMAX

NDA NDA050784

Jun 10, 2005

ZMAX

NDA NDA050797

Dec 19, 2006

AZITHROMYCIN

NDA NDA050809

Apr 27, 2007

AZASITE

NDA NDA050810

Sources

References

[1]
ClinicalTrials.gov — 377 trial records for Azithromycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zithromax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Azithromycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Azithromycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050810). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Zithromax

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2028

Q1 2029

Trials by Indication[1]

Azithromycin34 trials

COVID-1917 trials

Pneumonia10 trials

Asthma8 trials

Mortality6 trials

Cystic Fibrosis5 trials

Mycobacterium Avium Complex4 trials

Cesarean Delivery4 trials

Respiratory tract infection4 trials

Sinusitis4 trials

Pregnant Women3 trials

Chronic Obstructive Pulmonary Disease3 trials

Acne Vulgaris3 trials

TED2 trials

Gonorrhea2 trials

Chronic Rhinosinusitis2 trials

Bronchiolitis2 trials

Lung Disease2 trials

Antibiotics2 trials

Blepharitis2 trials

Diarrhea2 trials

Clinical Trial2 trials

Abortion1 trial

Bacterial Infections1 trial

Mycobacterium Avium Complex Pulmonary Disease1 trial

Chronic Graft Versus Host Disease1 trial

Mycobacterium1 trial

Corticosteroids1 trial

PPROM1 trial

Mycoplasma pneumoniae pneumonia1 trial

Malnutrition1 trial

Bone Marrow Transplantation1 trial

Effectiveness1 trial

Endometritis1 trial

Complication1 trial

Allergic Contact Dermatitis1 trial

Immune Deficiency1 trial

Conjunctivitis1 trial

Sickle Cell Disease1 trial

Inflammation1 trial

SARS CoV 2 Infection1 trial

Cardiovascular1 trial

Bronchiectasis1 trial

Ciprofloxacin1 trial

Abscess1 trial

Lung Transplantation1 trial

HIV-Infected Individuals1 trial

Lymphatic Filariasis1 trial

Cryptosporidiosis1 trial

Idiopathic Pulmonary Fibrosis1 trial

Ventilator-Associated Pneumonia1 trial

Chronic Lung Disease1 trial

Mycobacterium avium complex disease1 trial

Multiple Sclerosis1 trial

Mycoplasma Genitalium1 trial

Respiratory Failure1 trial

Adult Subject1 trial

Neonatal Infection1 trial

Pulmonary Tuberculosis1 trial

Antibiotic Prophylaxis1 trial

Tolerance1 trial

Heart Disease1 trial

Plasmodium Falciparum1 trial

Fluoroquinolone1 trial

Double-blind1 trial

Growth1 trial

Typhoid Fever1 trial

Tics1 trial

Pertussis1 trial

Pre-Term1 trial

Child Health1 trial