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 93 indications[4].[1]

Zithromax is one of 970 small molecule programs targeting Typhoid Fever. It is currently in Approved.

Indications

380

Total Trials

Active Trials

969

Competitors

117

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Typhoid FeverUnknown status

Mycoplasma Pneumoniae PneumoniaApproved

AsthmaTerminated

OsteomyelitisApproved

Eye DiseaseApproved

SepsisApproved

TuberculosisApproved

Bronchial DiseaseApproved

Inclusion ConjunctivitisApproved

Coronavirus Infectious DiseaseApproved

Typhoid FeverApproved

Unknown status

Mycoplasma Pneumoniae PneumoniaApproved

Approved

AsthmaApproved

Terminated

OsteomyelitisApproved

Approved

Eye DiseaseApproved

Approved

SepsisApproved

Approved

TuberculosisApproved

Approved

Bronchial DiseaseApproved

Approved

Inclusion ConjunctivitisApproved

Approved

Coronavirus Infectious DiseaseApproved

Approved

Showing 10 of 88 indications

Competition

Competitive Landscape

309 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

Activella

Eli Lilly

Preclinical

—5

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 6

Benadryl

PParkedale

Preclinical

1 7

Nitrostat

VViatris Specialty LLC

Preclinical

1 8

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 9

Singulair

AstraZeneca

Preclinical

1 10

Biological Data

UUniversity Hospital, Bordeaux

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

PPROM

NCT06396078

Q4 2028

Phase 2Recruiting

Complication

NCT06488781

Post-ApprovalRecruiting

Malnutrition

NCT06010719

Post-ApprovalRecruiting

Mycobacterium Avium Complex Pulmonary Disease

NCT07213765

Q4 2029

Post-ApprovalRecruiting

Asthma

NCT07052942

Q2 2030

Phase 2/3Recruiting

Abscess

NCT04310930

Clinical

Trials by Indication[1]

Azithromycin37 trials

Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00564447·48 enrolled

An Open Label Trial of Azithromycin in Chronic Productive Cough

Unknown status·UUniversity of Nottingham·Phase 3·NCT02196493·50 enrolled

Azithromycin for Acute Exacerbations Requiring Hospitalization

Terminated·WWim Janssens·Phase 3·NCT02135354·301 enrolled

Show 34 more trials

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

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

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

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Completed· Pfizer logo

Pfizer··NCT01227395·476 enrolled

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

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

Azithromycin Reduction to Reach Elimination of Trachoma B

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT06289647

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Completed·JJohns Hopkins University·Phase 4·NCT00347776·1,452 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-Prevention in Labor Use Study (A-PLUS)

Completed·NNICHD Global Network for Women's and Children's Health·Phase 3·NCT03871491·58,747 enrolled

Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection

Terminated·WWashington University School of Medicine·Phase 3·NCT04341727·30 enrolled

A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients

Completed·UUniversity of Ibadan·Phase 1·NCT02527005·140 enrolled

The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT04349826·2,150 enrolled

A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants

Completed·SSpero Therapeutics·Phase 1·NCT05966688·39 enrolled

Azithromycin in Control of Trachoma II

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT00286026

Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management

Completed·—·Phase 1·NCT07394725·250 enrolled

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

Completed·LLihir Medical Centre·Phase 2·NCT03664063·42 enrolled

An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 1·NCT00760279·16 enrolled

Treatment of ppROM With Erythromycin vs. Azithromycin Trial

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 3·NCT03060473·21 enrolled

Single Dose Azithromycin in the Treatment of Adult Cholera

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00229944·220 enrolled

COVID-1917 trials

Azithromycin in Hospitalized COVID-19 Patients

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 4·NCT04359316·40 enrolled

Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Completed·SShehnoor Azhar·Phase 3·NCT04338698·550 enrolled

OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome

Withdrawn·FFondation Hôpital Saint-Joseph·Phase 3·NCT04365582

Show 14 more 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

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

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

Completed·IIna-Respond·Phase 3·NCT04613271·130 enrolled

Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

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

Proactive Care of Ambulatory COVID19 Patients

Suspended·—·Phase 3·NCT04371107·11 enrolled

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

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease

Terminated·LLCMC Health·Phase 3·NCT04344444·22 enrolled

The Effect of Azithromycin Use on Conduction System of Heart in COVID-19 Positive Children

Completed·KKayseri City Hospital··NCT04699097·105 enrolled

Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19

Terminated·UUniversity Hospital, Strasbourg, France·Phase 3·NCT04359953·16 enrolled

Bacteriotherapy in the Treatment of COVID-19

Unknown status·UUniversity of Roma La Sapienza··NCT04368351·70 enrolled

Pneumonia8 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

Treatment of Macrolide-resistant Mycoplasma Pneumoniae

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

Show 5 more trials

Treatment and Vaccine Development of Mycoplasma Pneumoniae

Unknown status·NNational Taiwan University Hospital·N/A·NCT03911440·100 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

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

Respiratory tract infection7 trials

Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT01778634·121 enrolled

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

Show 4 more trials

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

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

Completed· Pfizer logo

Pfizer··NCT00939185·400 enrolled

Mycoplasma Infection Rate and Macrolides Resistance in Children With Acute Respiratory Tract Infection

Unknown status·SShanghai Children's Medical Center··NCT04126304·2,312 enrolled

Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT03341273·514 enrolled

Asthma7 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

AZMATICS: AZithroMycin/Asthma Trial In Community Settings

Completed·UUniversity of Wisconsin, Madison·Phase 3·NCT00266851·97 enrolled

Show 4 more trials

Individualizing Treatment for Asthma in Primary Care (Full Study)

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

Antibiotic Treatment of Recurrent Episodes of Asthma in Children

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

Azithromycin Treatment for the Airway Microbiome in Asthma

Terminated·UUniversity of Chicago·Phase 2·NCT03736629·17 enrolled

81 more indications

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: Mortality Study

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

Show 3 more trials

Mortality Reduction After Oral Azithromycin: Morbidity Study

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

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

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

Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT03338244·66,228 enrolled

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

The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis

Unknown status·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT02531984·100 enrolled

Trial4 trials

BACE Trial Substudy 1 - PROactive Substudy

Completed·WWim Janssens·Phase 3·NCT02205242·60 enrolled

Nepal Undifferentiated Febrile Illness Trial

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 3·NCT02773407·330 enrolled

MORDOR II Burkina Faso: Longitudinal Trial

Completed·UUniversity of California, San Francisco·Phase 4·NCT03676751·500 enrolled

Show 1 more trial

EAT-DUTA AndroCoV Trial

Completed·CCorpometria Institute·Phase 2/3·NCT04729491·138 enrolled

Gonorrhea4 trials

Efficacy of Combination Therapies for Gonorrhea Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00926796·614 enrolled

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

Show 1 more trial

Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea

Completed·IInstitute of Tropical Medicine, Belgium·Phase 4·NCT05027516·42 enrolled

Antibiotics4 trials

Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02707042·108 enrolled

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

Show 1 more trial

Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT03545373·1,583 enrolled

Malnutrition3 trials

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

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

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT06010719·3,000 enrolled

Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

Completed·UUniversity of California, San Francisco·Phase 3·NCT03568643·301 enrolled

Chronic Obstructive Pulmonary Disease3 trials

Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease

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

Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)

Unknown status·UUniversity College, London·Phase 3·NCT01398072·200 enrolled

Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease

Terminated·JJohns Hopkins University·Phase 2·NCT00181272·18 enrolled

Blepharitis3 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

Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Terminated·SSouthern California Institute for Research and Education·N/A·NCT01560962·100 enrolled

Cesarean Delivery2 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

Efficacy and Safety2 trials

Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma

Completed·LLaboratoires Thea·Phase 3·NCT00356720

Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)

Withdrawn·—·Phase 4·NCT04351919

Lung Disease2 trials

Azithromycin in the Treatment of M. Avium Complex Lung Disease

Completed·TThe University of Texas Health Science Center at Tyler·Phase 4·NCT00599079·66 enrolled

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

Treatment2 trials

Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT03032042

Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

Terminated·UUniversity of New Mexico·Phase 2·NCT04458948·28 enrolled

Pregnancy2 trials

Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT03862495·200 enrolled

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Completed·UUniversity of Wisconsin, Madison··NCT00214331·150 enrolled

Pulmonary Sarcoidosis2 trials

Azithromycin a Treatment for Pulmonary Sarcoidosis

Completed·HHull University Teaching Hospitals NHS Trust·Phase 2·NCT04020380·21 enrolled

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

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

Corticosteroids2 trials

Eosinophil-guided Reduction of Inhaled Corticosteroids

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

Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT01272635·607 enrolled

Mycobacterium Avium Complex2 trials

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

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

Pregnant Women2 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

Complication2 trials

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

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

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term

Completed·UUniversity of Oklahoma·Phase 1·NCT03801252·186 enrolled

Idiopathic Pulmonary Fibrosis2 trials

Azithromycin in Idiopathic Pulmonary Fibrosis

Completed·IInsel Gruppe AG, University Hospital Bern·N/A·NCT02173145·27 enrolled

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

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

Antibiotic2 trials

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

Completed·AAbbott·Phase 4·NCT00644774·157 enrolled

Antibiotic Treatment Trial for the PANDAS/PANS Phenotype

Completed·UUniversity of South Florida·Phase 2·NCT01617083·47 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

Cryptosporidiosis2 trials

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

Completed· Pfizer logo

Pfizer·N/A·NCT00002328

Treatment of Chronic Cryptosporidiosis in AIDS Patients

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001128·16 enrolled

Chronic Lung Disease2 trials

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

Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT02426112·347 enrolled

Mycobacterium avium complex disease2 trials

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

Completed· Pfizer logo

Pfizer·N/A·NCT00002309

Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

Completed·KKevin Winthrop·Phase 2/3·NCT03672630·474 enrolled

Sinusitis2 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

Mycoplasma Genitalium2 trials

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

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

Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced

Unknown status·OOstergotland County Council, Sweden·Phase 4·NCT01661985·160 enrolled

Bronchiolitis Obliterans2 trials

Targeted Therapy of Bronchiolitis Obliterans Syndrome

Completed·SStephanie Lee·Phase 2·NCT01307462·36 enrolled

Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01959100·480 enrolled

Unknown status·JJomaa Pharma GmbH·Phase 2·NCT01464125·43 enrolled

Experimental1 trial

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04870138·16 enrolled

Influenza1 trial

A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 4·NCT02972957·364 enrolled

Pelvic Inflammatory Disease1 trial

Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

Completed· Pfizer logo

Pfizer·Phase 3·NCT00871494·76 enrolled

Crohn's Disease (CD)1 trial

Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT04186247·13 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

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

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

Mycoplasma pneumoniae pneumonia1 trial

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Terminated·—·N/A·NCT01217099·47 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

Effectiveness1 trial

The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001023·91 enrolled

Endometritis1 trial

Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

Withdrawn·UUniversity of Missouri, Kansas City·Phase 4·NCT01721616

Acne Vulgaris1 trial

Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

Completed·PPak Emirates Military Hospital·Phase 3·NCT05629468·75 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

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

Bronchiolitis1 trial

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

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

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

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

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

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

Acute otitis media1 trial

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

Completed·AAbbott·Phase 4·NCT00645112·357 enrolled

Tics1 trial

Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

Completed·LLaboratoires Thea·Phase 1·NCT00356850

Low Birth Weight1 trial

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Terminated·UUniversity of Alabama at Birmingham·Phase 1/2·NCT00599053·7 enrolled

Skin Disease1 trial

Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 4·NCT02775617·1,291 enrolled

Blindness1 trial

Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT00127504·80 enrolled

Cognition1 trial

Improving Cognition and Gestational Duration With Targeted Nutrition

Active, not recruiting·WWashington University School of Medicine·N/A·NCT05949190·1,660 enrolled

ART1 trial

Partnership for Rapid Elimination of Trachoma

Completed·JJohns Hopkins University·Phase 4·NCT00792922·128 enrolled

Lip1 trial

Lipids of the Human Tear Film and Their Effect on Tear Stability

Completed·UUniversity of Louisville·Phase 4·NCT00803452·31 enrolled

Oxidative Stress1 trial

Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis

Completed·IInstituto de Investigacion Sanitaria La Fe·N/A·NCT01463371·30 enrolled

Ebola Virus Disease1 trial

Multiple Treatments for Ebola Virus Disease (EVD)

Unknown status·CClinical Research Management, Inc.·Phase 1/2·NCT02380625·150 enrolled

Skin1 trial

Cantharidin-induced Skin Blister for Testing Anti-inflammatory Effects of Macrolides

Completed· GSK logo

GSK·Phase 1·NCT01026064·44 enrolled

Bariatric Surgery1 trial

Absorption of Drugs Post-Bariatric Surgery (Absorb-Azithromycin)

Completed·UUniversity of Alberta·N/A·NCT01154569·30 enrolled

Diarrhea1 trial

Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT02336516·148 enrolled

Unspecified1 trial

International Milk Composition (IMiC) Consortium

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

Regulatory

FDA Approval Timeline[5]

Nov 1, 1991

ZITHROMAX

NDA NDA050670

Sep 28, 1994

ZITHROMAX

NDA NDA050693

Oct 19, 1995

ZITHROMAX

NDA NDA050710

Mar 14, 1996

ZITHROMAX

NDA NDA050710

Mar 18, 1996

ZITHROMAX

NDA NDA050710

Jun 12, 1996

ZITHROMAX

NDA NDA050730

Jul 18, 1996

ZITHROMAX

NDA NDA050711

Dec 20, 1996

ZITHROMAX

NDA NDA050710

Jan 30, 1997

ZITHROMAX

NDA NDA050733

Jan 30, 1997

ZITHROMAX

NDA NDA050733

May 16, 1997

ZITHROMAX

NDA NDA050711

Jul 15, 1999

ZITHROMAX

NDA NDA050711

Oct 6, 1999

ZITHROMAX

NDA NDA050711

Oct 19, 1999

ZITHROMAX

NDA NDA050733

Nov 8, 1999

ZITHROMAX

NDA NDA050710

Nov 22, 1999

ZITHROMAX

NDA NDA050711

Nov 22, 1999

ZITHROMAX

NDA NDA050733

Nov 22, 1999

ZITHROMAX

NDA NDA050710

Dec 6, 1999

ZITHROMAX

NDA NDA050711

Feb 9, 2000

ZITHROMAX

NDA NDA050711

Nov 11, 2000

ZITHROMAX

NDA NDA050711

Nov 11, 2000

ZITHROMAX

NDA NDA050733

Nov 11, 2000

ZITHROMAX

NDA NDA050710

Feb 28, 2001

ZITHROMAX

NDA NDA050733

Dec 10, 2001

ZITHROMAX

NDA NDA050710

Dec 10, 2001

ZITHROMAX

NDA NDA050711

Dec 10, 2001

ZITHROMAX

NDA NDA050733

Dec 14, 2001

ZITHROMAX

NDA NDA050710

Dec 14, 2001

ZITHROMAX

NDA NDA050710

Mar 13, 2002

ZITHROMAX

NDA NDA050733

May 20, 2002

ZITHROMAX

NDA NDA050711

May 24, 2002

ZITHROMAX

NDA NDA050710

May 24, 2002

ZITHROMAX

NDA NDA050711

May 24, 2002

ZITHROMAX

NDA NDA050784

Jul 22, 2002

ZITHROMAX

NDA NDA050711

Jul 22, 2002

ZITHROMAX

NDA NDA050710

Jul 22, 2002

ZITHROMAX

NDA NDA050733

Oct 16, 2002

ZITHROMAX

NDA NDA050711

Oct 16, 2002

ZITHROMAX

NDA NDA050784

Oct 16, 2002

ZITHROMAX

NDA NDA050733

Oct 16, 2002

ZITHROMAX

NDA NDA050710

Dec 17, 2002

ZITHROMAX

NDA NDA050784

Jun 12, 2003

ZITHROMAX

NDA NDA050733

Jun 20, 2003

ZITHROMAX

NDA NDA050710

Dec 18, 2003

ZITHROMAX

NDA NDA050711

Dec 18, 2003

ZITHROMAX

NDA NDA050784

Dec 18, 2003

ZITHROMAX

NDA NDA050710

Jan 15, 2004

ZITHROMAX

NDA NDA050784

Jan 15, 2004

ZITHROMAX

NDA NDA050711

Jan 15, 2004

ZITHROMAX

NDA NDA050711

Jan 15, 2004

ZITHROMAX

NDA NDA050710

Jan 15, 2004

ZITHROMAX

NDA NDA050710

Jan 15, 2004

ZITHROMAX

NDA NDA050733

Jan 15, 2004

ZITHROMAX

NDA NDA050733

Jan 15, 2004

ZITHROMAX

NDA NDA050784

Apr 27, 2004

ZITHROMAX

NDA NDA050710

Jun 10, 2005

ZMAX

NDA NDA050797

Dec 19, 2006

AZITHROMYCIN

NDA NDA050809

Apr 27, 2007

AZASITE

NDA NDA050810

Oct 25, 2007

ZITHROMAX

NDA NDA050710

Oct 25, 2007

ZITHROMAX

NDA NDA050733

Oct 25, 2007

ZITHROMAX

NDA NDA050784

Oct 25, 2007

ZITHROMAX

NDA NDA050711

Mar 6, 2009

ZITHROMAX

NDA NDA050784

Mar 6, 2009

ZITHROMAX

NDA NDA050710

Mar 6, 2009

ZITHROMAX

NDA NDA050711

Mar 6, 2009

ZITHROMAX

NDA NDA050733

Aug 11, 2010

ZITHROMAX

NDA NDA050784

Aug 11, 2010

ZITHROMAX

NDA NDA050711

Aug 11, 2010

ZITHROMAX

NDA NDA050733

Aug 11, 2010

ZITHROMAX

NDA NDA050710

Jan 28, 2011

ZITHROMAX

NDA NDA050784

Jan 28, 2011

ZITHROMAX

NDA NDA050710

Jan 28, 2011

ZITHROMAX

NDA NDA050733

Jan 28, 2011

ZITHROMAX

NDA NDA050711

Nov 16, 2011

ZITHROMAX

NDA NDA050733

Jun 6, 2012

ZITHROMAX

NDA NDA050784

Jun 6, 2012

ZITHROMAX

NDA NDA050733

Jun 6, 2012

ZITHROMAX

NDA NDA050711

Jun 6, 2012

ZITHROMAX

NDA NDA050710

Nov 2, 2012

ZITHROMAX

NDA NDA050784

Nov 2, 2012

ZITHROMAX

NDA NDA050711

Nov 2, 2012

ZITHROMAX

NDA NDA050710

Feb 19, 2013

ZITHROMAX

NDA NDA050784

Feb 19, 2013

ZITHROMAX

NDA NDA050711

Feb 19, 2013

ZITHROMAX

NDA NDA050733

Feb 19, 2013

ZITHROMAX

NDA NDA050710

Jun 6, 2014

ZITHROMAX

NDA NDA050733

Jun 7, 2014

ZITHROMAX

NDA NDA050711

Jun 7, 2014

ZITHROMAX

NDA NDA050710

Jun 7, 2014

ZITHROMAX

NDA NDA050784

Jun 24, 2014

ZITHROMAX

NDA NDA050733

May 23, 2016

ZITHROMAX

NDA NDA050710

May 23, 2016

ZITHROMAX

NDA NDA050784

May 23, 2016

ZITHROMAX

NDA NDA050711

May 24, 2016

ZITHROMAX

NDA NDA050733

Feb 10, 2017

ZITHROMAX

NDA NDA050711

Feb 10, 2017

ZITHROMAX

NDA NDA050784

Feb 10, 2017

ZITHROMAX

NDA NDA050710

Feb 10, 2017

ZITHROMAX

NDA NDA050733

Mar 29, 2017

ZITHROMAX

NDA NDA050733

Mar 30, 2017

ZITHROMAX

NDA NDA050710

Mar 30, 2017

ZITHROMAX

NDA NDA050711

Mar 30, 2017

ZITHROMAX

NDA NDA050784

Apr 24, 2019

ZITHROMAX

NDA NDA050711

Apr 24, 2019

ZITHROMAX

NDA NDA050784

Apr 24, 2019

ZITHROMAX

NDA NDA050733

Apr 24, 2019

ZITHROMAX

NDA NDA050710

Nov 22, 2021

ZITHROMAX

NDA NDA050784

Nov 22, 2021

ZITHROMAX

NDA NDA050710

Nov 22, 2021

ZITHROMAX

NDA NDA050733

Nov 22, 2021

ZITHROMAX

NDA NDA050711

Jan 6, 2022

ZITHROMAX

NDA NDA050733

Jul 13, 2026

ZITHROMAX

NDA NDA050710

Jul 13, 2026

ZITHROMAX

NDA NDA050711

Jul 13, 2026

ZITHROMAX

NDA NDA050784

Jul 13, 2026

ZITHROMAX

NDA NDA050733

Sources

References

[1]
ClinicalTrials.gov — 380 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 NDA050710). 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 2028

Q4 2029

Q2 2030

Trials by Indication[1]

Azithromycin37 trials

COVID-1917 trials

Pneumonia8 trials

Respiratory tract infection7 trials

Asthma7 trials

Mortality6 trials

Cystic Fibrosis5 trials

Trial4 trials

Gonorrhea4 trials

Antibiotics4 trials

Malnutrition3 trials

Chronic Obstructive Pulmonary Disease3 trials

Blepharitis3 trials

Cesarean Delivery2 trials

Efficacy and Safety2 trials

Lung Disease2 trials

Treatment2 trials

Pregnancy2 trials

Pulmonary Sarcoidosis2 trials

Corticosteroids2 trials

Mycobacterium Avium Complex2 trials

Pregnant Women2 trials

Complication2 trials

Idiopathic Pulmonary Fibrosis2 trials

Antibiotic2 trials

Chronic Rhinosinusitis2 trials

Cryptosporidiosis2 trials

Chronic Lung Disease2 trials

Mycobacterium avium complex disease2 trials

Sinusitis2 trials

Mycoplasma Genitalium2 trials

Bronchiolitis Obliterans2 trials

TED1 trial

Cervicitis1 trial

Plasmodium falciparum malaria1 trial

Experimental1 trial

Influenza1 trial

Pelvic Inflammatory Disease1 trial

Crohn's Disease (CD)1 trial

Mycobacterium1 trial

PPROM1 trial

Abortion1 trial

Bacterial Infections1 trial

Mycobacterium Avium Complex Pulmonary Disease1 trial

Mycoplasma pneumoniae pneumonia1 trial

Bone Marrow Transplantation1 trial

Effectiveness1 trial

Endometritis1 trial

Acne Vulgaris1 trial

Chronic Bronchitis1 trial

Otitis media1 trial

Malaria1 trial

Bronchiolitis1 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

HIV infection1 trial

Preoperative1 trial

Immunology1 trial

Meibomian Gland Dysfunction1 trial

Abscess1 trial

Lung Transplantation1 trial

HIV-Infected Individuals1 trial

Lymphatic Filariasis1 trial

Ventilator-Associated Pneumonia1 trial