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 121 indications[4].[1]

Zithromax is one of 1519 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

121

Indications

372

Total Trials

Active Trials

1,518

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseApproved

MalnutritionApproved

Premature BirthApproved

GastroparesisActive, not recruiting

HIV InfectionActive, not recruiting

Bacterial DiseaseActive, not recruiting

SyphilisActive, not recruiting

Cardiovascular DiseaseApproved

AbscessActive, not recruiting

YawsActive, not recruiting

Coronary Artery DiseaseApproved

Approved

MalnutritionApproved

Approved

Premature BirthApproved

Approved

GastroparesisPhase 2

Active, not recruiting

HIV InfectionApproved

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

SyphilisPhase 3

Active, not recruiting

Cardiovascular DiseaseApproved

Approved

AbscessPhase 2/Phase 3

Active, not recruiting

YawsPhase 3

Active, not recruiting

Showing 10 of 115 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Zithromax

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

Approved

35 2

Spikevax

Moderna

Preclinical

21 3

Tricor

JJagotec

Preclinical

1 4

Precedex

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

Preclinical

1 5

Rayaldee

OOrganon and Co

Preclinical

1 6

Statin

Bristol-Myers Squibb

Preclinical

1 7

Olokizumab

UCB

Preclinical

1 8

Opaganib

RRedHill Biopharma Limited

Preclinical

1 9

Hymecromone

SStanford University

Preclinical

1 10

Saliva Collection

DDirection Centrale du Service de Santé des Armées

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/AActive, not recruiting

Cognition

NCT05949190

Post-ApprovalRecruiting

PPROM

NCT06396078

Phase 2/3Recruiting

Asthma

NCT06223828

Q3 2027

Recruiting

Infants

NCT03511118

Q4 2027

Phase 3Recruiting

Sinusitis

NCT05157685

Phase 3Recruiting

Cesarean Delivery

NCT06605118

Clinical

Trials by Indication[1]

Azithromycin35 trials

Improving Care Through Azithromycin Research for Infants in Africa

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

Single-dose Azithromycin for the Treatment of Yaws

Completed·LLihir Medical Centre·Phase 3·NCT01382004·255 enrolled

Effect of Azithromycin in Preventing Premature Labour

Completed·—··NCT05465304·200 enrolled

Show 32 more trials

Effect Of Azithromycin in Women at Risk of Preterm Labour

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

Trial II of Lung Protection With Azithromycin in the Preterm Infant

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

Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

Completed·—·N/A·NCT06077916·224 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

Nutritional Support for Lactating Women and Azithromycin to Infants - Mumta Lactating Women Trial

Completed·VVital Pakistan Trust·N/A·NCT03564652·957 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

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

Azithromycin for Acute Exacerbations Requiring Hospitalization

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

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00322465·305 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

Community Health Azithromycin Trial in Burkina Faso

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

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

Treatment of ppROM With Erythromycin vs. Azithromycin Trial

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

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

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

Single Dose Azithromycin in the Treatment of Adult Cholera

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

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

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

Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex

Unknown status·UUnity Health Toronto·Phase 2·NCT00298922·45 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

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

COVID-1923 trials

A Study of Combination Therapies to Treat COVID-19 Infection

Withdrawn·PProgenaBiome·Phase 2·NCT04459702

A Study of Quintuple Therapy to Treat COVID-19 Infection

Completed·PProgenaBiome·Phase 2·NCT04334512·118 enrolled

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

Show 20 more trials

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

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

Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

Unknown status·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 2·NCT04332094·276 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

Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19

Completed·IInstituto de Seguridad y Servicios Sociales de los Trabajadores del Estado·N/A·NCT04399746·30 enrolled

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

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

Terminated·LLCMC Health·Phase 3·NCT04344444·22 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

VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

Suspended·—·Phase 3·NCT04363203·300 enrolled

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

Unknown status·IIntermountain Health Care, Inc.·Phase 3·NCT04334382·1,550 enrolled

Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

Suspended·FFundacion GenesisCare·N/A·NCT04394182·15 enrolled

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

Suspended·AAzidus Brasil·Phase 1·NCT04329572·400 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

Hydroxychloroquine, Azithromycin in the Treatment of Covid-19

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

Effectiveness of Hydroxychloroquine in Covid-19 Patients

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

Asthma11 trials

Azithromycin for Critical Asthma - Pediatrics

Recruiting·JJohns Hopkins All Children's Hospital·Phase 2/3·NCT06223828·100 enrolled

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

Show 8 more trials

Azithromycin Treatment for Non-eosinophilic Chest Tightness Variant Asthma

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

AZMATICS: AZithroMycin/Asthma Trial In Community Settings

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

Effects of Macrolides on Asthma Control

Completed·EEuan J Cameron·Phase 3·NCT00852579·77 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

Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children

Unknown status·JJanielee Williamson·N/A·NCT01008761·440 enrolled

Anti-viral Effects of Azithromycin in Patients With Asthma and COPD

Unknown status·—·Phase 4·NCT04319705·100 enrolled

AZISAST Study: AZIthromycin in Severe ASThma Study

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

Pneumonia7 trials

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

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

Show 4 more trials

Treatment and Vaccine Development of Mycoplasma Pneumoniae

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

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

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

Mortality5 trials

Infant Mortality Reduction by the Mass Administration of Azithromycin

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

Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients

Unknown status·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT04341207·1,000 enrolled

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Completed·AAnna Griffiths, MRC·Phase 3·NCT01825031·1,805 enrolled

Show 2 more trials

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

82 more indications

Cystic Fibrosis4 trials

Prevention of Bronchiectasis in Infants With Cystic Fibrosis

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

OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

Completed·BBonnie Ramsey·Phase 3·NCT02054156·221 enrolled

Show 1 more trial

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

Antibiotics4 trials

Healthy Patients & Effect of Antibiotics

Completed·WWashington University School of Medicine·N/A·NCT03098485·20 enrolled

Intrapulmonary Pharmacokinetics of Antibiotics

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

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

Show 1 more trial

Biological Modulation of Bacterial QSSMs, Innate and Adaptive Immunity by Antibiotics, Probiotics and Prebiotics in Healthy Individuals

Completed·UUniversity of Nottingham·Phase 1·NCT01201577·40 enrolled

Respiratory tract infection4 trials

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

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

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

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

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

Completed· Pfizer logo

Pfizer··NCT00939185·400 enrolled

Show 1 more trial

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

Cesarean Delivery4 trials

The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

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

Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

Completed·—·Phase 4·NCT04062175·144 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

Mycobacterium Avium Complex3 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

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

A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00002140

Lung Disease3 trials

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

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

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

Bronchiolitis Obliterans3 trials

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting·—·Phase 2·NCT05922761·45 enrolled

Targeted Therapy of Bronchiolitis Obliterans Syndrome

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

Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans

Completed·CClaudio Castanos·Phase 4·NCT05299567·40 enrolled

Efficacy and Safety3 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

Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

Completed·UUniversity of North Carolina·N/A·NCT00287300·141 enrolled

Sinusitis3 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

Diarrhea3 trials

Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome

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

Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

Completed·UUniversity of Aarhus·Phase 3·NCT01531218·100 enrolled

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

Chronic Obstructive Pulmonary Disease2 trials

The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough

Completed·IIsala·Phase 3·NCT01071161·84 enrolled

Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)

Completed·UUniversity of Alabama at Birmingham··NCT00549445·53 enrolled

Ciprofloxacin2 trials

Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT03854929·364 enrolled

Ciprofloxacin Multiple Dose for Adult Cholera

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

Malnutrition2 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 for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

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

Acne Vulgaris2 trials

Vitamin A and Azithromycin for Acne Vulgaris

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

Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

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

Pertussis2 trials

Bordetella Pertussis Colonisation Challenge Study

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

Pertussis Challenge Study in Adults Vaccinated With BPZE1

Completed·IILiAD Biotechnologies·Phase 2·NCT05461131·53 enrolled

Gonorrhea2 trials

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

Efficacy of Combination Therapies for Gonorrhea Treatment

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

Pregnant Women2 trials

Transplacental Transfer of Drugs Used in Pregnant Women

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

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

Completed·—·Phase 4·NCT04278937·50 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

TED1 trial

Zoliflodacin in Uncomplicated Gonorrhoea

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

Pseudomonas Aeruginosa1 trial

Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa

Completed·JJin-Fu Xu·N/A·NCT02491723·71 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

Mycoplasma pneumoniae pneumonia1 trial

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

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

Premature rupture of membranes1 trial

Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes

Withdrawn·IIndiana University·Phase 3·NCT01556334

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

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

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

Chlamydial Infection1 trial

Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00980148·567 enrolled

Shigellosis1 trial

The Impact of Shigellosis and Recommended Treatment in Children

Not yet recruiting·JJohns Hopkins Bloomberg School of Public Health·Phase 2·NCT07433426·700 enrolled

Gastroparesis1 trial

Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis

Terminated·UUniversity of Florida·Phase 2·NCT01323582·26 enrolled

Otitis media1 trial

TELI COM - Telithromycin in Children With Otitis Media

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00315003·1,500 enrolled

Syphilis1 trial

Azithromycin/Bicillin Syphilis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00031499·593 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

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

Cervicitis1 trial

Empiric Therapy of Mucopurulent Cervicitis (MPC)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01072136·87 enrolled

Inflammation1 trial

Preschool Wheeze: Inflammation/Infection Guided Management

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

Plasmodium falciparum malaria1 trial

Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in Adults

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

Experimental1 trial

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

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

Bronchiectasis1 trial

Bronchiectasis and Long Term Azithromycin Treatment

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

Trial1 trial

BACE Trial Substudy 1 - PROactive Substudy

Completed·WWim Janssens·Phase 3·NCT02205242·60 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

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

Blepharitis1 trial

Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

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

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

Cognition1 trial

Improving Cognition and Gestational Duration With Targeted Nutrition

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

Mycoplasma Genitalium1 trial

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

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

Conjunctivitis1 trial

The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

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

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

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 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

Corticosteroids1 trial

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

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

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

Antibiotic Resistance1 trial

Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso

Completed·UUniversity of California, San Francisco·Phase 4·NCT03187834·252 enrolled

Disease Progression1 trial

A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications

Terminated· Roche logo

Roche·Phase 2·NCT04353661·12 enrolled

Cryptosporidiosis1 trial

Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

Completed· Pfizer logo

Pfizer·N/A·NCT00002082

Acute Chest Syndrome1 trial

A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease

Withdrawn·UUniversity of Mississippi Medical Center·Phase 1·NCT02630394

Bacterial Pneumonia1 trial

A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT02269644

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

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

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

Clinical Trial1 trial

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

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

Child Health1 trial

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

Withdrawn·—·Phase 4·NCT04171388

Unspecified5 trials

Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

Completed·SShahid Sadoughi University of Medical Sciences and Health Services·Phase 4·NCT01667692·78 enrolled

YCFM (Youth Correctional Facilities Males)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03249935·100 enrolled

Kebele Elimination of Trachoma for Ocular Health

Active, not recruiting·UUniversity of California, San Francisco·Phase 4·NCT03335072·320,000 enrolled

Show 2 more 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 — 372 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

Q3 2027

Q4 2027

Trials by Indication[1]

Azithromycin35 trials

COVID-1923 trials

Asthma11 trials

Pneumonia7 trials

Mortality5 trials

Cystic Fibrosis4 trials

Antibiotics4 trials

Respiratory tract infection4 trials

Cesarean Delivery4 trials

Mycobacterium Avium Complex3 trials

Lung Disease3 trials

Bronchiolitis Obliterans3 trials

Efficacy and Safety3 trials

Sinusitis3 trials

Diarrhea3 trials

Chronic Obstructive Pulmonary Disease2 trials

Ciprofloxacin2 trials

Malnutrition2 trials

Acne Vulgaris2 trials

Pertussis2 trials

Gonorrhea2 trials

Treatment2 trials

Pregnancy2 trials

Pregnant Women2 trials

Pre-Term1 trial

TED1 trial

Pseudomonas Aeruginosa1 trial

Mycobacterium Avium Complex Pulmonary Disease1 trial

Chronic Graft Versus Host Disease1 trial

Mycoplasma pneumoniae pneumonia1 trial

Premature rupture of membranes1 trial

Bone Marrow Transplantation1 trial

Effectiveness1 trial

Endometritis1 trial

Complication1 trial

PPROM1 trial

Chronic Bronchitis1 trial

Chlamydial Infection1 trial

Shigellosis1 trial

Gastroparesis1 trial

Otitis media1 trial

Syphilis1 trial

Bronchiolitis1 trial

Sickle Cell Disease1 trial

Cervicitis1 trial

Inflammation1 trial

Plasmodium falciparum malaria1 trial

SARS CoV 2 Infection1 trial

Experimental1 trial

Bronchiectasis1 trial

Influenza1 trial

Pelvic Inflammatory Disease1 trial

Trial1 trial

HIV infection1 trial

Preoperative1 trial

Immunology1 trial

Crohn's Disease (CD)1 trial

Blepharitis1 trial

Tics1 trial

Multiple Sclerosis1 trial

Cognition1 trial

Mycoplasma Genitalium1 trial

Conjunctivitis1 trial

Cardiovascular1 trial

Meibomian Gland Dysfunction1 trial

Infants1 trial

Lung Transplantation1 trial

Corticosteroids1 trial

Acute otitis media1 trial

Low Birth Weight1 trial

Skin Disease1 trial

Blindness1 trial