Skip to main content

Mycobacterium Avium Complex

8
Pipeline Programs
4
Companies
48
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
2
1
2
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Pfizer
ZITHROMAXApproved
azithromycin
Pfizer
oral1991
Pfizer
ZMAXApproved
azithromycin
Pfizer
oral2005

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
1
ZITHROMAX(azithromycin)Phase 35 trials
Active Trials
NCT00002122Completed720
NCT00002140Completed
NCT00002309Completed
+2 more trials
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
2 programs
1
1
AzithromycinPhase 2/3
ClofaziminePhase 2
Temple Therapeutics
Temple TherapeuticsNetherlands - Geleen
2 programs
1
1
AzithromycinPhase 2/31 trial
ClofaziminePhase 2
Active Trials
NCT03672630Completed474Est. Jan 2026
Spero Therapeutics
Spero TherapeuticsMA - Cambridge
1 program
1
SPR720Phase 21 trial
Active Trials
NCT04553406Terminated2Est. Jan 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin
Pfizerazithromycin

Showing 15 of 39 trials with date data

Clinical Trials (48)

Total enrollment: 13,153 patients across 48 trials

NCT00367120Pfizerazithromycin

Zmax Compared to Augmentin in Sinusitis

Start: Jun 2006Est. completion: Feb 2007762 patients
Phase 4Completed
NCT00643539Pfizerazithromycin

Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Start: Dec 2002Est. completion: Jul 2003360 patients
Phase 4Completed
NCT00324818Pfizerazithromycin

Treatment of Bacterial Vaginosis

Start: Jul 2002Est. completion: May 2006600 patients
Phase 4Completed
NCT00598962Pfizerazithromycin

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

Start: Dec 1994Est. completion: May 201758 patients
Phase 4Completed
NCT00599079Pfizerazithromycin

Azithromycin in the Treatment of M. Avium Complex Lung Disease

Start: Feb 1993Est. completion: May 201766 patients
Phase 4Completed
NCT00002122Pfizerazithromycin

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

720 patients
Phase 3Completed
NCT00002140Pfizerazithromycin

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

Phase 3Completed
NCT01103063Pfizerazithromycin

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Start: Oct 2010Est. completion: Nov 20132,891 patients
Phase 3Terminated
NCT00809328Pfizerazithromycin

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

Start: Feb 2009Est. completion: Mar 2010102 patients
Phase 3Completed
NCT00393835Pfizerazithromycin

A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Start: Nov 2006Est. completion: May 200799 patients
Phase 3Completed
NCT00367653Pfizerazithromycin

Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

Start: Nov 2006Est. completion: Sep 2007397 patients
Phase 3Completed
NCT00360464Pfizerazithromycin

A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

Start: Oct 2006Est. completion: Jun 200764 patients
Phase 3Completed
NCT00360295Pfizerazithromycin

A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

Start: Sep 2006Est. completion: May 2007153 patients
Phase 3Completed
NCT00140023Pfizerazithromycin

Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Start: Sep 2005Est. completion: Jun 200647 patients
Phase 3Completed
NCT00643149Pfizerazithromycin

A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

Start: May 2003Est. completion: Mar 2004693 patients
Phase 3Completed
NCT00648726Pfizerazithromycin

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

Start: Jan 2003Est. completion: Aug 2003139 patients
Phase 3Completed
NCT00643292Pfizerazithromycin

A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

Start: Jan 2003Est. completion: May 2004902 patients
Phase 3Completed
NCT00643227Pfizerazithromycin

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

Start: Jan 2003Est. completion: Mar 2004504 patients
Phase 3Completed
NCT00229944Pfizerazithromycin

Single Dose Azithromycin in the Treatment of Adult Cholera

Start: Dec 2002Est. completion: May 2004220 patients
Phase 3Completed
NCT00649831Pfizerazithromycin

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

Start: Oct 2002Est. completion: Jun 2003250 patients
Phase 3Completed

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

Start: Feb 2019Est. completion: Jan 2026474 patients
Phase 2/3Completed
NCT00677833Pfizerazithromycin

Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Start: Jun 2008Est. completion: Sep 2010361 patients
Phase 2/3Completed
NCT00084227Pfizerazithromycin

Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America

Start: Jul 2004Est. completion: Jul 2005244 patients
Phase 2/3Completed
NCT00082576Pfizerazithromycin

Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

Start: Jun 2004Est. completion: May 2006238 patients
Phase 2/3Completed
NCT00084240Pfizerazithromycin

Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

Start: Mar 2004Est. completion: Apr 200532 patients
Phase 2/3Terminated
NCT00074841Pfizerazithromycin

Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India

Start: Sep 2003Est. completion: Jan 2005230 patients
Phase 2/3Completed

Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Start: Dec 2020Est. completion: Jan 20212 patients
Phase 2Terminated
NCT01919996Pfizerazithromycin

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

Start: Dec 2013Est. completion: Nov 20158 patients
Phase 2Terminated
NCT00796224Pfizerazithromycin

Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

Start: Dec 2008Est. completion: Feb 200938 patients
Phase 2Completed
NCT00282919Pfizerazithromycin

A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

Start: Mar 2006Est. completion: Feb 2008110 patients
Phase 2Completed
NCT00323986Pfizerazithromycin

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

Start: Oct 2004Est. completion: Apr 200630 patients
Phase 2Terminated
NCT00082563Pfizerazithromycin

Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

Start: Aug 2004Est. completion: Nov 200414 patients
Phase 2Terminated
NCT00002344Pfizerazithromycin

A Study of Azithromycin in HIV-Infected Patients

12 patients
Phase 1Completed
NCT00002139Pfizerazithromycin

Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

Phase 1Completed
NCT01100060Pfizerazithromycin

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

Start: Apr 2010Est. completion: Jun 201040 patients
Phase 1Completed
NCT00844207Pfizerazithromycin

A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine

Start: Feb 2009Est. completion: Apr 200940 patients
Phase 1Completed
NCT00002328Pfizerazithromycin

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

N/ACompleted
NCT00002089Pfizerazithromycin

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

N/ACompleted
NCT00002090Pfizerazithromycin

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)

N/ACompleted
NCT00002085Pfizerazithromycin

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

N/ACompleted
NCT00002309Pfizerazithromycin

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

N/ACompleted
NCT01784770Pfizerazithromycin

Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

Start: Mar 2013Est. completion: Jul 201621 patients
N/ACompleted
NCT01671280Pfizerazithromycin

Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)

Start: Sep 2012Est. completion: Apr 2016403 patients
N/ACompleted
NCT01032694Pfizerazithromycin

Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

Start: Apr 2010Est. completion: Dec 201030 patients
N/ATerminated
NCT00998309Pfizerazithromycin

Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

Start: Oct 2009Est. completion: Jan 2011502 patients
N/ACompleted
NCT00827502Pfizerazithromycin

Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

Start: Feb 2009Est. completion: Jul 2009421 patients
N/ACompleted
NCT00939185Pfizerazithromycin

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

Start: Apr 2007Est. completion: Jan 2009400 patients
N/ACompleted
NCT01227395Pfizerazithromycin

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Start: Jul 2002Est. completion: Mar 2012476 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.