Ozmosi | Azithromycin Drug Profile
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Azithromycin

Alternative Names: azithromycin, zithromax, azasite, azenil, azythromycin, zmax, azitromicina
Clinical Status: Inactive
Latest Update: 2026-01-13
Latest Update Note: Clinical Trial Update

Product Description

Azithromycin is an antimicrobial medication used to treat and manage bacterial infections, including community-acquired pneumonia and sexually transmitted diseases. It is in the macrolide class of antimicrobials.Azithromycin is a broad-spectrum macrolide antimicrobial and is among the most prescribed antimicrobial drugs in the United States. It is a derivative of erythromycin with greatly enhanced activity against gram-negative bacteria (including Enterobacteriaceae) and provides coverage of many gram-positive organisms (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK557766/)

Mechanisms of Action: CYP3A4 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam

Approved Indications: None

Known Adverse Events: None

Company: Pfizer
Company Location: Eastern America
Company CEO: Albert Bourla
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Azithromycin

Countries in Clinic: Argentina, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hungary, India, Indonesia, Israel, Italy, Korea, Lao, Mali, Nepal, Netherlands, New Zealand, Sierra Leone, South Africa, Spain, Taiwan, United Kingdom, United States, Vietnam

Active Clinical Trial Count: 11

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Anemia, Neonatal|COVID-19|Communicable Diseases|Diarrhea|Inflammation|Injuries/wounds Unspecified|Lung Transplant|Malaria|Measles|Mycobacterium Infections, Nontuberculous|Mycobacterium avium-intracellulare Infection|Nontuberculous Mycobacterial Lung Disease|Pneumonia|Severe Acute Respiratory Syndrome|Trachoma|Vision, Low

Phase 2: Brain Cancer|Glioblastoma

Phase 1: Healthy Volunteers

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2016-003339-39

2016-003339-39

P3

Active, not recruiting

Injuries/wounds Unspecified

2019-02-28

2022-03-13

Treatments

2020-002545-42

ARISE

P3

Completed

Nontuberculous Mycobacterial Lung Disease

2023-05-09

17%

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT04677543

ARISE

P3

Completed

Mycobacterium avium-intracellulare Infection|Communicable Diseases|Mycobacterium Infections, Nontuberculous

2023-05-09

17%

2024-06-28

Primary Endpoints

ACTRN12619000640101p

2006-7041-83/hah

P2

Not yet recruiting

Glioblastoma|Brain Cancer

2020-05-20

NCT06082037

ROCKaspire

P3

Recruiting

Lung Transplant

2026-09-17

11%

2024-05-11

Primary Endpoints|Treatments

NCT04381936

RECOVERY

P3

Recruiting

COVID-19|Severe Acute Respiratory Syndrome

2026-06-30

2024-01-06

NCT04235816

ICARIA

P3

Active, not recruiting

Measles|Pneumonia|Anemia, Neonatal|Diarrhea|Malaria|Trachoma

2025-09-11

2025-07-24

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT05972772

RiCS

P3

Recruiting

Communicable Diseases

2025-08-31

2024-12-28

Primary Endpoints|Start Date|Treatments|Trial Status

NCT04424511

LAKANA

P3

Completed

Vision, Low|Malaria|Inflammation

2024-12-31

2025-05-22

Patient Enrollment|Primary Endpoints|Treatments

CTR20171463

CTR20171463

P1

Active, not recruiting

Pneumonia

None

2025-04-29

NCT05966688

SPR720-102

P1

Completed

Healthy Volunteers

2024-01-30

69%

2024-03-05

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments