TheraRadar
Data updated: May 26, 2026

ZITHROMAX (azithromycin)

Trial Activity: Declining
Infectious Disease Approved 1991-11-01

ZITHROMAX is indicated for the treatment of Community-Acquired Pneumonia; Pelvic Inflammatory Disease.

Source: FDA Label • Pfizer
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ZITHROMAX Works

Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis. It achieves this by binding to the 23S rRNA of the 50S ribosomal subunit of susceptible microorganisms, thereby blocking the translocation step of peptide chain elongation.

Source: FDA Label

Development Insights

Imperial College London conducting 1 trials (33%)
3 indications explored (Focused)
→ asthma (1 trials)
→ low risk of preterm delivery (1 trials)
→ cutaneous leishmaniasis (1 trials)
12
Indications
--
Phase 3 Trials
2
Priority Reviews
34
Years on Market

Details

Status
Prescription
First Approved
1991-11-01
Routes
ORAL, INJECTION
Dosage Forms
TABLET, CAPSULE, FOR SUSPENSION, INJECTABLE

Companies

Pfizer
Active Ingredient: AZITHROMYCIN

ZITHROMAX Approval History

1992
1993
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1995
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1998
1999
2000
2001
2002
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2004
2005
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2008
2009
2010
2011
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2018
2019
2020
2021
2022
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2026
Original
New Indication
New Form
Label Update
206 FDA actions from 1991 to 2022 · 4 indication expansions
Jan 2022 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Nov 2021 SUPPL
Label · Labeling
FDA Letter Label
Apr 2019 SUPPL
Label · Labeling
FDA Letter Label

What ZITHROMAX Treats

2 indications

ZITHROMAX is approved for 2 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Community-Acquired Pneumonia
  • Pelvic Inflammatory Disease
Source: FDA Label

ZITHROMAX Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN
2025 7 indic.
ZEVTERA
ISTX
2024 5 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ZITHROMAX

3 of 13

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AZITHROMYCIN
AZITHROMYCIN
1 shared
Sun Pharma
Shared indications:
Community-Acquired Pneumonia
CEFDINIR
CEFDINIR
1 shared
ALKEM LABS LTD
Shared indications:
Community-Acquired Pneumonia
CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL
1 shared
ANDA REPOSITORY
Shared indications:
Community-Acquired Pneumonia
View all 13 similar drugs Pro
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Clinical Trial Registry

168 trials
Trial Sponsor ID Phase Status Title
NCT04310930 FORMaT U1111-1209-0672 Ph 2, Ph 3 recruiting Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
NCT07314281 IHHN_IRB_2024_10_010 Ph 4 recruiting Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
NCT04381936 RECOVERY NDPHRECOVERY 2020-001113-21, ISRCTN50189673 Ph 3 recruiting Randomised Evaluation of COVID-19 Therapy
NCT03532464 CHLAZIDOXY CHUBX 2016/26 Ph 4 completed Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection
NCT06082037 ROCKaspire EFC17801 U1111-1280-6777, 2023-503462-23 Ph 3 recruiting A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
NCT07433426 TrtNDSD IRB00033101 U01AI179562 Ph 2 recruiting The Impact of Shigellosis and Recommended Treatment in Children
NCT04235816 ICARIA ICARIA OPP1196642 Ph 3 active not recruiting Improving Care Through Azithromycin Research for Infants in Africa
NCT04185402 ARRET results posted 19-28923 5UG1EY030833 Ph 4 completed Azithromycin Reduction to Reach Elimination of Trachoma
NCT04287049 IRB00221119 K23AI159145-01A1 Ph 2 completed A Study of Standard Drugs for Mycobacterium Avium Complex
NCT05994742 Co-SAM 150522 Ph 3 active not recruiting An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
NCT01233297 AB-studie 2010-018592-16 Ph 2 active not recruiting Antibiotic Treatment of Recurrent Episodes of Asthma in Children
NCT06289647 ARRET 19-28923B 5UG1EY030833 Ph 4 withdrawn Azithromycin Reduction to Reach Elimination of Trachoma B
NCT06488781 APPOINT 2.0 Ph 2 recruiting Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
NCT04069312 RELIANCE IRB00179281 Ph 4 completed Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
NCT05922761 23-043 Ph 2 recruiting BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
NCT07394725 130/IRV/SLMC/SWL Ph 1 completed Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management
NCT04677569 ENCORE INS-416 2020-003079-16, 2023-505273-33-00 Ph 3 completed Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
NCT03672630 MAC2v3 18819 PCS-2017C2-7764 Ph 2, Ph 3 completed Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
NCT04481555 COPERNICOS COPERNICOS_JUJCPR 2020-003014-12 Ph 4 completed Eosinophil-guided Reduction of Inhaled Corticosteroids
NCT06396078 2024H0122 Ph 4 recruiting Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
NCT04294641 results posted 200058 20-C-0058 Ph 2 completed Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
NCT04349826 ACT-South Asia 25NP Ph 4 completed The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)
NCT07306234 DOMINO DOMINO KNIH Ph 4 not yet recruiting Doxycycline vs. Macrolide for MRMP (DOMINO)
NCT06223828 CR-AZI Kids CR-AZI IRB00410054 Ph 2, Ph 3 recruiting Azithromycin for Critical Asthma - Pediatrics
NCT02754583 SWIFT I/II 14-14004 U10EY023939 Ph 3 completed Sanitation, Water, and Instruction in Face-washing for Trachoma I/II
NCT04344379 PREP-COVID APHP200386 2020-001273-73 Ph 3 completed Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
NCT06618534 STUDY00008433 CDC-STUDY00008433, 2025P012505 Ph 2 recruiting Azithromycin for Meningococcal Carriage
NCT07052942 iTREAT-PC PLACER-2021C3-24737-IC_Full PLACER-2021C3-24737-IC_Full Ph 4 recruiting Individualizing Treatment for Asthma in Primary Care (Full Study)
NCT03335072 KETFO 17-22201 1UG1EY028088 Ph 4 active not recruiting Kebele Elimination of Trachoma for Ocular Health
NCT06010719 AMOUR 23-39411 5R01HD111532 Ph 4 recruiting Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
NCT07213765 2025-KY-004 Ph 4 recruiting Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
NCT03959527 results posted STI_Zoli001 2019-000990-22 Ph 3 completed Zoliflodacin in Uncomplicated Gonorrhoea
NCT07164131 AD-CAP 24-006503 Ph 4 recruiting Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
NCT06273891 PRACET INOVA-2023-58 23-08-WC-0198 Ph 3 recruiting Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
NCT02707042 160078 16-I-0078 Ph 1 completed Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)
NCT03273296 1341/6.00.00/2017 Ph 4 completed Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
NCT05121974 PR-21005 Ph 2 active not recruiting Tebipenem Trial in Children With Shigellosis
NCT04921943 MAC-HS Ph 4 recruiting Hypertonic Saline for MAC
NCT04326478 2020P000457 Ph 2 active not recruiting Single Dose Azithromycin to Prevent Cholera in Children
NCT04186247 PAZAZ results posted 19-3100 585718 Ph 2 terminated Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
NCT03162497 OPHT-030815 Ph 4 completed Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction
NCT04424511 LAKANA LAKANA trial INV-003354 Ph 3 completed Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali
NCT04224987 AVENIR results posted 19-28387A Ph 4 completed Azithromycin for Child Survival in Niger: Mortality and Resistance Trial
NCT04716712 MIRAMA 20-32979 Ph 4 active not recruiting Infant Mortality Reduction by the Mass Administration of Azithromycin
NCT05461131 CHAMPION-1 results posted IB-202P Ph 2 completed Pertussis Challenge Study in Adults Vaccinated With BPZE1
NCT04669288 AZ-SWED UG3HL147016 Ph 3 terminated AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
NCT05473234 results posted 22-36912 Ph 3 terminated Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
NCT03676764 CHAT results posted OPP1187628-A Ph 4 completed Community Health Azithromycin Trial in Burkina Faso
NCT05972772 RiCS 26-23 Ph 2, Ph 3 recruiting Rickettsia Clearance Study
NCT04353661 results posted GE42063 Ph 2 terminated A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications

Showing 50 of 168 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZITHROMAX FDA Label Details

Indications & Usage

FDA Label (PDF)

ZITHROMAX is indicated for the treatment of Community-Acquired Pneumonia; Pelvic Inflammatory Disease.

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Data Sources

FDA Approval: NDA050711 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment