Azithromycin clinical trials
Azithromycin is named as an intervention in 14 current clinical trials in our France, Canada, Netherlands, Denmark, Egypt, China, Spain, Italy, Belgium, Sweden, Japan, South Korea, Australia, Israel, USA, Germany, Austria, Czechia, Norway, India, Portugal, Taiwan, Singapore and Mexico registers. 10 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Assiut University (2). The most-studied condition is Lung Transplant Rejection. The EU clinical trials register (CTIS) separately lists 5 authorised or ongoing trials.
Where Azithromycin is approved
All regulators →Of the three regulators tracked here, the first to approve Azithromycin was the US, on 1 Nov 1991. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for prevention of bronchopulmonary dysplasia (14 Jan 2022, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Azithromycin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Azithromycin works
All drug targets →- Bacterial 70S ribosome inhibitor InhibitorChEMBL only
- Acute otitis mediaPhase 3
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- Helicobacter pylori infectious diseasePhase 3
- Intraventricular hemorrhagePhase 3
- Mycobacterium avium complex diseasePhase 3
- Orthocoronavirinae infectious diseasePhase 3
- Orthomyxoviridae infectious diseasePhase 3
- Respiratory tract infectionPhase 3
- Ureaplasma urethritisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL529, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6510, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Azithromycin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Azithromycin
- ChEMBL
- CHEMBL529
- DrugBank
- DB00207
- PubChem CID
- 447043
- CAS number
- 83905-01-5
- FDA UNII
- F94OW58Y8V
- Wikidata
- Q165399
- Wikipedia
- Azithromycin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Azithromycin
14 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Azithromycin in the EU trials register (CTIS)
5 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Azithromycin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Azithromycin across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
8 single-substance products containing Azithromycin on the HPRA medicines list.
- Azithromycin Clonmel 250 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/150/001 · Marketed
- Azithromycin Teva 250 mg film-coated tabletsTeva Pharma B.V. · PA0749/039/002 · Marketed
- Azromax 250 mg film-coated tabletsViatris Limited · PA23266/043/001 · Marketed
- Azyter 15 mg/g eye drops, solution, in single-dose containerLaboratoires Thea · PA1107/004/001 · Marketed
- Zithromax 250 mg hard capsulesPfizer Healthcare Ireland Unlimited Company · PA0822/191/001 · Marketed
Supply shortages
- Azithromycin TabletUS (FDA) · Resolved · updated 9 Apr 2026
- Azithromycin InjectionUS (FDA) · Resolved · updated 20 Jan 2026
Conditions studied with Azithromycin
24 conditionsAll 24 conditions
| Condition (as registered) | Trials |
|---|---|
| Lung Transplant Rejection | 1 |
| Pneumonia | 1 |
| Mycobacterium Avium Complex Pulmonary Disease | 1 |
| Sinusitis, Chronic | 1 |
| Sinus Infection Chronic | 1 |
| Lung Infection | 1 |
| MAC Lung Disease | 1 |
| Pulmonary Disease Due to Mycobacteria (Diagnosis) | 1 |
| Childhood Asthma With Acute Exacerbation | 1 |
| Nontuberculous Mycobacterial Lung Disease | 1 |
| Nontuberculous Mycobacterium Infection | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Infant Growth | 1 |
| Maternal Health | 1 |
| Infant Nutrition | 1 |
| Mycoplasma Pneumoniae | 1 |
| Mycoplasma Pneumoniae Pneumonia | 1 |
| Non-cystic Fibrosis Bronchiectasis | 1 |
| Bronchiectasis Adult | 1 |
| Bronchiectasis | 1 |
| Bronchiectasis With Acute Exacerbation | 1 |
| Idiopathic Pulmonary Fibrosis | 1 |
| Atopic Dermatitis | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Assiut University | 2 |
| Sanofi | 1 |
| University of Oxford | 1 |
| Bin Cao | 1 |
| Centre Hospitalier Intercommunal Creteil | 1 |
| Centre Hospitalier Universitaire, Amiens | 1 |
| The University of Queensland | 1 |
| Copenhagen Studies on Asthma in Childhood | 1 |
| Oregon Health and Science University | 1 |
| Duke University | 1 |
| University of Manitoba | 1 |
| Young June Choe | 1 |
| Cairo University | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Azithromycin trials
How many clinical trials are testing Azithromycin?
14 current trials in our France, Canada, Netherlands, Denmark, Egypt, China, Spain, Italy, Belgium, Sweden, Japan, South Korea, Australia, Israel, USA, Germany, Austria, Czechia, Norway, India, Portugal, Taiwan, Singapore and Mexico registers name Azithromycin as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Azithromycin trials recruiting patients?
Yes. 10 of the 14 trials are recruiting: 4 with sites in France, 3 with sites in Canada, 3 with sites in Netherlands, 2 with sites in Denmark, 2 with sites in Egypt, 2 with sites in China, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Belgium, 2 with sites in Sweden, 2 with sites in Japan, 1 with sites in South Korea, 2 with sites in Australia, 2 with sites in Israel, 1 with sites in USA, 1 with sites in Germany, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Norway, 1 with sites in India, 1 with sites in Portugal, 1 with sites in Taiwan, 1 with sites in Singapore and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Azithromycin clinical trials?
Assiut University (2), Sanofi (1), University of Oxford (1) and Bin Cao (1), among 13 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Azithromycin licensed in Ireland?
Yes. The HPRA medicines list includes 8 single-substance products containing Azithromycin, for example Azithromycin Clonmel 250 mg film-coated tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Azithromycin shortage?
The registers we track list 2 entries for Azithromycin: US FDA: resolved; US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Azithromycin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Azithromycin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Azithromycin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.