Azithromycin
Azasite, Azithromycin, Trovan/zithromax Compliance, Zithromax (azithromycin) is a small molecule pharmaceutical. Azithromycin was first approved as Zithromax on 1991-11-01. It is used to treat bacterial infections, chlamydia infections, haemophilus infections, infectious skin diseases, and mycoplasma pneumonia amongst others in the USA. It is known to target motilin receptor.
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Commercial
Trade Name
FDA
EMA
Azasite, Azithromycin, Zithromax (discontinued: Azithromycin, Zithromax, Zmax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azithromycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZITHROMAX | Pfizer | N-050710 RX | 1995-10-19 | 2 products, RLD, RS |
| ZITHROMAX | Pfizer | N-050711 RX | 1996-07-18 | 1 products, RLD |
| ZITHROMAX | Pfizer | N-050733 RX | 1997-01-30 | 1 products, RLD, RS |
| ZITHROMAX | Pfizer | N-050784 RX | 2002-05-24 | 1 products, RLD |
| AZASITE | Thea Pharma | N-050810 RX | 2007-04-27 | 1 products, RLD, RS |
Show 5 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azasite | New Drug Application | 2024-07-25 |
| azithromycin | ANDA | 2026-04-13 |
| azithromycin azithromycin dihydrate | ANDA | 2026-03-17 |
| azithromycin dihydrate | ANDA | 2026-04-14 |
| azithromycin monohydrate | ANDA | 2023-06-20 |
| zithromax | New Drug Application | 2026-01-07 |
| zmax | New Drug Application | 2011-01-26 |
Indications
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EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FA: Macrolides
— J01FA10: Azithromycin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA07: Azithromycin, fluconazole and secnidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA26: Azithromycin
Clinical
Clinical Trials
701 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 11 | 34 | 43 | 5 | 24 | 106 |
| Infections | D007239 | EFO_0000544 | — | 9 | 16 | 19 | 11 | 28 | 81 |
| Communicable diseases | D003141 | — | — | 5 | 12 | 12 | 9 | 21 | 57 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 8 | 17 | 12 | 21 | 56 |
| Malaria | D008288 | EFO_0001068 | B54 | 5 | 13 | 14 | 5 | 2 | 33 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 7 | 11 | 8 | 3 | 29 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 6 | 5 | 11 | 6 | 28 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 3 | 10 | 7 | 1 | 6 | 24 |
| Respiratory tract infections | D012141 | — | J06.9 | 1 | 3 | 8 | 7 | 4 | 22 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 3 | 5 | 8 | 5 | 22 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 4 | 4 | — | 15 | 26 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 2 | 12 | 8 | — | — | 16 |
| Sars-cov-2 | D000086402 | — | — | 1 | 8 | 4 | — | 1 | 13 |
| Inflammation | D007249 | MP_0001845 | — | 2 | 2 | 6 | — | 3 | 12 |
| Conjunctivitis | D003231 | — | H10 | 1 | 1 | 6 | — | 1 | 9 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 3 | 4 | — | 3 | 8 |
| Virus diseases | D014777 | — | B34 | 2 | 4 | 1 | — | 1 | 7 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | 2 | — | 3 | 7 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 4 | 2 | — | — | 6 |
| Respiratory sounds | D012135 | — | R06.1 | — | 3 | 3 | — | — | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 3 | — | — | 2 | 5 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 2 | 3 | — | — | 1 | 5 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 2 | — | — | 2 | 4 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 2 | — | — | 1 | 4 |
| Whooping cough | D014917 | EFO_0000650 | A37 | — | 1 | — | — | 3 | 4 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 4 | — | — | — | 4 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 4 | — | — | — | 4 |
| Cryptosporidiosis | D003457 | — | A07.2 | 1 | 1 | — | — | 3 | 4 |
| Coronavirus | D017934 | — | — | — | 1 | — | — | 2 | 3 |
| Acute lung injury | D055371 | EFO_0004610 | — | 1 | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial eye infections | D015818 | — | — | 5 | — | — | — | — | 5 |
| Pulmonary infarction | D054060 | EFO_1001408 | — | 1 | — | — | — | — | 1 |
| Dental implants | D015921 | — | — | 1 | — | — | — | — | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Acute chest syndrome | D056586 | EFO_0007129 | — | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | — | 1 |
| Quorum sensing | D053038 | — | — | 1 | — | — | — | — | 1 |
| Prebiotics | D056692 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 3 | 3 |
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | — | — | — | — | 2 | 2 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | — | — | — | 2 | 2 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 2 | 2 |
| Surgical wound infection | D013530 | — | — | — | — | — | — | 2 | 2 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 2 | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | — | — | 2 | 2 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
Show 67 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Azithromycin |
| INN | azithromycin |
| Description | Azithromycin is a macrolide antibiotic useful for the treatment of bacterial infections. It has a role as an antibacterial drug, an environmental contaminant and a xenobiotic. |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strains) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O |
Identifiers
| PDB | — |
| CAS-ID | 83905-01-5 |
| RxCUI | 1299904 |
| ChEMBL ID | CHEMBL529 |
| ChEBI ID | 2955 |
| PubChem CID | 447043 |
| DrugBank | DB00207 |
| UNII ID | F94OW58Y8V (ChemIDplus, GSRS) |
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Zithromax – Pfizer
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Estimated US medical usage
Azithromycin
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Trends
PubMed Central
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Safety
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41,951 adverse events reported
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