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
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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 |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azasite | New Drug Application | 2024-07-25 |
| azithromycin | ANDA | 2026-05-14 |
| azithromycin azithromycin dihydrate | ANDA | 2026-03-17 |
| azithromycin dihydrate | ANDA | 2026-05-13 |
| 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
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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
705 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 6 | 2 | 2 | 11 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | — | 2 | 2 | 4 | 8 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | 1 | 2 | 1 | 5 |
| Tonsillitis | D014069 | — | — | — | 1 | 3 | 1 | — | 5 |
| Rhinosinusitis | D000096825 | — | — | — | — | 1 | 1 | — | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | 2 | — | 2 |
| Mycobacterium avium complex | D015269 | — | — | — | — | — | 2 | — | 2 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | — | — | 1 | — | 1 |
| Vaginal diseases | D014623 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 2 | 1 | 2 | — | 8 | 13 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 1 | 2 | — | 7 | 13 |
| Communicable diseases | D003141 | — | — | 2 | 1 | 2 | — | 7 | 12 |
| Malaria | D008288 | EFO_0001068 | B54 | 2 | 6 | 7 | — | — | 10 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | — | 7 | 7 | — | — | 9 |
| Mycobacterium infections | D009164 | — | A31.9 | — | — | 2 | — | 4 | 6 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 1 | — | 2 | 3 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | 1 | 2 | — | — | 3 |
| Otitis | D010031 | — | — | — | 1 | 2 | — | — | 3 |
| Chronic bronchitis | D029481 | — | J42 | — | — | 3 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 2 | 1 | — | — | 1 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | — | — | 2 | 4 |
| Pharmacokinetics | D010599 | — | — | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
| Obstructive lung diseases | D008173 | — | — | — | 1 | — | — | — | 1 |
| Tracheostomy | D014139 | — | — | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Toxoplasmosis | D014123 | EFO_0007517 | B58 | 1 | — | — | — | — | 1 |
| Cerebral toxoplasmosis | D016781 | EFO_0007200 | B58.2 | 1 | — | — | — | — | 1 |
| Encephalitis | D004660 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cryptosporidiosis | D003457 | — | A07.2 | — | — | — | — | 2 | 2 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 2 | 2 |
| Legionnaires' disease | D007877 | EFO_0007343 | A48.1 | — | — | — | — | 1 | 1 |
| Legionellosis | D007876 | EFO_0007342 | — | — | — | — | — | 1 | 1 |
| Soft tissue infections | D018461 | — | — | — | — | — | — | 1 | 1 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | J44.81 | — | — | — | — | 1 | 1 |
| Bone marrow transplantation | D016026 | — | — | — | — | — | — | 1 | 1 |
| Bronchiolitis | D001988 | — | — | — | — | — | — | 1 | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | — | — | — | 1 | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 1 | 1 |
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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Azithromycin
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Safety
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41,951 adverse events reported
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