Dirithromycin
Dynabac (dirithromycin) is a small molecule pharmaceutical. Dirithromycin was first approved as Dynabac on 1995-06-19. It is used to treat bacterial pneumonia, bronchitis, community-acquired infections, haemophilus infections, and staphylococcal infections amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dirithromycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DYNABAC | Eli Lilly | N-050678 DISCN | 1995-06-19 | 1 products |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial pneumonia | EFO_1001272 | D018410 | J15.9 |
| bronchitis | — | D001991 | J40 |
| community-acquired infections | — | D017714 | — |
| haemophilus infections | EFO_1001127 | D006192 | — |
| staphylococcal infections | — | D013203 | A49.01 |
| streptococcal infections | EFO_1001476 | D013290 | — |
| tonsillitis | HP_0011110 | D014069 | J03 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 13 | — | — | 1 | — | 14 | ||
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 3 | 2 | 1 | 6 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 2 | 2 | 1 | 6 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 3 | 1 | 4 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | — | — | 3 | 1 | 4 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | 2 | 1 | — | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | 2 | — | 3 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 2 | 1 | 3 |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 3 | — | 3 | |
| Coronary disease | D003327 | — | — | 2 | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 2 | 1 | — | — | 3 | |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | — | — | 3 |
| Internal carotid artery dissection | D020215 | — | — | 1 | — | — | 1 | ||
| Vertebral artery dissection | D020217 | I77.74 | — | — | 1 | — | — | 1 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 3 | — | — | — | 3 |
| Carotid stenosis | D016893 | — | 1 | — | — | 1 | 2 | ||
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | 1 | — | — | — | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | — | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | 1 | — | — | — | 1 | ||
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | 1 | — | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | 1 | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary angiography | D017023 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | — | — | 1 | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 1 | 1 | |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | — | 1 | 1 | |
| Hyperemia | D006940 | EFO_0003822 | H34.82 | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | R09.02 | — | — | — | — | 1 | 1 | |
| Essential hypertension | D000075222 | I10 | — | — | — | — | 1 | 1 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Psychotic disorders | D011618 | F20.81 | — | — | — | — | 1 | 1 | |
| Splenectomy | D013156 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DIRITHROMYCIN |
| INN | dirithromycin |
| Description | Dirithromycin is the hemi-aminal resulting from the condensation of the erythromycin derivative (9S)-erythromycyclamine with 2-(2-methoxyethoxy)acetaldehyde. As the oxazine ring containing the hemi-aminal group is unstable under both acidic and alkaline conditions, dirithromycin functions as a more lipid-soluble prodrug for (9S)-erythromycyclamine. Administered as enteric coated tablets to protect it from acid catalysed hydrolysis in the stomach, it is used to treat respiratory tract, skin, and soft tissue infections caused by susceptible organisms. It has a role as a prodrug. |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strain) |
| 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)[C@@H]2N[C@@H](COCCOC)O[C@H]([C@H]2C)[C@]1(C)O |
Identifiers
| PDB | — |
| CAS-ID | 62013-04-1 |
| RxCUI | 23437 |
| ChEMBL ID | CHEMBL1237072 |
| ChEBI ID | 474014 |
| PubChem CID | 6473883 |
| DrugBank | DB00954 |
| UNII ID | 1801D76STL (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Additional graphs summarizing 344 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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5,045 adverse events reported
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