Omadacycline
Nuzyra (omadacycline) is a small molecule pharmaceutical. Omadacycline was first approved as Nuzyra on 2018-10-02. It is used to treat bacterial infections, bacterial pneumonia, and bacterial skin diseases in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Nuzyra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Omadacycline tosylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NUZYRA | Paratek Pharmaceuticals | N-209816 RX | 2018-10-02 | 1 products, RLD, RS |
| NUZYRA | Paratek Pharmaceuticals | N-209817 RX | 2018-10-02 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nuzyra | New Drug Application | 2025-03-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial infections | — | D001424 | A49 |
| bacterial skin diseases | — | D017192 | — |
| bacterial pneumonia | EFO_1001272 | D018410 | J15.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OMADACYCLINE TOSYLATE, NUZYRA, PARATEK PHARMS INC | |||
| 2028-10-02 | GAIN | ||
| 2023-10-02 | NCE | ||
Patent Expiration
HCPCS
Code | Description |
|---|---|
| J0121 | Injection, omadacycline, 1 mg |
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 2 | 2 | 2 | 1 | 1 | 8 |
| Communicable diseases | D003141 | — | — | 2 | 2 | 2 | 1 | 1 | 8 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | 1 | — | 2 | — | — | 3 |
| Soft tissue infections | D018461 | — | — | — | — | 3 | — | — | 3 |
| Bacterial infections | D001424 | — | A49 | 1 | — | 2 | — | — | 3 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | 1 | — | — | 2 |
| Infectious skin diseases | D012874 | — | — | — | 1 | 1 | — | — | 2 |
| Abscess | D000038 | EFO_0003030 | — | — | — | 2 | — | — | 2 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | 2 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | 1 | — | — | 2 |
| Community-acquired pneumonia | D000098968 | — | — | 1 | — | 1 | — | — | 2 |
| Community-acquired infections | D017714 | — | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | — | — | — | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | — | — | — | 1 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | 1 | — | — | — | 1 |
| Bacterial skin diseases | D017192 | — | — | — | 1 | — | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
| Nontuberculous mycobacterium infections | D009165 | EFO_0007461 | A31.9 | — | 1 | — | — | — | 1 |
| Mycobacterium infections | D009164 | — | A31.9 | — | 1 | — | — | — | 1 |
| Infectious arthritis | D001170 | EFO_1001351 | M00 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Wound infection | D014946 | — | — | 1 | — | — | — | 1 | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | — | 1 | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Focal infection | D005490 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Omadacycline |
| INN | omadacycline |
| Description | Omadacycline is a member of tetracyclines. |
| Classification | Small molecule |
| Drug class | antibiotics (tetracycline derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)c1cc(CNCC(C)(C)C)c(O)c2c1C[C@H]1C[C@H]3[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C2=O |
Identifiers
| PDB | — |
| CAS-ID | 389139-89-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1689772 |
| ChEBI ID | — |
| PubChem CID | 54697325 |
| DrugBank | DB12455 |
| UNII ID | 090IP5RV8F (ChemIDplus, GSRS) |
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Nuzyra – Zai Lab
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Trends
PubMed Central
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Additional graphs summarizing 1,330 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,113 adverse events reported
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