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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
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
skin and connective tissue diseasesD017437
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
NUZYRAPARATEK PHARMS INCN-209816 RX2018-10-02
1 products, RLD, RS
NUZYRAPARATEK PHARMS INCN-209817 RX2018-10-02
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nuzyraNew Drug Application2020-11-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infectionsD001424A49
bacterial pneumoniaEFO_1001272D018410J15.9
bacterial skin diseasesD017192
Agency Specific
FDA
EMA
Expiration
Code
OMADACYCLINE TOSYLATE, NUZYRA, PARATEK PHARMS INC
2028-10-02GAIN
2023-10-02NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Omadacycline Tosylate, Nuzyra, Paratek Pharms Inc
103838842037-10-31U-2576
108355422037-10-31U-2576
101118902037-08-03U-2444
93144752031-03-18DP
83836102030-09-23DP
92657402029-03-05U-1569
97243582029-03-05U-1569
101240142029-03-05U-2449
75538282024-06-02DP
73266962023-09-24DP
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01A: Tetracycline antibiotics
J01AA: Tetracyclines
J01AA15: Omadacycline
HCPCS
Code
Description
J0121
Injection, omadacycline, 1 mg
Clinical
Clinical Trials
1 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ankylosing spondylitisD013167EFO_0003898M4511
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOMADACYCLINE
INNomadacycline
Description
Omadacycline is a member of tetracyclines.
Classification
Small molecule
Drug classantibiotics (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-ID389139-89-3
RxCUI
ChEMBL IDCHEMBL1689772
ChEBI ID
PubChem CID54697325
DrugBankDB12455
UNII ID090IP5RV8F (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Nuzyra - Zai Lab
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 697 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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50 adverse events reported
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