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Drug ReportsTigecycline
Tygacil(tigecycline)
Tigecycline, Tygacil (tigecycline) is a small molecule pharmaceutical. Tigecycline was first approved as Tygacil on 2005-06-15. It is used to treat bacteremia, bacterial infections, bacterial pneumonia, bacterial skin diseases, and bacteroides infections amongst others in the USA. It has been approved in Europe to treat bacterial infections, bacterial skin diseases, infectious skin diseases, intraabdominal infections, and soft tissue infections.
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Financial
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Events Timeline
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Tygacil (generic drugs available since 2015-05-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tigecycline
Tradename
Company
Number
Date
Products
TIGECYCLINEAccord HealthcareN-208744 RX2018-01-18
1 products
TIGECYCLINEAmneal PharmaceuticalsN-211158 RX2018-08-02
1 products
TIGECYCLINEFresenius KabiN-205645 RX2016-12-01
1 products, RLD, RS
TYGACILCV SciencesN-021821 RX2005-06-15
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tigecyclineANDA2024-10-01
tygacilNew Drug Application2023-04-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
intraabdominal infections—D059413—
bacterial skin diseases—D017192—
escherichia coli infectionsEFO_1001318D004927B96.20
clostridium infectionsEFO_1000874D003015A05.2
streptococcal infectionsEFO_1001476D013290—
bacterial pneumoniaEFO_1001272D018410J15.9
staphylococcal infections—D013203A49.01
bacteremiaEFO_0003033D016470R78.81
klebsiella infectionsEFO_1001353D007710—
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Tigecycline, Tigecycline, Amneal
98553352033-04-07DP
Tigecycline, Tygacil, Pf Prism Cv
83729952030-10-08DP
78798282029-02-05DP
89752422028-10-24DP
92543282026-03-13DP
96940782026-03-13DP
105889752026-03-13DP
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01A: Tetracycline antibiotics
— J01AA: Tetracyclines
— J01AA12: Tigecycline
HCPCS
Code
Description
J3243
Injection, tigecycline, 1 mg
J3244
Injection, tigecycline (accord) not therapeutically equivalent to j3243, 1 mg
Clinical
Clinical Trials
79 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544——416101240
Communicable diseasesD003141———3129629
Intraabdominal infectionsD059413———255415
PneumoniaD011014EFO_0003106—1163112
Skin diseasesD012871—L00-L99—22228
Infectious skin diseasesD012874———21137
SepsisD018805HP_0100806A41.9—23216
BacteremiaD016470EFO_0003033R78.81111226
PeritonitisD010538EFO_0008588K65———224
Cross infectionD003428————31—4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial pneumoniaD018410EFO_1001272J15.9—26—19
Bacterial infectionsD001424—A49—15—39
Community-acquired infectionsD017714————2—24
Enterobacteriaceae infectionsD004756EFO_1001313——11—23
Mycobacterium infectionsD009164—A31.9—21——2
Gram-positive bacterial infectionsD016908————2——2
Surgical wound infectionD013530————1——1
Diabetic footD017719EFO_1001459———1——1
OsteomyelitisD010019EFO_0003102M86——1——1
EmergenciesD004630————1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Staphylococcal skin infectionsD013207EFO_1001849L00—1———1
CellulitisD002481EFO_0003035L03.90—1———1
Mycobacterium abscessusD000073358———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951———12
Myeloid leukemiaD007951—C921———12
Healthy volunteers/patients———2————2
Chronic kidney failureD007676EFO_0003884N18.91————1
Myeloid leukemia acuteD015470—C92.01————1
Liver cirrhosisD008103EFO_0001422K74.01————1
FibrosisD005355——1————1
Biliary liver cirrhosisD008105—K74.31————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inappropriate prescribingD057970——————11
Acinetobacter infectionsD000151EFO_1000792—————11
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—————11
Extracorporeal membrane oxygenationD015199——————11
PharmacokineticsD010599——————11
Urogenital neoplasmsD014565EFO_0003863D07————11
Septic shockD012772—A48.3————11
DiarrheaD003967HP_0002014R19.7————11
Clostridium infectionsD003015EFO_1000874A05.2————11
Clostridioides difficileD016360NCBITaxon_1496—————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTigecycline
INNtigecycline
Description
Tigecycline, sold under the brand name Tygacil, is a tetracycline antibiotic medication for a number of bacterial infections. It is a glycylcycline administered intravenously. It was developed in response to the growing rate of antibiotic resistant bacteria such as Staphylococcus aureus, Acinetobacter baumannii, and E. coli. As a tetracycline derivative antibiotic, its structural modifications has expanded its therapeutic activity to include Gram-positive and Gram-negative organisms, including those of multi-drug resistance.
Classification
Small molecule
Drug classantibiotics (tetracycline derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)c1cc(NC(=O)CNC(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-ID220620-09-7
RxCUI—
ChEMBL IDCHEMBL376140
ChEBI ID149836
PubChem CID5282044
DrugBankDB00560
UNII ID70JE2N95KR (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Tygacil – Pfizer
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 17,929 documents
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Safety
Black-box Warning
Black-box warning for: Tigecycline, Tygacil
Adverse Events
Top Adverse Reactions
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4,162 adverse events reported
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