NDAINTRAVENOUSPOWDER
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 14h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Tigecycline is a broad-spectrum tetracycline-class antibiotic administered intravenously as a powder for reconstitution. It is used to treat complicated skin and soft tissue infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. The drug works by inhibiting bacterial protein synthesis across a wide range of gram-positive, gram-negative, and anaerobic pathogens.
$0.597MPart D
Peak6.5 years to LOEPeak-stage antibiotic with modest Medicare utilization (652 Part D claims in 2023) signals a stable but niche market with limited commercial team expansion.
Mechanism of Action
Pharmacologic Class:
Tetracycline-class Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Started Nov 2012
470 enrolled
Intra-abdominal Infection
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Started Mar 2012
12 enrolled
Obesity
Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects
Started Aug 2011
0Skin DiseasesInfection
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Started Jul 2011
10 enrolled
DiarrheaClostridium Difficile
Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia
Started Mar 2011
27 enrolled
Acute Myeloid Leukemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.