TIGECYCLINE
TIGECYCLINE is indicated for the treatment of Skin and Skin Structure Infections; Intra-abdominal Infections; Community-Acquired Pneumonia.
How TIGECYCLINE Works
Tigecycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit and blocking the entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents the incorporation of amino acid residues into elongating peptide chains. It is generally considered bacteriostatic. As a glycylcycline, it is designed to overcome two common tetracycline resistance mechanisms: efflux pump expression and ribosomal protection.
Details
- Status
- Prescription
- First Approved
- 2015-05-27
- Patent Cliff
- 2033
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
TIGECYCLINE Approval History
What TIGECYCLINE Treats
3 indicationsTIGECYCLINE is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin and Skin Structure Infections
- Intra-abdominal Infections
- Community-Acquired Pneumonia
TIGECYCLINE Boxed Warning
ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage ( 1.4 ), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)]. WARNING: ALL-C...
WARNING: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage ( 1.4 ), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)]. WARNING: ALL-CAUSE MORTALITY See full prescribing information for complete boxed warning. All-cause mortality was higher in patients treated with tigecycline for injection than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable ( 1.4 , 5.1 , 5.2 , 6.1 ).
TIGECYCLINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TIGECYCLINE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial |
| NCT06893835 MDRS | Multidrug resistance | Ph 4 | active not recruiting | Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline |
| NCT04042077 DRESS results posted | DELA-01 2018-001082-17 | Ph 3 | terminated | Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections |
| NCT01970371 CARE results posted | ACHN-490-007 2013-001997-18, U1111-1151-2686 | Ph 3 | completed | A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE) |
| NCT01721408 results posted | B1811185 | Ph 4 | completed | A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection |
| NCT01560143 results posted | 11-007 WS2001231 | Ph 4 | completed | Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects |
| NCT01332786 | OZM-029 | Ph 1 | completed | Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia |
| NCT00719810 results posted | RX-3341-201 | Ph 2 | completed | Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections |
| NCT01602874 | 3074K4-3340 B1811003 | Ph 3 | withdrawn | Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia |
| NCT00707239 results posted | 3074K6-2000 B1811004 | Ph 2 | terminated | Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia |
| NCT00914888 | 3074K4-3340 B1811003 | Ph 3 | withdrawn | Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia |
| NCT00911573 | 3074K4-3339 B1811002 | Ph 3 | withdrawn | 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 |
| NCT01287793 | B1811062 | Ph 1 | completed | Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TIGECYCLINE FDA Label Details
Indications & Usage
FDA Label (PDF)TIGECYCLINE is indicated for the treatment of Skin and Skin Structure Infections; Intra-abdominal Infections; Community-Acquired Pneumonia.
WARNING: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for inj...
TIGECYCLINE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for TIGECYCLINE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.