CLINICAL TRIALS PROFILE FOR TIGECYCLINE

All Clinical Trials for TIGECYCLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00136201 ↗	Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-11-01	The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections.
NCT00081575 ↗	Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2004-01-01	To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
NCT00079989 ↗	Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2003-12-01	To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.
NCT00079885 ↗	Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2003-11-01	To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.
NCT00079976 ↗	Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2003-10-01	To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.
NCT00080496 ↗	Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2003-07-01	To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
NCT00081744 ↗	Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2002-11-01	Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

Clinical Trial Conditions for TIGECYCLINE

Condition Name

Condition Name for TIGECYCLINE
Intervention	Trials
Cross Infection	4
Skin Diseases, Infectious	3
Bacterial Infections	3
Bacterial Pneumonia	3

Condition MeSH

Condition MeSH for TIGECYCLINE
Intervention	Trials
Infections	32
Infection	32
Communicable Diseases	25
Intraabdominal Infections	16

Clinical Trial Locations for TIGECYCLINE

Trials by Country

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−

Trials by Country for TIGECYCLINE
Location	Trials
United States	117
China	29
Canada	16
Argentina	13
Korea, Republic of	9

Trials by US State

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−

Trials by US State for TIGECYCLINE
Location	Trials
California	9
Ohio	7
Florida	7
Pennsylvania	6
Georgia	6

Clinical Trial Progress for TIGECYCLINE

Clinical Trial Phase

Clinical Trial Phase for TIGECYCLINE
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	18
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for TIGECYCLINE
Clinical Trial Phase	Trials
Completed	36
Withdrawn	6
Unknown status	5

Clinical Trial Sponsors for TIGECYCLINE

Sponsor Name

Sponsor Name for TIGECYCLINE
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	23
Pfizer	11
Department of Health and Human Services	2

Sponsor Type

Sponsor Type for TIGECYCLINE
Sponsor	Trials
Other	53
Industry	40
U.S. Fed	2

Tigecycline: Clinical Trials, Market Analysis, and Projections

Introduction

Tigecycline, a broad-spectrum glycylcycline antibiotic, has been a significant player in the treatment of complicated infections. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy and Safety

Complicated Skin and Skin Structure Infections (cSSSI)

Clinical trials have shown that tigecycline is effective in treating cSSSI. In two phase 3, double-blind studies, tigecycline demonstrated similar clinical cure rates to vancomycin-aztreonam, with cure rates of 86.3% and 86.4% for tigecycline versus 88.6% for the comparator[3].

Complicated Intra-abdominal Infections (cIAI) and Community-Acquired Bacterial Pneumonia (CAP)

Tigecycline has also been found to be effective in treating cIAI and CAP. Clinical cure rates for tigecycline were comparable to those of other antibiotics, such as vancomycin-aztreonam, imipenem-cilastatin, and levofloxacin. For patients with secondary bacteremia, tigecycline showed a clinical cure rate of 81.3% compared to 78.5% for the comparator agents[1].

Safety Concerns

Despite its efficacy, tigecycline has been associated with higher mortality rates in some clinical trials. A pooled analysis of phase 3 and 4 trials revealed numerically higher mortality rates in patients treated with tigecycline compared to those treated with other antibiotics. This has led to the recommendation that tigecycline should only be used when other antibiotics are unsuitable[4].

Market Analysis

Global Market Overview

The global tigecycline market is segmented by application into skin and soft tissue infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. The market is also bifurcated by target bacteria type into Gram-positive and Gram-negative bacteria. Currently, the Asia-Pacific region dominates the market, with significant adoption in the pharmaceutical industry[2].

Regional Market Performance

• Asia-Pacific: This region is expected to continue its dominance in the tigecycline market due to high demand and increasing incidence of antibiotic-resistant infections.
• North America and Europe: These regions are also expected to witness healthy growth rates driven by the need for effective treatments against complicated infections[2].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the tigecycline market, particularly in China. The sales value of tigecycline in China decreased in 2020 due to disruptions in healthcare services, but it is expected to recover and grow in the coming years[5].

Market Projections

Sales Growth and Forecast

The sales value of tigecycline is projected to increase, driven by the rising incidence of antibiotic-resistant infections. In China, the sales value of tigecycline is expected to grow with the potential approval of new indications, such as community and hospital-acquired pneumonia[5].

Competitive Landscape

The tigecycline market in China includes both branded and generic versions, with several local manufacturers contributing to the market. The competitive landscape is expected to remain dynamic, with ongoing research and development aimed at improving the drug's efficacy and safety profile[5].

Special Considerations

Use in Immune-Compromised Patients

Tigecycline is recommended for use in immune-compromised patients or those with cancer, as well as in cases of acute myeloid leukemia. Its broad-spectrum activity makes it a valuable option in these challenging patient populations[2].

Dosage and Administration

Tigecycline is administered intravenously every 12 hours. Patients with impaired liver function require a lower dose, while no adjustments are necessary for those with impaired kidney function[2].

Key Takeaways

• Clinical Efficacy: Tigecycline is effective in treating cSSSI, cIAI, and CAP, with cure rates comparable to other antibiotics.
• Safety Concerns: Higher mortality rates have been reported in some clinical trials, necessitating cautious use.
• Market Dominance: The Asia-Pacific region currently dominates the global tigecycline market.
• Growth Projections: The market is expected to grow driven by increasing antibiotic resistance and potential new indications.
• Special Considerations: Tigecycline is valuable in treating immune-compromised patients and requires careful dosing adjustments.

FAQs

What are the primary indications for tigecycline?

Tigecycline is primarily indicated for the treatment of complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI)[5].

Why is tigecycline associated with higher mortality rates in some clinical trials?

The exact cause is unknown, but it may be related to poorer efficacy and/or safety profile compared to other antibiotics, particularly in patients who develop superinfections like nosocomial pneumonia[4].

How is tigecycline administered?

Tigecycline is administered intravenously every 12 hours. Patients with impaired liver function require a lower dose, while no adjustments are necessary for those with impaired kidney function[2].

What is the current market trend for tigecycline?

The global tigecycline market is expected to grow, driven by increasing demand for effective treatments against antibiotic-resistant infections, particularly in the Asia-Pacific region[2].

Are there any new indications under review for tigecycline?

Yes, in China, a new indication for tigecycline in the treatment of community and hospital-acquired pneumonia is under review, which could further boost its market value[5].

Sources

1. Clinical Infectious Diseases: "Safety and Efficacy of Intravenous Tigecycline in Subjects with Secondary Bacteremia Associated with Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, and Community-acquired Bacterial Pneumonia"[1].
2. IndustryARC: "Tigecycline Market - Forecast(2025)"[2].
3. Clinical Infectious Diseases: "Efficacy and Safety of Tigecycline in the Treatment of Skin and Skin-Structure Infections"[3].
4. GOV.UK: "Tigecycline (Tygacil): increased mortality in clinical trials"[4].
5. Business Wire: "Investigation Report on China's Tigecycline Markets, 2016-2020, 2021-2025"[5].