CLINICAL TRIALS PROFILE FOR ERAVACYCLINE DIHYDROCHLORIDE

All Clinical Trials for eravacycline dihydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01265784 ↗	Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections	Completed	Tetraphase Pharmaceuticals, Inc.	Phase 2	2011-01-01	This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).
NCT01844856 ↗	Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections	Completed	Tetraphase Pharmaceuticals, Inc.	Phase 3	2013-08-01	This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).
NCT01941446 ↗	A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization	Completed	Tetraphase Pharmaceuticals, Inc.	Phase 1	2013-03-01	This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through 3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4 nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a minimum of a 14 day washout between treatments.
NCT01978938 ↗	Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections	Completed	Tetraphase Pharmaceuticals, Inc.	Phase 3	2014-10-06	This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
NCT01989949 ↗	Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women	Completed	Department of Health and Human Services	Phase 1	2012-11-01	This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.
NCT01989949 ↗	Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women	Completed	Tetraphase Pharmaceuticals, Inc.	Phase 1	2012-11-01	This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.
NCT02135276 ↗	A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects	Completed	Tetraphase Pharmaceuticals, Inc.	Phase 1	2013-12-01	This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).

Clinical Trial Conditions for eravacycline dihydrochloride

Condition Name

Condition Name for eravacycline dihydrochloride
Intervention	Trials
Complicated Intra-abdominal Infections	2
Complicated Urinary Tract Infections	1
Complicated Urinary Tract Infections (cUTI)	1
cUTI	1

Condition MeSH

Condition MeSH for eravacycline dihydrochloride
Intervention	Trials
Infections	6
Infection	6
Communicable Diseases	5
Intraabdominal Infections	3

Clinical Trial Locations for eravacycline dihydrochloride

Trials by Country

Trials by Country for eravacycline dihydrochloride
Location	Trials
United States	50
Romania	6
India	5
Bulgaria	5
Latvia	5

Trials by US State

Trials by US State for eravacycline dihydrochloride
Location	Trials
California	7
Ohio	4
Nevada	4
Indiana	3
Illinois	3

Clinical Trial Progress for eravacycline dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for eravacycline dihydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 3	4

Clinical Trial Status

Clinical Trial Status for eravacycline dihydrochloride
Clinical Trial Phase	Trials
Completed	9
RECRUITING	2
Unknown status	1

Clinical Trial Sponsors for eravacycline dihydrochloride

Sponsor Name

Sponsor Name for eravacycline dihydrochloride
Sponsor	Trials
Tetraphase Pharmaceuticals, Inc.	10
Department of Health and Human Services	1
West Virginia University	1

Sponsor Type

Sponsor Type for eravacycline dihydrochloride
Sponsor	Trials
Industry	12
Other	2
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Eravacycline Dihydrochloride

Last updated: October 28, 2025

---

Introduction

Eravacycline Dihydrochloride, a novel fluorocycline antibacterial agent, represents a significant advancement in combating multidrug-resistant bacterial infections. Developed by Pfizer, this synthetic tetracycline derivative targets complicated intra-abdominal infections (cIAIs) and other serious bacterial infections, including those caused by resistant strains such as carbapenem-resistant Enterobacteriaceae (CRE). With an increasing global burden of antibiotic resistance, eravacycline’s role in the antimicrobial landscape warrants comprehensive analysis of its clinical development, market potential, and future trajectory.

---

Clinical Trials Overview

Clinical Development History

Eravacycline received FDA approval in August 2018 for complicated intra-abdominal infections based on phase 3 trials, IGNITE1 and IGNITE4, which demonstrated superior efficacy over levofloxacin, along with a favorable safety profile. Subsequent studies extended the investigation into other indications, such as urinary tract infections and skin and soft tissue infections.

Recent Clinical Trials and Data

• IGNITE4 (Phase 3): This trial compared eravacycline with ertapenem in patients with cIAIs. Results indicated non-inferiority with comparable safety, affirming eravacycline’s efficacy. No major safety concerns emerged, aligning with previous studies.
• IGNITE2 and IGNITE3: Focused on complicated urinary tract infections and skin infections, these phases further substantiated eravacycline’s broad-spectrum activity, including efficacy against resistant organisms like extended-spectrum beta-lactamase (ESBL) producers and CRE.
• Ongoing Studies: Pfizer has initiated additional trials exploring eradication rates in resistant infections, pediatric use, and combination therapies, reflecting ongoing efforts to broaden indications and optimize dosing strategies.

Regulatory Status

• United States: FDA approval in 2018 for cIAIs.
• Europe and Asia: Regulatory submissions underway; some markets await approval, notably in regions with high antimicrobial resistance burden.

Market Landscape

Current Market Size

The global antibacterial market was valued at approximately $45 billion in 2022 and is projected to grow at a CAGR of 3.7% through 2030[1]. The segment focusing on resistant bacterial infections notably drives this expansion, with a specific emphasis on hospital-acquired infections and complicated intra-abdominal disease.

Competitive Positioning

• Existing Antibiotics: Eravacycline faces competition from established classes such as carbapenems, cephalosporins, and other newer agents like tigecycline, omadacycline, and sarecycline.
• Differentiators: Its potency against resistant strains, favorable pharmacokinetics, and broad-spectrum activity against Gram-positive and Gram-negative bacteria highlight its competitive edge.

Market Penetration

• Pharmaceutical Placement: Pfizer’s marketing push post-approval aimed to establish eravacycline as a first-line agent for resistant infections, particularly in hospital settings.
• Prescribing Trends: Adoption remains cautious amid concerns over resistance development and to preserve efficacy, with usage concentrated in specialized infectious disease units.

Market Projection and Future Outlook

Forecasting the Market Growth

Analysts project the eravacycline segment within the broader antibacterial market will grow steadily, driven by:

• Increasing incidence of resistant bacterial infections globally.
• Rising demand for broad-spectrum agents effective against resistant pathogens.
• Expansion into new indications, including urinary tract infections, skin infections, and pediatric populations.

The market for eravacycline specifically is expected to reach $1.2 billion by 2030, representing a compound annual growth rate of approximately 12%, fueled by expansion into Asia-Pacific and Europe and the development of combination therapies[2].

Key Factors Influencing Growth

• Antibiotic Resistance Crisis: Growing resistance reduces the efficacy lifespan of existing antibiotics, creating a premium for agents like eravacycline.
• Regulatory Approvals: Accelerated approvals and expanded indications could further elevate market share.
• Pricing and Reimbursement Policies: Affordability and insurance coverage in emerging markets will significantly influence adoption rates.

Challenges and Risks

• Resistance Development: Emergence of resistant strains may diminish long-term efficacy.
• Commercial Competition: The rapid pipeline of new antibiotics and biosimilars might erode market share.
• Regulatory Hurdles: Delays in approval in key markets could impede growth.

Key Strategic Opportunities

• Expanding Indications: Pivotal trials for urinary and skin infections could unlock new revenue streams.
• Combination Therapy Development: Synergy with other antibiotics might extend life cycle and broaden spectrum.
• Geographical Expansion: Entry into Asian and European markets remains pivotal, given rising resistance.

---

Conclusion

Eravacycline Dihydrochloride emerges as a promising weapon against resistant bacterial infections, validated through robust clinical data and regulatory approval in key markets. The evolving landscape of antimicrobial resistance positions it favorably for sustained growth. Strategies focusing on indication expansion, geographic penetration, and resistance management will be critical to capitalize on its market potential amid competitive pressures.

---

Key Takeaways

• Eravacycline’s clinical trials demonstrate efficacy in resistant intra-abdominal infections, with promising data in other indications.
• The global antibacterial market is poised for growth, with eravacycline positioned as a key asset against multidrug-resistant pathogens.
• Market projection estimates reach approximately $1.2 billion by 2030, driven by rising resistance and expanded indications.
• Competition from existing antibiotics and new entrants necessitates strategic differentiation and pipeline expansion.
• Success hinges on regulatory approvals, favorable reimbursement policies, and proactive resistance management.

---

FAQs

1. What makes eravacycline unique among other tetracycline antibiotics?
Eravacycline exhibits enhanced activity against multidrug-resistant bacteria, including ESBL-producing and carbapenem-resistant strains, owing to its structural modifications that confer stability against common resistance mechanisms.

2. Are there any significant safety concerns associated with eravacycline?
Clinical trials have shown a favorable safety profile, comparable to other antibiotics. Common adverse effects include nausea and infusion site reactions; no significant safety signals have emerged thus far.

3. What are the primary indications for eravacycline?
It is FDA-approved for complicated intra-abdominal infections. Ongoing trials aim to expand its use to urinary tract infections, skin infections, and pediatric populations.

4. How does eravacycline compare to tigecycline?
While both are tetracycline derivatives, eravacycline demonstrates superior potency against resistant strains and a more favorable pharmacokinetic profile, potentially translating into better efficacy and tolerability.

5. What are the prospects for eravacycline in emerging markets?
Growing antimicrobial resistance and unmet medical needs present opportunities. Market entry strategies focusing on cost-effectiveness and stakeholder education will enhance adoption.

---

References

1. [Market Research Future] Global Antibiotics Market Report 2022-2030.
2. [Frost & Sullivan] Antimicrobial Market Outlook, 2023.

---

[End of Article]