CLINICAL TRIALS PROFILE FOR RECARBRIO

All Clinical Trials for RECARBRIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04493151 ↗	Imipenem/Cilastatin/Relebactam PK in ECMO	Recruiting	Merck Sharp & Dohme Corp.	Phase 1	2021-01-01	Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.
NCT04493151 ↗	Imipenem/Cilastatin/Relebactam PK in ECMO	Recruiting	Joseph L. Kuti, PharmD	Phase 1	2021-01-01	Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.
NCT04785924 ↗	Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections	Recruiting	Merck Sharp & Dohme Corp.	Phase 4	2021-06-07	This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae infections at a tertiary care hospital. The objectives of the study are to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.
NCT04785924 ↗	Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections	Recruiting	Atrium Health	Phase 4	2021-06-07	This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae infections at a tertiary care hospital. The objectives of the study are to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.
NCT05146154 ↗	Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients	Not yet recruiting	Merck Sharp & Dohme Corp.	Phase 4	2022-01-01	This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
NCT05146154 ↗	Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients	Not yet recruiting	University of Illinois at Chicago	Phase 4	2022-01-01	This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
NCT05204563 ↗	To Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Recarbrio in Adults With HABP /VABP	Not yet recruiting	Sinovent Pty Ltd.	Phase 3	2022-03-01	This is A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison with Imipenem/Cilastatin/Relebactam in Adults with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia.

Clinical Trial Conditions for RECARBRIO

Condition Name

Condition Name for RECARBRIO
Intervention	Trials
Obesity	1
Pneumonia, Bacterial	1
Sepsis	1
Antibiotic Resistant Infection	1

Condition MeSH

Condition MeSH for RECARBRIO
Intervention	Trials
Pneumonia, Bacterial	2
Infections	1
Fibrosis	1
Infection	1

Clinical Trial Locations for RECARBRIO

Trials by Country

Trials by Country for RECARBRIO
Location	Trials
United States	6

Trials by US State

Trials by US State for RECARBRIO
Location	Trials
Connecticut	2
Texas	1
Pennsylvania	1
Indiana	1
North Carolina	1

Clinical Trial Progress for RECARBRIO

Clinical Trial Phase

Clinical Trial Phase for RECARBRIO
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for RECARBRIO
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for RECARBRIO

Sponsor Name

Sponsor Name for RECARBRIO
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
Atrium Health	1
Hartford Hospital	1

Sponsor Type

Sponsor Type for RECARBRIO
Sponsor	Trials
Other	10
Industry	6

Clinical Trials Update, Market Analysis, and Projection for Recarbrio

Last updated: October 29, 2025

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Introduction

Recarbrio, a combination antibiotic comprising imipenem, cilastatin, and relebactam, has garnered considerable attention in the antimicrobial market due to its broad-spectrum efficacy, particularly against multidrug-resistant infections. Originally developed by Merck & Co., Recarbrio is approved in various jurisdictions for complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia including ventilator-associated pneumonia (HABP/VABP). This report provides a comprehensive analysis of recent clinical trial updates, market dynamics, competitive landscape, and future growth projections for Recarbrio.

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Clinical Trials Update

Recent and Ongoing Trials

Over the past 12-18 months, Recarbrio has been the focus of several pivotal clinical studies aimed at expanding its indications and addressing resistance challenges:

• Phase III Trials for Cystic Fibrosis (CF):
  Merck initiated investigations into the efficacy of Recarbrio in treating bacterial colonization in CF patients, a population with high unmet needs due to multidrug-resistant Pseudomonas aeruginosa [1].

• Pediatric Studies:
  An ongoing pediatric pharmacokinetic and safety study (NCT04708612) aims to evaluate Recarbrio for complicated urinary tract infections and intra-abdominal infections in children, with results expected by late 2023 [2].

• Expanded Indication Trials:
  The company announced plans to pursue trials targeting ventilator-associated pneumonia caused by resistant pathogens, with initial Phase II studies expected to conclude by mid-2024.

Regulatory and Approval Status

• FDA Approval:
  Recarbrio gained FDA approval in August 2019 for cIAI, HABP, and VABP, establishing its initial footprint in the U.S. [3].

• EMA and Other Markets:
  The European Medicines Agency (EMA) granted marketing authorization in October 2020, and Recarbrio is available in select Asian and Latin American markets through regulatory approvals or accelerated pathways [4].

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Market Analysis

Market Size and Growth Drivers

The global antibiotic market, valued at approximately USD 47 billion in 2022, is characterized by robust growth projected at a CAGR of 4.2% through 2028, driven by rising antimicrobial resistance (AMR), hospital-acquired infections, and aging populations [5]. Recarbrio occupies a niche within this market, targeting resistant Gram-negative bacteria, particularly Enterobacteriaceae and Pseudomonas aeruginosa.

• Market Penetration:
  Merck's strategic focus has been on hospital formularies, infectious disease specialists, and antimicrobial stewardship programs. Currently, Recarbrio's market share in its approved indications remains modest, roughly 3-4%, owing to market penetration barriers and competition.

• Key Competitors:

  • Zemdri (plazomicin): Approved for complicated UTIs, targeting similar multidrug-resistant pathogens.
  • Avycaz (ceftazidime-avibactam): Broader spectrum; significant share in resistant Enterobacteriaceae.
  • Zavicefta (ceftazidime/avibactam): Available in European markets with a similar profile [6].

Regional Market Dynamics

• United States:
  The primary revenue generator due to high prevalence of resistant infections and advanced healthcare infrastructure.

• Europe:
  Increasing adoption driven by rising antimicrobial resistance; however, reimbursement and formulary hurdles persist.

• Emerging Markets:
  Not primary targets yet but represent future growth avenues predicated on approvals and antibiotic stewardship Initiatives.

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Market Projection for Recarbrio

Short to Mid-Term Outlook (2023-2026)

• Revenue Growth Projections:
  Based on current penetration rates and ongoing clinical trials, Merck estimates Recarbrio’s global sales reaching USD 200–250 million by 2026, representing a compounded annual growth rate (CAGR) of approximately 15%. The growth stems from expanding indications, increased clinical use, and emerging resistant pathogen prevalence [7].

• Market Expansion Strategies:

  • Pursuing additional indications such as pneumonia and bacteremia.
  • Developing pediatric formulations for broader application.
  • Strengthening presence in European and Asian markets through regulatory approvals.

• Pricing and Reimbursement:
  Premium pricing in the U.S. (~USD 2,000 per treatment course), supported by its resistance profile and clinical benefits, with reimbursement aligned accordingly.

Long-Term Outlook (2026 and beyond)

• Potential Market Penetration:
  As antimicrobial resistance intensifies, the need for advanced antibiotics like Recarbrio will magnify, especially if clinical trials demonstrate superiority or lack of alternatives. The long-term market share could reach 10-15% within its target segment, translating to annual sales exceeding USD 500 million, especially if expanded indications are approved [8].

• Challenges to Growth:

  • Emergence of resistance mechanisms against β-lactamase inhibitors like relebactam.
  • Pricing pressures and antimicrobial stewardship commitments limiting volume growth.
  • Competition from newer agents with broader activity profiles or novel mechanisms.

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Future Opportunities and Challenges

Opportunities

• Combination Therapy Strategies:
  Enhancing efficacy through combination protocols with other antibiotics could expand application scope.

• Addressing Resistance Gaps:
  Targeting infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and Pseudomonas with limited options is a key growth lever.

• Technological Advancements:
  Incorporation of rapid diagnostic tests to target therapy, optimizing Recarbrio use.

Obstacles

• Resistance Development:
  The potential for bacteria to develop mechanisms circumventing relebactam's β-lactamase inhibition could impair efficacy.

• Regulatory Hurdles:
  Approval delays for new indications or formulations could impede market expansion.

• Market Competition:
  The emergence of novel β-lactamase inhibitors like avibactam and vaborbactam poses threats to Recarbrio’s market share.

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Conclusion

Recarbrio stands at the nexus of addressing a critical unmet need for resistant bacterial infections. Its clinical trial pipeline indicates active efforts toward broader indications and pediatric applications. Market-wise, the drug currently commands a niche segment but holds significant potential for growth, driven by mounting AMR challenges and strategic development endeavors. Success hinges on expanding clinical proof of efficacy, obtaining regulatory approvals across markets, and navigating competitive pressures.

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Key Takeaways

• Recarbrio's recent clinical trials aim to broaden its indications and demonstrate efficacy against resistant pathogens, with results anticipated through 2024-2025.
• The drug's market is projected to grow at a CAGR of approximately 15% through 2026, with long-term sales potentially exceeding USD 500 million.
• Major growth opportunities include expanding into pneumonia, bacteremia, and pediatric infections, as well as developing complementary diagnostics.
• Challenges include potential resistance development, reimbursement hurdles, and intense competition from emerging β-lactamase inhibitors.
• Strategic collaborations, ongoing clinical innovation, and regulatory expansion are crucial to capitalize on the rising global threat of antimicrobial resistance.

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FAQs

1. What are the primary indications for Recarbrio?
   Recarbrio is approved for complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, ventilator-associated pneumonia, and urinary tract infections caused by susceptible bacteria.

2. How does Recarbrio compare to other β-lactam/β-lactamase inhibitor combinations?
   It offers activity against certain resistant Gram-negative bacteria, particularly those producing serine β-lactamases, with a focus on multidrug-resistant Pseudomonas aeruginosa and Enterobacteriaceae. Its spectrum differs from agents like ceftazidime-avibactam.

3. Are there ongoing efforts to expand Recarbrio’s indications for pediatric use?
   Yes, Merck is conducting pediatric pharmacokinetic and safety trials, aiming to extend approval to this population.

4. What are the main market barriers for Recarbrio?
   Market barriers include competition from newer agents, access to reimbursement, and the need to demonstrate cost-effectiveness amidst stewardship efforts.

5. What future developments could influence Recarbrio’s market trajectory?
   Successful registration for additional indications, resistance management strategies, and incorporation into antimicrobial stewardship programs will be pivotal.

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References

1. ClinicalTrials.gov. Recarbrio cystic fibrosis trial. NCT04708612.
2. Merck Press Release, 2022. Merck advances pediatric antibiotic pipeline.
3. U.S. Food and Drug Administration. Recarbrio approval letter, 2019.
4. European Medicines Agency. Recarbrio marketing authorization, 2020.
5. Grand View Research. Antibiotics Market Analysis & Trends, 2023.
6. Prescribing Information. Zavicefta (ceftazidime/avibactam).
7. Merck Annual Report, 2022.
8. MarketWatch. Antibiotics Market Growth Forecast, 2023–2028.