CLINICAL TRIALS PROFILE FOR DORIBAX

All Clinical Trials for DORIBAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00925392 ↗	Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects	Completed	Pulmonary Associates, PA	Phase 1	2009-06-01	This study is being performed to measure the amount of the antibiotic doripenem (study drug) found in the fluid and cells of the lung and blood after receiving three doses of doripenem. The major objectives of this research are to see how much and for how long doripenem gets into the fluids and cells of the lungs of healthy adult subjects.
NCT00925392 ↗	Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects	Completed	Keith A. Rodvold	Phase 1	2009-06-01	This study is being performed to measure the amount of the antibiotic doripenem (study drug) found in the fluid and cells of the lung and blood after receiving three doses of doripenem. The major objectives of this research are to see how much and for how long doripenem gets into the fluids and cells of the lungs of healthy adult subjects.
NCT00965848 ↗	A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections	Completed	Janssen-Cilag Ltd.,Thailand	Phase 4	2009-06-01	The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).
NCT01763008 ↗	A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections	Completed	Janssen Pharmaceutica		2009-11-01	The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.

Clinical Trial Conditions for DORIBAX

Condition Name

Condition Name for DORIBAX
Intervention	Trials
Pneumonia, Ventilator-Associated	1
Urinary Tract Infection	1
Urinary Tract Infections	1
Bacterial Infections	1

Condition MeSH

Condition MeSH for DORIBAX
Intervention	Trials
Healthcare-Associated Pneumonia	2
Urinary Tract Infections	2
Cross Infection	2
Communicable Diseases	2

Clinical Trial Locations for DORIBAX

Trials by Country

Trials by Country for DORIBAX
Location	Trials
Thailand	1
United States	1
Philippines	1

Trials by US State

Trials by US State for DORIBAX
Location	Trials
Arizona	1

Clinical Trial Progress for DORIBAX

Clinical Trial Phase

Clinical Trial Phase for DORIBAX
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for DORIBAX
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for DORIBAX

Sponsor Name

Sponsor Name for DORIBAX
Sponsor	Trials
Pulmonary Associates, PA	1
Keith A. Rodvold	1
Janssen-Cilag Ltd.,Thailand	1

Sponsor Type

Sponsor Type for DORIBAX
Sponsor	Trials
Other	2
Industry	2

Summary: DORIBAX (doripenem) is a broad-spectrum carbapenem antibiotic developed by Merck. It targets complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), and pneumonia. Current clinical trials focus on expanding indications and evaluating resistance profiles. Market projections indicate moderate growth driven by rising antibiotic resistance, with challenges arising from competition and stewardship concerns.

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What is the current status of clinical trials for DORIBAX?

Last updated: February 6, 2026

DORIBAX was approved by the FDA in 2012 for the treatment of complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections. Merck discontinued its U.S. marketing of DORIBAX in 2014 due to slow sales but maintained ongoing development for other indications in global markets.

Recent clinical trial activity mostly pertains to post-approval studies, including:

• Phase IV studies examining real-world efficacy and safety in specific patient populations.
• Trials assessing combination therapies to combat resistant bacteria.
• Investigations into new delivery methods for better bioavailability.

There are no ongoing active Phase I–III trials registered publicly for DORIBAX as of the latest update. Most recent updates occur in the form of observational studies and registries.

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How does DORIBAX compare to other carbapenems in development or marketed?

Parameter	DORIBAX (doripenem)	Meropenem	Imipenem	Ertapenem
Jurisdiction	Global (discontinued in U.S.)	Widely used	Widely used	Restricted indications
Spectrum	Broad (including Pseudomonas)	Broad	Broad	Narrower, once daily dosing
Approved indications	cUTI, cIAI	Meningitis, pneumonia, cUTI	Meningitis, pneumonia	Skin, soft tissue infections
Market presence	Discontinued in US	Leading	Leading	Market share declining

DORIBAX faced competition from other carbapenems with broader or more established profiles. Its dissolution in the U.S. limits its market dominance. Globally, it still holds value where resistance patterns favor its use.

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What are market dynamics and future projections for DORIBAX?

The global antibiotic market is projected to grow modestly, driven by increasing antimicrobial resistance (AMR). According to MarketsandMarkets, the antibiotic market is expected to reach $46 billion by 2025, with carbapenems holding a significant share.

Key factors influencing DORIBAX prospects include:

• Resistance patterns: Rising prevalence of multidrug-resistant gram-negative bacteria favours carbapenem use, including doripenem, especially in Asia and Europe.

• Stewardship policies: Strict antimicrobial stewardship limits the use of broad-spectrum antibiotics, constraining sales.

• Market competition: Generics and newer agents, such as meropenem-vaborbactam, reduce DORIBAX's attractiveness.

• Regulatory landscape: Regulatory agencies emphasize cautious use to prevent resistance, impacting approval of new indications.

In the short term, DORIBAX's market presence is limited outside select global regions. Long-term growth depends on its positioning in resistant infection management and potential new formulations or combination therapies.

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What are the obstacles and opportunities for DORIBAX's future?

Obstacles

• Discontinued U.S. sales reduce its visibility and restrict further domestic development.
• Competition from newer carbapenems with enhanced spectra, pharmacokinetics, or stewardship profiles.
• Limited clinical pipeline diminishes prospects for expansion into additional indications.
• Regulatory pressures limit aggressive marketing and new approvals.

Opportunities

• Emerging resistance against other carbapenems creates niche markets for DORIBAX where susceptibility remains.
• Combination therapies could restore utility in resistant infections.
• Focus on global markets where approval persists, especially in regions with limited alternatives.

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Key Takeaways

• DORIBAX (doripenem) is a broad-spectrum carbapenem approved primarily for cUTI and cIAI, with development activity lacking in recent years.
• Its U.S. marketing has been discontinued; global use persists in select regions.
• The global antibiotic market offers growth potential but is constrained by resistance, stewardship, and competition.
• The future for DORIBAX hinges on resistance trends, strategic repositioning, and potential combination therapy development.

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FAQs

1. Will DORIBAX regain U.S. approval?
   Unlikely, given current marketing discontinuation and limited ongoing clinical trial activity.

2. What are alternative drugs for infections DORIBAX targets?
   Meropenem, imipenem, and ertapenem are primary alternatives with broader or similar spectrums.

3. Are there any ongoing trials for new indications?
   No publicly registered Phase I–III trials for new indications are active as of now.

4. How does DORIBAX’s resistance profile compare to competitors?
   It maintains activity against certain resistant gram-negative bacteria, but resistance development reduces its utility.

5. Which regions are most relevant for DORIBAX sales?
   Europe, Asia, and Latin America, where approval remains intact and resistance patterns favor its use.

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References

[1] MarketsandMarkets. "Antibiotic Market by Product Type, Route of Administration, Technology, Application, and Region – Global Forecast to 2025." 2021.

[2] FDA. "DORIBAX (doripenem) Highlights of Prescribing Information." 2012.

[3] ClinicalTrials.gov. "DORIBAX Clinical Trials." Accessed December 2022.

[4] CDC. "Antimicrobial Resistance Threats in the United States." 2019.

[5] European Medicines Agency. DORIBAX Summary of Product Characteristics.