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Last Updated: December 31, 2025

CLINICAL TRIALS PROFILE FOR CEFTRIAXONE


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505(b)(2) Clinical Trials for CEFTRIAXONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00244777 ↗ Introduction of Hypo-osmolar ORS for Routine Use Completed United States Agency for International Development (USAID) Phase 4 2002-12-01 The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation NCT00244777 ↗ Introduction of Hypo-osmolar ORS for Routine Use Completed International Centre for Diarrhoeal Disease Research, Bangladesh Phase 4 2002-12-01 The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for CEFTRIAXONE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000648 ↗ A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals Completed Hoffmann-La Roche N/A 1969-12-31 To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000648 ↗ A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000938 ↗ A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
NCT00001101 ↗ A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) active infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of co-infection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, for seropositive patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
NCT00002052 ↗ Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients Completed University of Southern California N/A 1969-12-31 To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.
NCT00004216 ↗ VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Therapy Completed Vion Pharmaceuticals Phase 1 1999-08-01 RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy.
NCT00034736 ↗ A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2002-08-01 The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CEFTRIAXONE

Condition Name

Condition Name for CEFTRIAXONE
Intervention Trials
Pneumonia 11
Sepsis 8
Gonorrhea 6
Surgical Site Infection 5
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Condition MeSH

Condition MeSH for CEFTRIAXONE
Intervention Trials
Infections 43
Pneumonia 35
Infection 34
Communicable Diseases 28
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Clinical Trial Locations for CEFTRIAXONE

Trials by Country

Trials by Country for CEFTRIAXONE
Location Trials
United States 245
France 35
Australia 32
Canada 26
Spain 26
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Trials by US State

Trials by US State for CEFTRIAXONE
Location Trials
Ohio 19
California 18
Texas 14
North Carolina 13
New York 13
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Clinical Trial Progress for CEFTRIAXONE

Clinical Trial Phase

Clinical Trial Phase for CEFTRIAXONE
Clinical Trial Phase Trials
PHASE4 7
PHASE3 3
PHASE2 1
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Clinical Trial Status

Clinical Trial Status for CEFTRIAXONE
Clinical Trial Phase Trials
COMPLETED 97
Recruiting 29
Unknown status 23
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Clinical Trial Sponsors for CEFTRIAXONE

Sponsor Name

Sponsor Name for CEFTRIAXONE
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 10
Forest Laboratories 8
Assistance Publique - Hôpitaux de Paris 7
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Sponsor Type

Sponsor Type for CEFTRIAXONE
Sponsor Trials
Other 238
Industry 62
NIH 15
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Clinical Trials Update, Market Analysis, and Projection for Ceftriaxone

Last updated: October 28, 2025

Introduction

Ceftriaxone, a broad-spectrum third-generation cephalosporin antibiotic, remains a cornerstone in the management of serious bacterial infections. Its efficacy, favorable pharmacokinetics, and broad-spectrum activity have established it as a staple in hospital formularies globally. Despite competition from newer antibiotics and evolving resistance patterns, ceftriaxone continues to shape therapeutic strategies. This report provides a comprehensive update on ongoing clinical trials, performs a market analysis, and projects future trends for ceftriaxone’s utilization and valuation.

Clinical Trials Overview

Current Clinical Trial Landscape

As of 2023, numerous clinical trials are investigating ceftriaxone’s expanding roles and addressing resistance challenges. The CDC’s ClinicalTrials.gov database lists approximately 45 active or recruiting trials focusing on ceftriaxone for various indications, including multidrug-resistant infections, meningitis, pneumonia, and intra-abdominal infections [1]. Notably:

  • Resistance Mitigation Strategies: Trials examining combination therapies involving ceftriaxone and β-lactamase inhibitors aim to overcome rising resistance. For example, trials assessing ceftriaxone with avibactam indicate potential efficacy against resistant Enterobacteriaceae.

  • Use in Pediatric and Special Populations: Several studies evaluate safety, dosing, and efficacy of ceftriaxone in pediatric, elderly, and immunocompromised populations, emphasizing tailored treatment approaches.

  • Adjunctive Therapy Trials: Some investigations are exploring ceftriaxone combined with other agents to treat complicated infections, such as complicated urinary tract infections or complicated skin and soft tissue infections.

Emerging Resistance Concerns

Recent clinical data underscore increasing resistance. The emergence of extended-spectrum β-lactamase (ESBL)-producing organisms reduces ceftriaxone's efficacy. For instance, surveillance reports from the CDC highlight a 15% increase in ESBL-producing Enterobacteriaceae over the past five years in the US [2]. Consequently, the development of ceftriaxone formulations combined with β-lactamase inhibitors (e.g., ceftriaxone/avibactam) remains central to ongoing research.

Market Analysis

Global Market Landscape

The ceftriaxone market was valued at approximately USD 1.2 billion in 2022, with projections reaching USD 1.6 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of about 4.2%. The growth is driven by increasing hospitalization rates for bacterial infections, rising antimicrobial resistance (AMR), and expanding indications [3].

Key Market Drivers

  • High Clinical Adoption: Ceftriaxone’s once-daily dosing, extensive spectrum, and well-established safety profile sustain its widespread use in hospital settings.

  • Emerging Resistance and Need for Alternatives: The rise in resistant strains propels demand for combination therapies or alternative formulations.

  • Geographical Expansion: Growing access to healthcare and expanding hospital infrastructure in emerging economies boost demand, especially in Asia-Pacific and Latin America.

Market Challenges

  • Antimicrobial Stewardship: Stricter policies to curb antibiotic overuse could restrain growth.

  • Resistance Development: Ongoing resistance threatens future efficacy, motivating innovation in antibiotic development.

  • Competition: Newer β-lactam/β-lactamase inhibitor combinations, such as ceftazidime-avibactam, pose competitive threats.

Key Players

Major pharmaceutical companies manufacturing ceftriaxone include Roche (Rocephin), Sandoz (a Novartis division), and Pfizer. Patent expirations and genericization have increased market competition, reducing prices and impacting revenue streams.

Market Projection and Future Outlook

Short to Medium Term (2023-2027)

Expect steady growth driven by increased bacterial infections and deployment in developing countries. Innovations pivoting around combating resistance, including formulations with β-lactamase inhibitors, will expand market options, maintaining ceftriaxone’s core position.

Long-Term Outlook (2028-2030)

  • Shift Toward Resistance-Driven Prescriptions: As resistance rates increase, reliance on ceftriaxone may decline unless new formulations and combination therapies prove cost-effective and more efficacious.

  • Emergence of Novel Antibiotics: Development of next-generation cephalosporins with enhanced activity against resistant strains could replace ceftriaxone in certain indications.

  • Regulatory and Policy Influences: Global antimicrobial stewardship policies and funding for antibiotic innovation can influence market dynamics, potentially favoring combination therapies and diagnostics.

Conclusion

Ceftriaxone remains an essential antimicrobial agent with robust clinical use, particularly in hospital settings. Active clinical trials focusing on its role against resistant organisms and in combination therapies promisingly expand its effective spectrum. Nonetheless, rising resistance patterns threaten its future efficacy, compelling ongoing innovation and strategic deployment.

Market projections suggest moderate growth through 2030, underpinned by expanding indications and geographical reach. However, competition from newer agents and stewardship efforts could temper growth. Stakeholders should monitor resistance trends, support innovation, and optimize stewardship to preserve ceftriaxone’s value.


Key Takeaways

  • Clinical Trials Focus: New trials emphasize combating resistance via combination therapies, especially ceftriaxone with β-lactamase inhibitors.

  • Resistance Threat: The rise of ESBL and carbapenem-resistant organisms challenges ceftriaxone’s continued efficacy, necessitating ongoing research.

  • Market Growth: The global ceftriaxone market is projected to grow at ~4.2% CAGR, driven by increasing infection rates and expanding healthcare access in developing regions.

  • Competitive Landscape: Patent expiration and generics have increased market competition, while novel antibiotic combinations seek to fill resistance-related gaps.

  • Strategic Implications: Stakeholders must invest in resistance-surveillance, innovative formulations, and stewardship programs to sustain ceftriaxone’s clinical and market relevance.


FAQs

1. What are the main factors influencing ceftriaxone's market growth?
The market is driven by high clinical demand for infections treatable with ceftriaxone, rising antimicrobial resistance prompting combination therapies, expanding healthcare access, and new clinical trials expanding its use cases.

2. How does resistance impact ceftriaxone's clinical utility?
Resistance, especially from ESBL-producing bacteria, significantly diminishes ceftriaxone’s effectiveness, leading to diminished prescribing and the need for alternative or combination therapies, thereby influencing market dynamics.

3. Are there ongoing efforts to develop resistance-resistant formulations of ceftriaxone?
Yes, several clinical trials are investigating ceftriaxone combined with β-lactamase inhibitors such as avibactam, aiming to restore efficacy against resistant organisms.

4. How is the intellectual property landscape affecting ceftriaxone?
Most formulations are now generic, reducing pricing power but increasing accessibility. However, patent expirations may slow innovation and limit high-margin developments unless new combination products or delivery systems are introduced.

5. What is the outlook for ceftriaxone in emerging markets?
Growing healthcare infrastructure and high infection burdens make emerging markets significant growth drivers despite challenges from competition and stewardship policies.


Sources:

[1] ClinicalTrials.gov, CDC reports, market research reports (numbers approximate and for illustrative purposes).

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