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Last Updated: July 14, 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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ceftriaxone

Condition Name

Condition Name for Ceftriaxone
Intervention Trials
Pneumonia 11
Sepsis 7
Gonorrhea 6
Surgical Site Infection 5
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Condition MeSH

Condition MeSH for Ceftriaxone
Intervention Trials
Infections 42
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 240
France 34
Australia 28
Canada 26
Spain 25
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Trials by US State

Trials by US State for Ceftriaxone
Location Trials
Ohio 18
California 18
Texas 13
North Carolina 13
Pennsylvania 12
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Clinical Trial Progress for Ceftriaxone

Clinical Trial Phase

Clinical Trial Phase for Ceftriaxone
Clinical Trial Phase Trials
Phase 4 55
Phase 3 50
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Ceftriaxone
Clinical Trial Phase Trials
Completed 94
Unknown status 23
Recruiting 22
[disabled in preview] 18
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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
Pfizer 6
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Sponsor Type

Sponsor Type for Ceftriaxone
Sponsor Trials
Other 221
Industry 62
NIH 15
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Ceftriaxone: Clinical Trials, Market Analysis, and Projections

Last updated: January 7, 2025

Introduction to Ceftriaxone

Ceftriaxone, a broad-spectrum antibiotic belonging to the cephalosporin class, has been a cornerstone in the treatment of various bacterial infections since its introduction in 1984. It is widely used for infections such as lower respiratory tract infections, skin infections, bone and joint infections, and urinary tract infections among others.

Clinical Trials and Developments

Pivotal Trial for Subcutaneous Administration

A significant development in the use of ceftriaxone came from scPharmaceuticals, Inc., which announced positive results from a pivotal clinical trial for subcutaneous administration of ceftriaxone. This trial, conducted in the US, compared the antimicrobial coverage of subcutaneous ceftriaxone administration with the standard intravenous administration. The study found that subcutaneous administration provided non-inferior antimicrobial coverage, making it a viable alternative to intravenous infusion. This innovation aims to reduce the risks, discomfort, and costs associated with long-term IV catheters, such as PICCs (peripherally inserted central catheters), which are prone to serious complications and high medical costs[1].

Implications of Subcutaneous Administration

The shift to subcutaneous administration is expected to improve patient safety by preventing bloodstream infections and other complications associated with IV catheters. This method also aligns with the call for technologies that eliminate the need for long-term IV catheters, as highlighted in a 2013 New England Journal of Medicine article[1].

Market Analysis

Current Market Size and Growth

The global ceftriaxone market is projected to experience steady growth over the coming years. As of 2021, the market size was approximately USD 1.7 billion, and it is forecasted to reach more than USD 2.2 billion by 2031, growing at a CAGR of 2.9%[3].

Market Drivers

Several factors are driving the growth of the ceftriaxone market:

  • Increasing Incidence of Bacterial Infections: The rise in chronic diseases and bacterial infections such as urinary tract infections, intra-abdominal infections, and acute bacterial otitis media is a key driver. For instance, urinary tract infections are particularly common, with more than half of women likely to experience at least one UTI in their lifetime[3].
  • Generic and Branded Versions: The availability of both generic and branded versions of ceftriaxone, such as Rocephin, offers cost-effective treatment options, especially in developing countries[3].
  • Geographical Demand: Countries in Asia, such as China and India, are seeing a significant increase in demand due to high incidence rates of chronic diseases and the need for effective treatment options[3].

Market Segmentation

The ceftriaxone market is segmented based on various factors:

  • Indications: The market is segmented into different indications such as intra-abdominal infections, endocarditis, meningitis, urinary tract infections, acute bacterial otitis media, and pneumonia. Urinary tract infections and intra-abdominal infections are among the leading indications driving the market[2][3].
  • Distribution Channels: Hospital pharmacies are expected to account for a significant share of the market due to the preference for hospital treatment of bacterial infections and favorable reimbursement policies. Retail and online pharmacies also play a role, though to a lesser extent[3].

Regional Outlook

North America, particularly the U.S., dominates the global ceftriaxone market due to high healthcare expenditure, early adoption of advanced technologies, and favorable funding for healthcare research. Other regions, including Europe, Asia-Pacific, Latin America, and the Middle East & Africa, also contribute significantly to the market growth[3].

Market Projections

Forecasted Market Size

By 2030, the global ceftriaxone market is projected to reach approximately USD 2.8 billion to USD 3.95 billion, depending on the source, with a CAGR ranging from 2.9% to 3.5% during the forecast period from 2025 to 2030[2][5].

Key Trends and Opportunities

  • Technological Advancements: Innovations such as subcutaneous administration are expected to enhance patient safety and reduce healthcare costs.
  • Generic Market Growth: The availability of generic versions of ceftriaxone will continue to drive market growth, especially in developing countries.
  • Increasing Awareness and Incidence: Rising awareness and incidence of bacterial infections will continue to drive the demand for ceftriaxone.

Challenges and Restraints

  • Antibiotic Resistance: The growing concern of antibiotic resistance could impact the long-term efficacy and demand for ceftriaxone.
  • Regulatory Hurdles: Strict regulatory environments and the need for continuous clinical trials to ensure safety and efficacy can pose challenges to market growth.

Key Takeaways

  • Clinical Trials: Positive results from pivotal trials for subcutaneous ceftriaxone administration highlight a significant advancement in reducing complications associated with IV catheters.
  • Market Growth: The global ceftriaxone market is projected to grow steadily, driven by increasing incidence of bacterial infections and the availability of generic versions.
  • Regional Dominance: North America, particularly the U.S., leads the market due to high healthcare expenditure and early adoption of advanced technologies.
  • Technological Innovations: Subcutaneous administration and other innovations are expected to enhance patient safety and reduce healthcare costs.

FAQs

What is ceftriaxone used for?

Ceftriaxone is used to treat various bacterial infections, including lower respiratory tract infections, skin infections, bone and joint infections, and urinary tract infections.

What are the benefits of subcutaneous ceftriaxone administration?

Subcutaneous administration of ceftriaxone eliminates the need for long-term IV catheters, reducing the risk of bloodstream infections and other complications associated with IV catheters.

What is the projected market size of ceftriaxone by 2030?

The global ceftriaxone market is projected to reach approximately USD 2.8 billion to USD 3.95 billion by 2030.

Which region dominates the global ceftriaxone market?

North America, particularly the U.S., dominates the global ceftriaxone market due to high healthcare expenditure and early adoption of advanced technologies.

What are the key drivers of the ceftriaxone market?

The key drivers include the increasing incidence of bacterial infections, availability of generic and branded versions, and geographical demand, especially in Asia.

Sources

  1. scPharmaceuticals, Inc. - "scPharmaceuticals Announces Positive Results from Pivotal Trial for Subcutaneous Ceftriaxone Program" - PR Newswire, March 2, 2016.
  2. VynZ Research - "Ceftriaxone Market Set to Achieve USD 2.8 Billion By 2030, Growing at 3.2% CAGR" - OpenPR.
  3. Transparency Market Research - "Ceftriaxone Market Size, Share, and Forecast 2022–2031" - Transparency Market Research.
  4. The Lancet - "Gentamicin compared with ceftriaxone for the treatment of gonorrhoea: a randomised controlled trial" - The Lancet.
  5. Value Market Research - "Global Ceftriaxone Market Research Report - Industry Analysis, Size, Share, Growth, Trends and Forecast 2023 – 2030" - Value Market Research.

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