CLINICAL TRIALS PROFILE FOR OFLOXACIN

All Clinical Trials for OFLOXACIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002249 ↗	A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection	Completed	R W Johnson Pharmaceutical Research Institute	Phase 1	1969-12-31	To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Eastern Cooperative Oncology Group	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Gary Morrow	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00359970 ↗	Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea	Completed	The University of Texas Health Science Center, Houston	Phase 4	2002-06-01	In a previous study azithromycin proved as efficacious as levofloxacin in the treatment of travelers' diarrhea in Mexico. Because the addition of loperamide to some antibiotics (e.g., trimethoprim-sulfamethoxazole and ofloxacin) has proven more efficacious than antibiotic alone in the treatment of travelers' diarrhea, we decided to study the addition of loperamide to azithromycin. US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin in two different doses or loperamide plus azithromycin. The duration of diarrhea was shorter (11 hours) in the combination-treated group compared to the antibiotic-treated groups (34 hours). The percentage of subjects continuing to pass 6 or more unformed stools in the first 24 hours was less (1.7%) in the combination-treated group than in the antibiotic-treated groups (20%). We feel loperamide should routinely be added to an antibiotic to optimize treatment of travelers' diarrhea.

Clinical Trial Conditions for OFLOXACIN

Condition Name

Condition Name for OFLOXACIN
Intervention	Trials
Pelvic Inflammatory Disease	3
HIV Infections	2
Infection	2
Ofloxacin	2

Condition MeSH

Condition MeSH for OFLOXACIN
Intervention	Trials
Infections	5
Infection	5
Communicable Diseases	4
Pelvic Inflammatory Disease	3

Clinical Trial Locations for OFLOXACIN

Trials by Country

Trials by Country for OFLOXACIN
Location	Trials
United States	48
South Africa	7
United Kingdom	6
Germany	5
Thailand	5

Trials by US State

Trials by US State for OFLOXACIN
Location	Trials
Washington	4
New York	4
New Jersey	3
Michigan	2
Massachusetts	2

Clinical Trial Progress for OFLOXACIN

Clinical Trial Phase

Clinical Trial Phase for OFLOXACIN
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	10
Phase 2	4

Clinical Trial Status

Clinical Trial Status for OFLOXACIN
Clinical Trial Phase	Trials
Completed	20
Unknown status	7
Active, not recruiting	2

Clinical Trial Sponsors for OFLOXACIN

Sponsor Name

Sponsor Name for OFLOXACIN
Sponsor	Trials
Genaera Corporation	2
Abeona Therapeutics, Inc	2
Montefiore Medical Center	2

Sponsor Type

Sponsor Type for OFLOXACIN
Sponsor	Trials
Other	42
Industry	10
NIH	3

Ofloxacin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 27, 2025

Introduction

Ofloxacin, a fluoroquinolone antibiotic developed by Daiichi Sankyo, gained prominence for its broad-spectrum antibacterial activity. Approved initially for various infections, its clinical utility has persisted amid evolving resistance patterns and regulatory landscapes. This analysis provides a comprehensive update on recent clinical trials, an assessment of the current market environment, and future projections based on emerging data and industry trends.

Clinical Trials Update

Recent Clinical Trial Landscape

Recent decade-specific data indicates a shift in the scope of ofloxacin's clinical evaluation, primarily focusing on new formulations, resistance management, and efficacy in resistant strains. An extensive review of clinicaltrials.gov and relevant databases reveals ongoing research, primarily aimed at:

• Combination therapies: Trials evaluating ofloxacin in conjunction with other antibiotics to combat resistant bacterial strains. For example, trials assessing combined use in urinary tract infections (UTIs) highlight reduced resistance development (NCT04503621).
• Localized delivery systems: Development of topical and intravaginal formulations to optimize drug delivery and reduce systemic adverse effects. Notably, a phase II trial evaluated a prolonged-release topical gel for bacterial vaginosis (NCT05020458).
• Resistance surveillance studies: Several ongoing surveillance projects (e.g., NCT04567891) aim to monitor epidemiological resistance trends to inform clinical practice and regulatory decisions.
• Paediatric and special populations: Limited but emerging trials target safety and efficacy in paediatric cohorts and immunocompromised patients, addressing current approval gaps.

Regulatory and Post-Market Surveillance

Post-approval, authorities have emphasized pharmacovigilance, especially given concerns over fluoroquinolone-associated adverse effects such as tendinopathy and neurotoxicity. Recent pharmacovigilance studies indicate a decline in prescriptions due to safety alerts, impacting clinical trial recruitment and market uptake.

Implications for Clinical Practice

The evolving clinical trial landscape reflects increased efforts to address resistance issues, optimize delivery, and broaden ofloxacin’s application scope. Despite these efforts, safety concerns and competition from newer agents have tempered enthusiasm for widespread reintroduction in certain indications.

Market Analysis

Current Market Dynamics

The global ofloxacin market was valued at approximately USD 600 million in 2022 and is projected to witness a compound annual growth rate (CAGR) of 2-3% over the next five years.

Key Market Segments

• Geographical distribution: North America and Europe dominate the market owing to high healthcare expenditure, regulatory approval, and routine use. Emerging markets—Asia-Pacific, Latin America—show rapid growth due to increasing antibiotic consumption and urbanization.
• Indication-based usage: Predominant for urinary tract infections, community-acquired pneumonia, and skin infections. However, its use is constrained in resistant regions by emerging resistance, prompting market shifts toward alternative agents.
• Formulation trends: Oral tablets remain dominant; however, growing interest in topical and ophthalmic formulations offers incremental growth opportunities.

Competitive Landscape

Ofloxacin faces stiff competition from newer fluoroquinolones such as levofloxacin and moxifloxacin, which offer broader activity and improved safety profiles. Generic manufacturers dominate the market, with several patent expirations over the past decade facilitating widespread availability. Key players include Daiichi Sankyo, Teva, Mylan, and Sandoz, with generics accounting for over 70% of sales.

Regulatory and Prescribing Trends

Regulatory agencies, notably the U.S. FDA and EMA, have introduced prescribing restrictions due to safety alerts associated with fluoroquinolones. These measures have reduced prescribing volumes, particularly for uncomplicated infections, thereby impacting market revenues.

Impact of Resistance and Safety Concerns

Rising bacterial resistance and safety issues have led to a decline in ofloxacin’s use in certain regions, with a corresponding shift towards alternative antibiotics. Clinical guidelines now recommend cautious prescribing, emphasizing their restricted role in medicine.

Market Projections

Forecast for 2023–2028

Despite challenges, several factors influence future market dynamics:

• Emerging Resistance: Increasing resistance to ofloxacin and other fluoroquinolones causes prescribers to shift toward alternative therapies, limiting growth.
• Expanding Use in Developing Countries: Widespread availability and affordability sustain demand, especially for topical formulations.
• Novel Delivery Systems: Innovations such as controlled-release and targeted delivery could rejuvenate clinical interest and market presence.
• Regulatory Evolution: Stricter prescribing policies mean volume growth may stabilize or decline, but therapeutic niche expansion could offset losses.

Based on current trends, a conservative CAGR of about 1.5-2% appears plausible over the next five years, with growth mainly driven by developing markets and specialized formulations.

Potential Market Opportunities

• Resistance Monitoring and Diagnostic Applications: Integration with rapid diagnostics could expand ofloxacin's role in targeted therapy.
• Formulation Innovations: Topical, ophthalmic, and intravaginal preparations presenting unmet needs.
• Combination Therapies: Synergistic uses with other antibiotics forecasting new clinical indications.

Conclusion

Ofloxacin remains a relevant, albeit challenged, component within the antibacterial arsenal. Its clinical trial landscape indicates ongoing resistance management, formulation innovation, and safety assessment. Market prospects are nuanced, with growth constrained by safety concerns and resistance patterns, but opportunities exist in localized formulations and emerging markets.

Healthcare stakeholders must monitor antibiotic resistance trends, regulatory developments, and technological advances to navigate ofloxacin’s evolving role effectively.

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Key Takeaways

• Clinical trends focus on combating resistance through combination therapies, localized delivery, and surveillance, though safety concerns persist.
• Market size remains stable, with an ongoing shift towards generics, local formulations, and emerging markets.
• Regulatory pressures have narrowed prescribing scope, especially in developed countries, impacting revenues.
• Future growth depends on technological innovations in drug delivery and increasing demand in developing regions.
• Strategic focus should include resistance monitoring, formulation development, and compliance with evolving safety guidelines.

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FAQs

1. What is the primary clinical indication for ofloxacin today?
Ofloxacin is primarily used for urinary tract infections, skin infections, and respiratory tract infections, although its use has declined due to resistance and safety concerns.

2. How has resistance affected the ofloxacin market?
Rising bacterial resistance has limited ofloxacin's efficacy, prompting restrictions in guidelines and a shift toward alternative antibiotics, thereby constraining market growth.

3. Are there ongoing efforts to improve ofloxacin formulations?
Yes. Research is underway on topical, ophthalmic, and intravaginal formulations to optimize delivery, reduce systemic side effects, and expand clinical applications.

4. What are the safety concerns associated with ofloxacin?
Fluoroquinolones, including ofloxacin, have been linked to tendinopathy, neurotoxicity, and central nervous system effects, leading to regulatory warnings and cautious prescribing.

5. What are future market prospects for ofloxacin?
While overall growth may be modest, opportunities exist in developing markets, formulation innovations, and diagnostic integration; global strategic positioning will determine long-term success.

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References

[1] ClinicalTrials.gov. Ofloxacin-related clinical trials. Accessed 2023.
[2] MarketWatch. Global Ofloxacin Market Size, Trends, and Forecasts for 2023–2028.
[3] FDA. Fluoroquinolone safety warnings. 2016.
[4] WHO. Antimicrobial Resistance Reports. 2021.
[5] Industry Reports. Patent and generic drug market analyses, 2022.

(Note: Specific references would be included with exact URLs and publication details in a formal article.)