CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN

505(b)(2) Clinical Trials for CIPROFLOXACIN

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 Dosage	NCT01168895 ↗	Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder	Completed	Bayer	Phase 1	2010-07-01	The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.

All Clinical Trials for CIPROFLOXACIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000641 ↗	A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
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.
NCT00003407 ↗	Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia	Unknown status	National Cancer Institute (NCI)	Phase 2	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.
NCT00003407 ↗	Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia	Unknown status	Rush University Medical Center	Phase 2	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.
NCT00003824 ↗	S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer	Terminated	National Cancer Institute (NCI)	Phase 3	1999-04-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.

Clinical Trial Conditions for CIPROFLOXACIN

Condition Name

Condition Name for CIPROFLOXACIN
Intervention	Trials
Urinary Tract Infections	17
Healthy	12
Infection	8
Cystic Fibrosis	7

Condition MeSH

Condition MeSH for CIPROFLOXACIN
Intervention	Trials
Infections	47
Infection	39
Communicable Diseases	36
Urinary Tract Infections	34

Clinical Trial Locations for CIPROFLOXACIN

Trials by Country

Trials by Country for CIPROFLOXACIN
Location	Trials
United States	508
Germany	44
United Kingdom	43
Spain	43
Canada	39

Trials by US State

Trials by US State for CIPROFLOXACIN
Location	Trials
Texas	33
California	31
Florida	27
North Carolina	24
Ohio	23

Clinical Trial Progress for CIPROFLOXACIN

Clinical Trial Phase

Clinical Trial Phase for CIPROFLOXACIN
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN
Clinical Trial Phase	Trials
Completed	173
RECRUITING	46
Not yet recruiting	30

Clinical Trial Sponsors for CIPROFLOXACIN

Sponsor Name

Sponsor Name for CIPROFLOXACIN
Sponsor	Trials
Bayer	23
National Institute of Allergy and Infectious Diseases (NIAID)	8
PriCara, Unit of Ortho-McNeil, Inc.	6

Sponsor Type

Sponsor Type for CIPROFLOXACIN
Sponsor	Trials
Other	385
Industry	146
NIH	20

Last updated: October 26, 2025

inical Trials Update, Market Analysis, and Projection for Ciprofloxacin

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Introduction

Ciprofloxacin, a broad-spectrum fluoroquinolone antibiotic, has been a cornerstone in antibacterial therapy for decades. Widely prescribed for urinary tract infections, respiratory tract infections, and gastrointestinal infections, it has maintained a significant presence in both clinical practice and pharmaceutical markets. This report provides a comprehensive update on ciprofloxacin’s latest clinical trial activities, current market landscape, and future projections, considering regulatory, competitive, and epidemiological trends influencing its trajectory.

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Clinical Trials Landscape for Ciprofloxacin

Recent Clinical Trial Activities
Over the past five years, the scope of ciprofloxacin-related clinical research has shifted, focusing increasingly on resistance patterns, safety profile refinements, and novel indications. According to ClinicalTrials.gov, approximately 15 interventional studies involving ciprofloxacin have been registered globally since 2018, with a notable emphasis on resistance trends.

Key Trials and Outcomes

• Resistance Monitoring Studies: Multiple trials are evaluating the evolving resistance of Escherichia coli and Pseudomonas aeruginosa strains to ciprofloxacin, especially in urinary and respiratory infections. Results indicate a rising resistance rate, with some regions reporting resistance exceeding 20%, limiting efficacy in certain infections [1].
• Combination Therapy Trials: New studies assess ciprofloxacin in combination with other antibiotics to combat resistant infections. These trials aim to optimize dosing regimens and mitigate resistance development.
• Safety and Side-Effect Profile: Additional phase IV studies are examining long-term safety, including impacts on the microbiome and incidence of adverse events like tendinopathy and neurotoxicity, especially in vulnerable populations such as the elderly and children [2].

Regulatory and Off-Label Uses
While ciprofloxacin’s primary approval remains for specific bacterial infections, ongoing trials investigate its off-label applications, including treatments for biothreat agents and multidrug-resistant tuberculosis, though none have yet led to regulatory approvals in these areas.

Future Directions
Clinical research is likely to persist focusing on overcoming resistance challenges via novel formulations (e.g., liposomal ciprofloxacin), adjunct therapies, and precision prescribing. The FDA and EMA continue to monitor resistance data, influencing future trial designs and indications.

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Market Overview of Ciprofloxacin

Global Market Size and Trends
The ciprofloxacin market was valued at approximately USD 960 million in 2022 [3]. Despite being a mature product, it retains significant demand due to its broad-spectrum activity, low cost, and extensive clinical experience. The compound's dominance remains strong in emerging markets, where access to newer antibiotics is limited, and resistance remains manageable.

Regional Market Dynamics

• North America & Europe: Market growth is modest, driven by generic penetration and the rise of antibiotic stewardship programs aimed at curbing unnecessary use. Regulatory bodies such as the FDA have issued warnings about side effects, prompting cautious prescribing.
• Asia-Pacific: Leads market expansion due to rising infectious disease burdens, increasing healthcare infrastructure, and higher antibiotic consumption rates. Countries like China and India account for substantial volume shares and exhibit faster growth rates.
• Latin America & Africa: Markets are characterized by increasing healthcare access, though constrained by affordability and regulatory challenges.

Competitive Landscape
Ciprofloxacin faces limited direct competition from other fluoroquinolones like levofloxacin or moxifloxacin, but the market is impacted by the proliferation of newer antibiotics with potentially better safety profiles. Key manufacturers include Bayer (original patent holder), Sandoz, Teva, and several local generic producers.

Regulatory and Public Health Impact
Regulatory agencies worldwide have heightened restrictions, emphasizing stewardship to prevent resistance development. The European Medicines Agency (EMA) has restricted ciprofloxacin use in uncomplicated urinary tract infections, favoring narrower-spectrum agents [4].

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Market Projections and Future Outlook

Forecasted Market Trends (2023-2030)
The ciprofloxacin market is projected to decline at a compound annual growth rate (CAGR) of approximately 2.5%, primarily influenced by resistance shortfalls, safety concerns, and evolving prescribing guidelines [3]. However, the global burden of infectious diseases sustains recurrent demand, especially in resource-limited settings.

Market Drivers

• Continued use in regions with limited access to newer antibiotics.
• Expansion of indications, such as intra-abdominal infections, prostatitis, and biothreat emergencies.
• Development of advanced formulations (e.g., sustained-release, liposomal delivery) aimed at improving efficacy and reducing side effects [5].

Market Challenges

• Rising resistance limiting the drug's clinical utility.
• Regulatory restrictions and safety warnings reducing prescription volumes.
• Emergence of alternative therapies, including phage therapy and novel antibiotics targeting multi-drug resistant organisms [6].

Innovative Strategies and Opportunities
Manufacturers investing in stewardship programs, educational initiatives, and combination products can prolong ciprofloxacin’s lifecycle. Additionally, repurposing research and direct-to-consumer marketing in emerging markets present strategic avenues for growth.

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Conclusion and Expert Insights

Ciprofloxacin remains a vital antibiotic within global infectious disease management. However, its future hinges on addressing resistance issues, adapting to evolving regulatory landscapes, and innovating formulations. While the market may contract modestly over the next decade, significant opportunities exist in developing regions, where infectious disease burdens persist. Stakeholders must prioritize antimicrobial stewardship and invest in clinical trials aimed at resistance mitigation and safety enhancement to sustain ciprofloxacin’s viability.

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Key Takeaways

• Clinical trials focus increasingly on resistance monitoring, safety, and novel formulations, indicating ongoing efforts to optimize ciprofloxacin's utility.
• The global ciprofloxacin market, valued at nearly USD 1 billion in 2022, faces gradual contraction due to resistance and regulatory restrictions but remains vital in emerging economies.
• Resistance trends threaten long-term efficacy, necessitating continued innovation and stewardship to extend ciprofloxacin’s relevance.
• Developing formulations, combination therapies, and targeted indications could revitalize sales and clinical relevance.
• Policymakers and manufacturers must collaborate to balance access and safety, ensuring ciprofloxacin remains a cornerstone therapy where appropriate.

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FAQs

Q1: What are the main concerns regarding ciprofloxacin's safety profile?
A: Ciprofloxacin has been associated with adverse effects such as tendinopathy, neurotoxicity, and impacts on cartilage development. Regulatory agencies advise cautious use, especially in children and the elderly.

Q2: How has antibiotic resistance affected the clinical utility of ciprofloxacin?
A: Rising resistance, particularly in respiratory and urinary pathogens, has reduced efficacy in certain infections, prompting shifts toward alternative agents and stewardship policies.

Q3: Are there new formulations of ciprofloxacin under development?
A: Yes, research includes liposomal ciprofloxacin, extended-release formulations, and combination products aimed at enhancing efficacy and limiting side effects.

Q4: How do regulatory agencies influence ciprofloxacin's market?
A: Agencies like the FDA and EMA restrict indications, recommend dosing adjustments, and emphasize stewardship, all impacting prescribing practices and market demand.

Q5: What future trends could prolong ciprofloxacin’s clinical relevance?
A: Innovative formulations, combination therapies, targeted indications, and global health initiatives to combat infectious diseases will shape its future.

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References

[1] ClinicalTrials.gov. "Ciprofloxacin Resistance Studies." Accessed December 2022.

[2] Food and Drug Administration (FDA). "Postmarketing Reports of Tendinopathy with Fluoroquinolones." 2021.

[3] MarketResearch.com. "Global Antibiotic Market Report," 2022.

[4] European Medicines Agency (EMA). "Restriction of Fluoroquinolones in Urinary Tract Infections," 2019.

[5] Johnson, L. et al. "Advances in Liposomal Antibiotics," Journal of Drug Delivery Science and Technology, 2021.

[6] World Health Organization. "Emerging Alternatives to Antibiotics," 2020.