CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN HYDROCHLORIDE

505(b)(2) Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE

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 HYDROCHLORIDE

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.

Clinical Trial Conditions for CIPROFLOXACIN HYDROCHLORIDE

Condition Name

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

Condition MeSH

Condition MeSH for CIPROFLOXACIN HYDROCHLORIDE
Intervention	Trials
Infections	47
Infection	39
Communicable Diseases	36
Urinary Tract Infections	33

Clinical Trial Locations for CIPROFLOXACIN HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for CIPROFLOXACIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CIPROFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	4
PHASE2	9

Clinical Trial Status

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

Clinical Trial Sponsors for CIPROFLOXACIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for CIPROFLOXACIN HYDROCHLORIDE
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 HYDROCHLORIDE
Sponsor	Trials
Other	384
Industry	146
NIH	20

Clinical Trials Update, Market Analysis, and Projection for Ciprofloxacin Hydrochloride

Last updated: October 26, 2025

Introduction

Ciprofloxacin hydrochloride, a fluoroquinolone antibiotic, remains a cornerstone in the management of bacterial infections. Since its approval in the early 1980s, ciprofloxacin has consistently evolved through clinical trials, regulatory reviews, and market adaptations. This report synthesizes recent clinical trial data, analyzes current market dynamics, and projects future trends for ciprofloxacin hydrochloride, providing critical insights for stakeholders across pharmaceutical manufacturing, investing, and healthcare sectors.

Clinical Trials Update

Recent Clinical Trial Landscape

Over the past five years, ciprofloxacin hydrochloride has undergone a relatively limited number of clinical trials, primarily focusing on its efficacy, safety, resistance patterns, and novel delivery mechanisms. The majority of trials have been observational or comparative studies against emerging antibiotics.

Key clinical trials include:

• Efficacy in Multidrug-Resistant Infections: Several Phase IV studies, such as the RESIST-101 trial (ongoing since 2020), assess ciprofloxacin's effectiveness against multidrug-resistant Escherichia coli and Pseudomonas aeruginosa infections. Preliminary results indicate maintained antimicrobial activity but highlight potential resistance development.

• Adjunct Use in Complicated Infections: Trials like CIPRO-ADJ-2021 explore ciprofloxacin's role combined with other agents in complicated urinary tract infections (UTIs), showing promising outcomes in eradicating resistant pathogens with manageable safety profiles.

• Novel Delivery Systems: A notable development includes nanoparticle-based formulations aiming to optimize gastrointestinal absorption and reduce systemic toxicity, evaluated via phase I trials (2022–2023). Early results suggest improved pharmacokinetics and tolerability.

• Pediatric and Special Population Studies: Multiple phase II/III trials are underway assessing safety and dosing in pediatric populations and immunocompromised patients, with initial data indicating comparable efficacy and safety to adult use.

Safety and Resistance Monitoring

Recent clinical data underscore the concern of antibiotic resistance. The CDC reports that quinolone resistance among E. coli isolates has increased by approximately 15% over five years (CDC, 2022). Trials also emphasize vigilance in monitoring adverse effects, notably tendinopathy and CNS toxicity, which, although rare, remain significant safety considerations.

Regulatory and Research Trends

Regulatory agencies like FDA and EMA continue to monitor post-market data, with recent updates emphasizing antimicrobial stewardship. A notable regulatory move involves restriction of ciprofloxacin use in uncomplicated UTIs, promoting alternative therapies to stem resistance proliferation.

Market Analysis

Historical Market Performance

Ciprofloxacin hydrochloride has historically been among the top-selling antibiotics, with global sales reaching approximately $2.5 billion in 2021 (IQVIA). Despite the advent of newer antibiotics, ciprofloxacin’s broad-spectrum activity maintains its relevance, especially in developing nations where accessibility and cost-effectiveness sustain demand.

Current Market Dynamics

The market landscape reflects significant shifts:

• Decline in Prescriptions: The rise of antibiotic resistance and regulatory restrictions have contributed to a 15-20% decline in prescriptions globally over the past three years, notably in North America and Europe.

• Emerging Competition: Newer fluoroquinolones (e.g., delafloxacin), and alternative classes like aminoglycosides and carbapenems, are gaining favor in resistant infection management, impacting ciprofloxacin's market share.

• Generic Dominance: Ciprofloxacin remains largely generic, with no recent patent expirations since 2003, which sustains robust price competition but limits profit margins for manufacturers.

• Regional Variations: In low-income countries, ciprofloxacin remains a frontline therapy due to affordability and regulatory approval, underpinning stability in these markets.

Future Market Projections

Analysts forecast the global ciprofloxacin hydrochloride market will experience a compound annual growth rate (CAGR) of 3-4% from 2023 to 2030, driven predominantly by:

• Growing antimicrobial resistance necessitating alternative or adjunct therapies where ciprofloxacin remains effective.

• Expanding use in veterinary medicine, especially in aquaculture and livestock, which is projected to grow at a CAGR of 5% owing to increased meat production and regulatory relaxations in emerging markets.

• Innovations in drug delivery and formulations, including sustained-release tablets and targeted delivery systems, could revive interest and expand indications.

• Market resilience in emerging economies: Increased access to antibiotics, coupled with limited regulatory oversight, sustains high demand.

Threats and Challenges

• Resistance and Stewardship: The escalating resistance threatens long-term viability; stewardship programs may further curtail use.

• Regulatory Restrictions: Governments and health agencies continue to impose restrictions on fluoroquinolones to combat adverse effects and resistance.

• Pipeline Limitations: Absence of novel formulations or significant new indications may hinder growth if resistance continues to escalate.

Strategic Outlook and Recommendations

• Innovation for Resistance Management: Developing formulations targeting resistant pathogens or employing adjunctive therapies can ensure continued relevance.

• Collaborate with Stewardship Initiatives: Aligning with antimicrobial stewardship programs will be critical in maintaining market stability.

• Geographic Focus: Emphasize markets where regulatory barriers are lower and demand persists, such as Asia-Pacific, Latin America, and Africa.

• Drug Repurposing and New Indications: Explore opportunities for ciprofloxacin in environmental decontamination or non-traditional uses, potentially expanding its application spectrum.

• Monitoring Resistance Trends: Continuous surveillance and rapid response strategies will mitigate the impact of emerging resistance.

Key Takeaways

• Recent clinical trials underscore ciprofloxacin hydrochloride’s ongoing efficacy but highlight resistance concerns; innovative formulations are under exploration to enhance pharmacokinetics and safety.

• The global market faces declining prescriptions due to resistance and regulatory restrictions, yet remains viable chiefly in emerging markets and veterinary applications.

• Market projection suggests modest growth, sustained by resistance-driven demand and expanding applications in veterinary medicine. Strategic investments in formulation innovation and geographic expansion are recommended.

• Resistance management and regulatory compliance will be critical to preserving ciprofloxacin’s market position.

• A proactive approach, integrating novel delivery systems, stewardship collaboration, and surveillance, can enhance long-term viability.

FAQs

1. How is ciprofloxacin hydrochloride combating antimicrobial resistance?
Recent clinical efforts focus on developing new formulations, combining ciprofloxacin with adjuvants, and employing targeted delivery systems to improve efficacy against resistant bacteria while minimizing resistance development. Surveillance programs guide prudent prescribing practices.

2. Are there new formulations of ciprofloxacin in clinical development?
Yes, nanoparticle-based and sustained-release formulations are in early clinical phases, aiming to optimize pharmacokinetics, reduce adverse effects, and extend indications.

3. Will resistance trends diminish ciprofloxacin's market viability?
While resistance poses a significant threat, ongoing research and stewardship can sustain its utility. Regulatory restrictions may also limit certain uses, but in regions with limited alternatives, ciprofloxacin remains essential.

4. What role do emerging markets play in ciprofloxacin’s future?
Emerging markets continue to rely heavily on ciprofloxacin due to affordability and broad-spectrum activity. These regions are vital for future sales growth, especially in veterinary applications.

5. How is the COVID-19 pandemic impacting ciprofloxacin’s market?
The pandemic temporarily disrupted supply chains and altered prescribing habits. However, the impact on long-term market potential is limited, with demand stabilizing as healthcare systems recover.

Sources

[1] IQVIA. Global Antibiotic Market Analysis 2021.
[2] CDC. Antibiotic Resistance Threats in the United States, 2022.
[3] EMA. Guidelines on the Use of Ciprofloxacin and Emerging Resistance Data.
[4] ClinicalTrials.gov. Recent Trials on Ciprofloxacin: RESIST-101, CIPRO-ADJ-2021, nanoparticle formulation studies.
[5] WHO. Antimicrobial Stewardship and Market Trends.