CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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).

Clinical Trial Conditions for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Condition Name

Condition Name for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Intervention	Trials
Urinary Tract Infections	14
Healthy	11
Infection	8
Cystic Fibrosis	7

Condition MeSH

Condition MeSH for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Intervention	Trials
Infections	38
Infection	32
Communicable Diseases	30
Urinary Tract Infections	25

Clinical Trial Locations for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Trials by Country

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Trials by Country for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Location	Trials
United States	466
Germany	44
United Kingdom	41
Canada	38
Spain	32

Trials by US State

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−

Trials by US State for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Location	Trials
Texas	30
California	28
Florida	25
Ohio	22
North Carolina	20

Clinical Trial Progress for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	58
Phase 3	62
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	151
Recruiting	31
Terminated	25

Clinical Trial Sponsors for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Sponsor	Trials
Bayer	22
Novartis	6
PriCara, Unit of Ortho-McNeil, Inc.	6

Sponsor Type

Sponsor Type for CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Sponsor	Trials
Other	316
Industry	135
NIH	14

Ciprofloxacin and Ciprofloxacin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Ciprofloxacin, a broad-spectrum antibiotic belonging to the fluoroquinolone family, has been a cornerstone in the treatment of various bacterial infections. This article delves into the latest clinical trials, market analysis, and projections for ciprofloxacin and its hydrochloride form.

Clinical Trials Update

RESPIRE 1 Trial: Ciprofloxacin DPI for NCFB

A significant clinical trial, RESPIRE 1, has been conducted to evaluate the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis (NCFB). This phase III, placebo-controlled, randomized trial involved 416 patients randomized to either a 14-day on/off or a 28-day on/off regimen of ciprofloxacin DPI or placebo.

• The 14-day on/off regimen of ciprofloxacin DPI significantly prolonged the time to the first exacerbation compared to the pooled placebo group, with a median time of more than 336 days versus 186 days (hazard ratio 0.53, 97.5% CI 0.36–0.80; p=0.0005)[1].
• This regimen also reduced the frequency of exacerbations by 39% compared to the matching placebo group (mean number of exacerbations 0.6 versus 1.0; incidence rate ratio 0.61, 97% CI 0.40–0.91; p=0.0061)[1].

However, the 28-day on/off regimen did not show statistically significant differences from the placebo group.

Safety Profile

The safety profile of ciprofloxacin DPI in the RESPIRE 1 trial was favorable, aligning with previous studies that have shown ciprofloxacin to be relatively safe with mild to moderate side effects. The most common side effects include gastrointestinal reactions, which led to treatment discontinuation in some cases[1][3].

Market Analysis

Global Market Size and Growth

The global ciprofloxacin hydrochloride market is expected to experience significant growth due to the increasing incidence of bacterial infections and the growing need for effective antibiotic therapies.

• The market size is projected to grow from approximately USD 970.53 million in 2023 to USD 1.684 billion by 2032, at a Compound Annual Growth Rate (CAGR) of 6.32% during the forecast period (2024–2032)[2][5].

Regional Insights

The Asia-Pacific region is anticipated to dominate the market over the forecast period. This is driven by the enhancement of healthcare infrastructure and increased access to essential medications in developing regions.

• Emerging markets in Asia-Pacific and Latin America represent lucrative opportunities due to rising healthcare investments and improving economic conditions[2][5].

Driving Factors

The demand for ciprofloxacin hydrochloride is primarily driven by several key factors:

• Rising Incidence of Bacterial Infections: Conditions such as urinary tract infections (UTIs), skin and soft tissue infections, respiratory tract infections, and gastrointestinal infections are prevalent globally, increasing the demand for effective antibiotics[2][5].
• Global Health Initiatives: Efforts to improve healthcare access, particularly in developing regions, are contributing to the market's expansion[5].
• Technological Advancements: Innovations in manufacturing processes, such as automated production lines and advanced quality control measures, have led to cost reductions and improved product quality[5].

Market Projections

Growth Rate

The ciprofloxacin hydrochloride market is expected to grow at a CAGR of approximately 6.32% from 2024 to 2032. This growth is driven by the increasing need for effective antimicrobial agents and improvements in healthcare infrastructure[2][5].

Innovations and Trends

Innovations in formulations and manufacturing processes are crucial for the market's growth. These advancements enhance the efficacy and safety of ciprofloxacin hydrochloride, making it a preferred choice for healthcare professionals.

• Automated Production: Technological advancements have standardized practices among leading manufacturers, ensuring consistent product availability and reliability[5].
• Regulatory Compliance: Companies that adapt quickly to stringent regulatory changes are likely to gain a competitive edge in the market[5].

Partnerships and Distribution

Partnerships between pharmaceutical companies and healthcare providers play a significant role in enhancing distribution channels and improving patient education regarding medication use.

• These collaborations facilitate better access to essential medications, particularly in regions with historically limited healthcare access[5].

Key Takeaways

• Clinical Efficacy: Ciprofloxacin DPI has shown significant efficacy in reducing exacerbations in patients with NCFB, particularly with the 14-day on/off regimen.
• Market Growth: The global ciprofloxacin hydrochloride market is expected to grow at a CAGR of 6.32% from 2024 to 2032.
• Regional Dominance: The Asia-Pacific region is expected to dominate the market due to enhanced healthcare infrastructure and increasing healthcare investments.
• Driving Factors: Rising bacterial infections, global health initiatives, and technological advancements are key drivers of the market.
• Innovations: Improvements in manufacturing processes and regulatory compliance are crucial for market growth.

FAQs

1. What is the primary use of ciprofloxacin hydrochloride?

Ciprofloxacin hydrochloride is a broad-spectrum antibiotic used to treat various bacterial infections, including urinary tract infections, skin and soft tissue infections, respiratory tract infections, and gastrointestinal infections.

2. What are the key findings of the RESPIRE 1 trial?

The RESPIRE 1 trial showed that the 14-day on/off regimen of ciprofloxacin DPI significantly prolonged the time to the first exacerbation and reduced the frequency of exacerbations in patients with NCFB.

3. What is the projected growth rate of the ciprofloxacin hydrochloride market?

The ciprofloxacin hydrochloride market is projected to grow at a CAGR of approximately 6.32% from 2024 to 2032.

4. Which regions are expected to see significant growth in the ciprofloxacin hydrochloride market?

Regions such as Asia-Pacific and Latin America are anticipated to experience substantial growth due to enhanced healthcare access and increasing healthcare investments.

5. How do innovations impact the ciprofloxacin hydrochloride market?

Innovations in manufacturing processes, such as automated production lines and advanced quality control measures, enhance the efficacy and safety of ciprofloxacin hydrochloride, driving market growth.

Sources

1. ERS Publications: RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis.
2. Introspectivemarketresearch: Ciprofloxacin HCl Market - Overview and Outlook by (2024–2032).
3. PubMed: Safety of oral ciprofloxacin. An update based on clinical trial results.
4. JAMA Network: Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide.
5. Market Research Intellect: Global Ciprofloxacin Hydrochloride Market Size And Projection.