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.

Clinical Trial Conditions for CIPROFLOXACIN

Condition Name

Condition Name for CIPROFLOXACIN
Intervention	Trials
Urinary Tract Infections	16
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	31

Clinical Trial Locations for CIPROFLOXACIN

Trials by Country

Trials by Country for CIPROFLOXACIN
Location	Trials
United States	504
Germany	44
United Kingdom	43
Spain	41
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
Phase 4	65
Phase 3	66
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN
Clinical Trial Phase	Trials
Completed	169
Recruiting	35
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	360
Industry	143
NIH	20

CIPROFLOXACIN Market Analysis and Financial Projection

Ciprofloxacin: Clinical Trials, Market Analysis, and Projections

Introduction to Ciprofloxacin

Ciprofloxacin is a broad-spectrum antibiotic belonging to the fluoroquinolone class, widely used to treat various bacterial infections. Its efficacy and safety have been evaluated in numerous clinical trials, and it remains a significant player in the pharmaceutical market.

Clinical Trials Update

RESPIRE 1 and 2 Trials for Bronchiectasis

Recent clinical trials, namely the RESPIRE 1 and 2 trials, have provided promising results for the treatment of non-cystic fibrosis bronchiectasis using ciprofloxacin dry powder inhalation (DPI). These trials, published in the European Respiratory Journal, are the largest clinical trial program ever conducted in bronchiectasis.

• Patient Enrollment and Treatment Regimens: The trials involved 416 patients in RESPIRE 1 and 521 patients in RESPIRE 2, randomized 2:1 to receive either twice-daily ciprofloxacin DPI 32.5 mg or a placebo. The treatment regimens consisted of on/off cycles of 14 or 28 days for 48 weeks[1].
• Outcomes: RESPIRE 1 showed a statistically significant increase in the time to first exacerbation and a reduced frequency of exacerbations in the 14-day on/off regimen. Although RESPIRE 2 did not show statistically significant improvements, it suggested a trend towards clinical benefits[1].

Treatment of Human Plague

Ciprofloxacin has also been successfully used to treat human plague, as evidenced by a study published by the CDC. This study involved five cases of culture-confirmed human plague treated with oral ciprofloxacin, including one case of pneumonic plague. The results supported the broader use of oral ciprofloxacin for treating plague, especially in resource-poor areas[4].

Market Analysis

Global Market Size and Growth

The global ciprofloxacin market has shown significant growth and is expected to continue this trend. Here are some key market insights:

• Current Market Size: The global ciprofloxacin market size was valued at several million dollars in recent years. For instance, the global ciprofloxacin ophthalmic solution market was valued at USD 160.46 million in 2023[3].
• Growth Rate: The market is projected to grow at a compound annual growth rate (CAGR) of around 5% from 2024 to 2031. For example, the ciprofloxacin ophthalmic solution market is expected to reach USD 244.40 million by 2031, with a CAGR of 5.4% during the forecast period[3].

Regional Analysis

The market is segmented into several regions, each with its own growth dynamics:

• North America: This region is expected to dominate the market due to its advanced healthcare infrastructure and robust medical facilities. North America benefits from widespread adoption of ciprofloxacin for various medical conditions[3].
• Asia-Pacific: This region is expected to grow significantly, driven by increased investments in healthcare infrastructure and rising awareness about health issues. Countries like China, Japan, and India are key contributors to this growth[3][5].
• Europe: Europe also represents a significant market, with countries like the UK, Germany, and France contributing to the overall growth. The region's well-established healthcare system supports the demand for ciprofloxacin[5].

Market Segmentation by Applications

Ciprofloxacin is used to treat a variety of infections, which segments the market as follows:

• Urogenital Infections: Ciprofloxacin is commonly used to treat urinary tract infections and other urogenital infections.
• Respiratory Tract Infections: As seen in the RESPIRE trials, ciprofloxacin is being explored for its efficacy in treating respiratory infections like bronchiectasis.
• Gastrointestinal Infections: It is also used to treat gastrointestinal infections, among other applications[5].

Market Projections

Future Growth and Trends

The market for ciprofloxacin is expected to grow due to several factors:

• Advancements in Healthcare Infrastructure: Increased investments in healthcare, especially in regions like Asia-Pacific, will drive the demand for advanced treatments, including ciprofloxacin[3].
• Research and Innovation: Continuous research and innovation in formulations and delivery mechanisms will enhance the efficacy and patient experience, contributing to market growth[3].
• Regulatory Approvals: Recent approvals, such as the FDA approval for treating plague, will expand the use of ciprofloxacin, further boosting the market[4].

Challenges and Opportunities

While the market shows promising growth, there are also challenges and opportunities to consider:

• Challenges: The rise of antibiotic resistance and the availability of substitutes are potential challenges. Additionally, regulatory changes and economic factors can impact market dynamics[5].
• Opportunities: The growing need for effective treatments in resource-poor areas and the expanding use of ciprofloxacin in new indications present significant opportunities for market growth[4][5].

Key Takeaways

• Clinical Trials: The RESPIRE 1 and 2 trials and the CDC study on human plague treatment highlight the potential of ciprofloxacin in new and existing indications.
• Market Growth: The global ciprofloxacin market is expected to grow, driven by advancements in healthcare infrastructure, research, and regulatory approvals.
• Regional Dynamics: North America, Europe, and Asia-Pacific are key regions driving the market, each with unique growth factors.
• Applications: Ciprofloxacin is used across various infection types, including urogenital, respiratory, and gastrointestinal infections.

FAQs

What are the recent clinical trial findings for ciprofloxacin in treating bronchiectasis?

The RESPIRE 1 and 2 trials showed a trend towards clinical benefits in patients treated with ciprofloxacin DPI, including prolonged time to first exacerbation and reduced frequency of exacerbations in certain treatment regimens[1].

How is the global ciprofloxacin market projected to grow?

The global ciprofloxacin market is projected to grow at a CAGR of around 5% from 2024 to 2031, driven by advancements in healthcare infrastructure and research innovations[3].

What regions are expected to dominate the ciprofloxacin market?

North America is expected to dominate the market due to its advanced healthcare infrastructure, while the Asia-Pacific region is expected to grow significantly due to increased investments in healthcare[3][5].

What are the common applications of ciprofloxacin?

Ciprofloxacin is commonly used to treat urogenital infections, respiratory tract infections, and gastrointestinal infections[5].

Has ciprofloxacin been approved for treating plague?

Yes, the FDA has approved ciprofloxacin for treating plague based on animal studies and clinical evidence from human cases[4].

Sources

1. ERS: RESPIRE 1 and 2 trials offer hope for bronchiectasis treatment - ERS
2. Cognitive Market Research: Ciprofloxacin Market Report 2024 (Global Edition)
3. Data Bridge Market Research: Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast
4. CDC: Successful Treatment of Human Plague with Oral Ciprofloxacin
5. Maia Research: Global Ciprofloxacin Hcl Consumption Market Research Report 2013-2025