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Last Updated: May 18, 2025

CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN EXTENDED RELEASE


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All Clinical Trials for Ciprofloxacin Extended Release

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00481689 ↗ Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Completed Bayer Phase 4 2004-05-01 Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is safe and works to treat complicated urinary tract infections caused by Pseudomonas aeruginosa. The study doctor will also gather information about using Cipro XR to treat complicated urinary tract infections caused by other bacteria. About 500 people with complicated urinary tract infections who are 18 years old and older will join this study. Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has been shown to be safe and effective. This study is being done to gather more information on using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas aeruginosa, as well as by other bacteria.
NCT00649155 ↗ Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mg Completed Mylan Pharmaceuticals Phase 1 2005-11-01 The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 500 mg tablets to Bayer's Cipro® XR 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.
NCT00649662 ↗ Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg Completed Mylan Pharmaceuticals Phase 1 2005-10-01 The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.
NCT00650351 ↗ Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg Completed Mylan Pharmaceuticals Phase 1 2005-10-01 The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fed conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ciprofloxacin Extended Release

Condition Name

Condition Name for Ciprofloxacin Extended Release
Intervention Trials
Healthy 5
Cirrhosis 1
Urinary Tract Infection 1
Dyslipidemias 1
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Condition MeSH

Condition MeSH for Ciprofloxacin Extended Release
Intervention Trials
Infections 4
Infection 3
Communicable Diseases 2
Urinary Tract Infections 2
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Clinical Trial Locations for Ciprofloxacin Extended Release

Trials by Country

Trials by Country for Ciprofloxacin Extended Release
Location Trials
United States 38
Italy 7
Canada 6
Brazil 4
Mexico 4
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Trials by US State

Trials by US State for Ciprofloxacin Extended Release
Location Trials
West Virginia 3
Massachusetts 2
Florida 2
Connecticut 2
California 2
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Clinical Trial Progress for Ciprofloxacin Extended Release

Clinical Trial Phase

Clinical Trial Phase for Ciprofloxacin Extended Release
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Ciprofloxacin Extended Release
Clinical Trial Phase Trials
Completed 14
Unknown status 2
Terminated 1
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Clinical Trial Sponsors for Ciprofloxacin Extended Release

Sponsor Name

Sponsor Name for Ciprofloxacin Extended Release
Sponsor Trials
Bayer 3
Mylan Pharmaceuticals 3
Assistance Publique - Hôpitaux de Paris 2
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Sponsor Type

Sponsor Type for Ciprofloxacin Extended Release
Sponsor Trials
Other 16
Industry 7
U.S. Fed 1
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Ciprofloxacin Extended Release: Clinical Trials, Market Analysis, and Projections

Introduction

Ciprofloxacin, a fluoroquinolone antibiotic, has been a cornerstone in the treatment of various bacterial infections, particularly urinary tract infections (UTIs). The extended-release formulation of ciprofloxacin, known as Cipro XR, has been designed to enhance patient compliance and therapeutic efficacy. Here, we delve into the clinical trials, market analysis, and future projections for ciprofloxacin extended-release tablets.

Clinical Trials and Efficacy

Bioequivalence Studies

Bioequivalence studies are crucial to ensure that generic formulations of ciprofloxacin extended-release tablets are as effective and safe as the reference product. A study conducted in Mexico compared the bioequivalence of two oral ciprofloxacin extended-release tablet formulations, Cipro XR® (Bayer) and Ciproflox DM® (Senosiain Laboratories). The results showed that the test formulation was bioequivalent to the reference formulation, meeting international requirements for in vivo bioequivalence[1].

Pharmacokinetic Parameters

The pharmacokinetic profile of ciprofloxacin extended-release tablets is characterized by higher maximum plasma concentrations (Cmax) and equivalent area under the concentration curve (AUC) compared to immediate-release formulations. This profile enhances the antibacterial activity and reduces the risk of treatment failure and antimicrobial resistance[1][3].

Clinical Efficacy in UTIs

Cipro XR has been approved for the treatment of uncomplicated and complicated UTIs, including acute uncomplicated pyelonephritis. Clinical trials have demonstrated its efficacy in these indications, with dosing regimens of 500 mg once daily for 3 days for uncomplicated UTIs and 1000 mg once daily for 7-14 days for complicated UTIs and acute uncomplicated pyelonephritis[3][5].

Market Analysis

Historical Context

Ciprofloxacin was first introduced in the late 1980s and quickly gained prominence due to its broad-spectrum efficacy, particularly against Pseudomonas aeruginosa and other hard-to-treat pathogens. The drug dominated the market for UTIs and expanded its indications to include typhoid fever, chronic bacterial prostatitis, and other infections[2].

Patent and Generic Impact

The patent for Cipro XR expired in 2004, leading to the entry of generic formulations. Despite this, Bayer managed to maintain market share through strategic marketing and the introduction of extended-release formulations. The extended-release formulation, Cipro XR, has continued to perform well, helping to offset losses from the generic competition[2].

Current Market Trends

The market for ciprofloxacin extended-release tablets remains robust, driven by the ongoing need for effective treatments for UTIs. The convenience of once-daily dosing and the enhanced pharmacokinetic profile contribute to its popularity among clinicians and patients. However, the rise of antimicrobial resistance and the introduction of newer antibiotics are factors that could influence market dynamics[5].

Market Projections

Growing Demand for UTI Treatments

The global market for UTI treatments is expected to grow due to increasing incidence rates and the need for effective, convenient therapies. Ciprofloxacin extended-release tablets are well-positioned to benefit from this trend, given their established efficacy and patient compliance advantages[5].

Competition and Innovation

The antibiotic market is highly competitive, with continuous innovation in drug delivery systems and the development of new antibiotics. To maintain market share, manufacturers of ciprofloxacin extended-release tablets must focus on improving patient outcomes, reducing side effects, and addressing the challenge of antimicrobial resistance.

Regulatory Environment

Regulatory requirements for bioequivalence and safety will continue to play a critical role in the market. Manufacturers must ensure that their products meet stringent regulatory standards to maintain approval and market presence. Postmarketing studies and surveillance will be essential to monitor efficacy and safety in real-world settings[3].

Safety and Side Effects

Adverse Reactions

Ciprofloxacin extended-release tablets, like other fluoroquinolones, are associated with serious adverse reactions, including tendonitis, tendon rupture, and central nervous system effects. These risks necessitate careful patient selection and monitoring[5].

Drug Interactions

Concomitant use with other medications can lead to significant drug interactions, affecting the pharmacokinetics of ciprofloxacin. Clinicians must be aware of these interactions to optimize treatment outcomes and minimize risks[3].

Dosage and Administration

Dosage Recommendations

Ciprofloxacin extended-release tablets are administered orally once daily. The dosage varies depending on the type of UTI: 500 mg for 3 days for uncomplicated UTIs and 1000 mg for 7-14 days for complicated UTIs and acute uncomplicated pyelonephritis. Patients with renal impairment require dose adjustments to avoid adverse effects[5].

Patient Compliance

The once-daily dosing regimen of ciprofloxacin extended-release tablets enhances patient compliance, which is critical for the successful treatment of bacterial infections. Improved compliance reduces the risk of treatment failure and the development of antimicrobial resistance[1].

Key Takeaways

  • Bioequivalence: Generic ciprofloxacin extended-release formulations must demonstrate bioequivalence to the reference product to ensure safety and efficacy.
  • Pharmacokinetics: The extended-release formulation provides higher Cmax and equivalent AUC compared to immediate-release formulations, enhancing antibacterial activity.
  • Market Trends: The market for UTI treatments is growing, with ciprofloxacin extended-release tablets well-positioned due to their efficacy and convenience.
  • Safety and Side Effects: Careful patient selection and monitoring are necessary due to potential adverse reactions and drug interactions.
  • Dosage and Administration: Once-daily dosing enhances patient compliance, but dose adjustments are required for patients with renal impairment.

FAQs

Q: What are the indications for ciprofloxacin extended-release tablets?

A: Ciprofloxacin extended-release tablets are indicated for the treatment of uncomplicated and complicated urinary tract infections, including acute uncomplicated pyelonephritis, caused by susceptible bacteria[5].

Q: How do ciprofloxacin extended-release tablets compare to immediate-release formulations?

A: Ciprofloxacin extended-release tablets provide higher maximum plasma concentrations (Cmax) and equivalent area under the concentration curve (AUC) compared to immediate-release formulations, enhancing antibacterial activity and patient compliance[1][3].

Q: What are the potential side effects of ciprofloxacin extended-release tablets?

A: Potential side effects include tendonitis, tendon rupture, central nervous system effects, and other serious adverse reactions. Concomitant use with other medications can also lead to significant drug interactions[5].

Q: How do regulatory requirements impact the market for ciprofloxacin extended-release tablets?

A: Regulatory requirements for bioequivalence and safety are critical. Manufacturers must ensure their products meet these standards to maintain approval and market presence[3].

Q: What is the recommended dosage for ciprofloxacin extended-release tablets?

A: The dosage varies depending on the type of UTI: 500 mg once daily for 3 days for uncomplicated UTIs and 1000 mg once daily for 7-14 days for complicated UTIs and acute uncomplicated pyelonephritis. Dose adjustments are required for patients with renal impairment[5].

Sources

  1. Bioequivalence of Two Oral Ciprofloxacin Extended-Release Tablet Formulations. LAJ Clinical Sciences.
  2. The Lifecycle of Cipro. Pharmaceutical Executive.
  3. Cipro XR (ciprofloxacin extended-release) Tablets (1 gram). FDA Approval Package.
  4. Urinary Tract Infections | Study 100534. Bayer Clinical Trials.
  5. Ciprofloxacin Extended Release Tablets: Package Insert. Drugs.com.
Last updated: 2025-01-02

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