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.
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 HYDROCHLORIDE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for CIPROFLOXACIN HYDROCHLORIDE

Trials by Country

Trials by Country for CIPROFLOXACIN HYDROCHLORIDE
Location	Trials
United States	509
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	32
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	6
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	174
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	388
Industry	146
NIH	20

Ciprofloxacin Hydrochloride clinical trials update, market analysis, and projection (2026–2035)

Last updated: July 26, 2026

What is ciprofloxacin hydrochloride and where is it used clinically?

Ciprofloxacin hydrochloride is a fluoroquinolone antibiotic used for bacterial infections, including:

• Urinary tract infections (complicated and uncomplicated, depending on labeling)
• Prostatitis
• Intra-abdominal and gastrointestinal infections (when susceptible organisms are implicated)
• Bone and joint infections
• Skin/soft tissue infections
• Respiratory infections in selected indications and susceptibility contexts

What is the current clinical-trials landscape for ciprofloxacin hydrochloride?

Ciprofloxacin’s development activity is largely “life-cycle” rather than de novo brand-new drug development. Clinical trial work tends to cluster in:

• Formulation improvements (bioavailability, dosing convenience, tolerability)
• Line-extension studies in specific populations (pediatrics, elderly, renal impairment)
• Comparative effectiveness and resistance surveillance studies
• Regulatory-required studies (bioequivalence, bridging, safety follow-up where applicable)

Clinical-trials update (category-level):

• Interventional antibiotic trials: Ongoing in geographic regions where ciprofloxacin remains part of standard-of-care algorithms and where stewardship studies are feasible.
• Formulation/bioavailability trials: Common, including studies tied to oral solid dose changes and generic entrants’ bridging packages.
• Comparative trials: Often compare fluoroquinolone choices across susceptibility patterns and resistance burden.

Because ciprofloxacin is mature and widely generically available in most markets, trial visibility is often fragmented across sponsors, geographies, and investigator-led protocols.

How does ciprofloxacin’s patent and exclusivity status affect trial activity?

Ciprofloxacin has limited practical “new product” runway due to historical patent expiry and broad generic availability. That shifts clinical work toward:

• Generic development programs (bioequivalence studies, label-bridging)
• Safety and resistance monitoring studies
• Contract research around stewardship and dosing optimization

Are there ciprofloxacin hydrochloride Phase 3 or pivotal trials ongoing?

In most jurisdictions, ciprofloxacin is not typically the target of large, pivotal Phase 3 programs because the substance is established and commercially mature. Ongoing late-stage activity, when it occurs, usually relates to:

• Specific labeled subpopulations or dosing regimens
• Comparative trials against other antibiotics in susceptible infections
• Occasionally new delivery concepts (less common versus generic formulation work)

What drives the ciprofloxacin clinical evidence cycle today?

Key drivers:

• Antimicrobial resistance patterns by country and indication
• Safety monitoring expectations for fluoroquinolones (tendon, neurologic, QT risk)
• Stewardship restrictions that alter prescribing volume
• Local guideline updates based on resistance and comparative efficacy

What is the market size for ciprofloxacin hydrochloride and how is it segmented?

Ciprofloxacin is traded as a generic “core fluoroquinolone” ingredient across:

• Oral tablets/capsules (major share)
• Oral suspension (pediatrics and adherence contexts)
• Parenteral formulations (hospital share where used)

Market segmentation by end user

• Hospitals (inpatient bacterial infections, IV administration)
• Retail/pharmacy (UTIs, outpatient infection regimens)
• Long-term care and nursing facilities (where guidelines permit)

Market segmentation by geography

• Asia-Pacific: high volume demand and competitive generic supply
• Europe: mature generic penetration with tighter stewardship and prescribing restrictions
• North America: high baseline generic use, with stewards influencing volume and indication narrowing

What is the competitive landscape for ciprofloxacin hydrochloride?

Competition is structured around:

• Large generic manufacturers controlling high-volume oral presentations
• Regional suppliers with strong distributor relationships
• Cost-driven tendering in hospital markets

Commercial dynamics

• Price erosion is persistent due to scale generic supply
• Product differentiation is limited to formulation and packaging rather than new mechanism
• Regulatory compliance, quality systems, and tender eligibility drive share

What are the key commercial risks for ciprofloxacin market growth?

• Antimicrobial stewardship policies limiting fluoroquinolone use where alternatives exist
• Regulatory and guideline pressure in response to safety concerns associated with class effects
• Rising resistance in certain infection categories that can reduce empirical use
• Supply chain and quality recalls risk in high-volume generic ecosystems

How do ciprofloxacin class safety and resistance trends impact demand?

Demand is sensitive to:

• Label and guideline restrictions in urinary and respiratory indications
• Prescriber preference shifts to narrow-spectrum agents where susceptibility is predictable
• Longer-treatment protocols in resistant infections, which can sustain volume in some scenarios but raise failure rates in others

What is the market projection for ciprofloxacin hydrochloride (2026–2035)?

Ciprofloxacin’s long-term outlook is shaped by:

• Continued generics dominance
• Growth in antibiotics consumption driven by population and inpatient capacity in parts of APAC
• Offsetting constraints from stewardship and safety-driven avoidance in higher-risk segments

Projection framework (directional, market-wide):

• 2026–2030: Low-to-mid single digit growth rate potential, driven mainly by volume expansion in high-demand regions and replenishment cycles.
• 2030–2035: Growth decelerates as stewardship intensifies in major markets and resistance constraints increase treatment failures in certain indications.

Expected pattern (typical for mature generics):

• Net value growth is slower than volume growth, due to ongoing price compression.
• Share moves toward suppliers that secure hospital tenders and maintain compliant supply.

How does ciprofloxacin compare with other fluoroquinolones in market and growth?

Compared with alternatives like levofloxacin and moxifloxacin:

• Ciprofloxacin usually maintains stronger niche use in Gram-negative coverage contexts (especially where susceptible organisms dominate).
• Market growth is more influenced by local resistance ecology and stewardship than by new clinical breakthroughs.

In generic fluoroquinolones, relative share shifts are common when guidelines update empiric treatment recommendations.

What generic entry risks exist for ciprofloxacin hydrochloride?

Generic entry is already widespread. The “entry risk” model differs from newer drugs and is more about:

• Regulatory/quality risk: batch rejections, compliance-driven supply interruptions
• Tender qualification: product listing barriers at hospital systems
• Manufacturing/IP barriers: typically resolved at the molecule level, but process, polymorph, and formulation patents can still matter for specific presentations in select markets

How strong is the patent estate for ciprofloxacin hydrochloride?

For ciprofloxacin as an active pharmaceutical ingredient:

• The molecule-level patent estate is largely historical.
• Current IP value typically comes from formulation-specific patents, process improvements, packaging, and local line extensions that can vary by company and jurisdiction.

For business planning, the relevant question is not “can others make ciprofloxacin?” but “which company owns enforceable rights for a specific dosage form and process in a specific country.”

What patents protect ciprofloxacin formulations (tablets, IV, suspensions)?

Across mature generics, formulation protection (where it exists) can include:

• Controlled-release or modified-release forms (if any in market)
• Specific excipient systems improving stability or dissolution
• Parenteral formulation and lyophilized intermediates
• Manufacturing process improvements and scale-up steps

The enforceability and remaining term are jurisdiction-specific, and claims vary by supplier and product line.

What litigation affects ciprofloxacin hydrochloride in the US or EU?

Litigation for ciprofloxacin in the current era is typically limited compared with newer drugs because:

• IP barriers at the molecule level are largely expired
• Many products are already approved and widely substituted

Where disputes arise, they tend to be about:

• Patent validity/infringement for specific formulation or process patents
• ANDA labeling and exclusivity disputes in earlier years

What is the Orange Book status of ciprofloxacin hydrochloride?

Ciprofloxacin is generally present as an established generic product on FDA systems with numerous ANDA approvals. For business decisions, the actionable Orange Book use-case is mapping:

• Listed patents for specific NDA/strength/dosage forms
• Whether any listed patents remain in force that could delay generic availability for a particular presentation

Which companies are the largest suppliers of ciprofloxacin hydrochloride?

The market includes multiple multinational and regional generic manufacturers. In practical commercial terms, share concentrates around:

• Companies with high-capacity sterile and non-sterile manufacturing
• Companies with stable US/EU regulatory records
• Manufacturers that secure national distribution and hospital contracts

What is the pricing outlook for ciprofloxacin hydrochloride?

Given the mature generic status:

• Ongoing price compression is expected in most geographies
• Upside value growth depends on tender wins, volume retention, and avoiding supply disruptions
• Sterile/IV supply can price differently due to manufacturing capacity constraints

How do FDA pathways and approvals influence market availability for ciprofloxacin?

Ciprofloxacin approvals are generally handled through ANDA pathways in the US for generics and through supplements for manufacturing changes. Business implications:

• Market supply is a regulatory and quality execution story
• Rapid scaling and consistent product release timelines determine which manufacturers can win distribution

What manufacturing and regulatory barriers can delay ciprofloxacin supply?

Barriers are less about molecular IP and more about:

• Sterile manufacturing facility compliance (for IV products)
• Stability and shelf-life validation
• Raw material control (API sourcing quality)
• Batch release capacity and pharmacovigilance systems

How does ciprofloxacin utilization trend affect forecast accuracy?

Utilization is influenced by:

• Empiric prescribing norms (which change with resistance and stewardship)
• Seasonal infection patterns
• Local guideline updates that move patients to other antibiotic classes

Forecasts should therefore treat usage as a function of resistance and policy, not purely as market growth.

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Key Takeaways

• Ciprofloxacin hydrochloride is a mature, widely generically available antibiotic, so current “clinical trials” activity is concentrated in formulation, bridging, and targeted comparative or stewardship studies.
• Market growth is constrained by price compression typical of mature generics, with volume growth potential driven by geography and infection-treatment demand.
• Main risks are antimicrobial stewardship restrictions and fluoroquinolone class safety concerns, plus resistance patterns that affect empirical use and outcomes.
• Projection from 2026 to 2035 is best framed as low-to-mid single digit value growth with slower value than volume, with stronger headwinds in markets tightening stewardship policies.

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FAQs

1) What dosing strengths of ciprofloxacin hydrochloride are most commonly marketed?

Oral solid forms (tablets/capsules) and IV formulations at standard ciprofloxacin strengths are the most widely supplied; retail and hospital formulations differ by region and tendering.

2) Are there any ciprofloxacin hydrochloride new delivery technologies in clinical development?

Clinical visibility is more common for formulation/bridging programs than for radical delivery changes; any new delivery concepts typically remain niche compared with established oral/IV products.

3) How does quinolone resistance change ciprofloxacin prescribing patterns?

Higher resistance reduces empirical prescribing and can shift use toward culture-guided therapy or alternative agents, affecting both volume and payer mix.

4) What matters most for a generic ciprofloxacin launch in hospital tenders?

Regulatory approval status, consistent supply, quality track record, and ability to meet tender specifications for packaging, stability, and shelf-life.

5) What is the main revenue driver for ciprofloxacin suppliers?

Winning and maintaining hospital distribution contracts and maintaining uninterrupted manufacturing compliance, which protects volume amid competitive pricing.

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References (APA)

No sources were provided or cited in the prompt.