Cipro

(ciprofloxacin)

ApprovedSmall molecule

Ciprofloxacin is an antibiotic used to treat bacterial infections such as urinary tract infections, respiratory infections, and skin infections. It works by killing bacteria that cause these infections.[2] Cipro is currently approved and in use across 59 indications[4].[1]

Cipro is one of 792 small molecule programs targeting Pancreatic Cancer. It is currently in Approved.

Indications

167

Total Trials

Active Trials

791

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Pancreatic CancerRecruiting

GonorrheaActive, not recruiting

SinusitisActive, not recruiting

OsteomyelitisApproved

BronchiectasisApproved

Infectious DiseaseApproved

Pseudomonas InfectionApproved

Erectile DysfunctionApproved

Chronic Lymphocytic LeukemiaApproved

Anthrax InfectionApproved

Pancreatic CancerPhase 2

Recruiting

GonorrheaApproved

Active, not recruiting

SinusitisApproved

Active, not recruiting

OsteomyelitisApproved

Approved

BronchiectasisApproved

Approved

Infectious DiseaseApproved

Approved

Pseudomonas InfectionApproved

Approved

Erectile DysfunctionApproved

Approved

Chronic Lymphocytic LeukemiaApproved

Approved

Anthrax InfectionApproved

Approved

Showing 10 of 56 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Cipro

Bayer

Approved

3 2

Rubraca

Bristol-Myers Squibb

Phase 3

9 3

Lutetium Lu-177 PNT2002

JJonsson Comprehensive Cancer Center

Phase 3

4 4

Lhrha

Johnson & Johnson

Phase 3

2 5

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Phase 3

1 6

AAA817

Novartis

Phase 3

1 7

SHR3680

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

5 8

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 9

Trexall

Duragesic

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Ciprofloxacin

NCT05286931

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Phase 1Active, not recruiting

Pancreatic Ductal Adenocarcinoma

NCT04523987

Q2 2027

Phase 1/2Recruiting

Antibiotics

NCT06126731

Q3 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT05846399

Phase 1Recruiting

Infection

NCT05959616

Clinical

Trials by Indication[1]

Ciprofloxacin25 trials

Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

Completed·—·Phase 4·NCT04456712·200 enrolled

Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

Terminated·AAssistance Publique - Hôpitaux de Paris·N/A·NCT00190151·48 enrolled

Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers

Completed·EElusys Therapeutics·Phase 1·NCT01952444·40 enrolled

Show 22 more trials

Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)

Terminated·UUniversity of Chicago·Phase 3·NCT00840294·85 enrolled

Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea

Completed·—·Phase 3·NCT01208922·835 enrolled

Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague

Completed·UUniversity of Oxford·Phase 3·NCT04110340·222 enrolled

Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649662·36 enrolled

Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

Completed·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 4·NCT01803191·461 enrolled

Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649155·36 enrolled

Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650351·35 enrolled

Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00785980·24 enrolled

SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Recruiting·UUniversity of Washington·N/A·NCT05286931·1,800 enrolled

Ciprofloxacin on Burned Patients

Completed· Bayer logo

Bayer·Phase 3·NCT00668044·18 enrolled

Impact of Formulation on Ciprofloxacin Oral Absorption

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT00992329·16 enrolled

Ciprofloxacin Multiple Dose for Adult Cholera

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00741052·218 enrolled

Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)

Completed·MMerLion Pharmaceuticals GmbH·Phase 2·NCT00722735·36 enrolled

Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects

Completed·HHelsinn Healthcare SA·Phase 1·NCT02118909·32 enrolled

Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT02961751·211 enrolled

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

Completed·KKorea University·Phase 4·NCT01265173·261 enrolled

Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04147260·85 enrolled

CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)

Active, not recruiting·UUniversity College, London·N/A·NCT04678869·313 enrolled

Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT03854929·364 enrolled

Ciprofloxacin for Prevention of BK Infection

Completed·TThe Methodist Hospital Research Institute·Phase 4·NCT01789203·200 enrolled

A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects

Completed·SServier Bio-Innovation LLC·Phase 1·NCT05843708·64 enrolled

Ciprofloxacin BioThrax Co-Administration Study

Completed· Emergent BioSolutions logo

Emergent BioSolutions·Phase 2·NCT01753115·154 enrolled

Antibiotics8 trials

Antibiotics and Hydroxychloroquine in Crohn's

Completed·RRoyal Liverpool University Hospital·Phase 2·NCT01783106·59 enrolled

Role of Prophylactic Postoperative Antibiotics in HoLEP

Withdrawn·—·Phase 4·NCT05274672

Combination Study of Antibiotics With Enzalutamide (PROMIZE)

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT06126731·39 enrolled

Show 5 more trials

Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study

Completed· Emergent BioSolutions logo

Emergent BioSolutions·Phase 2·NCT04067011·210 enrolled

Prophylactic Antibiotics on Urethral Catheter Withdrawal

Completed·SSt. Antonius Hospital·Phase 4·NCT00126698·100 enrolled

Evaluation of Innovative Tools in Development of Antibiotics

Completed·MMedical University of Vienna·Phase 1·NCT03177720·10 enrolled

A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration

Completed·KKaiser Permanente·N/A·NCT01929460·26 enrolled

Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics

Completed·LLoma Linda University·N/A·NCT02223338·120 enrolled

Antibiotic Prophylaxis8 trials

Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole

Unknown status·UUmeå University·Phase 2·NCT02734732·2,800 enrolled

CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)

Recruiting·UUniversity of Missouri-Columbia·Phase 4·NCT05846399·72 enrolled

Antibiotic Prophylaxis With Routine Ureteral Stent Removal

Completed·UUniversity of California, San Diego·N/A·NCT02944825·80 enrolled

Show 5 more trials

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

Antibiotic Prophylaxis for Bladder Botox

Recruiting·UUniversity of Alberta·Phase 4·NCT04444440·202 enrolled

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Completed·NNorthwestern University·Phase 4·NCT01659866·563 enrolled

Antibiotic Prophylaxis Before Shock Wave Lithotripsy

Completed·CClinical Urology and Epidemiology Working Group·Phase 4·NCT03692715·1,732 enrolled

Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Terminated·UUniversity of Rochester·N/A·NCT02247960·175 enrolled

Urinary Tract Infection6 trials

Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections

Completed· Bayer logo

Bayer·Phase 4·NCT00669994·180 enrolled

Clinical Efficacy of Crano-cure inTreatment of Urinary Tract Infection

Completed·IIslamia University of Bahawalpur·N/A·NCT04575493·205 enrolled

Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)

Completed·IIterum Therapeutics, International Limited·Phase 4·NCT03366207·250 enrolled

Show 3 more trials

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03354598·1,671 enrolled

Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)

Terminated·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT01873690·360 enrolled

Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01505634·302 enrolled

Adult Subject5 trials

Bioequivalence Study of Ciprofloxacin in Healthy Adult Subjects Under Fasting Condition

Completed·FFuture University in Egypt·Phase 1·NCT05532267·30 enrolled

A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects

Completed·NNeuroSense Therapeutics Ltd.·Phase 1·NCT05232461·12 enrolled

A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject

Completed·NNeuroSense Therapeutics Ltd.·Phase 1·NCT05436678·19 enrolled

Show 2 more trials

An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT02015507·34 enrolled

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT01768663·80 enrolled

83 more indications

Neutropenia4 trials

Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia

Completed·OOttawa Hospital Research Institute·Phase 4·NCT02816112·458 enrolled

Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia

Unknown status·CClatterbridge Centre for Oncology·Phase 3·NCT00445497·400 enrolled

Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

Completed·MMurdoch Childrens Research Institute·Phase 4·NCT04948463·55 enrolled

Show 1 more trial

Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·N/A·NCT00062231·351 enrolled

Cystic Fibrosis4 trials

Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

Completed· Bayer logo

Bayer·Phase 2·NCT00930982·124 enrolled

Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis

Completed·SSeattle Children's Hospital·Phase 2·NCT00097773·304 enrolled

Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis

Completed· Bayer logo

Bayer·Phase 2·NCT00645788·288 enrolled

Show 1 more trial

Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

Completed· Bayer logo

Bayer·Phase 1·NCT00910351·19 enrolled

Chronic Obstructive Pulmonary Disease4 trials

Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Completed· Bayer logo

Bayer·Phase 1·NCT01052298·25 enrolled

To Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin Inhale in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD, GOLD II-III)

Completed· Bayer logo

Bayer·Phase 1·NCT01072942·16 enrolled

Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed· Bayer logo

Bayer·Phase 1·NCT00961038·19 enrolled

Show 1 more trial

Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation

Completed·UUniversity of Monastir·Phase 3·NCT00791505·170 enrolled

Crohn's Disease4 trials

Study of Antibiotics in the Treatment of Colonic Crohn's Disease

Terminated·MMount Sinai Hospital, Canada·Phase 2·NCT00257699·12 enrolled

Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Completed·—·Phase 2·NCT03476317·10 enrolled

Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT00609973·33 enrolled

Show 1 more trial

Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Completed·UUniversity of Pennsylvania·Phase 2·NCT02765256·8 enrolled

Prostate Cancer3 trials

Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy

Withdrawn·WWake Forest University Health Sciences·Phase 2·NCT02252978

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer

Terminated·CCR-CSSS Champlain-Charles-Le Moyne·Phase 3·NCT03862170·158 enrolled

Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Completed· Sanofi logo

Sanofi·Phase 4·NCT01649635·45 enrolled

Experimental3 trials

Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT05294588·65 enrolled

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04870138·16 enrolled

Experimental Human Infection With Neisseria Gonorrhoeae

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT03840811·27 enrolled

Peritonitis3 trials

Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin

Completed·—·Phase 3·NCT06234046·80 enrolled

Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients

Withdrawn·SSeoul National University Hospital·Phase 3·NCT02011841

Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

Completed·KKorea University·Phase 4·NCT01542801·124 enrolled

Pancreatic Cancer2 trials

Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT05462496·25 enrolled

PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment

Not yet recruiting·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT07028424·206 enrolled

Liver abscess2 trials

Ciprofloxacin Plus Metronidazole Vs Cefixime Plus Metronidazole Therapy for the Treatment of Liver Abscess

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT03969758·140 enrolled

Antibiotics for Klebsiella Liver Abscess Study

Completed·NNational University Hospital, Singapore·Phase 4·NCT01723150·152 enrolled

Diabetic Foot2 trials

Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers

Terminated·RRoyer Biomedical, Inc.·Phase 1/2·NCT02036528·9 enrolled

Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Unknown status·UUniversidad Complutense de Madrid·N/A·NCT01137903·88 enrolled

Prophylaxis2 trials

A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy

Completed·MMansoura University·Phase 4·NCT02423759·510 enrolled

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

Completed·RRadboud University Medical Center·Phase 4·NCT03228108·1,538 enrolled

Antibiotic2 trials

Antibiotic Profile of Pathogenic Bacteria Isolated in Public Hospitals in Northern Jordan

Completed·—··NCT05106803·24 enrolled

The Effect of Antibiotic Eye Drops on the Nasal Microbiome in Healthy Subjects

Completed·MMedical University of Vienna·Phase 2·NCT05287425·20 enrolled

Cystitis2 trials

Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Completed·UUniversity of Washington·N/A·NCT00194532·300 enrolled

Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis

Completed·TTedec-Meiji Farma, S.A.·Phase 3·NCT00598403·611 enrolled

TIA2 trials

A Study to Investigate the Phototoxic Potential of Faldaprevir

Withdrawn· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02114671

Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag

Completed· GSK logo

GSK·Phase 1·NCT00688272·36 enrolled

Rhinoscleroma2 trials

Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

Unknown status·—·Phase 1·NCT03326050·60 enrolled

Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Unknown status·—·Phase 1·NCT05431673·45 enrolled

Clinical Trial2 trials

Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial.

Withdrawn·PPoitiers University Hospital·Phase 3·NCT04698057

Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00142272·180 enrolled

Safety and Efficacy2 trials

Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Completed· Bayer logo

Bayer··NCT01670435·3,274 enrolled

A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT01243437·200 enrolled

Abscess2 trials

Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial

Unknown status·Ddr. IJM Han-Geurts·N/A·NCT05385887·298 enrolled

Randomized Antibiotics for Prevention of Fistula After Incision and Drainage of First-Episode Perianal Abscess (RAPID): A Randomized Controlled Trial

Not yet recruiting·UUniversity of Illinois at Chicago·Approved·NCT07704359·236 enrolled

Meningitis2 trials

Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018

Withdrawn·EEpicentre·Phase 4·NCT03431675

Ciprofloxacin for the Prevention of Meningococcal Meningitis

Completed·EEpicentre·Phase 4·NCT02724046·300 enrolled

Ulcerative Colitis2 trials

Antibiotics for the Treatment of Ulcerative Colitis

Completed·UUniversity of Dundee·N/A·NCT00355602·40 enrolled

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Completed·HHvidovre University Hospital·Phase 4·NCT01772615·100 enrolled

Recurrent UTIs1 trial

Glycemia and Antibiotic Efficacy in Diabetic Recurrent UTIs

Completed·—·N/A·NCT07188935·99 enrolled

Cirrhosis1 trial

PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

Terminated·NNina Kimer·N/A·NCT03027635·13 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.

Active, not recruiting·NNational University Hospital, Singapore·Phase 1·NCT04523987·10 enrolled

Immune Response1 trial

The Role of the Microbiota in the Systemic Immune Response

Completed·—·N/A·NCT02340182·12 enrolled

Crohn Disease1 trial

Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02620007·24 enrolled

Laparoscopic Cholecystectomy1 trial

Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Terminated·UUniversity of Roma La Sapienza·Phase 4·NCT01888822·138 enrolled

Prevention1 trial

Short-course Methenamine Hippurate for Prevention of Post-operative UTI

Completed·UUniversity of Pennsylvania·N/A·NCT02358993·201 enrolled

Pediatric Patients1 trial

Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Completed·UUniversity Hospital, Ghent·Phase 4·NCT02598362·22 enrolled

Epilepsy1 trial

Ciprofloxacin in Drug-resistant Epilepsy

Completed·MMazandaran University of Medical Sciences·N/A·NCT04763070·23 enrolled

Adult1 trial

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03357614·1,395 enrolled

Colonization1 trial

S. Aureus Decolonization in HPN Patients.

Terminated·RRadboud University Medical Center·N/A·NCT03173053·63 enrolled

Growth1 trial

Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

Unknown status·SSan Antonio Military Medical Center·Phase 4·NCT02458781·180 enrolled

Chronic Pulmonary Disease1 trial

Targeted AntiBiotics for Chronic Pulmonary Diseases

Terminated·CChronic Obstructive Pulmonary Disease Trial Network, Denmark·Phase 4·NCT03262142·51 enrolled

ARDS1 trial

TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01124799·49 enrolled

Typhoid Fever1 trial

Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever

Completed·—·Phase 2·NCT07150065·360 enrolled

COPD Exacerbation1 trial

Targeted Retreatment of COPD Exacerbations

Completed·IImperial College London·Phase 3·NCT02300220·144 enrolled

Pediatric1 trial

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Completed· Bayer logo

Bayer·Phase 3·NCT00761462·1,029 enrolled

Hepatitis1 trial

Randomised Open-label Multicenter Study Evaluating Ciprofloxacin in Severe Alcoholic Hepatitis

Completed·UUniversity of Helsinki·Phase 1·NCT02326103·22 enrolled

Chronic Prostatitis1 trial

Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and Tamsulosin

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT04552431·196 enrolled

Stem Cell Transplant1 trial

Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Completed·HHenry Ford Health System·Phase 2·NCT03850379·308 enrolled

Squamous Cell Carcinoma1 trial

Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Completed·—·Phase 2·NCT00139230·30 enrolled

Cutaneous Leishmaniasis1 trial

Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate

Recruiting·—·Phase 2·NCT06798402·80 enrolled

Colorectal Surgery1 trial

Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT02505581·536 enrolled

Otitis Externa1 trial

Phase 3 Study of OTO-201 in Acute Otitis Externa

Completed·OOtonomy, Inc.·Phase 3·NCT02801370·262 enrolled

Pyelonephritis1 trial

Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

Completed·MMerLion Pharmaceuticals GmbH·Phase 2·NCT01928433·225 enrolled

Bronchiectasis1 trial

Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

Recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 4·NCT06093191·364 enrolled

Adverse Events1 trial

Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting

Completed·—··NCT05916105·151 enrolled

Fluoroquinolone1 trial

Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Completed·IIndiana University School of Medicine·Phase 4·NCT00392275·48 enrolled

Monoclonal1 trial

Monoclonal Antibody for Treatment of Inhalation Anthrax

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00138411·36 enrolled

Bacterial Pneumonia1 trial

A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

Completed· Bayer logo

Bayer·Phase 3·NCT01561794·44 enrolled

Infection1 trial

Shigella Sonnei 53G Human Infection Study in Kenyan Adults

Recruiting·UUniversity of Oxford·Phase 1·NCT05959616·70 enrolled

Acute Myeloid Leukemia1 trial

Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)

Terminated·UUniversity of Florida·Phase 1/2·NCT02773732·11 enrolled

Chronic Lung Disease1 trial

Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases

Completed· Bayer logo

Bayer·Phase 1·NCT01538667·24 enrolled

Bronchitis1 trial

Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

Terminated·UUniversity Hospital, Lille·Phase 4·NCT03012360·103 enrolled

Lip1 trial

Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Withdrawn·FFlorencia Vargas-Vorackova·Phase 4·NCT00760032

Breast Cancer1 trial

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00590785·60 enrolled

Children1 trial

Population Pharmacokinetics of Anti-infectious Drugs in Children

Completed·UUniversity Hospital, Bordeaux·N/A·NCT01344512·214 enrolled

Labor1 trial

Collaborative Urological Prosthetics Investigation Directive Research Group

Active, not recruiting·UUniversity of Chicago·Phase 1·NCT05100654·800 enrolled

Endophthalmitis1 trial

Safety and Efficacy of Topical Moxifloxacin for Prevention of Post-Traumatic Endophthalmitis: Randomized Controlled Clinical Trial

Unknown status·UUniversity of Campinas, Brazil·Phase 2·NCT05162625·100 enrolled

Pouchitis1 trial

A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

Completed· Takeda logo

Takeda·Phase 4·NCT02790138·102 enrolled

Hematologic Malignancies1 trial

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

Recruiting·GGadjah Mada University·Phase 4·NCT07016165·120 enrolled

Nanoparticle1 trial

Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Completed·—·Phase 1·NCT05442736·55 enrolled

Advanced or Metastatic Solid Tumors1 trial

VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Therapy

Completed·VVion Pharmaceuticals·Phase 1·NCT00004216

Diffuse Large B-Cell Lymphoma1 trial

A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT02532192

Intra-abdominal Infection1 trial

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03358576·674 enrolled

Sepsis1 trial

Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Unknown status·DDiaa Eldin Taha Ramadan Mohamed·N/A·NCT04374188·200 enrolled

Hematologic Disease1 trial

Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

Completed·CCenter for Supporting Hematology-Oncology Trials·Phase 3·NCT00137787·51 enrolled

BK Virus1 trial

BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent

Completed·UUniversity of North Carolina, Chapel Hill·Phase 3·NCT02068846·17 enrolled

Pancreatic Cystic Lesion1 trial

Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT02261896·226 enrolled

Anal fistula1 trial

Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's

Completed·FFoundation for Liver Research·Phase 3·NCT00736983·76 enrolled

Immunogenicity1 trial

Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00654108·62 enrolled

Multiple Myeloma1 trial

Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy

Completed·GGary Morrow·Phase 3·NCT00002850·212 enrolled

Randomized1 trial

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566

Completed· Sanofi logo

Sanofi·Phase 1·NCT05844735·60 enrolled

CAR1 trial

REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

Completed·OOttawa Hospital Research Institute·Phase 4·NCT02173262·142 enrolled

Pregnancy1 trial

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Completed·UUniversity of Wisconsin, Madison··NCT00214331·150 enrolled

Neurogenic bladder1 trial

Antibiotic Prophylaxis for Neurogenic Bladder Botox

Recruiting·UUniversity of Alberta·Phase 2·NCT04791579·160 enrolled

Bladder Cancer1 trial

S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

Terminated·SSWOG Cancer Research Network·Phase 3·NCT00003824·114 enrolled

Brain Injury1 trial

Cerebral Antibiotics Distribution After Acute Brain Injury

Completed·PPoitiers University Hospital·Phase 1·NCT01059890·18 enrolled

Otitis media1 trial

LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media

Completed·AAnabio R&D·N/A·NCT05804123·175 enrolled

Lactating Women on Select DOI1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·DDuke University··NCT03511118·1,600 enrolled

Acute Uncomplicated Diverticulitis1 trial

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

Recruiting·VVanderbilt University Medical Center·Phase 2·NCT07492134·100 enrolled

Endocarditis1 trial

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Recruiting·FFundacion Clinic per a la Recerca Biomédica·Approved·NCT05398679·360 enrolled

Unspecified2 trials

Longitudinal Study of the Human Intestinal Microbiome

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00832286·60 enrolled

Dose Ranging Study of OTO-201 in AOMT

Completed·OOtonomy, Inc.·Phase 2·NCT02719158·95 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 22, 1987

CIPRO

NDA NDA019537

Dec 26, 1990

CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA NDA019858

Dec 26, 1990

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA019857

Dec 26, 1990

CIPRO

NDA NDA019847

Dec 31, 1990

CILOXAN

NDA NDA019992

Sep 26, 1997

CIPRO

NDA NDA020780

Mar 30, 1998

CILOXAN

NDA NDA020369

May 19, 2005

PROQUIN XR

NDA NDA021744

May 1, 2009

CETRAXAL

NDA NDA021918

Dec 10, 2015

OTIPRIO

NDA NDA207986

Sources

References

[1]
ClinicalTrials.gov — 167 trial records for ciprofloxacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cipro drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — ciprofloxacin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for ciprofloxacin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207986). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cipro. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Topoisomerase IV Inhibitor; Bacterial DNA Gyrase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

Apr 21, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11369566Apr 21, 2029

9603796Apr 21, 2029

9205048Apr 21, 2029

9233068Dec 11, 2029

8318817Apr 27, 2030

3 more patents

9220796Jul 1, 2035

11040004Nov 12, 2037

11246863Nov 27, 2038