NDAORALTABLETPriority Review
Approved
Oct 1987
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CIPRO (ciprofloxacin hydrochloride) is an oral fluoroquinolone antibiotic approved in 1987 for treating bacterial infections, including Mycobacterium avium complex and HIV-related infections. It functions as a small-molecule inhibitor of bacterial DNA gyrase and topoisomerase IV, preventing DNA replication in susceptible organisms.
$0.029BPart D
LOE ApproachingDeclining
With LOE approaching and minimal Part D spending ($29K in 2023), the CIPRO franchise is in managed decline mode with reduced team investment and focus on defending market position against generics.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Started Oct 2025
1,524 enrolled
Metastatic Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Started Apr 2025
3,291 enrolled
Neisseria Gonorrheae Infection
Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity
Started Oct 2024
300 enrolled
Migraine
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
Started Apr 2023
64 enrolled
Healthy Subjects
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
Started Jun 2022
313 enrolled
Acute Lymphoblastic Leukaemia - Category
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.