NDAORALCAPSULEPriority Review
Approved
Oct 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYCAMTIN (topotecan) is a small-molecule topoisomerase I inhibitor indicated for ovarian cancer, small cell lung cancer, and cervical cancer. It works by stabilizing the topoisomerase I-DNA complex, leading to DNA damage and cell death in rapidly dividing cancer cells. The oral capsule formulation, approved in 2007, offers convenience compared to intravenous administration.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30%), suggesting brand teams are focused on lifecycle extension and preparation for generic competition.
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)
Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
Started Aug 2025
600 enrolled
SCLC
Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer
Started Aug 2025
128 enrolled
Extensive-stage Small Cell Lung Cancer (ES-SCLC)Extensive-stage Small Cell Lung Cancer (SCLC)Small Cell Lung Cancer ( SCLC )
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Started Sep 2024
180 enrolled
Relapsed Small Cell Lung Cancer
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)
Started Aug 2024
722 enrolled
Small Cell Lung Cancer
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Started Oct 2023
302 enrolled
Extensive-stage Small-cell Lung Cancer
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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.