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 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYCAMTIN (topotecan) is a small-molecule topoisomerase I inhibitor approved as an oral capsule for cancer treatment since 2007. It functions by inhibiting topoisomerase I, an enzyme essential for DNA replication, thereby inducing apoptosis in rapidly dividing cancer cells. The drug is used across multiple solid tumor indications where DNA damage-based cytotoxicity is the therapeutic mechanism.
LOE Approaching
With LOE approaching and no current Part D spending data available, the brand team is likely in defensive mode with smaller commercial footprint and reduced investment in field expansion.
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.