HYCAMTIN

LOE Approaching

topotecan

NDAORALCAPSULEPriority Review
Approved
Oct 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
23

Mechanism of Action

single-strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents re-ligation of these single-strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex…

Indications (1)

Clinical Trials (5)

NCT07145333Phase 2/3Active Not Recruiting

Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

Started Aug 2025
600 enrolled
SCLC
NCT05429502Phase 1Terminated

Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

Started Dec 2022
12 enrolled
Neuroblastoma
NCT04768296Phase 2Completed

Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

Started Mar 2021
76 enrolled
Small-cell Lung Cancer
NCT04047251Phase 1Active Not Recruiting

A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma

Started Nov 2019
NCT02963090Phase 2Terminated

Pembrolizumab vs Topotecan in Patients With Small Cell Lung Cancer

Started May 2017
9 enrolled
Small Cell Lung Cancer