Wednesday, July 8, 2026

Drug profile · INN

topotecan hydrochloride

topotecan hydrochloride (TOPOTECAN HYDROCHLORIDE) is a dna topoisomerase i, mitochondrial inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 20
News articles 0
Drug details — topotecan hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
20
Data quality
0.84

Quick answer

topotecan hydrochloride (TOPOTECAN HYDROCHLORIDE) is a dna topoisomerase i, mitochondrial inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN topotecan hydrochloride
Brand TOPOTECAN HYDROCHLORIDE
Mechanism DNA topoisomerase I, mitochondrial inhibitor
Target DNA topoisomerase 1
Route ORAL
Formulation INJECTABLE

Mechanism of action

DNA topoisomerase I, mitochondrial inhibitor

Primary target: DNA topoisomerase 1

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 223674 Phase 3 · GSK Glaxo Smith · Neoplasms, Lung
  2. ALKS 4230-007 Phase 3 · Createrna Science and · Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Pr
  3. D8991C00001 Phase 3 · AstraZeneca · Advanced Platinum-resistant Epithelial Ovarian Cancer
  4. DS6000-109 Phase 3 · Daiichi Sankyo US · Platinum-resistant, high-grade serous ovarian cancer (OVC),h
  5. DS7300-188 Phase 3 · Daiichi Sankyo US · Small Cell Lung Cancer (SCLC)
  6. GCO-003 TARLANEC Phase 3 · CERo Therapeutics · Advanced pulmonary or gastroenteropancreatic poorly differen
  7. GCT1184-02 Phase 3 · Genmab · Platinum-resistant Ovarian Cancer
  8. GS-US-600-6165 Phase 3 · Gilead Sciences · Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Related & competitor drugs

  1. etirinotecan pegol Antineoplastic and immunomodulating agents (L01)
  2. irinotecan hydrochloride DNA topoisomerase I inhibitor
  3. fam-trastuzumab deruxtecan-nxki DNA topoisomerase I inhibitor
  4. sacituzumab govitecan-hziy DNA topoisomerase I inhibitor
  5. datopotamab deruxtecan Antineoplastic and immunomodulating agents (L01)
  6. irinotecan hydrochloride trihydrate Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is topotecan hydrochloride?

topotecan hydrochloride (TOPOTECAN HYDROCHLORIDE) is a dna topoisomerase i, mitochondrial inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for topotecan hydrochloride?

TOPOTECAN HYDROCHLORIDE is a marketed brand name for topotecan hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of topotecan hydrochloride?

topotecan hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.