Wednesday, July 8, 2026

Drug profile · INN

irinotecan hydrochloride

irinotecan hydrochloride (IRINOTECAN HYDROCHLORIDE) is a dna topoisomerase i inhibitor. Associated with Teva Pharma GmbH. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 18
News articles 0
Drug details — irinotecan hydrochloride
US status
approved
Class
Route
INJECTION
Patents
0
Programs
18
Data quality
0.89

Quick answer

irinotecan hydrochloride (IRINOTECAN HYDROCHLORIDE) is a dna topoisomerase i inhibitor. Associated with Teva Pharma GmbH. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN irinotecan hydrochloride
Brand IRINOTECAN HYDROCHLORIDE
Mechanism DNA topoisomerase I inhibitor
Target DNA topoisomerase 1
Route INJECTION
Formulation INJECTABLE, LIPOSOMAL

Mechanism of action

DNA topoisomerase I inhibitor

Primary target: DNA topoisomerase 1

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 20210081 Phase 3 · Amgen · Colorectal Cancer (CRC)
  2. C4221015 Phase 3 · First Biotech (Australia) · Colorectal cancer (BRAF V600E-mutant mCRC)
  3. CA2660003 Phase 3 · Bristol-Myers Squibb Australia · Untreated, Unresectable or Metastatic Colorectal Cancer
  4. D-US-60010-001 Phase 3 · Ipsen · Metastatic Pancreatic Adenocarcinoma
  5. DS7300-202 Phase 3 · Daiichi Sankyo US · Esophageal Squamous Cell Carcinoma (ESCC)
  6. FUNGEMAX Phase 3 · CERo Therapeutics · Metastatic pancreatic cancer
  7. PROICM 2021-01 GRE Phase 3 · George Institute for · Rectum cancer
  8. RMC-6236-302 Phase 3 · Revolution Medicines · Metastatic Pancreatic Ductal Adenocarcinoma

Related & competitor drugs

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

Frequently asked questions

What is irinotecan hydrochloride?

irinotecan hydrochloride (IRINOTECAN HYDROCHLORIDE) is a dna topoisomerase i inhibitor. Associated with Teva Pharma GmbH. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for irinotecan hydrochloride?

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

What is the US approval status of irinotecan hydrochloride?

irinotecan 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.