Irinotecan · Camptosar, Onivyde

What is Irinotecan?

Irinotecan is a camptothecin derivative that inhibits topoisomerase I, preventing religation of DNA single-strand breaks and causing double-strand DNA damage during replication.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Camptosar, Onivyde, Campto

Drug type

Small molecule

Targets

topoisomerase I (TOP1)

Mechanism

Inhibitor of topoisomerase I (TOP1)

Pathways

DNA damage, apoptosis

Therapy area

Oncology

Developer

Ipsen

In trials of

ACTU, AGEN, AZN, CMPS, CMPX, INBX, ONCY, SMMT

FDA status

Approved as Camptosar, Onivyde (October 22, 2015), NDA207793 · FDA label

✅ FDA-approved uses

• Metastatic carcinoma of the colon or rectum (first-line with 5-FU and leucovorin) (Camptosar)
• Metastatic carcinoma of the colon or rectum (after fluorouracil-based therapy) (Camptosar)
• Metastatic pancreatic adenocarcinoma (first-line with oxaliplatin, fluorouracil and leucovorin) (Onivyde)
• Metastatic pancreatic adenocarcinoma (after gemcitabine-based therapy with fluorouracil and leucovorin) (Onivyde)

From the indications section of the FDA label (version of May 12, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

CancerNeoplasm MetastasisNeoplasm of BoneNeoplasm of LungNeoplasm, BreastNeoplasms PancreaticNeoplasms,ColorectalPancreatic AdenocarcinomaPancreatic CancerRefractory CancerRefractory NeoplasmRefractory Non-Hodgkin LymphomaRenal CancerResistant Cancer

Other drugs acting on TOP1

Sources

• FDA label (DailyMed)
• FDA label Camptosar (2026-05-12), indications
• FDA label Onivyde (2025-03-03), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT01274624
• ClinicalTrials.gov NCT03678883
• ClinicalTrials.gov NCT05382442
• ClinicalTrials.gov NCT07662031

Updated Oct 3, 2026.