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Drug

Irinotecan

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as Camptosar, Irinotecan lactone, Onivyde, (+)-Irinotecan+2 more

Camptosar, Irinotecan lactone, Onivyde, (+)-Irinotecan, Irinotecan Hydrochloride, Irinotecanum.

19
Research papers
41
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Clinical trial2026-07-16Results expected Q4 2026 · ClinicalTrials.gov

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Clinical trial2026-07-06Results expected Q4 2030 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Irinotecan
Aliases & brands
CamptosarIrinotecan lactoneOnivyde(+)-IrinotecanIrinotecan HydrochlorideIrinotecanum
RxNorm CUI
51499
ChEMBL ID
CHEMBL481
ATC codes
L01CE02
UNII
7673326042
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-10-14
Latest approval
2016-10-14
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2016-10-14Approval
Approval: Onivyde pegylated liposomal (previously Onivyde) (EMA)
Indication: ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients withShow full indication

ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas, in adult patients who have progressed following gemcitabine based therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

198 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
198
registered trials across all phases
LATEST COMPLETION 2026
41
Active studies
27
Recruiting
31
Late-stage (III+)
99
Completed
58
Discontinued
PHASE DISTRIBUTIONn = 198
Early Phase 13Phase 148Phase 1 / 224Phase 292Phase 2 / 34Phase 326Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

19 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992024
Most influential

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer.

The New England journal of medicine · 2018 · 2,091 cites

Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009 · 1,150 cites

Encorafenib, Binimetinib, and Cetuximab in <i>BRAF</i> V600E-Mutated Colorectal Cancer.

The New England journal of medicine · 2019 · 1,029 cites

Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.

The New England journal of medicine · 2020 · 983 cites
Recent papers
Major research themes8
Colonic Neoplasms2Immunoconjugates2Pancreatic Neoplasms2Rectal Neoplasms2Triple Negative Breast Neoplasms2Adenocarcinoma1Antibodies, Monoclonal, Humanized1Antineoplastic Agents1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine5
  • JAMA network open2
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • Anticancer research1
  • Breast (Edinburgh, Scotland)1
  • Cancer chemotherapy and pharmacology1
Leading researchers
  • Yoshino T3
  • Ciardiello F2
  • Elez E2
  • Lonardi S2
  • Masi G2
  • Pietrantonio F2
  • Tabernero J2
  • Abdullah S1
Leading institutions
free-text, unnormalised
  • Sarah Cannon Research Institute2
  • Azienda Ospedaliero-Universitaria Pisana1
  • Center for Cancer Research1
  • Clinical Pharmacology1
  • Clinical Pharmacology Program1
  • Clinical Research1

Related diseases

10 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 18 of the same disease areas as Irinotecan in the shared literature.

18 shared diseases7 shared papers

Studied across 17 of the same disease areas as Irinotecan in the shared literature.

17 shared diseases7 shared papers

Studied across 12 of the same disease areas as Irinotecan in the shared literature.

12 shared diseases6 shared papers

Studied across 9 of the same disease areas as Irinotecan in the shared literature.

9 shared diseases6 shared papers

Studied across 12 of the same disease areas as Irinotecan in the shared literature.

12 shared diseases3 shared papers

Studied across 10 of the same disease areas as Irinotecan in the shared literature.

10 shared diseases2 shared papers

Studied across 8 of the same disease areas as Irinotecan in the shared literature.

8 shared diseases3 shared papers

Studied across 11 of the same disease areas as Irinotecan in the shared literature.

11 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.