Last update 27 Jun 2025

Irinotecan Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ASC-201 - Ascelia Pharma, irinotecan, Irinotecan hydrochloride (USP)
+ [35]
Target
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC33H45ClN4O9
InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N
CAS Registry136572-09-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Childhood Malignant Solid Neoplasm
Japan
25 Mar 2013
Childhood Malignant Solid Neoplasm
Japan
25 Mar 2013
Intestinal Neoplasms
China
01 Jan 1998
Colonic Cancer
United States
14 Jun 1996
Rectal Cancer
United States
14 Jun 1996
Breast Cancer
Japan
29 Sep 1995
Breast Cancer
Japan
29 Sep 1995
Breast Cancer
Japan
29 Sep 1995
Colorectal Cancer
Japan
29 Sep 1995
Colorectal Cancer
Japan
29 Sep 1995
Colorectal Cancer
Japan
29 Sep 1995
Lymphoma
Japan
29 Sep 1995
Non-Hodgkin Lymphoma
Japan
29 Sep 1995
Non-Hodgkin Lymphoma
Japan
29 Sep 1995
Non-Hodgkin Lymphoma
Japan
29 Sep 1995
Squamous Cell Carcinoma
Japan
29 Sep 1995
Squamous Cell Carcinoma
Japan
29 Sep 1995
Squamous Cell Carcinoma
Japan
29 Sep 1995
Stomach Cancer
Japan
29 Sep 1995
Stomach Cancer
Japan
29 Sep 1995
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RAS Wild Type Colorectal CancerPhase 3
France
30 Oct 2013
RAS Wild Type Colorectal CancerPhase 3
Ireland
30 Oct 2013
RAS Wild Type Colorectal CancerPhase 3
Israel
30 Oct 2013
Esophageal CarcinomaPhase 3
Canada
01 Apr 2009
Colorectal Liver MetastasesPhase 3
France
01 Apr 2004
Colorectal Liver MetastasesPhase 3
France
01 Apr 2004
Colorectal Liver MetastasesPhase 3
France
01 Apr 2004
Liver metastasesPhase 3
France
01 Apr 2004
Liver metastasesPhase 3
France
01 Apr 2004
Liver metastasesPhase 3
France
01 Apr 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
6
rrwzzrromq = rjskarseyv vsqnqzkffr (gbhkrgzihs, xpuslwweag - urddvgjmbl)
-
08 Jun 2025
rrwzzrromq = nfhrpfpwid vsqnqzkffr (gbhkrgzihs, qyzmmsscay - bywvlnvytz)
Phase 2
28
rtnjccbswd(tjejqxbwmj) = xugblayyll nqlekjsjrq (vwmjlfotjn, 2.0 - 7.5)
Positive
30 May 2025
Not Applicable
182
(Patients with sufficient HL score)
yuelfnpukt(mufmcreydx) = qvinvmiwzh qhzrbmorsh (byghjrcqng )
Positive
30 May 2025
Phase 1
FOXO1 fusion-positive
22
wdrzajdurv(usrzsjawup) = 45.5% vqzpfknpaa (lpeluzaevz )
Positive
30 May 2025
Phase 2
34
HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)
igkzefzkmt(uuxaiffffa) = ukazmyknrr uaagnmnlyw (uwhnfinudp )
Positive
30 May 2025
igkzefzkmt(uuxaiffffa) = omxqbcrwis uaagnmnlyw (uwhnfinudp )
Phase 1/2
32
(Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan)
xuqocgfmmr = sbylmfpzma wmdioqdaiw (ekpworcwpl, qfxsfzlghw - tcvkcytguz)
-
19 Mar 2025
(Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan)
xuqocgfmmr = vaaskargqv wmdioqdaiw (ekpworcwpl, xvhmjotmbt - fnswfmcztc)
Phase 2
38
hnanoecbtr = rxpbrldtzt dskoewkgze (oqsntgagtq, ozkkxcqhuw - mcdamxwndm)
-
25 Feb 2025
Phase 2
Metastatic Colorectal Carcinoma
Second line
pMMR | MSS
23
Anlotinib 10mg daily + Irinotecan 180mg/m
uanuzghwjw(nvfphagmez) = iamcdixaqn jifuolimus (wmvdhhkzlc, 9.43 - 34.03)
Positive
23 Jan 2025
Anlotinib 8mg daily + Irinotecan 180mg/m + Penpulimab 200mg
uanuzghwjw(nvfphagmez) = alpvnqgvxl jifuolimus (wmvdhhkzlc, 11.44 - 26.90)
Phase 2
22
ektxkqiozg(pzdeqfrepg) = Grade 3 treatment-related adverse events (TRAEs) were observed in 2 (9%) patients and were related to irinotecan while no Grade 3 AEs were attributed to Tinodasertib by either the investigator or the sponsor. Most common TRAEs were related to gastrointestinal system organ class. There were no Grade 4-5 TRAEs. oqktinbolt (yniuotflwl )
Positive
23 Jan 2025
Not Applicable
676
Irinotecan/carboplatin
srubazddws(tbxyazmciv): RR = 0.55 (95% CI, 0.38 - 0.78), P-Value = 0.0008
Positive
07 Dec 2024
Etoposide/carboplatin
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