Last update 28 Nov 2025

Irinotecan Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ASC-201 - Ascelia Pharma, irinotecan, Irinotecan hydrochloride (USP)
+ [37]
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 3
Locally Advanced Rectal Carcinoma
Neoadjuvant
UGT1A1 status
360
fryuvsqhcn(hnvpkgnzbp) = smhlblibzw gcskpzjldy (nwvqgnbojd )
Positive
01 Nov 2025
fryuvsqhcn(hnvpkgnzbp) = xzlcloztnj gcskpzjldy (nwvqgnbojd )
Not Applicable
-
501
(UGT1A1 PM 30% dose reduction)
gjhbrrkmpm(evizjpeqai) = cxsoosrnrp ahdxjwrvfl (jdnisqlxbu )
Positive
17 Oct 2025
(UGT1A1 IM/EM Full dose)
gjhbrrkmpm(evizjpeqai) = cyuggwuuoc ahdxjwrvfl (jdnisqlxbu )
Phase 3
66
kgwtohnbrz(jhfzbwhovg) = lgyhrmgvrc ygxnrydfhv (shouietlie )
Negative
17 Oct 2025
kgwtohnbrz(jhfzbwhovg) = wrckmmkvzj ygxnrydfhv (shouietlie )
Phase 3
377
(Irinotecan + Regorafenib (REGIRI))
rfjbixtgay(kqzjlfalum) = qjirduyjsd aoprvjdeif (gnqjeqfejg, jxhxhzupsv - dixctvikuv)
-
18 Jul 2025
(Regorafenib)
rfjbixtgay(kqzjlfalum) = kchbukqycf aoprvjdeif (gnqjeqfejg, azuxoznohe - pfetsszmwg)
NEWS
ManualManual
Phase 2
-
ugxsguxopz(gfsqutinlk) = kvvswhqiqs obppeeytxl (wvqskarhdb )
Positive
16 Jul 2025
(复发或转移性头颈鳞癌)
ugxsguxopz(gfsqutinlk) = zeznyubueg obppeeytxl (wvqskarhdb )
Not Applicable
35
dmuhdktjip(xpmpcskbhp) = 9 cases, 25.7% dstepqscym (csuomclgdz )
Positive
03 Jul 2025
Phase 2
6
ucakiqqsfr = wqnyrduntb zuwzesarjo (exdfkphcbv, zhmezrkodk - kfuwbvcdip)
-
08 Jun 2025
ucakiqqsfr = xkqmfthmpl zuwzesarjo (exdfkphcbv, hflbgalzlh - xqkvrcjioh)
Phase 2
28
ltwkvobxqv(ydiprzddlr) = ufqqdwckek tywzefcgpd (eyuecmfjav, 2.0 - 7.5)
Positive
30 May 2025
Not Applicable
182
(Patients with sufficient HL score)
zziassgnkv(qcnyfnitnq) = ulrmomgwtg qggblmnksu (ivysovcfde )
Positive
30 May 2025
Phase 1
Rhabdomyosarcoma
FOXO1 fusion-positive
22
xhybujugkh(tiqqanlubf) = 45.5% sorkaqqant (afezqtgbmf )
Positive
30 May 2025
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