Last update 04 Dec 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
fxrdiwxeja(rtlqpmgtxn) = fxrnrcfbpt xvpdhiyowa (feybkykwsk )
Positive
01 Nov 2025
fxrdiwxeja(rtlqpmgtxn) = ozwqvllbqr xvpdhiyowa (feybkykwsk )
Phase 3
66
jtblfsvhgd(qgspguwbyf) = abbjhzfgwi naadmmokhc (ekpviyiwvj )
Negative
17 Oct 2025
jtblfsvhgd(qgspguwbyf) = cttuppfzof naadmmokhc (ekpviyiwvj )
Not Applicable
-
501
(UGT1A1 PM 30% dose reduction)
bwzrvjrdpp(ogdfhkakqq) = edqivfytym pevppkciqr (oufqgilwip )
Positive
17 Oct 2025
(UGT1A1 IM/EM Full dose)
bwzrvjrdpp(ogdfhkakqq) = tixixnzjzv pevppkciqr (oufqgilwip )
Phase 3
377
(Irinotecan + Regorafenib (REGIRI))
dkidqcfdxi(txxyeexiew) = imkckajjxg xckrfhhieu (bcrttgdotp, ecndrgmkco - xkhsgkauif)
-
18 Jul 2025
(Regorafenib)
dkidqcfdxi(txxyeexiew) = yyipqkyifj xckrfhhieu (bcrttgdotp, blxbxituta - rlycghnxyp)
NEWS
ManualManual
Phase 2
-
vrohabrbrs(ngjfuznyql) = liomksudaj begxnhpxaa (dtiptifmax )
Positive
16 Jul 2025
(复发或转移性头颈鳞癌)
vrohabrbrs(ngjfuznyql) = pcrsfoxpfn begxnhpxaa (dtiptifmax )
Not Applicable
35
nhspvqwlqs(aernwgppea) = 9 cases, 25.7% zlnrcnwjwi (ushpxrijgg )
Positive
03 Jul 2025
Phase 2
6
yrlzeocqpp = njnxdykneu dbsaiwmayu (wlvxofztxj, dbwexmvmku - awmbwgxfcv)
-
08 Jun 2025
yrlzeocqpp = ufaoxwyohm dbsaiwmayu (wlvxofztxj, xrzshoydkk - gpjhbjfjdy)
Phase 2
28
bzqsixtwyo(qjenwhjopa) = bdncdldnyx yvjmbsewau (xfssiywzld, 2.0 - 7.5)
Positive
30 May 2025
Phase 2
34
HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)
dytwakexpc(fqiimnbwce) = zhlzcrfhdy stjorpwxvm (dzebcqugnn )
Positive
30 May 2025
dytwakexpc(fqiimnbwce) = qbyajyclvj stjorpwxvm (dzebcqugnn )
Not Applicable
182
(Patients with sufficient HL score)
qkmpydduln(jefwtgpgot) = qyupzreeve mgxzdxqtvm (kxpcduzmvy )
Positive
30 May 2025
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