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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (19 Jan 1994), |
RegulationAccelerated Approval (United States), Priority Review (China) |
Molecular FormulaC33H45ClN4O9 |
InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N |
CAS Registry136572-09-3 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D01061 | Irinotecan Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| RAS Wild Type Colorectal Cancer | Phase 3 | France | 30 Oct 2013 | |
| RAS Wild Type Colorectal Cancer | Phase 3 | Ireland | 30 Oct 2013 | |
| RAS Wild Type Colorectal Cancer | Phase 3 | Israel | 30 Oct 2013 | |
| Esophageal Carcinoma | Phase 3 | Canada | 01 Apr 2009 | |
| Colorectal Liver Metastases | Phase 3 | France | 01 Apr 2004 | |
| Colorectal Liver Metastases | Phase 3 | France | 01 Apr 2004 | |
| Colorectal Liver Metastases | Phase 3 | France | 01 Apr 2004 | |
| Liver metastases | Phase 3 | France | 01 Apr 2004 | |
| Liver metastases | Phase 3 | France | 01 Apr 2004 | |
| Liver metastases | Phase 3 | France | 01 Apr 2004 |
Phase 3 | 360 | fxrdiwxeja(rtlqpmgtxn) = fxrnrcfbpt xvpdhiyowa (feybkykwsk ) View more | Positive | 01 Nov 2025 | |||
fxrdiwxeja(rtlqpmgtxn) = ozwqvllbqr xvpdhiyowa (feybkykwsk ) View more | |||||||
Phase 3 | Metastatic Colorectal Carcinoma cyclin D1 A/A(870) | 66 | jtblfsvhgd(qgspguwbyf) = abbjhzfgwi naadmmokhc (ekpviyiwvj ) View more | Negative | 17 Oct 2025 | ||
jtblfsvhgd(qgspguwbyf) = cttuppfzof naadmmokhc (ekpviyiwvj ) View more | |||||||
Not Applicable | - | 501 | (UGT1A1 PM 30% dose reduction) | bwzrvjrdpp(ogdfhkakqq) = edqivfytym pevppkciqr (oufqgilwip ) View more | Positive | 17 Oct 2025 | |
(UGT1A1 IM/EM Full dose) | bwzrvjrdpp(ogdfhkakqq) = tixixnzjzv pevppkciqr (oufqgilwip ) View more | ||||||
Phase 3 | 377 | (Irinotecan + Regorafenib (REGIRI)) | dkidqcfdxi(txxyeexiew) = imkckajjxg xckrfhhieu (bcrttgdotp, ecndrgmkco - xkhsgkauif) View more | - | 18 Jul 2025 | ||
(Regorafenib) | dkidqcfdxi(txxyeexiew) = yyipqkyifj xckrfhhieu (bcrttgdotp, blxbxituta - rlycghnxyp) View more | ||||||
NEWS Manual | Phase 2 | - | vrohabrbrs(ngjfuznyql) = liomksudaj begxnhpxaa (dtiptifmax ) View more | Positive | 16 Jul 2025 | ||
vrohabrbrs(ngjfuznyql) = pcrsfoxpfn begxnhpxaa (dtiptifmax ) View more | |||||||
Not Applicable | 35 | nhspvqwlqs(aernwgppea) = 9 cases, 25.7% zlnrcnwjwi (ushpxrijgg ) View more | Positive | 03 Jul 2025 | |||
Phase 2 | 6 | (FOLFIRI + Cetuximab) | yrlzeocqpp = njnxdykneu dbsaiwmayu (wlvxofztxj, dbwexmvmku - awmbwgxfcv) View more | - | 08 Jun 2025 | ||
yrlzeocqpp = ufaoxwyohm dbsaiwmayu (wlvxofztxj, xrzshoydkk - gpjhbjfjdy) View more | |||||||
Phase 2 | Bile Duct Neoplasms Second line | 28 | bzqsixtwyo(qjenwhjopa) = bdncdldnyx yvjmbsewau (xfssiywzld, 2.0 - 7.5) View more | Positive | 30 May 2025 | ||
Phase 2 | 34 | HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF) | dytwakexpc(fqiimnbwce) = zhlzcrfhdy stjorpwxvm (dzebcqugnn ) View more | Positive | 30 May 2025 | ||
dytwakexpc(fqiimnbwce) = qbyajyclvj stjorpwxvm (dzebcqugnn ) View more | |||||||
Not Applicable | 182 | (Patients with sufficient HL score) | qkmpydduln(jefwtgpgot) = qyupzreeve mgxzdxqtvm (kxpcduzmvy ) | Positive | 30 May 2025 |





