Irinotecan - PharmaKB

Camptosar, Onivyde pegylated liposomal (previously known as onivyde)(irinotecan)

Camptosar, Irinotecan, Onivyde (irinotecan) is a small molecule pharmaceutical. Irinotecan was first approved as Camptosar on 1996-06-14. It is used to treat breast neoplasms, colonic neoplasms, leukemia, lymphoma, and neoplasm metastasis amongst others in the USA. It has been approved in Europe to treat pancreatic neoplasms. The pharmaceutical is active against DNA topoisomerase 1.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
respiratory tract diseases	D012140
hemic and lymphatic diseases	D006425
skin and connective tissue diseases	D017437
endocrine system diseases	D004700
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Camptosar, Irinotecan, Onivyde (discontinued: Irinotecan)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Irinotecan hydrochloride

Tradename	Company	Number	Date	Products
ONIVYDE	Ipsen	N-207793 RX	2015-10-22	1 products, RLD, RS
CAMPTOSAR	Pfizer	N-020571 RX	1996-06-14	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
camptosar	New Drug Application	2024-08-14
irinotecan hydrochloide	ANDA	2023-10-31
irinotecan hydrochloide irinotecan hydrochloride	ANDA	2022-03-03
irinotecan hydrochloride	ANDA	2024-06-28
onivyde	New Drug Application	2024-06-10

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
leukemia	—	D007938	C95
breast neoplasms	EFO_0003869	D001943	C50
pancreatic neoplasms	EFO_0003860	D010190	C25
non-small-cell lung carcinoma	—	D002289	—
stomach neoplasms	EFO_0003897	D013274	C16
lymphoma	—	D008223	C85.9
colonic neoplasms	—	D003110	C18
rectal neoplasms	—	D012004	—
neoplasm metastasis	EFO_0009708	D009362	—

Agency Specific

FDA

EMA

Expiration	Code
IRINOTECAN HYDROCHLORIDE, ONIVYDE, IPSEN
2031-02-13	ODE-463

Patent Expiration

Patent	Expires	Flag	FDA Information
Irinotecan Hydrochloride, Onivyde, Ipsen
10456360	2036-10-15	DP
10993914	2036-10-15	DP
9339497	2033-06-12		U-1848
9364473	2033-06-12		U-1856
9452162	2033-06-12		U-1899
9492442	2033-06-12		U-1848, U-1899, U-1917
9717724	2033-06-12		U-1848, U-2091
10980795	2033-06-12		U-1848
11369597	2033-06-12		U-1848
8147867	2028-08-29	DS, DP
8329213	2027-01-06	DS, DP
8703181	2025-05-02		U-1434
8992970	2025-05-02	DS, DP
9724303	2025-05-02	DS, DP
9730891	2025-05-02		U-1848
9782349	2025-05-02	DS, DP
10722508	2025-05-02	DS, DP

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01C: Plant alkaloids and other natural products, antineoplastic drugs

— L01CE: Topoisomerase 1 (top1) inhibitors

— L01CE02: Irinotecan

HCPCS

Code	Description
J9205	Injection, irinotecan liposome, 1 mg
J9206	Injection, irinotecan, 20 mg

Clinical

Clinical Trials

1924 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179	—	—	156	451	123	11	62	716
Neoplasms	D009369	—	C80	197	113	26	2	12	301
Adenocarcinoma	D000230	—	—	64	137	29	1	12	215
Stomach neoplasms	D013274	EFO_0003897	C16	34	81	22	4	9	136
Neoplasm metastasis	D009362	EFO_0009708	—	19	57	27	3	16	113
Lung neoplasms	D008175	HP_0100526	C34.90	30	73	11	2	4	104
Rectal neoplasms	D012004	—	—	21	63	18	1	10	104
Esophageal neoplasms	D004938	—	C15	17	56	13	1	5	84
Colonic neoplasms	D003110	—	C18	25	43	17	1	8	82
Small cell lung carcinoma	D055752	—	—	25	53	11	2	5	80

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	92	178	37	—	21	282
Carcinoma	D002277	—	C80.0	35	76	20	—	3	118
Recurrence	D012008	—	—	29	37	9	—	3	68
Sarcoma	D012509	—	—	22	26	4	—	3	48
Pancreatic ductal carcinoma	D021441	—	—	17	29	5	—	3	48
Glioblastoma	D005909	EFO_0000515	—	23	28	3	—	—	45
Breast neoplasms	D001943	EFO_0003869	C50	15	25	1	—	4	42
Squamous cell carcinoma	D002294	—	—	7	21	7	—	—	32
Esophageal squamous cell carcinoma	D000077277	—	—	6	20	8	—	—	31
Rhabdomyosarcoma	D012208	—	—	15	18	4	—	1	30

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-small-cell lung carcinoma	D002289	—	—	22	36	—	—	2	49
Glioma	D005910	EFO_0000520	—	20	25	—	—	—	39
Central nervous system neoplasms	D016543	—	—	17	14	—	—	1	27
Nervous system neoplasms	D009423	—	—	15	14	—	—	—	24
Ovarian neoplasms	D010051	EFO_0003893	C56	12	13	—	—	1	22
Triple negative breast neoplasms	D064726	—	—	11	9	—	—	—	16
Lymphoma	D008223	—	C85.9	12	4	—	—	—	16
Ovarian epithelial carcinoma	D000077216	—	—	8	7	—	—	—	13
Astrocytoma	D001254	EFO_0000271	—	8	7	—	—	—	13
Gliosarcoma	D018316	—	—	6	6	—	—	—	11

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	6	—	—	—	—	6
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	3	—	—	—	1	4
Hodgkin disease	D006689	—	C81	3	—	—	—	—	3
Large b-cell lymphoma diffuse	D016403	—	C83.3	3	—	—	—	—	3
Acute disease	D000208	—	—	1	—	—	—	1	2
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	2	—	—	—	—	2
Chondrosarcoma	D002813	—	—	2	—	—	—	—	2
Weight loss	D015431	HP_0001824	—	1	—	—	—	1	2
Malignant mesothelioma	D000086002	—	—	2	—	—	—	—	2
Burkitt lymphoma	D002051	—	C83.7	2	—	—	—	—	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Prognosis	D011379	—	—	—	—	—	—	2	2
Lymphoid leukemia	D007945	—	C91	—	—	—	—	1	1
Body weight	D001835	EFO_0004338	—	—	—	—	—	1	1
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Chemoradiotherapy	D059248	—	—	—	—	—	—	1	1
Brain death	D001926	—	G93.82	—	—	—	—	1	1
Mucositis	D052016	EFO_1001898	—	—	—	—	—	1	1
Male breast neoplasms	D018567	—	—	—	—	—	—	1	1
Ultrasonic therapy	D014464	—	—	—	—	—	—	1	1
Multiple primary neoplasms	D009378	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Irinotecan
INN	irinotecan
Description	Irinotecan is a member of the class of pyranoindolizinoquinolines that is the carbamate ester obtained by formal condensation of the carboxy group of [1,4'-bipiperidine]-1'-carboxylic acid with the phenolic hydroxy group of (4S)-4,11-diethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2- hydrochloride]quinoline-3,14-dione. Used (in the form of its hydrochloride salt trihydrate) in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. It is converted via hydrolysis of the carbamate linkage to its active metabolite, SN-38, which is ~1000 times more active. It has a role as an apoptosis inducer, an EC 5.99.1.2 (DNA topoisomerase) inhibitor, an antineoplastic agent and a prodrug. It is a pyranoindolizinoquinoline, a N-acylpiperidine, a carbamate ester, a tertiary alcohol, a tertiary amino compound, a delta-lactone and a ring assembly. It is functionally related to a SN-38. It is a conjugate base of an irinotecan(1+).
Classification	Small molecule
Drug class	antineoplastics (camptothecin derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)[C@]3(O)CC