Etoposide

Overview

A semisynthetic derivative of podophyllotoxin that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

Indication

For use in combination with other chemotherapeutic agents in the treatment of refractory testicular tumors and as first line treatment in patients with small cell lung cancer. Also used to treat other malignancies such as lymphoma, non-lymphocytic leukemia, and glioblastoma multiforme.

Associated Conditions

Acute Lymphoblastic Leukaemias (ALL)
Acute Myeloid Leukemia
Advanced Hodgkin's Lymphoma
Ewing's Sarcoma
Gestational Trophoblastic Neoplasia
Merkel cell cancer
Multiple Myeloma (MM)
Neuroblastoma (NB)
Neuroendocrine Tumors
Non-Hodgkin's Lymphomas
Non-Small Cell Lung Cancer (NSCLC)
Osteosarcoma
Ovarian Cancer
Prostate Cancer
Retinoblastoma
Small Cell Lung Cancer (SCLC)
Wilms' tumor
Locally advanced Thymoma
Metastatic Thymic Cancer
Refractory Sarcoma
Refractory Testicular cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer	2025/09/15	NCT07172412	Not Applicable	Not yet recruiting	Tianjin Medical University Cancer Institute and Hospital
A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer	2025/09/04	NCT07155174	Not Applicable	Not yet recruiting	AbbVie
Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC	2025/08/22	NCT07136285	Not Applicable	Recruiting	Newsoara Biopharma Co., Ltd.
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study Protocol Number: LungMate-033	2025/08/01	NCT07097948	Not Applicable	Not yet recruiting	Shanghai Pulmonary Hospital, Shanghai, China
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma	2025/07/31	NCT07097363	Not Applicable	Not yet recruiting	University of Washington
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer	2025/07/11	NCT07061535	Not Applicable	Not yet recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML	2025/07/11	NCT07059975	Not Applicable	Not yet recruiting	Joanna Yi
Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer	2025/06/06	NCT07009457	Phase 1	Recruiting	Suzhou Suncadia Biopharmaceuticals Co., Ltd.
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)	2025/06/05	NCT07005128	Phase 3	Recruiting	Amgen
BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma	2025/06/03	NCT07002216	Phase 2	Recruiting	University of Miami

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Etoposide	Hikma Pharmaceuticals USA Inc.	0143-9511	INTRAVENOUS	20 mg in 1 mL	9/14/2023
Etoposide	Fresenius Kabi USA, LLC	63323-104	INTRAVENOUS	20 mg in 1 mL	6/2/2022
Etoposide	Accord Healthcare Inc.	16729-114	INTRAVENOUS	20 mg in 1 mL	9/9/2020
Etoposide	Hikma Pharmaceuticals USA Inc.	0143-9512	INTRAVENOUS	20 mg in 1 mL	9/14/2023
Etoposide	BluePoint Laboratories	68001-265	INTRAVENOUS	20 mg in 1 mL	6/20/2018
Etoposide	Hikma Pharmaceuticals USA Inc.	0143-9510	INTRAVENOUS	20 mg in 1 mL	9/14/2023
ETOPOPHOS	H2-Pharma, LLC	61269-410	INTRAVENOUS	100 mg in 1 1	12/16/2019
Etoposide	Hikma Pharmaceuticals USA Inc.	0143-9376	INTRAVENOUS	20 mg in 1 mL	10/4/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ETOPOSIDE-TEVA INJECTION 20 mg/ml	PHARMACHEMIE BV	SIN10059P	INJECTION	20 mg/ml	9/29/1998
ETOPOSIDE INJECTION 100 mg/5 ml	PFIZER (PERTH) PTY LTD	SIN07339P	INJECTION	100 mg/5 ml	2/11/1993

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LASTET CAP 100MG	N/A	main life corp ltd	N/A	N/A	6/5/1996

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
VEPESID Etoposide 50mg capsule blister pack	10233	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	7/12/1991
ETOPOSIDE EBEWE etoposide 400 mg/20 mL injection vial	96643	Sandoz Pty Ltd	Medicine	A	8/23/2005
Etoposide injection 100 mg in 5 mL (3)	312281	Pfizer (Perth) Pty Ltd	Medicine	A	12/6/2018
ETOPOSIDE EBEWE etoposide 50 mg/2.5 mL injection vial	96636	Sandoz Pty Ltd	Medicine	A	8/23/2005
Etoposide injection 100 mg in 5 mL (2)	312172	Pfizer (Perth) Pty Ltd	Medicine	A	12/4/2018
ETOPOPHOS etoposide 500mg (as phosphate) powder for injection vial	77219	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	1/29/2001
ETOPOSIDE EBEWE etoposide 100mg/5mL injection vial	96641	Sandoz Pty Ltd	Medicine	A	8/23/2005
ETOPOSIDE EBEWE etoposide 1000 mg/50 mL injection vial	96644	Sandoz Pty Ltd	Medicine	A	8/23/2005
VEPESID etoposide 100mg capsule blister pack	10234	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	7/12/1991
ETOPOPHOS Etoposide Phosphate 113.6mg (equivalent to 100mg etoposide) powder for injection vial	57483	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	12/18/1996

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ETOPOSIDE INJECTION	fresenius kabi canada ltd	02239961	Liquid - Intravenous	20 MG / ML	10/20/2014
VEPESID INJ 20MG/ML	bristol labs division of bristol-myers squibb	00523410	Liquid - Intravenous	20 MG / ML	12/31/1981
PMS-ETOPOSIDE	Pharmascience Inc	02237871	Liquid - Intravenous	20 MG / ML	N/A
ETOPOSIDE INJECTION, USP	Strides Pharma Canada Inc	02422530	Solution - Intravenous	20 MG / ML	7/10/2014
VEPESID	Cheplapharm Arzneimittel Gmbh	00616192	Capsule - Oral	50 MG	12/31/1984
ETOPOSIDE INJECTION	teva canada limited	02080036	Liquid - Intravenous	20 MG / ML	12/31/1994
ETOPOSIDE INJECTION	hikma canada limited	02552671	Solution - Intravenous	20 MG / ML	N/A
EPOSIN	Pharmachemie B.V.	02237428	Liquid - Intravenous	20 MG / ML	N/A
ETOPOSIDE INJECTION, USP	hospira healthcare ulc	02241182	Solution - Intravenous	20 MG / ML	12/28/1999
ETOPOSIDE - LIQ IV 20MG/ML	bdh inc.	02227509	Liquid - Intravenous	20 MG / ML	1/28/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ETOPÓSIDO SANDOZ 20 MG/ML CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG	Sandoz Farmaceutica S.A.	63625	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
VEPESID 100 mg CAPSULAS BLANDAS	Cheplapharm Arzneimittel Gmbh	56108	CÁPSULA BLANDA	Diagnóstico Hospitalario	Commercialized
ETOPOSIDO TEVAGEN 20mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION	Teva Pharma S.L.U.	62169	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
ETOPOSIDO ACCORD 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Accord Healthcare S.L.U.	79326	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
ETOPOSIDO HIKMA 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Hikma Farmaceutica (Portugal) S.A.	86400	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
VEPESID 50 mg CAPSULAS BLANDAS	Cheplapharm Arzneimittel Gmbh	56488	CÁPSULA BLANDA	Diagnóstico Hospitalario	Commercialized
ETOPOSIDO TEVA 20 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION	Teva Pharma S.L.U.	64713	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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