TheraRadar
Data updated: May 26, 2026

ETOPOSIDE

Topoisomerase Inhibitors
Oncology Approved 1994-02-10

ETOPOSIDE is indicated for the treatment of Testicular Cancer; Small Cell Lung Cancer.

Source: FDA Label • WATSON LABS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
13
Indications
--
Phase 3 Trials
32
Years on Market

Details

Status
Discontinued
First Approved
1994-02-10
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, CAPSULE

Companies

WATSON LABS MEITHEAL NATCO PHARMA USA Viatris PHARMACHEMIE BV Pfizer Teva ACCORD HLTHCARE Fresenius Kabi Hikma PIERRE FABRE WATSON LABS INC
Active Ingredient: ETOPOSIDE

ETOPOSIDE Approval History

1995
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Original
New Indication
New Form
Label Update
77 FDA actions from 1994 to 2018
Apr 2018 SUPPL
Label · Labeling
Nov 2017 ORIGINAL
Update
Oct 2017 ORIGINAL
Update

What ETOPOSIDE Treats

2 indications

ETOPOSIDE is approved for 2 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Testicular Cancer
  • Small Cell Lung Cancer
Source: FDA Label

ETOPOSIDE Boxed Warning

WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur....

ETOPOSIDE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

RYBREVANT FASPRO
Johnson &
2025 1 indic.
HYRNUO
Bayer
2025 1 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ETOPOSIDE

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AVOPEF
ETOPOSIDE
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AVYXA HOLDINGS
Shared indications:
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ETOPOPHOS PRESERVATIVE FREE
ETOPOSIDE PHOSPHATE
2 shared
CHEPLAPHARM
Shared indications:
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CISPLATIN
CISPLATIN
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Clinical Trial Registry

500 trials
Trial Sponsor ID Phase Status Title
NCT06406465 10001601 001601-C Ph 2 recruiting A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
NCT06172296 NCI-2023-08530 NCI-2023-08530, ANBL2131 Ph 3 recruiting Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT06528691 GLOBOTRK NCI-2024-02977 Ph 2 recruiting Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
NCT04301076 NCI-2020-01535 NCI-2020-01535, 10335 Ph 1 suspended Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)
NCT05675410 NCI-2022-10845 NCI-2022-10845, AHOD2131 Ph 3 recruiting A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
NCT03017326 PHITT RG_15-114 Ph 3 active not recruiting Paediatric Hepatic International Tumour Trial
NCT05019716 NCI-2021-08926 NCI-2021-08926, 10507 Ph 1, Ph 2 recruiting Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
NCT07583511 TNBG-IIT001 Ph 2 recruiting Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study
NCT07583550 2026 049 A Ph 2 not yet recruiting Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer
NCT07155174 SEZanne M24-633 2024-517490-24 Ph 2 recruiting 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
NCT03984448 NCI-2019-03711 NCI-2019-03711, A051701 Ph 2, Ph 3 active not recruiting Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
NCT05058651 NCI-2021-09851 NCI-2021-09851, S2012 Ph 2, Ph 3 recruiting Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
NCT06738368 RG1124788 NCI-2024-09417, FHIRB0020869 Ph 2 recruiting Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia
NCT06077500 DAREONᵀᴹ-8 1438-0008 Ph 1 active not recruiting DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
NCT07472517 1438-0012 2025-520565-51-00, U1111-1317-4955 Ph 3 recruiting DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy
NCT06132113 1438-0007 U1111-1292-1400, 2023-505870-13-00 Ph 1 recruiting DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
NCT06646276 CA245-0001 Ph 3 recruiting A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
NCT06230224 OLYMPIA-4 R1979-HM-2299 2022-502783-21-00 Ph 3 active not recruiting A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
NCT05453500 RG1122464 NCI-2022-05225, 11008 Ph 2 active not recruiting Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
NCT00871013 108053 Ph 2 active not recruiting Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy
NCT04804007 CTO-IUSCCC-0742 Ph 2 recruiting Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
NCT07227597 6070-003 MK-6070-003, U1111-1318-5025 Ph 1, Ph 2 recruiting A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
NCT04803201 A051902 NCI-2021-01380, U10CA180821 Ph 2 suspended Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
NCT01920932 results posted HLHR13 NCI-2013-01123 Ph 2 active not recruiting Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
NCT07544654 1438-0011 2025-523869-22, U1111-1328-6623 Ph 3 not yet recruiting DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
NCT06401330 AREN2231 NCI-2024-03424, AREN2231 Ph 3 recruiting A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
NCT04293562 AAML1831 NCI-2020-00546, AAML1831 Ph 3 recruiting A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NCT04322318 AREN1921 NCI-2020-01561, AREN1921 Ph 2 recruiting A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
NCT03067181 AGCT1531 NCI-2017-00178, AGCT1531 Ph 3 recruiting Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
NCT03182244 results posted 2215-CL-0303 CTR20170326 Ph 3 active not recruiting A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
NCT06217757 SCS-Lung01 Ph 1, Ph 2 recruiting Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC
NCT04684368 ACNS2021 NCI-2020-13175, ACNS2021 Ph 2 recruiting A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
NCT07005128 DeLLphi-312 20240178 Ph 3 recruiting A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
NCT02176967 ANBL1232 NCI-2014-00677, s15-00462 Ph 3 active not recruiting Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma
NCT05533775 iMATRIX GLO CO43810 Ph 1, Ph 2 recruiting A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
NCT05815160 Debio 0123-SCLC-104 2024-510980-40-00, U1111-1302-8787 Ph 1 terminated Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy
NCT02166463 results posted NCI-2014-01223 NCI-2014-01223, s15-00950 Ph 3 active not recruiting Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
NCT02112916 results posted NCI-2014-00712 NCI-2014-00712, s14-01925 Ph 3 active not recruiting Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT02101853 results posted NCI-2014-00631 NCI-2014-00631, s15-00970 Ph 3 active not recruiting Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 active not recruiting Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT06368817 ACNS2321 NCI-2024-03518, ACNS2321 Ph 2 recruiting A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
NCT02443077 results posted NCI-2015-00668 NCI-2015-00668, BMT CTN 1201 Ph 3 active not recruiting Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT03007147 AALL1631 NCI-2016-01588, AALL1631 Ph 3 active not recruiting Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT05624996 NRG-LU008 NCI-2022-08263, NRG-LU008 Ph 3 recruiting Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer
NCT02595424 results posted EA2142 NCI-2015-00547, EA2142 Ph 2 active not recruiting Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
NCT02003222 results posted NCI-2013-02229 NCI-2013-02229, ECOG-E1910 Ph 3 active not recruiting Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
NCT04092283 NCI-2019-06124 NCI-2019-06124, EA5181 Ph 3 active not recruiting Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
NCT03811002 results posted NCI-2019-00178 NCI-2019-00178, NRG-LU005 Ph 3 active not recruiting Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)
NCT01096368 results posted ACNS0831 NCI-2011-02029, 10-01676 Ph 3 completed Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
NCT03206671 B-NHL 2013 UKM12_0020 2013-003253-21 Ph 3 active not recruiting Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ETOPOSIDE FDA Label Details

Indications & Usage

ETOPOSIDE is indicated for the treatment of Testicular Cancer; Small Cell Lung Cancer.

⚠️ BOXED WARNING

WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur....

Looking for the branded version?

AVOPEF

Full clinical data, patents, trials, and competitive landscape for etoposide.

See AVOPEF

Data Sources

FDA Approval: ANDA074228 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.