Data updated: May 26, 2026
ETOPOPHOS PRESERVATIVE FREE (etoposide phosphate)
Trial Activity: Stable 13 active trials
Oncology
Approved 1996-05-17
ETOPOPHOS PRESERVATIVE FREE is indicated for the treatment of Testicular Cancer; Small Cell Lung Cancer.
Source: FDA Label • CHEPLAPHARM
Development Insights
National Cancer Institute (NCI) conducting 9 trials (31%)
102 indications explored (Broad Platform)
→ lymphoma (4 trials)
→ neuroblastoma (3 trials)
→ refractory acute myeloid leukemia (2 trials)
2
Indications
--
Phase 3 Trials
30
Years on Market
Details
- Status
- Prescription
- First Approved
- 1996-05-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ETOPOPHOS PRESERVATIVE FREE Approval History
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Original
New Indication
New Form
Label Update
17 FDA actions from 1996 to 2019
Dec 2001 SUPPL
Label
Aug 1999 SUPPL
Mfg
May 1996 ORIGINAL
New Ingredient
What ETOPOPHOS PRESERVATIVE FREE Treats
2 indicationsETOPOPHOS PRESERVATIVE FREE is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Testicular Cancer
- Small Cell Lung Cancer
Source: FDA Label
ETOPOPHOS PRESERVATIVE FREE Competitive Set
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Indication competitors
10
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What's emerging in ETOPOPHOS PRESERVATIVE FREE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ETOPOPHOS PRESERVATIVE FREE treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to ETOPOPHOS PRESERVATIVE FREE
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Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03983824 | NCI-2019-03607 NCI-2019-03607, PHI-103 | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia |
| NCT04759586 | NCI-2021-01071 NCI-2021-01071, ANHL1931 | Ph 3 | active not recruiting | Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma |
| 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 |
| NCT01871766 | RMS13 NCI-2013-00913 | Ph 2 | active not recruiting | Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy |
| NCT02106988 | 2013-0367 NCI-2014-01356 | Ph 2 | active not recruiting | Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma |
| NCT02306161 results posted | NCI-2014-02380 NCI-2014-02380, AEWS1221 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT01356290 MEMMAT | MUV-MEMMAT-01 | Ph 2 | recruiting | Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors |
| NCT05991388 Glo-BNHL | RG_21-124 ITCC-100, 1004701 | Ph 2, Ph 3 | recruiting | A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma |
| NCT01175356 results posted | ANBL09P1 NCI-2011-01745, ANBL09P1 | Ph 1 | completed | Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin |
| NCT03113500 results posted | 17058 NCI-2017-00573, 17058 | Ph 2 | active not recruiting | Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma |
| NCT06905509 | UCDCC316 NCI-2025-01557, UCDCC316 | Ph 2 | recruiting | Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma |
| NCT03440567 | 17428 NCI-2018-00098, 17428 | Ph 1 | completed | Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma |
| NCT02375204 | A031102 U10CA180821, NCI-2014-01696 | Ph 3 | active not recruiting | Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors |
| NCT01228331 | CDR0000686545 2009-012758-18 | Ph 2, Ph 3 | completed | Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL |
| NCT06188676 | PMBL-2022 | Ph 3 | recruiting | Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL |
| NCT00788125 results posted | 07053 P30CA033572, CHNMC-07053 | Ph 1, Ph 2 | terminated | Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors |
| NCT01256398 results posted | NCI-2011-02621 NCI-2011-02621, CALGB 10701/CTSU C10701 | Ph 2 | completed | Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT01026220 results posted | AHOD0831 NCI-2011-01994, CDR0000660550 | Ph 3 | completed | Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma |
| NCT00867178 | NCI-2012-03167 NCI-2012-03167, PBTC-026 | Ph 1 | completed | Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System |
| NCT01132807 results posted | CALGB-50604 CALGB-50604, NCI-2011-02042 | Ph 2 | completed | Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma |
| NCT04116359 | NCI-2019-06676 NCI-2019-06676, 10295 | Ph 1, Ph 2 | withdrawn | Testing of the Addition of a New Anti-cancer Drug, Molibresib, to Chemotherapy Treatment (Etoposide and Cisplatin) for Patients With NUT Carcinoma |
| NCT02137096 results posted | IRB201400316 PEDS008 | Ph 3 | terminated | Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma |
| NCT01969435 results posted | 201312115 | Ph 2 | completed | Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma |
| NCT02130869 | ASCIST NCI-2014-00275 | Ph 1 | completed | A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas |
| NCT01249430 | NCI-2011-02554 NCI-2011-02554, CDR0000689575 | Ph 1 | completed | Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01900509 | BECHEM TEVA ISS, NCI-2013-01148 | Ph 1 | completed | Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies |
| NCT00873093 results posted | NCI-2011-01908 NCI-2011-01908, AALL07P1 | Ph 2 | completed | Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT01160731 | 07-09 ICORG ICORG-07-09, EUDRACT-2008-003634-21 | Ph 1 | withdrawn | Panobinostat, Etoposide, and Cisplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer |
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Completed studies with published results, ranked by significance
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Trial Timeline
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.
ETOPOPHOS PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)ETOPOPHOS PRESERVATIVE FREE is indicated for the treatment of Testicular Cancer; Small Cell Lung Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment