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 |
|---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2025/07/11 | Not Applicable | Not yet recruiting | Joanna Yi | ||
2025/06/06 | Phase 1 | Recruiting | |||
2025/06/05 | Phase 3 | Not yet recruiting | |||
2025/06/03 | Phase 2 | Recruiting | |||
2025/05/02 | Phase 2 | Recruiting | Jennifer Amengual | ||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/04/22 | Phase 1 | Not yet recruiting | |||
2025/04/17 | Phase 4 | Not yet recruiting | |||
2025/04/01 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0143-9511 | INTRAVENOUS | 20 mg in 1 mL | 9/14/2023 | |
| Fresenius Kabi USA, LLC | 63323-104 | INTRAVENOUS | 20 mg in 1 mL | 6/2/2022 | |
| Accord Healthcare Inc. | 16729-114 | INTRAVENOUS | 20 mg in 1 mL | 9/9/2020 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9512 | INTRAVENOUS | 20 mg in 1 mL | 9/14/2023 | |
| BluePoint Laboratories | 68001-265 | INTRAVENOUS | 20 mg in 1 mL | 6/20/2018 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9510 | INTRAVENOUS | 20 mg in 1 mL | 9/14/2023 | |
| H2-Pharma, LLC | 61269-410 | INTRAVENOUS | 100 mg in 1 1 | 12/16/2019 | |
| 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 | SIN10059P | INJECTION | 20 mg/ml | 9/29/1998 | |
| ETOPOSIDE INJECTION 100 mg/5 ml | SIN07339P | INJECTION | 100 mg/5 ml | 2/11/1993 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Etoposide Phosphate for Injection | 国药准字H20053194 | 化学药品 | 注射剂 | 9/30/2020 | |
| Etoposide Phosphate for Injection | 国药准字H20113178 | 化学药品 | 注射剂 | 7/18/2024 | |
| Etoposide Injection | 国药准字H53021646 | 化学药品 | 注射剂 | 9/14/2020 | |
| Etoposide Injection | 国药准字H11021800 | 化学药品 | 注射剂 | 7/18/2022 | |
| Etoposide Injection | 国药准字H43022242 | 化学药品 | 注射剂 | 10/13/2020 | |
| Etoposide Injection | 国药准字H20045483 | 化学药品 | 注射剂(注射液) | 8/12/2020 | |
| Etoposide Injection | 国药准字H53021752 | 化学药品 | 注射剂 | 9/28/2020 | |
| Etoposide Injection | 国药准字H53021627 | 化学药品 | 注射剂 | 9/28/2020 | |
| Etoposide Injection | 国药准字H13023724 | 化学药品 | 注射剂 | 11/3/2020 | |
| Etoposide Injection | 国药准字H35021393 | 化学药品 | 注射剂 | 11/19/2019 |
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
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