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Etoposide (VP-16)
Etoposide (VP-16) is a Topoisomerase II inhibitor Small molecule drug developed by The University of Hong Kong. It is currently in Phase 3 development for Small cell lung cancer, Testicular cancer, Lymphomas. Also known as: VePesid.
Etoposide is a topoisomerase II inhibitor that prevents DNA religation, leading to DNA breaks and cancer cell death.
Etoposide is a topoisomerase II inhibitor that prevents DNA religation, leading to DNA breaks and cancer cell death. Used for Small cell lung cancer, Testicular cancer, Lymphomas.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Etoposide (VP-16) |
|---|---|
| Also known as | VePesid |
| Sponsor | The University of Hong Kong |
| Drug class | Topoisomerase II inhibitor |
| Target | Topoisomerase II |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Etoposide binds to the topoisomerase II-DNA complex and stabilizes the cleavage complex, preventing the religation of DNA strands. This results in accumulation of DNA double-strand breaks during the S and G2 phases of the cell cycle, triggering apoptosis in rapidly dividing cancer cells. It is a semisynthetic derivative of podophyllotoxin.
Approved indications
- Small cell lung cancer
- Testicular cancer
- Lymphomas
- Leukemias
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Nausea and vomiting
- Alopecia
- Mucositis
- Diarrhea
- Secondary acute leukemia
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- 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 (PHASE2)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Durvalumab as Consolidation for Patients LS-SCLC (PHASE2)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Etoposide (VP-16) CI brief — competitive landscape report
- Etoposide (VP-16) updates RSS · CI watch RSS
- The University of Hong Kong portfolio CI
Frequently asked questions about Etoposide (VP-16)
What is Etoposide (VP-16)?
How does Etoposide (VP-16) work?
What is Etoposide (VP-16) used for?
Who makes Etoposide (VP-16)?
Is Etoposide (VP-16) also known as anything else?
What drug class is Etoposide (VP-16) in?
What development phase is Etoposide (VP-16) in?
What are the side effects of Etoposide (VP-16)?
What does Etoposide (VP-16) target?
Related
- Drug class: All Topoisomerase II inhibitor drugs
- Target: All drugs targeting Topoisomerase II
- Manufacturer: The University of Hong Kong — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Small cell lung cancer
- Indication: Drugs for Testicular cancer
- Indication: Drugs for Lymphomas
- Also known as: VePesid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing