TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ETOPOSIDE

ETOPOSIDE Topoisomerase Inhibitors
Oncology Approved 1994-02-10
13
Indications
--
Phase 3 Trials
32
Years on Market

Details

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

ETOPOSIDE Approval History

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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....

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

ETOPOSIDE FDA Label Details

Pro

Indications & Usage

Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small Cell Lung Cancer Etoposide Injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

โš ๏ธ 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....

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Data Sources

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