Ozmosi | Epirubicin Drug Profile
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Epirubicin

Alternative Names: epirubicin, epidoxorubicin, epirubicine, acid 8, pharmorubicin, ellence
Clinical Status: Inactive
Latest Update: 2025-11-26
Latest Update Note: Clinical Trial Update

Product Description

Epirubicin is used in combination with other medications to treat breast cancer in patients who have had surgery to remove the tumor. Epirubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body. (Sourced from: https://medlineplus.gov/druginfo/meds/a603003.html)

Mechanisms of Action: TOP2 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam

Approved Indications: None

Known Adverse Events: None

Company: GSK
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Epirubicin

Countries in Clinic: China, France

Active Clinical Trial Count: 7

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Breast Cancer

Phase 2: Bladder Cancer|Hepatocellular Carcinoma|Inflammatory Breast Cancer|Muscle Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2019-005019-18

2019-005019-18

P2

Active, not recruiting

Breast Cancer

2025-07-31

NCT03515798

PELICAN

P2

Active, not recruiting

Inflammatory Breast Cancer

2022-08-22

2%

2024-07-27

CTR20181618

CTR20181618

P2

Active, not recruiting

Hepatocellular Carcinoma

None

2025-04-29

Patient Enrollment|Treatments

CTR20170169

CTR20170169

P2

Active, not recruiting

Muscle Cancer|Bladder Cancer

None

2025-04-29

CTR20231914

CTR20231914

P2

Active, not recruiting

Hepatocellular Carcinoma

None

2025-04-29

Patient Enrollment|Start Date|Treatments|Trial Status

NCT06144944

PILHLE-002

P3

Recruiting

Breast Cancer

2026-06-30

30%

2024-11-27

Primary Endpoints|Treatments

2011-001462-17

ADAPT

P3

Completed

Breast Cancer

2024-12-16

2025-05-06

Primary Completion Date|Study Completion Date