Overview
Eltrombopag is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen, have not worked well enough. ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Eltrombopag has also been recently approved (late 2012) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
Indication
Thrombopoietin receptor agonists are pharmaceutical agents that stimulate platelet production in the bone marrow. In this, they differ from the previously discussed agents that act by attempting to curtail platelet destruction.
Associated Conditions
- Chronic immune thrombocytopenia
- Severe Aplastic Anemia (SAA)
- Thrombocytopenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/19 | Phase 4 | Active, not recruiting | Centro de Atencion e Investigacion Medica | ||
2025/01/24 | Not Applicable | Not yet recruiting | Wuhan Union Hospital, China | ||
2024/10/08 | Phase 2 | Recruiting | Abhay Singh, MD MPH | ||
2024/09/23 | Phase 1 | Not yet recruiting | |||
2024/07/31 | Phase 1 | Recruiting | Renata PLC | ||
2024/07/10 | Phase 3 | Not yet recruiting | |||
2024/06/28 | Not Applicable | Recruiting | Yunfeng Cheng | ||
2024/06/14 | N/A | Completed | |||
2024/04/03 | Phase 2 | Recruiting | |||
2023/11/18 | N/A | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Camber Pharmaceuticals, Inc. | 31722-843 | ORAL | 50 mg in 1 1 | 3/27/2025 | |
| Camber Pharmaceuticals, Inc. | 31722-841 | ORAL | 12.5 mg in 1 1 | 3/27/2025 | |
| Camber Pharmaceuticals, Inc. | 31722-842 | ORAL | 25 mg in 1 1 | 3/27/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-0685 | ORAL | 25 mg in 1 1 | 3/27/2020 | |
| Novartis Pharmaceuticals Corporation | 0078-0697 | ORAL | 25 mg in 1 1 | 3/27/2020 | |
| Camber Pharmaceuticals, Inc. | 31722-301 | ORAL | 25 mg in 1 1 | 3/27/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-0684 | ORAL | 12.5 mg in 1 1 | 3/27/2020 | |
| Novartis Pharmaceuticals Corporation | 0078-0686 | ORAL | 50 mg in 1 1 | 3/27/2020 | |
| Novartis Pharmaceuticals Corporation | 0078-0687 | ORAL | 75 mg in 1 1 | 3/27/2020 | |
| Novartis Pharmaceuticals Corporation | 0078-0972 | ORAL | 12.5 mg in 1 1 | 3/27/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/11/2010 | ||
Authorised | 3/28/2025 | ||
Authorised | 3/11/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Revolade Tablet 50mg | SIN13910P | TABLET, FILM COATED | 50mg | 1/20/2011 | |
| Revolade Tablet 25mg | SIN13909P | TABLET, FILM COATED | 25mg | 1/20/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Eltrombopag Olamine For Suspension | 国药准字H20249763 | 化学药品 | 口服混悬剂 | 12/17/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20244606 | 化学药品 | 片剂 | 7/30/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20244420 | 化学药品 | 片剂 | 7/9/2024 | |
| Eltrombopag Olamine Tablets | 国药准字HJ20170387 | 化学药品 | 片剂 | 11/4/2022 | |
| Eltrombopag Olamine Tablets | 国药准字H20244389 | 化学药品 | 片剂 | 7/9/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20243008 | 化学药品 | 片剂 | 1/9/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20243007 | 化学药品 | 片剂 | 1/9/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20243006 | 化学药品 | 片剂 | 1/9/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20244372 | 化学药品 | 片剂 | 6/28/2024 | |
| Eltrombopag Olamine Tablets | 国药准字H20244485 | 化学药品 | 片剂 | 7/22/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| REVOLADE eltrombopag 75mg film-coated tablet blister pack | 200121 | Medicine | A | 9/5/2013 | |
| REVOLADE eltrombopag 12.5mg film-coated tablet blister pack | 236115 | Medicine | A | 3/30/2016 | |
| REVOLADE eltrombopag 50mg film-coated tablet blister pack | 158356 | Medicine | A | 7/16/2010 | |
| REVOLADE eltrombopag 25mg film-coated tablet blister pack | 158419 | Medicine | A | 7/16/2010 |
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