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 |
|---|---|---|---|---|---|
2025/08/11 | Not Applicable | ENROLLING_BY_INVITATION | |||
2025/07/30 | Not Applicable | Recruiting | |||
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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| REVOLADE 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 10612002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| REVOLADE 25 MG POLVO PARA SUSPENSION ORAL | 110612013 | POLVO PARA SUSPENSIÓN ORAL | Uso Hospitalario | Commercialized | |
| REVOLADE 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 10612005 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ELTROMBOPAG CIPLA 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Cipla Europe N.V. | 90302 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
| ELTROMBOPAG CIPLA 75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Cipla Europe N.V. | 90301 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
| ELTROMBOPAG CIPLA 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Cipla Europe N.V. | 90337 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.