Eltrombopag
Eltrombopag Olamine, Promacta, Revolade (eltrombopag) is a small molecule pharmaceutical. Eltrombopag was first approved as Promacta on 2008-11-20. It is used to treat aplastic anemia and thrombocytopenic purpura idiopathic in the USA. It has been approved in Europe to treat thrombocytopenic purpura idiopathic. The pharmaceutical is active against thrombopoietin receptor.
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Abbreviated New Drug Application (ANDA)
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alvaiz | New Drug Application | 2024-07-01 |
| eltrombopag | ANDA | 2025-09-03 |
| promacta | New Drug Application | 2025-08-18 |
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FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ELTROMBOPAG OLAMINE, PROMACTA, NOVARTIS | |||
| 2025-11-16 | ODE-210 | ||
ELTROMBOPAG OLAMINE, PROMACTA KIT, NOVARTIS | |||
| 2025-11-16 | ODE* | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Eltrombopag Olamine, Promacta, Novartis | |||
| 8052993 | 2027-08-01 | DP | U-930, U-1306, U-1575, U-1714, U-2451 |
| 8052994 | 2027-08-01 | DP | U-930, U-1306, U-1714, U-2451 |
| 8062665 | 2027-08-01 | DP | U-930, U-1306, U-1714, U-2451 |
| 8071129 | 2027-08-01 | DP | U-930, U-1306, U-1714, U-2451 |
| 8828430 | 2027-08-01 | DP | U-1306, U-2451 |
| 7547719 | 2025-07-13 | DS, DP | U-930, U-1306, U-1575, U-1736, U-2451, U-2452 |
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Clinical
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189 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 1 | 9 | 3 | 1 | 2 | 15 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 5 | 6 | — | 2 | 13 |
| Aplastic anemia | D000741 | — | D61.9 | 1 | 8 | 1 | — | 3 | 12 |
| Thrombocytopenic purpura | D011696 | — | — | — | 2 | 4 | — | 1 | 7 |
| Purpura | D011693 | HP_0000979 | D69.2 | — | 2 | 4 | — | 1 | 7 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 3 | 1 | — | — | 4 |
| Preleukemia | D011289 | — | — | — | 2 | 1 | — | — | 3 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | — | 2 |
| Hepatitis c | D006526 | — | B19.2 | — | — | 1 | — | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | 1 | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | 7 | — | — | 3 | 10 |
| Leukemia | D007938 | — | C95 | 1 | 5 | — | — | — | 5 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 5 | — | — | — | 5 |
| Myeloid leukemia | D007951 | — | C92 | 1 | 3 | — | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | — | 1 |
| Blood platelet disorders | D001791 | — | — | — | 1 | — | — | — | 1 |
| Pathologic complete response | D000095384 | — | — | 1 | 1 | — | — | — | 1 |
| Wiskott-aldrich syndrome | D014923 | EFO_0003903 | D82.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thromboembolism | D013923 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eltrombopag |
| INN | eltrombopag |
| Description | Eltrombopag, sold under the brand name Promacta among others, is a medication used to treat thrombocytopenia (abnormally low platelet counts) and severe aplastic anemia. Eltrombopag is sold under the brand name Revolade outside the US and is marketed by Novartis. It is a thrombopoietin receptor agonist. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | thrombopoetin agonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O |
Identifiers
| PDB | — |
| CAS-ID | 496775-61-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL461101 |
| ChEBI ID | 85010 |
| PubChem CID | 9846180 |
| DrugBank | DB06210 |
| UNII ID | S56D65XJ9G (ChemIDplus, GSRS) |
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Promacta – Ligand Pharmaceuticals
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Promacta – Novartis
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Additional graphs summarizing 3,401 documents
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Safety
Black-box Warning
Black-box warning for: Alvaiz, Eltrombopag, Promacta
Adverse Events
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23,002 adverse events reported
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