Eltrombopag olamine
Eltrombopag Olamine, Promacta, Revolade (eltrombopag olamine) is a small molecule pharmaceutical. Eltrombopag olamine 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.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Eltrombopag olamine, Promacta (discontinued: Promacta)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| eltrombopag | ANDA | 2025-03-27 |
| promacta | New Drug Application | 2025-12-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| thrombocytopenic purpura idiopathic | EFO_0007160 | D016553 | D69.3 |
| aplastic anemia | — | D000741 | D61.9 |
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 |
| 7795293 | 2023-05-21 | U-930, U-1306, U-1575, U-1736, U-2451 | |
ATC Codes
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Clinical
Clinical Trials
190 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 | 11 | 43 | 12 | 10 | 18 | 86 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | 8 | 20 | 15 | 10 | 20 | 71 |
| Purpura | D011693 | HP_0000979 | D69.2 | 5 | 8 | 8 | 2 | 8 | 31 |
| Thrombocytopenic purpura | D011696 | — | — | 4 | 8 | 8 | 2 | 7 | 29 |
| Aplastic anemia | D000741 | — | D61.9 | 3 | 16 | 4 | 2 | 6 | 27 |
| Healthy volunteers/patients | — | — | — | 3 | — | 1 | 1 | — | 5 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | 1 | 1 | 1 | 4 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | 3 | 16 | 2 | — | 3 | 20 |
| Leukemia | D007938 | — | C95 | 5 | 15 | 2 | — | — | 17 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 11 | 1 | — | 1 | 16 |
| Preleukemia | D011289 | — | — | 3 | 9 | 1 | — | — | 13 |
| Syndrome | D013577 | — | — | 3 | 8 | 1 | — | — | 12 |
| Hepatitis c | D006526 | — | B19.2 | 1 | 3 | 6 | — | 3 | 12 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 9 | 1 | — | — | 11 |
| Myeloid leukemia | D007951 | — | C92 | 4 | 8 | 2 | — | — | 10 |
| Hepatitis | D006505 | — | K75.9 | — | 3 | 5 | — | 1 | 8 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 3 | 5 | — | — | 7 |
Show 21 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood platelet disorders | D001791 | — | — | — | 3 | — | — | 1 | 4 |
| Pancytopenia | D010198 | — | D61.81 | 1 | 3 | — | — | — | 3 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 3 | — | — | — | 3 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 1 | — | — | 1 | 2 |
| Wiskott-aldrich syndrome | D014923 | EFO_0003903 | D82.0 | — | 2 | — | — | — | 2 |
| Fanconi anemia | D005199 | Orphanet_84 | D61.03 | — | 2 | — | — | — | 2 |
| Fanconi syndrome | D005198 | — | — | — | 2 | — | — | — | 2 |
| Megakaryoblastic leukemia acute | D007947 | — | C94.2 | 1 | 1 | — | — | — | 2 |
| Monocytic leukemia acute | D007948 | — | — | 1 | 1 | — | — | — | 2 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 1 | 1 | — | — | — | 2 |
Show 28 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 2 | — | — | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Connective and soft tissue neoplasms | D018204 | — | — | 1 | — | — | — | — | 1 |
| Radiation injuries | D011832 | — | T66 | 1 | — | — | — | — | 1 |
| Acute radiation syndrome | D054508 | — | — | 1 | — | — | — | — | 1 |
| Photosensitivity disorders | D010787 | — | L57.1 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Splenectomy | D013156 | — | — | — | — | — | — | 1 | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 1 | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | — | — | 1 | 1 |
| Skin manifestations | D012877 | — | — | — | — | — | — | 1 | 1 |
| Thromboembolism | D013923 | — | — | — | — | — | — | 1 | 1 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
| Bone marrow diseases | D001855 | — | — | — | — | — | — | 1 | 1 |
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eltrombopag olamine |
| INN | — |
| Description | Eltrombopag is a hydrazine in which each nitrogen atom is substituted, one by a 3'-carboxy-2-hydroxy[1,1'-biphenyl]-3-yl group and the other by a 1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene group. A small molecule agonist of the c-mpl (TpoR) receptor (the physiological target of the hormone thrombopoietin), it has been developed as a medication for conditions that lead to thrombocytopenia (abnormally low platelet counts). It has a role as a thrombopoietin receptor agonist and a xenobiotic. It is a member of hydrazines, a member of pyrazoles and a member of benzoic acids. |
| Classification | Small molecule |
| Drug class | — |
| 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.NCCO |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | 711942 |
| ChEMBL ID | CHEMBL461806 |
| ChEBI ID | — |
| PubChem CID | 135449332 |
| DrugBank | DB06210 |
| UNII ID | — |
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Promacta – Ligand Pharmaceuticals
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Promacta – Novartis
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Safety
Black-box Warning
Black-box warning for: Eltrombopag, Promacta
Adverse Events
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23,337 adverse events reported
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