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Drug ReportsEltrombopag
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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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
alvaizNew Drug Application2024-07-01
eltrombopagANDA2025-09-03
promactaNew Drug Application2025-08-18
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
ELTROMBOPAG OLAMINE, PROMACTA, NOVARTIS
2025-11-16ODE-210
ELTROMBOPAG OLAMINE, PROMACTA KIT, NOVARTIS
2025-11-16ODE*
Patent Expiration
Patent
Expires
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FDA Information
Eltrombopag Olamine, Promacta, Novartis
80529932027-08-01DPU-930, U-1306, U-1575, U-1714, U-2451
80529942027-08-01DPU-930, U-1306, U-1714, U-2451
80626652027-08-01DPU-930, U-1306, U-1714, U-2451
80711292027-08-01DPU-930, U-1306, U-1714, U-2451
88284302027-08-01DPU-1306, U-2451
75477192025-07-13DS, DPU-930, U-1306, U-1575, U-1736, U-2451, U-2452
ATC Codes
B: Blood and blood forming organ drugs
— B02: Antihemorrhagics
— B02B: Vitamin k and other hemostatics
— B02BX: Other systemic hemostatics in atc
— B02BX05: Eltrombopag
HCPCS
No data
Clinical
Clinical Trials
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
ThrombocytopeniaD013921HP_0001873D69.6114211101885
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.382015101970
PurpuraD011693HP_0000979D69.25882831
Thrombocytopenic purpuraD011696——4882729
Aplastic anemiaD000741—D61.921542525
Healthy volunteers/patients———3—11—5
Liver diseasesD008107EFO_0001421K70-K77—11114
Hematologic neoplasmsD019337———1—1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.93172—321
LeukemiaD007938—C955152——17
Myelodysplastic syndromesD009190—D463111—116
PreleukemiaD011289——3101——14
SyndromeD013577——391——13
Myeloid leukemia acuteD015470—C92.0491——11
Hepatitis cD006526—B19.2136—211
Myeloid leukemiaD007951—C92482——10
HepatitisD006505—K75.9—35—18
Hepatitis aD006506EFO_0007305B15—35——7
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood platelet disordersD001791———3——14
PancytopeniaD010198—D61.8113———3
B-cell chronic lymphocytic leukemiaD015451—C91.113———3
Autoimmune diseasesD001327EFO_0000540M30-M36—1——12
Wiskott-aldrich syndromeD014923EFO_0003903D82.0—2———2
Fanconi anemiaD005199Orphanet_84D61.03—2———2
Fanconi syndromeD005198———2———2
Megakaryoblastic leukemia acuteD007947—C94.211———2
Monocytic leukemia acuteD007948——11———2
Myelomonocytic leukemia acuteD015479—C92.511———2
Show 28 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——2————2
Liver cirrhosisD008103EFO_0001422K74.01————1
OsteosarcomaD012516——1————1
Connective and soft tissue neoplasmsD018204——1————1
Radiation injuriesD011832—T661————1
Acute radiation syndromeD054508——1————1
Photosensitivity disordersD010787—L57.11————1
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SplenectomyD013156——————11
Hematologic diseasesD006402EFO_0005803D75.9————11
Immune system diseasesD007154—D89.9————11
Blood coagulation disordersD001778EFO_0009314D68.9————11
Hemorrhagic disordersD006474—D69.9————11
Skin manifestationsD012877——————11
ThromboembolismD013923——————11
ThalassemiaD013789EFO_1001996D56————11
Bone marrow diseasesD001855——————11
Paroxysmal hemoglobinuriaD006457Orphanet_447D59.12————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEltrombopag
INNeltrombopag
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 classthrombopoetin agonists
Image (chem structure or protein)Loading
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-ID496775-61-2
RxCUI—
ChEMBL IDCHEMBL461101
ChEBI ID85010
PubChem CID9846180
DrugBankDB06210
UNII IDS56D65XJ9G (ChemIDplus, GSRS)
Target
Agency Approved
MPL
MPL
Organism
Homo sapiens
Gene name
MPL
Gene synonyms
TPOR
NCBI Gene ID
Protein name
thrombopoietin receptor
Protein synonyms
CD110, Myeloproliferative leukemia protein, myeloproliferative leukemia virus oncogene, Proto-oncogene c-Mpl, TPO-R
Uniprot ID
Mouse ortholog
Mpl (17480)
thrombopoietin receptor (Q8BRX0)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Promacta – Ligand Pharmaceuticals
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Promacta – Novartis
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,372 documents
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Safety
Black-box Warning
Black-box warning for: Alvaiz, Eltrombopag, Promacta
Adverse Events
Top Adverse Reactions
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23,002 adverse events reported
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