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Drug ReportsEltrombopag olamine
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
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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)
Eltrombopag olamine
Tradename
Company
Number
Date
Products
PROMACTANovartisN-022291 RX2008-11-20
4 products, RLD
PROMACTA KITNovartisN-207027 RX2015-08-24
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
eltrombopagANDA2025-03-27
promactaNew Drug Application2025-08-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
thrombocytopenic purpura idiopathicEFO_0007160D016553D69.3
aplastic anemia—D000741D61.9
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
Flag
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
77952932023-05-21U-930, U-1306, U-1575, U-1736, U-2451
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
187 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_0001873D69.61941216
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—56—213
Aplastic anemiaD000741—D61.9181—312
Thrombocytopenic purpuraD011696———24—17
PurpuraD011693HP_0000979D69.2—24—17
Myelodysplastic syndromesD009190—D46—31——4
PreleukemiaD011289———31——4
SyndromeD013577———21——3
Hepatitis cD006526—B19.2——1—12
HemorrhageD006470MP_0001914R58—11——2
NeoplasmsD009369—C80——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.917——310
LeukemiaD007938—C9515———5
Myeloid leukemia acuteD015470—C92.015———5
Myeloid leukemiaD007951—C9213———3
InfectionsD007239EFO_0000544——1———1
Chronic hepatitis bD019694EFO_0004239B18.1—1———1
Communicable diseasesD003141———1———1
Blood platelet disordersD001791———1———1
Pathologic complete responseD000095384——11———1
Wiskott-aldrich syndromeD014923EFO_0003903D82.0—1———1
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThromboembolismD013923——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEltrombopag 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—
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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—
RxCUI711942
ChEMBL IDCHEMBL461806
ChEBI ID—
PubChem CID135449332
DrugBankDB06210
UNII ID—
Target
No data
Variants
No data
Financial
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Promacta – Ligand Pharmaceuticals
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Promacta – Novartis
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 292 documents
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Safety
Black-box Warning
Black-box warning for: Eltrombopag, Promacta
Adverse Events
Top Adverse Reactions
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23,258 adverse events reported
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