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Drug ReportsEltrombopag
Alvaiz, Revolade(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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Events Timeline
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3M
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YTD
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2Y
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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
Alvaiz
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eltrombopag choline
Tradename
Company
Number
Date
Products
ALVAIZTevaN-216774 RX2023-11-29
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
alvaizNew Drug Application2024-07-01
eltrombopagANDA2025-09-03
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
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
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
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
4352
Protein name
thrombopoietin receptor
Protein synonyms
CD110, Myeloproliferative leukemia protein, myeloproliferative leukemia virus oncogene, Proto-oncogene c-Mpl, TPO-R
Uniprot ID
Q5JUZ0
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 3,329 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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