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Promacta, Revolade(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
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
promactaNew Drug Application2021-02-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aplastic anemiaHP_0001915D000741D61.9
thrombocytopenic purpura idiopathicEFO_0007160D016553D69.3
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
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
2 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Severe combined immunodeficiencyD016511D81.0——1—12
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameELTROMBOPAG OLAMINE
INNeltrombopag
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-ID496775-61-2
RxCUI711942
ChEMBL IDCHEMBL461806
ChEBI ID—
PubChem CID135449332
DrugBankDB06210
UNII IDS56D65XJ9G (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Promacta - Ligand Pharmaceuticals
$
€
£
₣
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Promacta - Novartis
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,330 documents
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Safety
Black-box Warning
Black-box warning for: Promacta
Adverse Events
Top Adverse Reactions
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76 adverse events reported
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