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Promacta, Revolade(eltrombopag)
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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Novartis Pharmaceuticals
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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
145 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3716126748
ThrombocytopeniaD013921HP_0001873D69.672062333
Hematologic neoplasmsD019337—1—1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Aplastic anemiaD000741HP_0001915D61.9—112—113
Myeloid leukemia acuteD015470C92.0371——8
Hepatitis cD006526B19.2123—27
Chronic hepatitis cD019698EFO_0004220B18.2—22——4
NeoplasmsD009369C801—1——2
Liver diseasesD008107EFO_0001421K70-K77—11——2
Hematopoietic stem cell transplantationD018380——1——1
Primary myelofibrosisD055728D47.4—11——1
Myeloid leukemia chronic-phaseD015466—11——1
Hiv infectionsD015658EFO_0000764B20——1——1
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4637———10
LeukemiaD007938C95—4———4
Wiskott-aldrich syndromeD014923D82.0—2———2
Megakaryoblastic leukemia acuteD007947C94.211———2
Monocytic leukemia acuteD00794811———2
Myelomonocytic leukemia acuteD015479C92.511———2
Myeloid leukemiaD007951C9211———2
Basophilic leukemia acuteD015471C94.811———2
Erythroblastic leukemia acuteD004915EFO_1001257C94.011———2
Eosinophilic leukemia acuteD01547211———2
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Liver cirrhosisD008103EFO_0001422K74.01————1
SarcomaD0125091————1
OsteosarcomaD0125161————1
Connective and soft tissue neoplasmsD0182041————1
Acute radiation syndromeD0545081————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameELTROMBOPAG
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 classthrombopoetin agonists
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
Identifiers
PDB—
CAS-ID496775-61-2
RxCUI711942
ChEMBL IDCHEMBL461101
ChEBI ID85010
PubChem CID135449332
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 (Q08351)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Promacta - Ligand Pharmaceuticals
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Promacta - Novartis
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£
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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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2,751 adverse events reported
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