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Drug ReportsIptacopan
Iptacopan
Fabhalta (iptacopan) is a small molecule pharmaceutical. Iptacopan was first approved as Fabhalta on 2023-12-05. It is known to target complement factor B.
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FDA approval date
EMA approval date
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Study first post date
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Completion date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Fabhalta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Iptacopan hydrochloride
Tradename
Company
Number
Date
Products
FABHALTANovartisN-218276 RX2023-12-05
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fabhaltaNew Drug Application2024-08-07
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
IPTACOPAN HYDROCHLORIDE, FABHALTA, NOVARTIS
2030-12-05ODE-456
2028-12-05NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Iptacopan Hydrochloride, Fabhalta, Novartis
116033632041-05-25DS, DP
96829682034-07-14DS, DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Paroxysmal hemoglobinuriaD006457Orphanet_447D59.12—34—411
HemoglobinuriaD006456—R82.3—34—411
Kidney diseasesD007674EFO_0003086N08—22——4
HemolysisD006461———13——4
Iga glomerulonephritisD005922EFO_0004194——12——3
GlomerulonephritisD005921HP_0000099N05—11—13
Hemolytic-uremic syndromeD006463—D59.3——3——3
SyndromeD013577————3——3
Atypical hemolytic uremic syndromeD065766————3——3
AzotemiaD053099————3——3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Membranous glomerulonephritisD015433EFO_0004254N03.2—1———1
Lupus nephritisD008181EFO_0005761——1———1
NephritisD009393—N05—1———1
Macular degenerationD008268EFO_0001365H35.30—1———1
Hematologic diseasesD006402EFO_0005803D75.9—1———1
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—1———1
ThrombocytopeniaD013921HP_0001873D69.6—1———1
Hemolytic anemia autoimmuneD000744EFO_1001264D59.12—1———1
VasculitisD014657HP_0002633——1———1
Anti-neutrophil cytoplasmic antibody-associated vasculitisD056648—I77.82—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107HP_0002910K70-K771————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIptacopan
INNiptacopan
Description
Iptacopan , sold under the brand name Fabhalta, is a medication used for the treatment of paroxysmal nocturnal hemoglobinuria. It is a complement factor B inhibitor that was developed by Novartis. It is taken by mouth.
Classification
Small molecule
Drug classcomplement receptor antagonists/complement inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCO[C@H]1CCN(Cc2c(OC)cc(C)c3[nH]ccc23)[C@H](c2ccc(C(=O)O)cc2)C1
Identifiers
PDB—
CAS-ID1644670-37-0
RxCUI—
ChEMBL IDCHEMBL4594448
ChEBI ID—
PubChem CID90467622
DrugBankDB16200
UNII ID8E05T07Z6W (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CFB
CFB
Organism
Homo sapiens
Gene name
CFB
Gene synonyms
BF, BFD
NCBI Gene ID
Protein name
complement factor B
Protein synonyms
B-factor, properdin, C3 proaccelerator, C3 proactivator, C3/C5 convertase, GBG, Glycine-rich beta glycoprotein, glycine-rich beta-glycoprotein, PBF2, properdin B, Properdin factor B
Uniprot ID
Mouse ortholog
Cfb (14962)
complement factor B (P04186)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Fabhalta – 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 259 documents
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Safety
Black-box Warning
Black-box warning for: Fabhalta
Adverse Events
Top Adverse Reactions
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31 adverse events reported
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