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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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Fabhalta
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fabhalta | New Drug Application | 2025-03-20 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
IPTACOPAN HYDROCHLORIDE, FABHALTA, NOVARTIS | |||
| 2030-12-05 | ODE-456 | ||
| 2028-12-05 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
36 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 hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | 3 | 5 | — | 6 | 14 |
| Hemoglobinuria | D006456 | — | R82.3 | — | 3 | 5 | — | 5 | 13 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 2 | 3 | — | 1 | 6 |
| Glomerulonephritis | D005921 | — | N05 | — | 2 | 1 | — | 2 | 5 |
| Hemolysis | D006461 | — | — | — | 1 | 3 | — | 1 | 5 |
| Proteinuria | D011507 | — | R80 | — | 1 | 3 | — | — | 4 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 2 | 1 | — | 1 | 4 |
| Hemolytic-uremic syndrome | D006463 | — | D59.3 | — | — | 3 | — | — | 3 |
| Syndrome | D013577 | — | — | — | — | 3 | — | — | 3 |
| Atypical hemolytic uremic syndrome | D065766 | — | — | — | — | 3 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | 1 | — | — | 1 | 2 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 1 | — | — | — | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 1 | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 1 | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | — | — | — | 1 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 1 | — | — | — | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | 1 | — | — | — | 1 |
| Microscopic polyangiitis | D055953 | EFO_1000784 | M31.7 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Iptacopan |
| INN | iptacopan |
| 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 class | complement receptor antagonists/complement inhibitors |
| Image (chem structure or protein) |  |
| 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-ID | 1644670-37-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594448 |
| ChEBI ID | — |
| PubChem CID | 90467622 |
| DrugBank | DB16200 |
| UNII ID | 8E05T07Z6W (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
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Financial
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Fabhalta – Novartis
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Trends
PubMed Central
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Additional graphs summarizing 439 documents
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Safety
Black-box Warning
Black-box warning for: Fabhalta
Adverse Events
Top Adverse Reactions
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451 adverse events reported
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