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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Fabhalta
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fabhalta | New Drug Application | 2024-08-07 |
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
28 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
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 | 4 | — | 4 | 11 |
| Hemoglobinuria | D006456 | — | R82.3 | — | 3 | 4 | — | 4 | 11 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 2 | 2 | — | — | 4 |
| Hemolysis | D006461 | — | — | — | 1 | 3 | — | — | 4 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 1 | 2 | — | — | 3 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | 1 | 1 | — | 1 | 3 |
| Hemolytic-uremic syndrome | D006463 | — | D59.3 | — | — | 3 | — | — | 3 |
| Syndrome | D013577 | — | — | — | — | 3 | — | — | 3 |
| Atypical hemolytic uremic syndrome | D065766 | — | — | — | — | 3 | — | — | 3 |
| Azotemia | D053099 | — | — | — | — | 3 | — | — | 3 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 1 | — | — | — | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 1 | — | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | 1 | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | — | — | — | 1 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | — | — | — | 1 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 1 | — | — | — | 1 |
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.12 | — | 1 | — | — | — | 1 |
| Vasculitis | D014657 | HP_0002633 | — | — | 1 | — | — | — | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Fabhalta – Novartis
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 264 documents
View more details
Safety
Black-box Warning
Black-box warning for: Fabhalta
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
144 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use