Belzutifan
Welireg (belzutifan) is a small molecule pharmaceutical. Belzutifan was first approved as Welireg on 2021-08-13. It is used to treat von hippel-lindau disease in the USA. It is known to target endothelial PAS domain-containing protein 1.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Welireg
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Belzutifan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| WELIREG | Merck Sharp & Dohme | N-215383 RX | 2021-08-13 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| welireg | New Drug Application | 2021-08-13 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BELZUTIFAN, WELIREG, MERCK SHARP DOHME | |||
| 2028-08-13 | ODE-364 | ||
| 2026-08-13 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
21 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 |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | 7 | 5 | 4 | — | — | 13 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 1 | — | — | — | 2 |
| Von hippel-lindau disease | D006623 | Q85.83 | — | 2 | — | — | — | 2 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | 1 | — | — | — | 1 | ||
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | 1 | — | — | — | 1 | ||
| Pancreatic ductal carcinoma | D021441 | — | 1 | — | — | — | 1 | ||
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | 1 | |
| Esophageal neoplasms | D004938 | C15 | — | 1 | — | — | — | 1 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | C24.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 1 | — | — | — | — | 1 | |
| Glioblastoma | D005909 | EFO_0000515 | 1 | — | — | — | — | 1 | |
| Clear cell adenocarcinoma | D018262 | 1 | — | — | — | — | 1 | ||
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 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 | BELZUTIFAN |
| INN | belzutifan |
| Description | Belzutifan, sold under the brand name Welireg, is an anti-cancer medication used for the treatment of von Hippel–Lindau disease-associated renal cell carcinoma. It is taken by mouth. Belzutifan is an hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor.
|
| Classification | Small molecule |
| Drug class | hypoxia-inducible factor (HIF) inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CS(=O)(=O)c1ccc(Oc2cc(F)cc(C#N)c2)c2c1[C@H](O)[C@H](F)[C@@H]2F |
Identifiers
| PDB | — |
| CAS-ID | 1672668-24-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4585668 |
| ChEBI ID | — |
| PubChem CID | 117947097 |
| DrugBank | DB15463 |
| UNII ID | 7K28NB895L (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
EPAS1
EPAS1
Organism
Homo sapiens
Gene name
EPAS1
Gene synonyms
BHLHE73, HIF2A, MOP2, PASD2
NCBI Gene ID
Protein name
endothelial PAS domain-containing protein 1
Protein synonyms
Basic-helix-loop-helix-PAS protein MOP2, bHLHe73, Class E basic helix-loop-helix protein 73, EPAS-1, HIF-1-alpha-like factor, HIF-1alpha-like factor, HIF-2-alpha, HIF2-alpha, HLF, hypoxia-inducible factor 2 alpha, Hypoxia-inducible factor 2-alpha, Member of PAS protein 2, PAS domain-containing protein 2
Uniprot ID
Mouse ortholog
Epas1 (13819)
endothelial PAS domain-containing protein 1 (P97481)
Variants
Clinical Variant
No data
Financial
Welireg - Merck Sharp & Dohme
$
€
£
₣
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
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 256 documents
View more details
Safety
Black-box Warning
Black-box warning for: Welireg
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
8 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more