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.
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Commercial
Therapeutic Areas
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 & Co | N-215383 RX | 2021-08-13 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| welireg | New Drug Application | 2025-05-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| von hippel-lindau disease | — | D006623 | Q85.83 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BELZUTIFAN, WELIREG, MERCK SHARP DOHME | |||
| 2028-08-13 | ODE-364 | ||
| 2026-12-14 | I-931 | ||
| 2026-08-13 | NCE | ||
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 |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 7 | 6 | 5 | — | — | 14 |
| Carcinoma | D002277 | — | C80.0 | 7 | 6 | 5 | — | — | 14 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Von hippel-lindau disease | D006623 | — | Q85.83 | — | 1 | — | — | 1 | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 1 | — | — | — | 1 |
| Pheochromocytoma | D010673 | — | — | — | 1 | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | 1 | — | — | — | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | — | — | — | 1 |
| Paraganglioma | D010235 | — | — | — | 1 | — | — | — | 1 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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
No data
Financial
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Welireg – Merck & Co
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Estimated US medical usage
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PubMed Central
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Additional graphs summarizing 900 documents
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Safety
Black-box Warning
Black-box warning for: Welireg
Adverse Events
Top Adverse Reactions
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991 adverse events reported
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