Belumosudil
Rezurock (belumosudil) is a small molecule pharmaceutical. Belumosudil was first approved as Rezurock on 2021-07-16. It is used to treat graft vs host disease in the USA. The pharmaceutical is active against rho-associated protein kinase 1 and rho-associated protein kinase 2.
Download report
Favorite
FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Rezurock
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Belumosudil mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REZUROCK | Sanofi | N-214783 RX | 2021-07-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rezurock | New Drug Application | 2021-07-16 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BELUMOSUDIL MESYLATE, REZUROCK, KADMON PHARMS LLC | |||
| 2028-07-16 | ODE-362 | ||
| 2026-07-16 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
19 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
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | D89.81 | — | 3 | — | — | — | 3 | |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 3 | — | — | — | 3 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 2 | — | — | — | 2 | |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | C80 | 2 | — | — | — | — | 2 | |
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Colorectal neoplasms | D015179 | 1 | — | — | — | — | 1 | ||
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Fibrosis | D005355 | 1 | — | — | — | — | 1 | ||
| Biological availability | D001682 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | BELUMOSUDIL |
| INN | belumosudil |
| Description | Belumosudil, sold under the brand name Rezurock among others, is a medication used for the treatment of chronic graft versus host disease (cGvHD). It is in the class of drugs known as serine/threonine kinase inhibitors. Specifically, it is an inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2; ROCK-II). Belumosudil binds to and inhibits the serine/threonine kinase activity of ROCK2. This inhibits ROCK2-mediated signaling pathways which play major roles in pro- and anti-inflammatory immune cell responses. A genomic study in human primary cells demonstrated that the drug also has effects on oxidative phosphorylation, WNT signaling, angiogenesis, and KRAS signaling.
|
| Classification | Small molecule |
| Drug class | vasodilators (undefined group): Rho protein kinase (ROCK) inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)NC(=O)COc1cccc(-c2nc(Nc3ccc4[nH]ncc4c3)c3ccccc3n2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 911417-87-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2005186 |
| ChEBI ID | — |
| PubChem CID | 11950170 |
| DrugBank | DB16703 |
| UNII ID | 834YJF89WO (ChemIDplus, GSRS) |
Target
Agency Approved
ROCK1
ROCK1
ROCK2
ROCK2
Organism
Homo sapiens
Gene name
ROCK1
Gene synonyms
NCBI Gene ID
Protein name
rho-associated protein kinase 1
Protein synonyms
p160 ROCK-1, p160ROCK, Renal carcinoma antigen NY-REN-35, Rho-associated, coiled-coil-containing protein kinase 1, Rho-associated, coiled-coil-containing protein kinase I, ROCK-I
Uniprot ID
Mouse ortholog
Rock1 (19877)
rho-associated protein kinase 1 (Q8C7H0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Rezurock - Sanofi
$
€
£
₣
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 111 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
1 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more