vosoritide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| natriuretic peptides | 5480 | 1480724-61-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Vosoritide is a modified type C natriuretic peptide (CNP). In patients with achondroplasia, endochondral bone growth is negatively regulated due to a gain of function mutation in fibroblast growth factor receptor 3 (FGFR3). Binding of vosoritide to natriuretic peptide receptor-B (NPR-B) antagonises FGFR3 downstream signalling by inhibiting the extracellular signal-regulated kinases 1 and 2 (ERK1/2) in the mitogen-activated protein kinase (MAPK) pathway at the level of rapidly accelerating fibrosarcoma serine/threonine protein kinase (RAF-1). As a result, vosoritide, like CNP, acts as a positive regulator of endochondral bone growth as it promotes chondrocyte proliferation and differentiation.
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Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 26, 2021 | EMA | BIOMARIN INTERNATIONAL LIMITED | |
| Nov. 19, 2021 | FDA | BIOMARIN PHARM | |
| June 20, 2022 | PMDA | BIOMARIN PHARMACEUTICAL K.K |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | M05BX07 | MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Other drugs affecting bone structure and mineralization |
| FDA CS | M0029831 | Natriuretic Peptide, C-Type |
| FDA EPC | N0000193980 | C-type Natriuretic Peptide Analog |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Achondroplasia | indication | 86268005 | DOID:4480 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | RE48267 | May 20, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | RE48267 | May 20, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | RE48267 | May 20, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 8198242 | June 11, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 8198242 | June 11, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 8198242 | June 11, 2030 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 10646550 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 10646550 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | 10646550 | Aug. 1, 2036 | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2026 | NEW CHEMICAL ENTITY |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2026 | NEW CHEMICAL ENTITY |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2026 | NEW CHEMICAL ENTITY |
| 0.4MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2028 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 0.56MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2028 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| 1.2MG/VIAL | VOXZOGO | BIOMARIN PHARM | N214938 | Nov. 19, 2021 | RX | POWDER | SUBCUTANEOUS | Nov. 19, 2028 | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Atrial natriuretic peptide receptor 2 | Enzyme | ACTIVATOR | EC50 | 8.77 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 7SE5582Q2P | UNII |
| C4519745 | UMLSCUI |
| CHEMBL3707276 | ChEMBL_ID |
| 119058036 | PUBCHEM_CID |
| DB11928 | DRUGBANK_ID |
| 10022 | INN_ID |
| 9068 | IUPHAR_LIGAND_ID |
| D11190 | KEGG_DRUG |
| 018891 | NDDF |
| 4040998 | VANDF |
| 2586354 | RXNORM |
| 353929 | MMSL |
| 40117 | MMSL |
| d09828 | MMSL |
| C000632572 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
None