palovarotene 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| arotinoid derivatives | 5737 | 410528-02-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
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n patients with FOP, abnormal bone formation, including heterotrophic ossification (HO), is driven by a gain-of-function mutation in the bone morphogenetic protein (BMP) type I receptor ALK2 (ACVR1).Palovarotene is an orally bioavailable retinoic acid receptor agonist, with particular selectivity at the gamma subtype of RAR. Through binding to RARgamma, palovarotene decreases the BMP/ALK2 downstream signaling pathway by inhibiting the phosphorylation of SMAD1/5/8, which reduces ALK2/SMAD-dependent chondrogenesis and osteocyte differentiation resulting in reduced endochondral bone formation.
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Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 16, 2023 | FDA | IPSEN BIOPHARMACEUTICALS INC |
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 | M09AX11 | MUSCULO-SKELETAL SYSTEM OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM Other drugs for disorders of the musculo-skeletal system |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Progressive myositis ossificans | indication | 82725007 | DOID:13374 |
| Pregnancy, function | contraindication | 289908002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Retinoic acid receptor gamma | Nuclear hormone receptor | AGONIST | IC50 | 6.35 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL2105648 | ChEMBL_ID |
| C546535 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8276 | IUPHAR_LIGAND_ID |
| DB05467 | DRUGBANK_ID |
| 019110 | NDDF |
| C2745017 | UMLSCUI |
| 9025 | INN_ID |
| 10295295 | PUBCHEM_CID |
| D09365 | KEGG_DRUG |
| 28K6I5M16G | UNII |
| 40772 | MMSL |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SOHONOS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0010 | CAPSULE | 1 mg | ORAL | NDA | 32 sections |
| SOHONOS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0015 | CAPSULE | 1.50 mg | ORAL | NDA | 32 sections |
| SOHONOS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0025 | CAPSULE | 2.50 mg | ORAL | NDA | 32 sections |
| SOHONOS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0050 | CAPSULE | 5 mg | ORAL | NDA | 32 sections |
| SOHONOS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0100 | CAPSULE | 10 mg | ORAL | NDA | 32 sections |