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palovarotene 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| arotinoid derivatives | 5737 | 410528-02-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.607 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.225 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 31.842 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 10.280 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 0.270 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 0.780 | % | High | 1 |
| herg | hERG pIC50 | 4.953 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 20.464 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 21.184 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.380 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,GSK3B,IKBKB,ITK,JAK2,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPKAPK2,PDK1,PDK2,PDK4,PIK3CB,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,TTK | 33 | |||
| kinase-selectivity-class | AXL,BRAF,EIF2AK3,EPHB4,GRK2,NTRK3,PDK4,STK33 | 8 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 2.523 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 14.588 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.420 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 13.552 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 0.330 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 15.136 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 4.290 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.270 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 69.823 | uM | High | 1 |
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 |
| FDA CS | M0018962 | Retinoids |
| FDA EPC | N0000175607 | Retinoid |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
| CHEBI has role | CHEBI:88336 | retinoic acid receptor γ agonist |
Related Drugs by ATC class:
M09AX Other drugs for disorders of the musculo-skeletal system 11 drugs
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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10292954 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12023312 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS (MYOSITIS) PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9314439 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9789074 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10292954 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12023312 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS (MYOSITIS) PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9314439 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9789074 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10292954 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12023312 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS (MYOSITIS) PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9314439 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9789074 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10292954 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12023312 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS (MYOSITIS) PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9314439 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9789074 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10292954 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12023312 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS (MYOSITIS) PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9314439 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 9789074 | Aug. 31, 2031 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10864194 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 11622959 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12138245 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12201614 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12458626 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10864194 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 11622959 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12138245 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12201614 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12458626 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10864194 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 11622959 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12138245 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12201614 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12458626 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10864194 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 11622959 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12138245 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12201614 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12458626 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 10864194 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 11622959 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12138245 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12201614 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIS (MYOSITIS) OSSIFICANS PROGRESSIVA |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | 12458626 | June 8, 2037 | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2028 | NEW CHEMICAL ENTITY |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2028 | NEW CHEMICAL ENTITY |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2028 | NEW CHEMICAL ENTITY |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2028 | NEW CHEMICAL ENTITY |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2028 | NEW CHEMICAL ENTITY |
| 1.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2030 | FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) |
| 10MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2030 | FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) |
| 1MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2030 | FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) |
| 2.5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2030 | FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) |
| 5MG | SOHONOS | IPSEN | N215559 | Aug. 16, 2023 | RX | CAPSULE | ORAL | Aug. 16, 2030 | FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) |
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 |
|---|---|
| CHEBI:188559 | CHEBI |
| CHEMBL2105648 | ChEMBL_ID |
| C546535 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8276 | IUPHAR_LIGAND_ID |
| DB05467 | DRUGBANK_ID |
| 1783991000168109 | SNOMEDCT_US |
| 4042535 | VANDF |
| C2745017 | UMLSCUI |
| 9025 | INN_ID |
| 10295295 | PUBCHEM_CID |
| 360106 | MMSL |
| 40772 | MMSL |
| d09902 | MMSL |
| 019110 | NDDF |
| D09365 | KEGG_DRUG |
| 28K6I5M16G | UNII |
| 2663954 | RXNORM |
| 28K6I5M16G | INXIGHT DRUGS |
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 |