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difamilast 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| phosphodiesterase IV (PDE IV) inhibitors | 5503 | 937782-05-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Difamilast is a novel atopic dermatitis drug that has phosphodiesterase 4 inhibitory activity. PDE4 inhibitors are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects.
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 |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,BRAF,CAMK2D,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4,PIK3CA,PIK3CG,PRKDC | 14 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 27, 2021 | PMDA | OTSUKA PHARMACEUTICAL Co., Ltd |
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 |
|---|---|---|
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D010726 | Phosphodiesterase Inhibitors |
| MeSH PA | D058988 | Phosphodiesterase 4 Inhibitors |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Atopic dermatitis | indication | 24079001 | DOID:3310 |
🐶 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% | ADQUEY | ACROTECH BIOPHARMA | N219474 | Feb. 12, 2026 | RX | OINTMENT | TOPICAL | RE46792 | March 1, 2028 | METHOD OF TREATING ATOPIC DERMATITIS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1% | ADQUEY | ACROTECH BIOPHARMA | N219474 | Feb. 12, 2026 | RX | OINTMENT | TOPICAL | Feb. 12, 2031 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| cAMP-specific 3',5'-cyclic phosphodiesterase 4B | Enzyme | INHIBITOR | IC50 | 7.95 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| CHEBI:756452 | CHEBI |
| CHEMBL3989968 | ChEMBL_ID |
| C000711049 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9776 | IUPHAR_LIGAND_ID |
| DB14987 | DRUGBANK_ID |
| C5139795 | UMLSCUI |
| D11314 | KEGG_DRUG |
| 10717 | INN_ID |
| 57855696 | PUBCHEM_CID |
| 44699 | MMSL |
| 020346 | NDDF |
| T3U32GLJ0F | UNII |
| 2737149 | RXNORM |
| C119208 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ADQUEY | Human Prescription Drug Label | 1 | 72893-017 | OINTMENT | 10 mg | TOPICAL | NDA | 21 sections |