| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5521 | 79338-84-4 |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 23, 2022 | FDA | DERMAVANT SCIENCES INC |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Folliculitis | 101.29 | 91.57 | 25 | 133 | 70292 | 63418572 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Folliculitis | 275.34 | 116.85 | 41 | 120 | 4525 | 34952245 |
None
None
| Source | Code | Description |
|---|---|---|
| FDA EPC | N0000194018 | Aryl Hydrocarbon Receptor Agonist |
| FDA MoA | N0000194019 | Aryl Hydrocarbon Receptor Agonists |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Plaque psoriasis | indication | 200965009 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1% | VTAMA | DERMAVANT SCI | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 10426743 | May 19, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 1% | VTAMA | DERMAVANT SCI | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11612573 | May 19, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 1% | VTAMA | DERMAVANT SCI | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11590088 | Nov. 13, 2039 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1% | VTAMA | DERMAVANT SCI | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | May 23, 2027 | NEW CHEMICAL ENTITY |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Aryl hydrocarbon receptor | Transcription factor | AGONIST | EC50 | 9.80 | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| CHEMBL259571 | ChEMBL_ID |
| C571829 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9686 | IUPHAR_LIGAND_ID |
| DB06083 | DRUGBANK_ID |
| 019085 | NDDF |
| 4041457 | VANDF |
| C4541381 | UMLSCUI |
| D11365 | KEGG_DRUG |
| 10253 | INN_ID |
| 6439522 | PUBCHEM_CID |
| 2602286 | RXNORM |
| 359272 | MMSL |
| 40699 | MMSL |
| 84HW7D0V04 | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VTAMA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81672-5051 | CREAM | 10 mg | TOPICAL | NDA | 23 sections |