Stem definition | Drug id | CAS RN |
---|---|---|
integrin antagonists | 5174 | 1025967-78-5 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 11, 2016 | FDA | SHIRE DEV LLC |
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 |
---|---|---|---|---|---|---|
Instillation site pain | 2914.69 | 48.53 | 400 | 4982 | 508 | 46680172 |
Instillation site reaction | 2288.01 | 48.53 | 300 | 5082 | 180 | 46680500 |
Eye irritation | 1074.82 | 48.53 | 270 | 5112 | 16344 | 46664336 |
Vision blurred | 1071.92 | 48.53 | 384 | 4998 | 79324 | 46601356 |
Dysgeusia | 621.15 | 48.53 | 216 | 5166 | 40275 | 46640405 |
Instillation site irritation | 599.62 | 48.53 | 78 | 5304 | 37 | 46680643 |
Instillation site pruritus | 558.08 | 48.53 | 71 | 5311 | 17 | 46680663 |
Instillation site erythema | 517.60 | 48.53 | 67 | 5315 | 28 | 46680652 |
Instillation site lacrimation | 427.63 | 48.53 | 54 | 5328 | 9 | 46680671 |
Eye pain | 318.64 | 48.53 | 120 | 5262 | 27820 | 46652860 |
Dry eye | 263.58 | 48.53 | 107 | 5275 | 30215 | 46650465 |
Instillation site discharge | 258.40 | 48.53 | 33 | 5349 | 9 | 46680671 |
Lacrimation increased | 228.48 | 48.53 | 81 | 5301 | 15780 | 46664900 |
Ocular hyperaemia | 225.77 | 48.53 | 85 | 5297 | 19625 | 46661055 |
Instillation site swelling | 217.91 | 48.53 | 27 | 5355 | 0 | 46680680 |
Eye discharge | 188.22 | 48.53 | 53 | 5329 | 4875 | 46675805 |
Product container issue | 181.43 | 48.53 | 42 | 5340 | 1757 | 46678923 |
Instillation site discomfort | 169.47 | 48.53 | 21 | 5361 | 0 | 46680680 |
Product quality issue | 159.17 | 48.53 | 79 | 5303 | 35569 | 46645111 |
Eye pruritus | 131.39 | 48.53 | 50 | 5332 | 11848 | 46668832 |
Visual impairment | 120.30 | 48.53 | 82 | 5300 | 66607 | 46614073 |
Product use complaint | 99.70 | 48.53 | 26 | 5356 | 1786 | 46678894 |
Instillation site dryness | 93.38 | 48.53 | 12 | 5370 | 4 | 46680676 |
Ocular discomfort | 90.76 | 48.53 | 27 | 5355 | 3008 | 46677672 |
Instillation site inflammation | 88.76 | 48.53 | 11 | 5371 | 0 | 46680680 |
Eyelid margin crusting | 85.35 | 48.53 | 19 | 5363 | 664 | 46680016 |
Eye disorder | 83.24 | 48.53 | 41 | 5341 | 18100 | 46662580 |
Inappropriate schedule of product administration | 83.22 | 48.53 | 65 | 5317 | 64948 | 46615732 |
Instillation site foreign body sensation | 78.07 | 48.53 | 10 | 5372 | 3 | 46680677 |
Instillation site burn | 72.62 | 48.53 | 9 | 5373 | 0 | 46680680 |
Product packaging quantity issue | 70.65 | 48.53 | 18 | 5364 | 1126 | 46679554 |
Taste disorder | 65.93 | 48.53 | 25 | 5357 | 5853 | 46674827 |
Eye swelling | 62.44 | 48.53 | 35 | 5347 | 20068 | 46660612 |
Foreign body sensation in eyes | 61.84 | 48.53 | 18 | 5364 | 1858 | 46678822 |
Instillation site hypersensitivity | 56.48 | 48.53 | 7 | 5375 | 0 | 46680680 |
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 |
---|---|---|---|---|---|---|
Instillation site reaction | 613.65 | 120.68 | 67 | 840 | 22 | 29951549 |
Instillation site pain | 505.70 | 120.68 | 58 | 849 | 61 | 29951510 |
Vision blurred | 444.99 | 120.68 | 122 | 785 | 41694 | 29909877 |
Eye irritation | 359.44 | 120.68 | 71 | 836 | 5625 | 29945946 |
Instillation site lacrimation | 131.78 | 120.68 | 14 | 893 | 0 | 29951571 |
Source | Code | Description |
---|---|---|
ATC | S01XA25 | SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals |
MeSH PA | D009883 | Ophthalmic Solutions |
MeSH PA | D019999 | Pharmaceutical Solutions |
FDA MoA | N0000192700 | Lymphocyte Function-Associated Antigen-1 Antagonists |
FDA EPC | N0000192701 | Lymphocyte Function-Associated Antigen-1 Antagonist |
CHEBI has role | CHEBI:35472 | anti-inflammatory drugs |
CHEBI has role | CHEBI:133024 | lfa-1 antagonist |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Tear film insufficiency | indication | 46152009 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.42 | acidic |
pKa2 | 12.3 | acidic |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | July 11, 2021 | NEW CHEMICAL ENTITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Integrin alpha-L/beta-2 | Adhesion | ANTAGONIST | IC50 | 8.05 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Intercellular adhesion molecule 1 | Unclassified | IC50 | 8.53 | CHEMBL |
ID | Source |
---|---|
D10374 | KEGG_DRUG |
4035938 | VANDF |
C3713860 | UMLSCUI |
CHEBI:133023 | CHEBI |
CHEMBL2048028 | ChEMBL_ID |
CHEMBL2048409 | ChEMBL_ID |
DB11611 | DRUGBANK_ID |
C575157 | MESH_SUPPLEMENTAL_RECORD_UI |
7533 | IUPHAR_LIGAND_ID |
9584 | INN_ID |
038E5L962W | UNII |
11965427 | PUBCHEM_CID |
1801820 | RXNORM |
243704 | MMSL |
31873 | MMSL |
016935 | NDDF |
720489009 | SNOMEDCT_US |
763569006 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Xiidra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0911 | SOLUTION/ DROPS | 50 mg | OPHTHALMIC | NDA | 24 sections |
Xiidra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54092-606 | SOLUTION/ DROPS | 50 mg | OPHTHALMIC | NDA | 23 sections |