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 | 2887.30 | 38.52 | 400 | 6195 | 454 | 50598075 |
Instillation site reaction | 2269.66 | 38.52 | 300 | 6295 | 149 | 50598380 |
Eye irritation | 1616.36 | 38.52 | 386 | 6209 | 16754 | 50581775 |
Vision blurred | 1296.47 | 38.52 | 455 | 6140 | 78192 | 50520337 |
Dysgeusia | 749.91 | 38.52 | 254 | 6341 | 38662 | 50559867 |
Instillation site irritation | 589.95 | 38.52 | 78 | 6517 | 37 | 50598492 |
Instillation site pruritus | 551.75 | 38.52 | 71 | 6524 | 14 | 50598515 |
Instillation site erythema | 512.93 | 38.52 | 67 | 6528 | 23 | 50598506 |
Eye pain | 466.97 | 38.52 | 165 | 6430 | 28284 | 50570245 |
Instillation site lacrimation | 426.37 | 38.52 | 54 | 6541 | 3 | 50598526 |
Ocular hyperaemia | 326.23 | 38.52 | 116 | 6479 | 20176 | 50578353 |
Dry eye | 271.23 | 38.52 | 115 | 6480 | 31980 | 50566549 |
Lacrimation increased | 268.74 | 38.52 | 96 | 6499 | 16896 | 50581633 |
Instillation site discharge | 256.78 | 38.52 | 33 | 6562 | 6 | 50598523 |
Eye discharge | 252.05 | 38.52 | 69 | 6526 | 5054 | 50593475 |
Instillation site swelling | 214.59 | 38.52 | 27 | 6568 | 0 | 50598529 |
Product container issue | 207.68 | 38.52 | 46 | 6549 | 1386 | 50597143 |
Eye pruritus | 183.80 | 38.52 | 67 | 6528 | 12467 | 50586062 |
Product quality issue | 169.72 | 38.52 | 82 | 6513 | 30776 | 50567753 |
Instillation site discomfort | 166.89 | 38.52 | 21 | 6574 | 0 | 50598529 |
Ocular discomfort | 150.07 | 38.52 | 42 | 6553 | 3331 | 50595198 |
Product use complaint | 145.50 | 38.52 | 36 | 6559 | 1766 | 50596763 |
Visual impairment | 144.21 | 38.52 | 97 | 6498 | 68178 | 50530351 |
Eye disorder | 115.84 | 38.52 | 54 | 6541 | 18685 | 50579844 |
Eyelid margin crusting | 92.52 | 38.52 | 21 | 6574 | 707 | 50597822 |
Instillation site dryness | 91.91 | 38.52 | 12 | 6583 | 4 | 50598525 |
Product packaging quantity issue | 89.32 | 38.52 | 22 | 6573 | 1058 | 50597471 |
Instillation site inflammation | 87.41 | 38.52 | 11 | 6584 | 0 | 50598529 |
Foreign body sensation in eyes | 78.04 | 38.52 | 22 | 6573 | 1789 | 50596740 |
Eye swelling | 77.19 | 38.52 | 42 | 6553 | 20102 | 50578427 |
Instillation site foreign body sensation | 76.84 | 38.52 | 10 | 6585 | 3 | 50598526 |
Inappropriate schedule of product administration | 76.46 | 38.52 | 68 | 6527 | 71763 | 50526766 |
Taste disorder | 74.08 | 38.52 | 31 | 6564 | 8293 | 50590236 |
Instillation site burn | 71.52 | 38.52 | 9 | 6586 | 0 | 50598529 |
Superficial injury of eye | 69.16 | 38.52 | 13 | 6582 | 167 | 50598362 |
Instillation site hypersensitivity | 55.62 | 38.52 | 7 | 6588 | 0 | 50598529 |
Product taste abnormal | 48.08 | 38.52 | 15 | 6580 | 1730 | 50596799 |
Instillation site paraesthesia | 47.68 | 38.52 | 6 | 6589 | 0 | 50598529 |
Madarosis | 46.28 | 38.52 | 16 | 6579 | 2544 | 50595985 |
Product dose omission issue | 43.11 | 38.52 | 82 | 6513 | 183756 | 50414773 |
Swelling of eyelid | 43.04 | 38.52 | 14 | 6581 | 1846 | 50596683 |
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 | 603.50 | 115.31 | 67 | 1005 | 19 | 29573436 |
Vision blurred | 538.41 | 115.31 | 146 | 926 | 40030 | 29533425 |
Instillation site pain | 508.04 | 115.31 | 58 | 1014 | 37 | 29573418 |
Eye irritation | 464.05 | 115.31 | 91 | 981 | 5807 | 29567648 |
Lacrimation increased | 133.41 | 115.31 | 34 | 1038 | 6946 | 29566509 |
Instillation site lacrimation | 129.24 | 115.31 | 14 | 1058 | 0 | 29573455 |
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 | 2344.18 | 46.94 | 292 | 3184 | 387 | 64494869 |
Instillation site reaction | 1830.29 | 46.94 | 218 | 3258 | 129 | 64495127 |
Vision blurred | 805.05 | 46.94 | 264 | 3212 | 90052 | 64405204 |
Eye irritation | 521.44 | 46.94 | 129 | 3347 | 15727 | 64479529 |
Instillation site irritation | 429.45 | 46.94 | 50 | 3426 | 14 | 64495242 |
Instillation site erythema | 420.63 | 46.94 | 49 | 3427 | 14 | 64495242 |
Dysgeusia | 402.69 | 46.94 | 134 | 3342 | 46913 | 64448343 |
Instillation site pruritus | 362.90 | 46.94 | 42 | 3434 | 9 | 64495247 |
Instillation site lacrimation | 303.64 | 46.94 | 35 | 3441 | 6 | 64495250 |
Eye pain | 192.45 | 46.94 | 70 | 3406 | 31555 | 64463701 |
Instillation site swelling | 185.46 | 46.94 | 21 | 3455 | 0 | 64495256 |
Ocular hyperaemia | 183.51 | 46.94 | 62 | 3414 | 22502 | 64472754 |
Product quality issue | 159.34 | 46.94 | 60 | 3416 | 29739 | 64465517 |
Instillation site discomfort | 158.96 | 46.94 | 18 | 3458 | 0 | 64495256 |
Instillation site discharge | 158.96 | 46.94 | 18 | 3458 | 0 | 64495256 |
Lacrimation increased | 128.08 | 46.94 | 45 | 3431 | 18301 | 64476955 |
Eye discharge | 125.54 | 46.94 | 33 | 3443 | 5051 | 64490205 |
Product container issue | 111.95 | 46.94 | 22 | 3454 | 909 | 64494347 |
Eye pruritus | 84.31 | 46.94 | 30 | 3446 | 12629 | 64482627 |
Instillation site burn | 79.47 | 46.94 | 9 | 3467 | 0 | 64495256 |
Visual impairment | 75.64 | 46.94 | 48 | 3428 | 74029 | 64421227 |
Instillation site inflammation | 70.64 | 46.94 | 8 | 3468 | 0 | 64495256 |
Product dose omission issue | 62.62 | 46.94 | 64 | 3412 | 194683 | 64300573 |
Instillation site foreign body sensation | 61.81 | 46.94 | 7 | 3469 | 0 | 64495256 |
Inappropriate schedule of product administration | 54.94 | 46.94 | 43 | 3433 | 92243 | 64403013 |
Eye swelling | 52.18 | 46.94 | 25 | 3451 | 22256 | 64473000 |
Product use complaint | 51.95 | 46.94 | 13 | 3463 | 1633 | 64493623 |
Instillation site dryness | 50.54 | 46.94 | 6 | 3470 | 3 | 64495253 |
None
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 | lymphocyte function-associated antigen-1 antagonists |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Tear film insufficiency | indication | 46152009 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.42 | acidic |
pKa2 | 12.3 | acidic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 10124000 | Nov. 5, 2024 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 7745460 | Nov. 5, 2024 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 7790743 | Nov. 5, 2024 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 8592450 | May 17, 2026 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 8367701 | April 15, 2029 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 9447077 | April 15, 2029 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
5% | XIIDRA | NOVARTIS | N208073 | July 11, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 8168655 | May 9, 2029 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
None
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 | Antibody | IC50 | 8.53 | CHEMBL |
ID | Source |
---|---|
038E5L962W | UNII |
D10374 | KEGG_DRUG |
4035938 | VANDF |
C3713860 | UMLSCUI |
CHEBI:133023 | CHEBI |
CHEMBL2048028 | ChEMBL_ID |
11965427 | PUBCHEM_CID |
DB11611 | DRUGBANK_ID |
CHEMBL2048409 | ChEMBL_ID |
7533 | IUPHAR_LIGAND_ID |
1801820 | RXNORM |
243704 | MMSL |
31873 | MMSL |
720489009 | SNOMEDCT_US |
763569006 | SNOMEDCT_US |
016935 | NDDF |
C575157 | MESH_SUPPLEMENTAL_RECORD_UI |
9584 | INN_ID |
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 | 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 |