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| Stem definition | Drug id | CAS RN |
|---|---|---|
| growth factors | 5235 | 1772578-74-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Cenegermin is a recombinant form of human nerve growth factor. Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors. Nerve growth factor receptors are expressed in the anterior segment of the eye (cornea, conjunctiva, iris, ciliary body, and lens), by the lacrimal gland, and by posterior segment intraocular tissues. The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 6, 2017 | EMA | Dompe farmaceutici s.p.a. |
| 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 |
|---|---|---|---|---|---|---|
| Eye pain | 1707.41 | 76.16 | 354 | 1980 | 43814 | 90582299 |
| Eye irritation | 454.66 | 76.16 | 116 | 2218 | 33862 | 90592251 |
| Ocular hyperaemia | 358.34 | 76.16 | 96 | 2238 | 33702 | 90592411 |
| Ocular discomfort | 265.63 | 76.16 | 55 | 2279 | 6315 | 90619798 |
| Photophobia | 261.39 | 76.16 | 68 | 2266 | 21201 | 90604912 |
| Eyelid pain | 226.35 | 76.16 | 35 | 2299 | 748 | 90625365 |
| Periorbital pain | 200.02 | 76.16 | 28 | 2306 | 290 | 90625823 |
| Product dose omission issue | 195.04 | 76.16 | 110 | 2224 | 291577 | 90334536 |
| Eye swelling | 165.04 | 76.16 | 51 | 2283 | 29335 | 90596778 |
| Vision blurred | 154.91 | 76.16 | 69 | 2265 | 110224 | 90515889 |
| Therapy interrupted | 142.05 | 76.16 | 52 | 2282 | 50056 | 90576057 |
| Lacrimation increased | 135.34 | 76.16 | 43 | 2291 | 27019 | 90599094 |
| Corneal deposits | 124.94 | 76.16 | 19 | 2315 | 361 | 90625752 |
| Eye discharge | 113.94 | 76.16 | 29 | 2305 | 8229 | 90617884 |
| Foreign body sensation in eyes | 111.65 | 76.16 | 24 | 2310 | 3276 | 90622837 |
| Product administration error | 99.90 | 76.16 | 34 | 2300 | 26389 | 90599724 |
| Swelling of eyelid | 99.64 | 76.16 | 24 | 2310 | 5430 | 90620683 |
| Eye infection bacterial | 83.18 | 76.16 | 13 | 2321 | 297 | 90625816 |
| 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 |
|---|---|---|---|---|---|---|
| Eye pain | 618.21 | 104.16 | 125 | 759 | 16905 | 42603546 |
| Eye irritation | 198.22 | 104.16 | 46 | 838 | 11272 | 42609179 |
| Ocular hyperaemia | 148.18 | 104.16 | 39 | 845 | 15924 | 42604527 |
| Ocular discomfort | 112.92 | 104.16 | 23 | 861 | 3034 | 42617417 |
| Photophobia | 105.58 | 104.16 | 26 | 858 | 8093 | 42612358 |
| 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 |
|---|---|---|---|---|---|---|
| Eye pain | 1277.00 | 78.18 | 266 | 1650 | 49833 | 110537550 |
| Eye irritation | 366.78 | 78.18 | 90 | 1826 | 33362 | 110554021 |
| Ocular hyperaemia | 284.56 | 78.18 | 76 | 1840 | 39210 | 110548173 |
| Photophobia | 201.34 | 78.18 | 53 | 1863 | 25718 | 110561665 |
| Ocular discomfort | 195.88 | 78.18 | 42 | 1874 | 8491 | 110578892 |
| Eyelid pain | 178.79 | 78.18 | 27 | 1889 | 742 | 110586641 |
| Product dose omission issue | 145.58 | 78.18 | 82 | 1834 | 321700 | 110265683 |
| Vision blurred | 143.84 | 78.18 | 61 | 1855 | 128961 | 110458422 |
| Lacrimation increased | 129.11 | 78.18 | 39 | 1877 | 30911 | 110556472 |
| Eye swelling | 126.59 | 78.18 | 39 | 1877 | 33009 | 110554374 |
| Corneal deposits | 116.44 | 78.18 | 18 | 1898 | 578 | 110586805 |
| Periorbital pain | 115.12 | 78.18 | 16 | 1900 | 240 | 110587143 |
| Therapy interrupted | 99.49 | 78.18 | 36 | 1880 | 49786 | 110537597 |
| Eye discharge | 97.84 | 78.18 | 24 | 1892 | 8730 | 110578653 |
| Foreign body sensation in eyes | 97.11 | 78.18 | 20 | 1896 | 3314 | 110584069 |
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| Source | Code | Description |
|---|---|---|
| ATC | S01XA24 | SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals |
| FDA CS | M0328210 | Nerve Growth Factor |
| FDA EPC | N0000193854 | Recombinant Human Nerve Growth Factor |
| CHEBI has role | CHEBI:39456 | antiglaucoma drug |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Neurotrophic keratitis | indication | 128080005 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| High affinity nerve growth factor receptor | Kinase | AGONIST | UNKNOWN | DRUG LABEL | |||||
| Tumor necrosis factor receptor superfamily member 16 | Membrane receptor | AGONIST | UNKNOWN | DRUG LABEL |
| ID | Source |
|---|---|
| B6E7K36KT8 | UNII |
| 4038032 | VANDF |
| C4541383 | UMLSCUI |
| CHEBI:757294 | CHEBI |
| CHEMBL4297852 | ChEMBL_ID |
| DB13926 | DRUGBANK_ID |
| D11028 | KEGG_DRUG |
| 10381 | INN_ID |
| C000647429 | MESH_SUPPLEMENTAL_RECORD_UI |
| 773954004 | SNOMEDCT_US |
| 773957006 | SNOMEDCT_US |
| 267667 | MMSL |
| 2104332 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| OXERVATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71981-020 | SOLUTION/ DROPS | 20 ug | OPHTHALMIC | BLA | 25 sections |