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lotilaner 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antagonists of GABA (gamma-aminobutyric acid) regulated chloride channels, antiparasitic agents | 5567 | 1369852-71-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibition of these GABA chloride channels causes a paralytic action in the target organism leading to its death. Lotilaner is not an inhibitor of mammalian GABA mediated chloride channels when tested at up to 30 microM (18 microg/mL) in vitro (approximately 1100 times the RHOD).
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,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TTK,ZAP70 | 40 | |||
| kinase-selectivity-class | GRK2,PDK1,PDK4 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 24, 2023 | FDA | TARSUS |
FDA Adverse Event Reporting System (Female)
| 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 irritation | 521.27 | 85.68 | 113 | 1048 | 33865 | 90593421 |
| Instillation site irritation | 266.81 | 85.68 | 32 | 1129 | 191 | 90627095 |
| Ocular hyperaemia | 232.90 | 85.68 | 59 | 1102 | 33739 | 90593547 |
| Vision blurred | 187.06 | 85.68 | 65 | 1096 | 110228 | 90517058 |
| Eye pain | 175.71 | 85.68 | 50 | 1111 | 44118 | 90583168 |
| Eye pruritus | 172.06 | 85.68 | 45 | 1116 | 28982 | 90598304 |
| Lacrimation increased | 118.15 | 85.68 | 33 | 1128 | 27029 | 90600257 |
| Eye swelling | 97.72 | 85.68 | 29 | 1132 | 29357 | 90597929 |
| Eye discharge | 95.74 | 85.68 | 22 | 1139 | 8236 | 90619050 |
FDA Adverse Event Reporting System (Male)
| 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 irritation | 185.29 | 94.96 | 19 | 300 | 37 | 42620979 |
| Eye irritation | 153.61 | 94.96 | 31 | 288 | 11287 | 42609729 |
FDA Adverse Event Reporting System (Geriatric)
| 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 irritation | 600.91 | 98.34 | 124 | 1127 | 33328 | 110554720 |
| Instillation site irritation | 377.62 | 98.34 | 42 | 1209 | 131 | 110587917 |
| Ocular hyperaemia | 271.30 | 98.34 | 67 | 1184 | 39219 | 110548829 |
| Vision blurred | 220.13 | 98.34 | 74 | 1177 | 128948 | 110459100 |
| Eye pain | 203.04 | 98.34 | 56 | 1195 | 50043 | 110538005 |
| Eye pruritus | 201.54 | 98.34 | 51 | 1200 | 32724 | 110555324 |
| Lacrimation increased | 136.33 | 98.34 | 37 | 1214 | 30913 | 110557135 |
| Eye discharge | 119.20 | 98.34 | 26 | 1225 | 8728 | 110579320 |
| Eye swelling | 102.28 | 98.34 | 30 | 1221 | 33018 | 110555030 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | S01AX25 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Other antiinfectives |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000977 | Antiparasitic Agents |
| FDA EPC | N0000194050 | Ectoparasiticide |
| CHEBI has role | CHEBI:38956 | ectoparasiticide |
| CHEBI has role | CHEBI:38999 | GABA-gated chloride channel antagonist |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
Related Drugs by ATC class:
S01AX Other antiinfectives 13 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Demodex blepharitis | indication | 403152000 |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| Dogs | Flea infestations caused by Ctenocephalides felis | Indication |
| Dogs | Treatment and control of tick infestations with Amblyomma americanum (lone star tick) | Indication |
| Dogs | Treatment and control of tick infestations with Dermacentor variabilis (American dog tick) | Indication |
| Dogs | Treatment and control of tick infestations with Ixodes scapularis (black-legged tick) | Indication |
| Dogs | Treatment and control of tick infestations with Rhipicephalus sanguineus (brown dog tick) | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| Credelio | Elanco US Inc. | 1 |
| Credelio CAT | Elanco US Inc. | 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.25% | XDEMVY | TARSUS | N217603 | July 24, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10835517 | Dec. 14, 2038 | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE |
| 0.25% | XDEMVY | TARSUS | N217603 | July 24, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 11197847 | Dec. 14, 2038 | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE |
| 0.25% | XDEMVY | TARSUS | N217603 | July 24, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 11690826 | Dec. 14, 2038 | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE |
| 0.25% | XDEMVY | TARSUS | N217603 | July 24, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 11690827 | Dec. 14, 2038 | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE |
| 0.25% | XDEMVY | TARSUS | N217603 | July 24, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 12171750 | Dec. 14, 2038 | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.25% | XDEMVY | TARSUS | N217603 | July 24, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | July 24, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA-A receptor | Ion channel | INHIBITOR | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:229657 | CHEBI |
| CHEMBL3707310 | ChEMBL_ID |
| C000711088 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4042449 | VANDF |
| C4550692 | UMLSCUI |
| 9867 | INN_ID |
| D11212 | KEGG_DRUG |
| 76959255 | PUBCHEM_CID |
| 41836 | MMSL |
| 017865 | NDDF |
| HEH4938D7K | UNII |
| 1998841 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| XDEMVY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81942-125 | SOLUTION/ DROPS | 2.50 mg | OPHTHALMIC | NDA | 24 sections |