Lotilaner
Xdemvy (lotilaner) is a small molecule pharmaceutical. Lotilaner was first approved as Xdemvy on 2023-07-24.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Xdemvy
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lotilaner
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XDEMVY | Tarsus Pharmaceuticals | N-217603 RX | 2023-07-24 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xdemvy | New Drug Application | 2024-08-10 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LOTILANER, XDEMVY, TARSUS | |||
| 2028-07-24 | NCE | ||
ATC Codes
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HCPCS
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Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 3 | 2 | 1 | — | 5 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | 1 | — | — | — | 4 |
| Meibomian gland dysfunction | D000080343 | — | H02.88 | — | 2 | — | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | — | 1 |
| Rosacea | D012393 | — | L71 | — | 1 | — | — | — | 1 |
| Parasitic diseases | D010272 | EFO_0001067 | B88 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lotilaner |
| INN | lotilaner |
| Description | Lotilaner, sold under the brand name Xdemvy, is an ectoparasiticide (anti-parasitic) medication used for the treatment of blepharitis (inflammation of the eyelid) caused by infestation by Demodex (tiny mites). It is used as an eye drop.
|
| Classification | Small molecule |
| Drug class | antagonists of GABA (gamma-aminobutyric acid) regulated chloride channels, antiparasitic agents |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(C2=NO[C@@](c3cc(Cl)c(Cl)c(Cl)c3)(C(F)(F)F)C2)sc1C(=O)NCC(=O)NCC(F)(F)F |
Identifiers
| PDB | — |
| CAS-ID | 1369852-71-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707310 |
| ChEBI ID | — |
| PubChem CID | 76959255 |
| DrugBank | DB17992 |
| UNII ID | HEH4938D7K (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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1,737 adverse events reported
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