lotilaner
Trade name: xdemvy
Approved
Jul 24, 2023
Clinical trial activity
9 trials · 5 clinical orgs · 1 marketing orgs
Earliest trial started Sep 9, 2020 (NCT04475432)
Timeline
2020s
- Jan 1, 2020
Tarsus Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2021
Tarsus Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2021
Tarsus Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Jul 24, 2023
Tarsus Pharmaceuticals — Earliest FDA Approval
- Jul 24, 2023
Tarsus Pharmaceuticals — NDA Secondary Org
- Jul 24, 2023
Tarsus Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- GABA-A receptorINHIBITOR
GABA-A receptor inhibitor
- Unspecified targetOTHER
Ectoparasiticide
Approved veterinary. Inhibits gamma–aminobutyric acid (GABA)-gated chloride channels in ticks/fleas.
Active against fleas (Ctenocephalides felis and Ctenocephalides canis) and tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Approval history
- approvedJul 24, 2023
Chemistry & pharmacology
SMILES
Cc1cc(C2=NO[C@@](c3cc(Cl)c(Cl)c(Cl)c3)(C(F)(F)F)C2)sc1C(=O)NCC(=O)NCC(F)(F)F- Mol. weight
- 596.76 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL3707310 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06182358 | Phase 4 | Dec 31, 2023 | Tarsus Pharmaceuticals |
| NCT06054217 | Phase 2 | Aug 1, 2023 | Tarsus Pharmaceuticals |
| NCT05838170 | Phase 2 | Mar 1, 2023 | Tarsus Pharmaceuticals |
| NCT05720364 | Phase 1 | Jan 19, 2023 | Tarsus Pharmaceuticals |
| NCT05629390 | Phase 3 | Oct 23, 2022 | LianBio LLC, Xiamen University |
| NCT05454956 | Phase 2 | Aug 3, 2022 | Tarsus Pharmaceuticals |
| NCT04784091 | Phase 3 | Apr 29, 2021 | Tarsus Pharmaceuticals, The Eye Care Institute |
| NCT05138861 | Phase 1 | Feb 9, 2021 | Tarsus Pharmaceuticals |
| NCT04475432 | Phase 2/Phase 3 (Phase 3) | Sep 9, 2020 | Eye Research Foundation, Tarsus Pharmaceuticals |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Tarsus Pharmaceuticals | For profit | 8 | 8 | 4 | 2020 |
| Eye Research Foundation | Academic/Hospital | 1 | 0 | 1 | 2020 |
| LianBio LLC | For profit | 1 | 1 | 1 | 2022 |
| The Eye Care Institute | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Xiamen University | Academic/Hospital | 1 | 0 | 1 | 2022 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Tarsus Pharmaceuticals | For profit | NDA2 | Jul 24, 2023 |
| Tarsus Pharmaceuticals | For profit | NDA | Jul 24, 2023 |