> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/lotilaner-93e7b35f-f1c9-407a-9965-0594b8eb6795
> Record changed: 2026-10-13

# Lotilaner

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

First approval year

2017

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

## Development status

**First approval year**

2017

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**Drug name**

Lotilaner

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**Molecular weight**

596.76

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**Structure (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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

### Brand names (8)

- Adtab (previously lotilaner elanco)
- adtab previously lotilaner elanco
- credelio
- Credelio
- lotimax
- Lotimax
- xdemvy
- Xdemvy

### Other names (20)

- credelio
- Credelio
- lotilaner
- Lotilaner
- Lotilaner (ema epar: veterinary)
- LOTILANER \[GREEN BOOK\]
- lotilaner \[INN\]
- LOTILANER \[MI\]
- LOTILANER \[USAN\]
- Lotilaner \[WHO-DD\]
- lotilaner ema epar veterinary
- lotilaner green book
- lotilaner inn
- lotilaner mi
- lotilaner usan
- lotilaner who dd
- TP-05 (lotilaner oral capsules)
- TP-05 (lotilaner) High Dose
- TP-05 (lotilaner) Low Dose
- Xdemvy

## Identifiers

**ATC classification codes**

- S01AX25

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**CAS registry numbers**

- 1369852-71-0

**ChEMBL ID**

CHEMBL3707310

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**InChIKey**

HDKWFBCPLKNOCK-SFHVURJKSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707310)

**PubChem compound IDs**

- 76959255

**RxNorm IDs (RxCUI)**

- 1998841

**FDA ingredient codes (UNII)**

- HEH4938D7K

## Regulatory information

### United States

**Applicant**

TARSUS

**Approval date**

24 Jul 2023

**Application number**

NDA217603

### Other regulatory facts

**Patents**

9

**Designations**

0

**Earliest recorded loss of exclusivity**

14 Dec 2038

**First in class**

Yes

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Drug name stem**

\-laner

#### Administration routes

- topical

### Investigated indications (4)

- **Condition**  
Blepharitis

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0009536

**Subject identifier**  
D001762
- **Condition**  
Rosacea

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000760

**Subject identifier**  
D012393
- **Condition**  
Eye Infections

**Highest recorded phase**  
4

**Condition identifier**  
EFO:1001888

**Subject identifier**  
D015817
- **Condition**  
Eye Infections, Parasitic

**Highest recorded phase**  
4

**Condition identifier**  
EFO:1001888

**Subject identifier**  
D015822

### Open Targets indications (10)

- **Condition identifier**  
EFO\_0009536

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1000760

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001888
- **Condition identifier**  
EFO\_1001888

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004785

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005101

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005980

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006604

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0015459
- **Condition identifier**  
MONDO\_0015459

**Highest recorded phase**  
4

### Trial references (4)

- NCT04475432  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04475432)
- NCT04784091  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04784091)
- NCT05629390  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629390)
- NCT05838170  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838170)

## Dosing

**Dose**

6 mg/kg

**Route**

Oral

**How often**

Once a month

### Conditions of use

- Administer with food

## Chemical properties

**Hydrogen bond acceptors**

5

**Hydrogen bond donors**

2

**Polar surface area**

79.79

**Calculated partition coefficient (ALogP)**

6.01

**Calculated partition coefficient (XLogP)**

6.6

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

2

**Rotatable bonds**

6

**Heavy atoms**

36

**Molecular formula**

C20H14Cl3F6N3O3S

**Monoisotopic mass**

594.972565

**Natural product**

No

## National Drug Codes

- 81942-125

## Evidence counts

**Recorded assays**

2

**Active assays**

1

### Active assay types

- Confirmatory

## Pharmacologic actions

- Antiparasitic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000977.html)

## Related records

### Trials (9)

- A Pharmacokinetic Study of TP-05 in Healthy Subjects
- A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects
- [A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure](https://trialight.com/data/trial/a-study-to-evaluate-safety-and-efficacy-of-tp-05-in-healthy-36bbc9a7-af6b-4fa7-8a63-3fa6390bb569.md)
- Demodex Blepharitis in Scleral Lens Wearers
- Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
- Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
- Study of TP-04 in Participants With Papulopustular Rosacea
- Study to Evaluate the Food Effect of TP-05 in Healthy Participants
- Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

### Approved for (2)

- Eye infectious disorder
- Parasitic eye infection

### In development for (2)

- Blepharitis Phase 3
- Rosacea Phase 2

### Other linked conditions (1)

- [Nasopharyngeal carcinoma](https://trialight.com/data/condition/nasopharyngeal-carcinoma-9ead4a97-f794-5dda-b62e-20f8ca202f89.md)

---

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