> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/azetukalner-bdf1d84d-c0a0-49bc-a75e-2afa9bab990b
> Record changed: 2026-11-04

# Azetukalner

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

**Drug name**

Azetukalner

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

**Molecular weight**

368.5

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

**Structure (SMILES)**

Cc1cc(N2CCc3cc(F)ccc3C2)cc(C)c1NC(=O)CC(C)(C)C

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

### Other names (16)

- azetukalner
- Azetukalner
- azetukalner \[INN\]
- AZETUKALNER \[USAN\]
- azetukalner inn
- azetukalner usan
- encukalner
- Encukalner
- xen 1101
- XEN-1101
- xen1101
- XEN1101
- xen1101 10 mg
- XEN1101 10 mg
- xen1101 20 mg
- XEN1101 20 mg

## Identifiers

**CAS registry numbers**

- 1009344-33-5

**ChEMBL ID**

CHEMBL5095264

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

**InChIKey**

FJNPZKZPWVVSON-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095264)

**PubChem compound IDs**

- 24743936

**FDA ingredient codes (UNII)**

- 91WL7OD122

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Pharmacology name**

azetukalner

**Type**

Synthetic organic

**Drug name stem**

\-kalner

### Mechanisms of action (2)

- **Action**  
Activation

**Action type**  
ACTIVATION

**Target**  
Kv7.3

**Gene symbol**  
KCNQ3

**Protein identifier**  
O43525
- **Action**  
Activation

**Action type**  
ACTIVATION

**Target**  
Kv7.2

**Gene symbol**  
KCNQ2

**Protein identifier**  
O43526

### Investigated indications (5)

- **Condition**  
Epilepsies, Partial

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004263

**Subject identifier**  
D004828
- **Condition**  
Seizures

**Highest recorded phase**  
3

**Condition identifier**  
HP:0001250

**Subject identifier**  
D012640
- **Condition**  
Epilepsy, Tonic-Clonic

**Highest recorded phase**  
3

**Condition identifier**  
HP:0002069

**Subject identifier**  
D004830
- **Condition**  
Depressive Disorder, Major

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002009

**Subject identifier**  
D003865
- **Condition**  
Depression

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0002050

**Subject identifier**  
D003863

### Open Targets indications (11)

- **Condition identifier**  
EFO\_0000474

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0004263

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0001250
- **Condition identifier**  
HP\_0001250

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0002069

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0007359

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002009

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002050
- **Condition identifier**  
MONDO\_0004985

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005027

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005384

**Highest recorded phase**  
2

### Trial references (6)

- NCT03796962  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03796962)
- NCT04827901  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04827901)
- NCT05376150  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05376150)
- NCT05614063  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05614063)
- NCT05716100  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05716100)
- NCT05667142  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05667142)

## Chemical properties

**Hydrogen bond acceptors**

2

**Hydrogen bond donors**

1

**Polar surface area**

32.34

**Calculated partition coefficient (ALogP)**

5.38

**Calculated partition coefficient (XLogP)**

5.2

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

3

**Heavy atoms**

27

**Molecular formula**

C23H29FN2O

**Monoisotopic mass**

368.22639171

**Natural product**

No

## Evidence counts

**Recorded assays**

1

**Active assays**

1

### Active assay types

- Confirmatory

## Related records

### Trials (13)

- A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
- A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
- A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
- A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
- A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
- A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
- A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
- A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
- An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
- An Open-Label Study of Azetukalner in Major Depressive Disorder
- [An Open-label Study of XEN1101 in Epilepsy](https://trialight.com/data/trial/an-open-label-study-of-xen1101-in-epilepsy-0d699eef-135a-4609-a1a7-1559c7e18529.md)
- Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
- XEN1101 for Major Depressive Disorder

### In development for (7)

- [Bipolar disorder](https://trialight.com/data/condition/bipolar-disorder-a61ecd6f-6fb9-5323-bc0d-ebf861411d3c.md) Phase 3
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 1
- [Epilepsy](https://trialight.com/data/condition/epilepsy-633a5321-bf08-5a6b-8459-d44b2b00904e.md) Phase 1
- Epilepsy with generalized tonic-clonic seizures Phase 3
- [Focal epilepsy](https://trialight.com/data/condition/focal-epilepsy-33745322-62b7-5575-aa6a-87e311f726cc.md) Phase 2
- [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Phase 2
- [Visual epilepsy](https://trialight.com/data/condition/visual-epilepsy-9eee333f-f968-5e66-b952-f1f9696c6533.md) Phase 3

### Targets (2)

- [KCNQ2](https://trialight.com/data/target/kcnq2-415ec5cd-814f-5e15-9777-685a63a649db.md)
- [KCNQ3](https://trialight.com/data/target/kcnq3-4e92323c-a44a-58a7-81df-40cf413ca7e5.md)

---

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