> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/remibrutinib-75d9d8dd-832c-4f8a-af6e-5f02229693d6
> Record changed: 2026-10-13

# Remibrutinib

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

**Drug name**

Remibrutinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

**Molecular weight**

507.54

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

**Structure (SMILES)**

C=CC(=O)N(C)CCOc1c(N)ncnc1-c1cc(F)cc(NC(=O)c2ccc(C3CC3)cc2F)c1C

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

### Other names (18)

- lou064 nxa
- LOU064-NXA
- nvp lou064 nxa
- NVP-LOU064-NXA
- remibrutinib
- Remibrutinib
- Remibrutinib (blinded)
- Remibrutinib (Blinded)
- Remibrutinib (Open label)
- Remibrutinib (Open Label)
- remibrutinib \[INN\]
- REMIBRUTINIB \[USAN\]
- Remibrutinib \[WHO-DD\]
- remibrutinib inn
- remibrutinib usan
- remibrutinib who dd
- rhapsido
- RHAPSIDO

## Identifiers

**ATC classification codes**

- L04AA60

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

**CAS registry numbers**

- 1787294-07-8

**ChEMBL ID**

CHEMBL4483575

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

**InChIKey**

CUABMPOJOBCXJI-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4483575)

**PubChem compound IDs**

- 118107483

**RxNorm IDs (RxCUI)**

- 2724365

**FDA ingredient codes (UNII)**

- I7MVZ8HDNU

## Regulatory information

### European Union

**Status**

Authorised

**Status date**

23 Apr 2026

**Authorisation date**

23 Apr 2026

**Approved indications**

Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.

**Product number**

EMEA/H/C/006313

**Authorisation holder**

Novartis Europharm Limited

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Urticaria

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/rhapsido)

### Other regulatory facts

**Patents**

3

**Designations**

0

**Earliest recorded loss of exclusivity**

19 Jan 2043

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

## Pharmacology

### Drug classification

**Pharmacology name**

remibrutinib

**Type**

Synthetic organic

**Drug name stem**

\-tinib

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
Bruton tyrosine kinase

**Gene symbol**  
BTK

**Protein identifier**  
Q06187

**Median affinity**  
9

**Affinity units**  
pIC50

### Investigated indications (6)

- **Condition**  
Immune System Diseases

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000540

**Subject identifier**  
D007154
- **Condition**  
Sjogren's Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000699

**Subject identifier**  
D012859
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Hypersensitivity

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005271

**Subject identifier**  
D006967
- **Condition**  
Multiple Sclerosis

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005301

**Subject identifier**  
D009103
- **Condition**  
Chronic Urticaria

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0044212

**Subject identifier**  
D000080223

### Open Targets indications (15)

- **Condition identifier**  
EFO\_0000540
- **Condition identifier**  
EFO\_0000699

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001421

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0007425

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004979

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005046

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005271

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005301

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005492

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0006534

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006559

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0009688

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0010030

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0022799

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0044212

**Highest recorded phase**  
3

### Trial references (10)

- NCT04035668  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04035668)
- NCT05030311  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030311)
- NCT05032157  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05032157)
- NCT05513001  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05513001)
- NCT05677451  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05677451)
- NCT06042478  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06042478)
- NCT05147220  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05147220)
- NCT05156281  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281)
- NCT05432388  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05432388)
- NCT05753592  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753592)

## Chemical properties

**Hydrogen bond acceptors**

6

**Hydrogen bond donors**

2

**Polar surface area**

110.44

**Calculated partition coefficient (ALogP)**

4.47

**Calculated partition coefficient (XLogP)**

3.9

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

9

**Heavy atoms**

37

**Molecular formula**

C27H27F2N5O3

**Monoisotopic mass**

507.20819606

**Natural product**

No

## National Drug Codes

- 0078-1483

## Evidence counts

**Recorded assays**

342

**Active assays**

24

### Active assay types

- Confirmatory

## Pharmacologic actions

- Tyrosine Kinase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000092004.html)

## Biological measurements

These details could not be displayed.

## Related records

### Trials (94)

- 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
- A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)
- A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
- A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
- A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa
- A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
- A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
- A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
- A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
- A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
- A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
- A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
- A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
- A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
- A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines
- A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
- A Safety, Tolerability, PD and PK Study in Healthy Adults
- A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
- A Study of LAM-003 in Patients With Acute Myeloid Leukemia
- A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

### In development for (6)

- Allergic disease Phase 2
- Chronic idiopathic urticaria Phase 3
- [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) Phase 3
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 3
- [Sjogren syndrome](https://trialight.com/data/condition/sjogren-syndrome-a76424ca-3898-5b4e-82c0-867f8103dce0.md) Phase 2

---

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