Remibrutinib
Highest phase reached
Phase 3
Drug type
Small molecule
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Small molecule
- Drug name
- Remibrutinib
- Molecular weight
- 507.54
- Structure (SMILES)
- C=CC(=O)N(C)CCOc1c(N)ncnc1-c1cc(F)cc(NC(=O)c2ccc(C3CC3)cc2F)c1C
- 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
- ATC classification codes
- L04AA60
Sources for recorded values
- CAS registry numbers
- 1787294-07-8
- ChEMBL ID
- CHEMBL4483575
- InChIKey
- CUABMPOJOBCXJI-UHFFFAOYSA-N
- PubChem compound IDs
- 118107483
- RxNorm IDs (RxCUI)
- 2724365
- FDA ingredient codes (UNII)
- I7MVZ8HDNU
- 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
- 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 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
- 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
- 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
- NCT04035668
- NCT05030311
- NCT05032157
- NCT05513001
- NCT05677451
- NCT06042478
- NCT05147220
- NCT05156281
- NCT05432388
- NCT05753592
- 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
- 0078-1483
- Recorded assays
- 342
- Active assays
- 24
Active assay types
- Confirmatory
- Tyrosine Kinase Inhibitors
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 Phase 3
- Liver disorder Phase 1
- Multiple sclerosis Phase 3
- Sjogren syndrome Phase 2