Drug
Remibrutinib clinical trials
Also written LOU064.
- studies test it
- 35
- open now
- 12
- in phase 3
- 22
- first study started
- 2016
Keep track of what changes. Save the remibrutinib studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
34 studies that test it; most in 2025 (8); 1 more planned to start later
| Year | Studies |
|---|---|
| 2016 | 1 |
| 2019 | 5 |
| 2021 | 4 |
| 2022 | 4 |
| 2023 | 4 |
| 2025 | 8 |
| 2026 | 8 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 4
- Phase 2
- 9
- Phase 3
- 22
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 34 · Other 1
Novartis Pharmaceuticals (34) · Moein Amin (1)
Often tested with
Tested in the same studies.
Iscalimab (1) · LYS-006 (1) · Arumakimig (1) · Ianalumab (1) · Omalizumab (1)
Studies
Open first, then newest update. How each study uses remibrutinib is read from its arms, and is right about nine times in ten.
Testing it · 35
- Remibrutinib Open Label Roll-over Post-trial Access ProtocolRecruitingPhase 3Novartis PharmaceuticalsNCT07456891Written as Remibrutinib
- A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HSRecruitingPhase 1Novartis PharmaceuticalsNCT07855276Written as LOU064
- A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)RecruitingPhase 2Novartis PharmaceuticalsNCT07681271Written as LOU064
- A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)RecruitingPhase 3Novartis PharmaceuticalsNCT07700056Written as Remibrutinib
- An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HSRecruitingPhase 3Novartis PharmaceuticalsNCT07665437Written as Remibrutinib
- A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple SclerosisRecruitingPhase 3Novartis PharmaceuticalsNCT07225504Written as Remibrutinib (blinded)
- A 52-week Study of Remibrutinib in IgE-mediated Food AllergyRecruitingPhase 3Novartis PharmaceuticalsNCT07768371Written as Remibrutinib
- A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)RecruitingPhase 3Novartis PharmaceuticalsNCT07811869Written as Remibrutinib
- Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 WeeksRecruitingPhase 3Novartis PharmaceuticalsNCT07816328Written as Remibrutinib
- Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic UrticariaRecruitingPhase 2Novartis PharmaceuticalsNCT06865651Written as Remibrutinib
- Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.RecruitingPhase 3Novartis PharmaceuticalsNCT06846281Written as Remibrutinib oral treatment
- A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MSNot yet recruitingPhase 2Moein AminNCT07222956Written as Remibrutinib (Open Label)
- Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis SuppurativaCompletedPhase 2Novartis PharmaceuticalsNCT03827798Written as LOU064 25mg
- A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistaminesActive, not recruitingPhase 3Novartis PharmaceuticalsNCT05976243Written as Remibrutinib
- 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)Active, not recruitingPhase 3Novartis PharmaceuticalsNCT06799000Written as Remibrutinib Dose A
- 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-upActive, not recruitingPhase 3Novartis PharmaceuticalsNCT05677451Written as LOU064 (blinded)
- A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis SuppurativaActive, not recruitingPhase 3Novartis PharmaceuticalsNCT06840392Written as Remibrutinib Dose A
- Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.Active, not recruitingPhase 3Novartis PharmaceuticalsNCT06042478Written as Remibrutinib
- A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistaminesActive, not recruitingPhase 3Novartis PharmaceuticalsNCT06868212Written as Remibrutinib
- A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia GravisActive, not recruitingPhase 3Novartis PharmaceuticalsNCT06744920Written as Remibrutinib (Blinded)
Codes
What other systems call remibrutinib · ClinicalTrials.gg INT001907
- MeSH (NLM) C000722911remibrutinibConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) I7MVZ8HDNUREMIBRUTINIBConfirmed FDA, NLM, Wikidata
- Wikidata Q123499462remibrutinibConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C175851RemibrutinibOne source FDA
- DrugBank DB16852One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000722911 | remibrutinib | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | I7MVZ8HDNU | REMIBRUTINIB | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q123499462 | remibrutinib | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C175851 | Remibrutinib | One source FDA |
| DrugBank | DB16852 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.