Drugs / Remibrutinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rhapsido | — | 2026-04-23 | europa.eu ↗ |
| Approved | US (FDA) | RHAPSIDO | — | 2025-09-30 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07032272 | Jul → Oct 2025 | immune dysregulation, autoimmunity, and autoinflammation | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05753592 | Oct 2022 → Dec 2023 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03918980 | Aug 2016 → Jan 2020 | atopic eczema | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07681271 | Jul 2026 → Dec 2027 expected | rosacea | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07222956 | Jun 2026 → Oct 2030 expected | primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Moein Amin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06865651 | May 2025 → Aug 2027 expected | chronic urticaria | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT05432388 | Oct 2022 → Mar 2025 | food allergy | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04109313 | Oct 2019 → Sep 2022 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03944707 | Jul 2019 → Apr 2020 | asthma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04035668 | Jul 2019 → Nov 2021 | Sjogren syndrome | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03926611 | Jun 2019 → Jan 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03827798 | Feb 2019 → Dec 2024 overdue | hidradenitis suppurativa | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT07700056 | Aug 2026 → Dec 2029 expected | — | Novartis Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07665437 | Jul 2026 → Oct 2031 expected | hidradenitis suppurativa | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07456891 | Apr 2026 → Jan 2033 expected | — | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07225504 | Nov 2025 → Dec 2030 expected | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06868212 | Jul 2025 → Feb 2027 expected | chronic idiopathic urticaria | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06846281 | Jun 2025 → Jul 2029 expected | multiple sclerosis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06840392 | Mar 2025 → Jun 2027 expected | hidradenitis suppurativa | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06744920 | Feb 2025 → Feb 2028 expected | generalized myasthenia gravis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06799000 | Jan 2025 → May 2027 expected | hidradenitis suppurativa | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05976243 | Dec 2023 → May 2026 overdue | chronic inducible urticaria | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06042478 | Nov 2023 → Sep 2025 overdue | chronic urticaria | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05677451 | Jul 2023 → Nov 2026 expected | chronic idiopathic urticaria | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05795153 | Apr 2023 → Apr 2024 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05513001 | Dec 2022 → Aug 2024 overdue | chronic idiopathic urticaria | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05048342 | Jan 2022 → Dec 2023 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05147220 | Dec 2021 → Jul 2026 overdue | multiple sclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05156281 | Dec 2021 → Jul 2026 overdue | multiple sclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05032157 | Dec 2021 → Dec 2023 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05030311 | Nov 2021 → Dec 2023 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05170724 | — | chronic urticaria | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-27 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria (CSU) novartis.com ↗ |
| 2026-02-23 | Novartis Pharmaceuticals | Novartis presents Rhapsido® (remibrutinib) data at AAAAI, showing potential beyond chronic spontaneous urticaria (CSU) novartis.com ↗ |
| 2026-02-18 | Novartis Pharmaceuticals | Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU) novartis.com ↗ |
| 2025-09-30 | Novartis Pharmaceuticals | Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU) novartis.com ↗ |
| 2024-05-31 | Novartis Pharmaceuticals | Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria novartis.com ↗ |
| 2023-11-09 | Novartis Pharmaceuticals | Novartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2 novartis.com ↗ |
| 2023-08-09 | Novartis Pharmaceuticals | Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria novartis.com ↗ |
| 2021-09-30 | Novartis Pharmaceuticals | Novartis data show rapid and effective disease activity control with remibrutinib (LOU064) in patients with chronic spontaneous urticaria novartis.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | remibrutinib | “Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor, offers fast disease control in patients with chronic spontaneous urticaria (CSU) who remain...” PMID 37866460 ↗ Oct 2023 |
| Known as | LOU064 | “A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of...” NCT05976243 ↗15“Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor, offers fast disease control in patients with chronic spontaneous urticaria (CSU) who remain...” PMID 37866460 ↗ Oct 2023 “The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks” NCT06042478 ↗ “Remibrutinib (LOU064) in Participants With Hepatic Impairment” NCT05753592 ↗ |
| Known as | LOU064-NXA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4483575 ↗ |
| Known as | NVP-LOU064-NXA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4483575 ↗ |
| Action | Inhibit | “Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor” PMID 37866460 ↗ Oct 2023 |
| Modality | Small molecule | — CHEMBL4483575 ↗ |
| Route | Oral | “LOU064 25 mg administered orally” NCT03827798 ↗ |
| Target | BTK | “Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor” PMID 37866460 ↗ Oct 2023 |