Drugs / Remibrutinib
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic idiopathic urticaria 3 milestones | |||||
| Filed | China (NMPA) | — | chronic idiopathic urticaria | 2025-04-29 | “Regulatory submissions for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) were completed in the US, EU and China.” novartis.com ↗ |
| Filed | EU (EMA) | — | chronic idiopathic urticaria | 2025-04-29 | “Regulatory submissions for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) were completed in the US, EU and China.” novartis.com ↗ |
| Filed | US (FDA) | — | chronic idiopathic urticaria | 2025-04-29 | “Regulatory submissions for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) were completed in the US, EU and China.” novartis.com ↗ “FDA submission for remibrutinib in the symptomatic dermographism subtype of chronic inducible urticaria (CIndU) was completed” novartis.com ↗ |
| Filed familial dermatographia 1 milestone | |||||
| Filed | US (FDA) | Rhapsido | familial dermatographia | — | “Rhapsido is under FDA review for CIndU symptomatic dermographism subtype” novartis.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Rhapsido | — | 2026-04-23 | europa.eu ↗ |
| Approved | US (FDA) | RHAPSIDO | — | 2025-09-30 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07855276 | Oct 2026 → Jun 2028 expected | hidradenitis suppurativa | Novartis Pharmaceuticals | Not yet recruiting | No outcome recorded |
| 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 · 3 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| Phase 2 | NCT04035668 | Jul 2019 → Nov 2021 | Sjogren syndrome | Novartis Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT03926611 | Jun 2019 → Jan 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03827798 | Feb 2019 → Dec 2024 overdue | hidradenitis suppurativa | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 322 trials · 3 met primary | ||||||
| Phase 3 | NCT07811869 | Oct 2026 → Feb 2029 expected | — | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07816328 | Sep 2026 → Jun 2028 expected | chronic idiopathic urticaria | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07768371 | Aug 2026 → Mar 2029 expected | food allergy | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07700056 | Aug 2026 → Dec 2029 expected | — | Novartis Pharmaceuticals | 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 | Active not 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT05030311 | Nov 2021 → Dec 2023 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05170724 | — | chronic urticaria | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | Novartis Pharmaceuticals | Regulatory Novartis Rhapsido® (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU) novartis.com ↗
Basel, October 7, 2026 – Novartis announced today that the U.S. Food and Drug Administration (FDA) approved Rhapsido® (remibrutinib), an oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi), as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. |
| 2026-09-01 | Novartis Pharmaceuticals | Results Novartis remibrutinib, a high-efficacy oral BTK inhibitor, significantly reduces relapse rates and shows favorable safety profile in Phase III RMS trials novartis.com ↗
Basel, September 1, 2026 – Novartis today announced positive topline results from its Phase III REMODEL-1/-2 trials of remibrutinib in relapsing multiple sclerosis. |
| 2026-06-12 | Novartis Pharmaceuticals | Results Novartis RemIND data at EAACI show Rhapsido® potential as first targeted therapy for chronic inducible urticaria (CIndU) novartis.com ↗
In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. |
| 2026-04-27 | Novartis Pharmaceuticals | Regulatory Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria novartis.com ↗
Novartis announced today that the European Commission (EC) approved Rhapsido ® (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. |
| 2026-02-27 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria (CSU) novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for remibrutinib. |
| 2026-02-18 | Novartis Pharmaceuticals | Results Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU) novartis.com ↗
The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria and cholinergic urticaria, achieving significantly higher complete response rates versus placebo at Week 12 1 . |
| 2025-09-30 | Novartis Pharmaceuticals | Regulatory Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU) novartis.com ↗
Novartis announced today that Rhapsido ® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. |
| 2025-07-17 | Novartis Pharmaceuticals | Results Novartis reports strong Q2 with double-digit sales growth and core margin expansion; raises FY 2025 core operating income guidance novartis.com ↗
A Phase II study with remibrutinib in food allergy met its primary endpoint with a statistically significant and clinically meaningful benefit. |
| 2024-05-31 | Novartis Pharmaceuticals | Results Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria novartis.com ↗
Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU) 1 . |
| 2023-11-09 | Novartis Pharmaceuticals | Results 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 | Results Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria novartis.com ↗
Novartis today announced positive top-line results from the Phase III REMIX-1 and REMIX-2 studies evaluating remibrutinib 25 mg b.i.d., a Bruton’s tyrosine kinase (BTK) inhibitor, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines |
| 2021-09-30 | Novartis Pharmaceuticals | Results Novartis data show rapid and effective disease activity control with remibrutinib (LOU064) in patients with chronic spontaneous urticaria novartis.com ↗
Novartis today announced positive Phase IIb data showing remibrutinib (LOU064), a potentially best-in-class oral BTK inhibitor, demonstrated rapid and effective disease control in patients with inadequately controlled chronic spontaneous urticaria (CSU). |
| 2021-09-29 | Novartis Pharmaceuticals | Results Novartis data show achieving complete control of chronic spontaneous urticaria (CSU) improves overall quality of life, as reported by patients novartis.com ↗
Novartis will also present late-breaking Phase II data for remibrutinib in CSU, showing that multiple doses provide significant improvements from baseline versus placebo with a favorable safety profile across the entire dose range. |
All press releases naming this drug 14 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 37 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 202324“This study aims to better understand how Bruton's tyrosine kinase (BTK) inhibition with remibrutinib works in hidradenitis suppurativa (HS), a complex inflammatory disease with...” NCT07855276 ↗ “LOU064 (remibrutinib)” NCT05795153 ↗ |
| 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 |