drug · small molecule
remibrutinib
Marketedupdated 5mo agoby $NVS NOVARTIS AG🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for immune system disease and 5 investigational indications.
all catalysts(1)
Trials studying remibrutinib
- phase3A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
- phase3A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
- phase3Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
- phase2Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
- phase3An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
- phase3Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
- phase3A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
- phase3A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 30, 2030
~4.0 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (3)
- Jan 20, 2043method-of-use (U-4281)US 12419889
- Nov 13, 2034method-of-use (U-4280)US 10457647
- Nov 13, 2034compositionUS 9512084
FDA exclusivities (1)
- Sep 30, 2030NCENew Chemical Entity (5y)4.0y
News(10)
- FDA starts review of Roche’s multiple sclerosis pillThe FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s program.biopharma_dive · 3d ago
- Novartis ends ALS program after phase 2 flop, adding to R&D woesNovartis has extended its losing streak, stopping an amyotrophic lateral sclerosis program after flunking a phase 2 trial.fiercebiotech · 17d ago
- Novartis’ board faces investor scrutiny after M&A misfires and R&D flopsBack-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.biospace · 23d ago
- Novartis shareholder calls for board overhaul following costly deal setbacks: ReutersNovartis’ recent dual clinical setbacks have prompted questions from a major shareholder about the board’s oversight of dealmaking.fiercebiotech · 23d ago
- Novartis stock slides as centerpiece of $12B Avidity buyout flunks ‘crucial’ phase 3 testThe phase 3 Harbor trial of Novartis’ del-desiran has missed its primary endpoint, dealing a major blow to an asset that the Swiss drugmaker acquired in the $12 billion takeover of Avidity Bioscien…fiercebiotech · 26d ago
- Novartis’ Rhapsido cuts MS progression in Phase 3 trial, teeing up Roche battleNovartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche's own BTK inhibitor fenebrutinib.biospace · 1mo ago
- Novartis says MS pill succeeds in two large studiesNotably, Novartis revealed that remibrutinib wasn’t associated with the kind of liver-related side effects other BTK inhibitors like it have encountered.biopharma_dive · 1mo ago
- Novartis' Rhapsido safer than rivals, Phase 3 multiple sclerosis data suggestNovartis’ BTK inhibitor Rhapsido has a chance of expanding from a chronic itch treatment to the multiple sclerosis market following wins in two identical Phase 3 trials. The pill significantly cut…endpoints · 1mo ago
- Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ RhapsidoProcessa Pharmaceuticals has made a push into the autoimmune space via the acquisition of Vidya Therapeutics, which delivers a potential rival to Novartis’ Rhapsido.fiercebiotech · 2mo ago
- Novartis climbs on upbeat drug sales as key readouts loomA return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.biopharma_dive · 2mo ago
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