drug · small molecule
rilzabrutinib
Marketedupdated 3mo agoby $SNY Sanofi🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for autoimmune thrombocytopenic purpura and 10 investigational indications.
indications
investigational
Sickle Cell Disease
targets
Tyrosine-protein kinase BTK
all catalysts(0)
nothing on the calendar yet
Trials studying rilzabrutinib
- phase2Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
- phase3The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
- phase3A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
- phase3A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
- phase2A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
- phase2A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
- phase3Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
- phase2A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Aug 29, 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 (6)
- Feb 20, 2041compositionUS 11708370
- Oct 13, 2040method-of-use (U-4267)US 12178818
- Sep 6, 2033compositionUS 8940744
- Sep 6, 2033compositionUS 9266895
- Sep 6, 2033compositionUS 9994576
- Mar 1, 2033compositionUS 9580427
FDA exclusivities (1)
- Aug 29, 2030NCENew Chemical Entity (5y)4.0y
News(1)
- Sanofi MS drug rejected in US gets an endorsement in EuropeTolebrutinib, which the FDA recently turned back due to safety concerns, received a positive recommendation that positions the therapy for its first regulatory approval.biopharma_dive · 3mo ago
Data sources
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