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Also known as rilzabrutinib, Rilzabrutinib
Rilzabrutinib dose 1 · 1 trial · 1 indication
Free thyroxine
| Arm | Type | Description |
|---|---|---|
| Rilzabrutinib dose 1 | EXPERIMENTAL | Rilzabrutinib |
| Rilzabrutinib dose 2 | EXPERIMENTAL | Rilzabrutinib |
| Name | Type | Description |
|---|---|---|
| Rilzabrutinib dose 1 | DRUG | Pharmaceutical form:Tablet-Route of administration:Oral |
| Rilzabrutinib dose 2 | DRUG | Pharmaceutical form:Tablet-Route of administration:Oral |
Inclusion Criteria: * Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening. * A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at s...
Rilzabrutinib is an investigational small molecule being studied for immune thrombocytopenia (ITP), atopic dermatitis, warm autoimmune hemolytic anemia, chronic spontaneous urticaria, and hepatic function abnormalities. It is also evaluated in healthy volunteers. The drug is not approved and remains in clinical development.
Rilzabrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It is designed to inhibit Bruton's tyrosine kinase (BTK), a key enzyme in B-cell and mast cell signaling pathways. This mechanism is being investigated for autoimmune and allergic conditions.
Rilzabrutinib is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Rilzabrutinib is in Phase 2 and Phase 3 clinical trials. It has completed Phase 2 studies and is currently in Phase 3 trials for immune thrombocytopenia. The drug has received orphan drug and fast track designations from the FDA, but it is not yet approved.
Rilzabrutinib is being studied in several trials, including NCT03395210 (Phase 2, completed, ITP), NCT04562766 (Phase 3, active, ITP), NCT05018806 (Phase 2, completed, atopic dermatitis), and NCT07216079 (Phase 3, active, ITP in Japan). These trials are randomized, double-blind, and placebo-controlled.
Yes, Rilzabrutinib is also known as Rilzabrutinib dose 1. This alternative name may be used in clinical trial documentation or dosing protocols. Both names refer to the same investigational drug developed by Sanofi.