MedPath

Rilzabrutinib

Generic Name
Rilzabrutinib
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C36H40FN9O3
CAS Number
1575591-66-0
Unique Ingredient Identifier
5G1WE425BI
Background

Rilzabrutinib is an oral, reversible covalent inhibitor of Bruton's tyrosine kinase being investigated for the treatment of immune disorders, such as immune thrombocytopenic purpura.

Associated Conditions
-
Associated Therapies
-
synapse.patsnap.com
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First Positive Phase 3 BTK Inhibitor Study in ITP Shows Efficacy with Rilzabrutinib

Rilzabrutinib, an oral BTK inhibitor, showed efficacy in treating immune thrombocytopenia (ITP) in the LUNA 3 phase 3 study, with 65% of patients achieving a platelet response. It significantly improved quality of life, reduced bleeding, and decreased the need for rescue therapy. Safety profile was consistent with previous studies. Currently under regulatory review, it holds promise for ITP and other immune-mediated diseases.

Positive Phase 3 Trial Results for Rilzabrutinib Support Buy Rating Amidst Strong Efficacy and Safety Profile

Leerink Partners analyst David Risinger reiterated a Buy rating for SNYNF, citing positive Phase 3 LUNA 3 trial results for rilzabrutinib in treating ITP, showing significant efficacy and safety. Berenberg Bank also maintained a Buy rating. Sanofi, a pharmaceutical company, focuses on research, production, and distribution across various segments.

Phase III trial of rilzabrutinib for thrombocytopenia meets endpoint

Sanofi's Phase III LUNA 3 trial of rilzabrutinib for persistent or chronic immune thrombocytopenia (ITP) met its primary endpoint, showing a 23% durable platelet response in therapy-treated adults. The study involved a 24-week treatment period with rilzabrutinib 400mg twice daily or placebo, followed by a 28-week open-label period. A 65% platelet response rate was observed in the therapy group versus 33% in the placebo group, with significant improvements in secondary endpoints like decreased bleeding and need for rescue therapy. The therapy is under regulatory review in the EU and US.
pmlive.com
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Sanofi's rilzabrutinib shows promise in phase 3 immune thrombocytopenia study

Sanofi's phase 3 LUNA 3 study of rilzabrutinib, an oral BTK inhibitor for immune thrombocytopenia (ITP), showed durable platelet response in 23% of patients vs. 0% in placebo. Rilzabrutinib also demonstrated significant improvements in bleeding reduction, rescue therapy use, and quality of life measures.
yahoo.com
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Sanofi's Phase III trial of rilzabrutinib for thrombocytopenia meets endpoint

Sanofi's Phase III LUNA 3 trial of rilzabrutinib for immune thrombocytopenia met primary endpoint, showing 23% durable platelet response. Rilzabrutinib demonstrated a 65% platelet response rate, compared to 33% for placebo, with significant improvements in secondary endpoints and quality of life measures. The therapy is under regulatory review in the EU and US.
marketscreener.com
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Positive phase III data in IPT

Sanofi presents positive phase III results for rilzabrutinib in treating persistent or chronic ITP at ASH annual meeting, showing rapid and durable platelet response, reduced bleeding, and improved quality of life.
biopharma-asia.com
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Sanofi's rilzabrutinib demonstrates significant benefit in phase 3 study for immune thrombocytopenia

Sanofi's rilzabrutinib shows promise in treating immune thrombocytopenia (ITP) in a phase 3 study, with 65% of patients achieving platelet response versus 33% on placebo. It offers a favorable safety profile and significant improvements in platelet count, quality of life, and bleeding reduction.
pharmiweb.com
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ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP

Rilzabrutinib showed rapid, durable platelet response, reduced bleeding, and improved quality of life in ITP patients in the LUNA 3 phase 3 study. 65% on rilzabrutinib achieved platelet response vs. 33% on placebo. It's under US and EU regulatory review, offering hope for ITP treatment.
biospace.com
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Press Release: ASH: rilzabrutinib demonstrated significant benefits in phase 3 study for ITP patients

Rilzabrutinib, a BTK inhibitor, showed significant benefits in a phase 3 study for ITP patients, achieving durable platelet response in 23% vs. 0% on placebo, reducing bleeding, and improving quality of life. It's under regulatory review in the US and EU, with potential as a first-in-class ITP treatment.
medpagetoday.com
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Novel BTK Inhibitor Succeeds in Heavily Pretreated Immune Thrombocytopenia

Rilzabrutinib, an oral BTK inhibitor, demonstrated safety and efficacy in boosting platelet counts in heavily pretreated ITP patients, achieving a durable platelet response in 23% vs. 0% placebo at week 25. The study met secondary endpoints, showing reduced fatigue, rescue medication use, and bleeding events. Rilzabrutinib may offer a safer treatment option for ITP compared to first-generation BTK inhibitors.
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