Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Rilzabrutinib LUNA 3 Phase 3 Study Met Primary Endpoint in Immune Thrombocytopenia
Details : PRN1008 (rilzabrutinib) is an oral, reversible covalent BTK inhibitor, small molecule drug candidate. It is being evaluated for the treatment of adults with immune thrombocytopenia.
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 23, 2024
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : PRN1008 (rilzabrutinib) is an oral, reversible covalent BTK inhibitor. It is being evaluated for the treatment of adults with moderate-to-severe chronic spontaneous urticaria.
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 24, 2024
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sanofi, a Leader in Immune-mediated Rare Blood Disorders, to Present Latest Data at EHA 2022
Details : PRN1008 (rilzabrutinib) is an oral Bruton’s tyrosine kinase (BTK) inhibitor incorporating Sanofi’s TAILORED COVALENCY® technology being investigated for the treatment of immune-mediated diseases, including ITP.
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 10, 2022
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Rilzabrutinib is an investigational oral Bruton tyrosine kinase inhibitor (BTKi) for the treatment of ITP, a rare acquired autoimmune disorder in which platelets are destroyed or damaged and for which there are limited treatment options.
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 14, 2022
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sanofi Provides Update on Phase 3 Study Evaluating Rilzabrutinib for the Treatment of Pemphigus
Details : Rilzabrutinib is a potential first-in-class, oral Bruton's tyrosine kinase (BTK) inhibitor in development for immune-mediated diseases. Rilzabrutinib’s safety profile remained consistent with previous results and no new safety signals were identified.
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 09, 2021
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Patient Enrollment Concluded Early in PEGASUS Phase 3 Pemphigus Trial for Rilzabrutinib
Details : PEGASUS is a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial enrolling approximately 120 participants to evaluate rilzabrutinib versus placebo, using a background treatment of tapering doses of corticosteroids (CS).
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 24, 2020
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018.
Brand Name : PRN1008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 18, 2020
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Principia Announces First Patient Dosed in Phase 2A Trial of Rilzabrutinib in IgG4-Related Disease
Details : The multicenter Phase 2A trial is anticipated to enroll approximately 25 patients with active IgG4-RD in two arms, rilzabrutinib with glucocorticoids or glucocorticoids only.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 17, 2020
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Principia Announces Positive Data from its Phase 2 Part B Trial in Pemphigus
Details : The significance of this Phase 2 Part B trial is that rilzabrutinib, a reversible covalent oral BTK inhibitor, demonstrated a 40 percent complete remission (CR) rate after 24 weeks of treatment while the median corticosteroid (CS) dose was reduced to 6 m...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 12, 2020
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Principia Announces AAD Late Breaker Research Presentation of its Pemphigus Phase 2 Part B Trial
Details : Dr. Dedee Murrell from University of New South Wales will present data from Phase 2 Part B pemphigus trial drug rilzabrutinib, Principia’s leading Bruton’s tyrosine kinase inhibitor.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 12, 2020
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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