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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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2024
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2024
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
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).
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
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 mg.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2020
RDD 2024
Not Confirmed
Contact Supplier
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