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Drugs in Development
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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 II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Phase 2 Results Show Rilzabrutinib Reduced Itch Severity in Chronic Spontaneous Urticaria
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 III
Partner/Sponsor/Collaborator : 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
Partner/Sponsor/Collaborator : 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
Partner/Sponsor/Collaborator : 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
Partner/Sponsor/Collaborator : 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
Partner/Sponsor/Collaborator : 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 II
Partner/Sponsor/Collaborator : 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 III
Partner/Sponsor/Collaborator : 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
Partner/Sponsor/Collaborator : 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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 6859-99-0
End Use API : Rilzabrutinib
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
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A Rilzabrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rilzabrutinib, including repackagers and relabelers. The FDA regulates Rilzabrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rilzabrutinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Rilzabrutinib supplier is an individual or a company that provides Rilzabrutinib active pharmaceutical ingredient (API) or Rilzabrutinib finished formulations upon request. The Rilzabrutinib suppliers may include Rilzabrutinib API manufacturers, exporters, distributors and traders.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Rilzabrutinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rilzabrutinib API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Rilzabrutinib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Rilzabrutinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rilzabrutinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rilzabrutinib suppliers with NDC on PharmaCompass.
Rilzabrutinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Rilzabrutinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Rilzabrutinib GMP manufacturer or Rilzabrutinib GMP API supplier for your needs.
A Rilzabrutinib CoA (Certificate of Analysis) is a formal document that attests to Rilzabrutinib's compliance with Rilzabrutinib specifications and serves as a tool for batch-level quality control.
Rilzabrutinib CoA mostly includes findings from lab analyses of a specific batch. For each Rilzabrutinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Rilzabrutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Rilzabrutinib EP), Rilzabrutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rilzabrutinib USP).
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