A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Start Date19 Dec 2024

Sponsor / Collaborator

Sanofi

NCT06342700

/ CompletedPhase 1

A Randomized, Open-label, Single-dose, 4-period, 4--sequence, Crossover Phase I Relative Bioavailability Study Comparing Crystalline Formulation Tablet Versus Reference Amorphous Formulation Tablet of Rilzabrutinib (SAR444671) in Fasted and Fed Conditions in Healthy Male and Female Participants

This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.
The total study duration per participant is expected to be up to 36 days, including:
Screening: up to 4 weeks
Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.
Washout: One day washout is planned after each treatment period hence providing 2 days between doses.
Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.

Start Date25 Mar 2024

Sponsor / Collaborator

Sanofi

ChiCTR2300069707

/ CompletedPhase 1IIT

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, safety and Tolerability of Rilzabrutinib (PRN1008/ SAR444671) in Chinese Healthy Male and Female Subjects

Start Date23 Mar 2023

Sponsor / Collaborator-

100 Clinical Results associated with Rilzabrutinib

100 Translational Medicine associated with Rilzabrutinib

100 Patents (Medical) associated with Rilzabrutinib

Literatures (Medical) associated with Rilzabrutinib

01 Mar 2025·American Journal of Hematology

Efficacy and Safety Results With Rilzabrutinib, an Oral Bruton Tyrosine Kinase Inhibitor, in Patients With Immune Thrombocytopenia: Phase 2 Part B Study

Article

Author: Bird, Robert ; Percy, Charles ; Košťál, Milan ; Bogdanov, Lachezar H. ; Cooper, Nichola ; Tarantino, Michael D. ; Mayer, Jiří ; Gernsheimer, Terry B. ; Goncalves, Isaac ; McDonald, Vickie ; Kuter, David J. ; Daak, Ahmed ; Garg, Mamta ; Sholzberg, Michelle ; Yao, Mengjie ; Diab, Remco ; Jansen, A. J. Gerard ; Ypma, Paula F.

ABSTRACTCurrent treatments for persistent or chronic immune thrombocytopenia (ITP) are limited by inadequate response, toxicity, and impaired quality of life. The Bruton tyrosine kinase inhibitor rilzabrutinib was evaluated to further characterize safety and durability of platelet response. LUNA2 Part B is a multicenter, phase 1/2 study in adults with ITP (≥ 3 months duration, platelet count < 30 × 109/L) who failed ≥ 1 ITP therapy (NCT03395210, EudraCT 2017–004012‐19). Oral rilzabrutinib 400 mg bid was given over 24 weeks, with optional long‐term extension (LTE). Primary endpoints were safety and platelet counts ≥ 50 × 109/L on ≥ 8 of the last 12 weeks of main treatment without rescue medication. From 22 March2018 to 31 January2023, 26 patients were enrolled. Patients had baseline median platelet count 13 × 109/L, ITP duration 10.3 years, and six prior ITP therapies (46% splenectomized). Nine (35%) patients achieved the primary endpoint. Platelet counts ≥ 50 × 109/L or ≥ 30 × 109/L and doubling from baseline without rescue therapy were sustained for a mean 9.3 weeks. 11 (42%) LTE‐eligible patients were ongoing with median LTE platelet > 80 × 109/L. Three (12%) patients received rescue medication during main treatment, none in LTE. Clinically meaningful improvements were observed in fatigue and women's health. With a median treatment duration of 167 days (main treatment), 16 (62%) patients had ≥ 1 treatment‐related adverse event (AE), mainly grade 1, including diarrhea (35%), headache (23%), and nausea (15%). There was no treatment‐related grade ≥ 2 bleeding/thrombotic events/infections, serious AE, or death. Rilzabrutinib continues to demonstrate durable platelet responses with favorable safety profile in previously treated ITP patients.Trial Registration: NCT03395210, EudraCT 2017‐004012‐19

12 Nov 2024·Blood Advances

Selective Btk inhibition by PRN1008/PRN473 blocks human CLEC-2, and PRN473 reduces venous thrombosis formation in mice

Article

Author: Thomas, Mark R. ; Mukai, Shin ; Jooss, Natalie J. ; Perez-Toledo, Marisol ; Nicolson, Phillip L. R. ; Foulke, Matthew C. ; Chauhan, Abhi ; Nunn, Philip A. ; Jossi, Sian ; Owens, Tim ; Francesco, Michelle ; Langrish, Claire ; Brown, Helena C. ; LaStant, Jacob ; Storek, Michael ; Ivanova, Vanesa-Sindi ; Cunningham, Adam F. ; Rookes, Kieran ; Campos, Joana ; Harbi, Maan ; Brill, Alexander ; Theodore, Lindsay N. ; Watson, Steve P. ; Hicks, Alexandra ; Garcia-Quintanilla, Lourdes ; Smith, Christopher W.

AbstractPlatelet C-type lectin-like receptor 2 (CLEC-2) is a hem-immunoreceptor tyrosine–based activation motif-containing receptor that has a critical role in venous thrombosis but minimal involvement in hemostasis. CLEC-2 can be blocked by Btk inhibitors. Treatment with ibrutinib is associated with increased bleeding due to off-target inhibition of Src family kinases (SFKs). Patients with X-linked agammaglobulinemia (XLA) who lack Btk, however, do not bleed, suggesting selective Btk inhibition as a viable antithrombotic strategy. We assessed the effects of selective Btk inhibitors PRN1008 (rilzabrutinib) and PRN473 on platelet signaling and function mediated by CLEC-2 and glycoprotein-VI. We used healthy donors and XLA platelets to determine off-target inhibitor effects. Inferior vena cava (IVC) stenosis and Salmonella infection mouse models were used to assess antithrombotic effects of PRN473 in vivo. PRN1008 and PRN473 potently inhibited CLEC-2–mediated platelet activation to rhodocytin. No off-target inhibition of SFKs was seen. PRN1008 treatment of Btk-deficient platelets resulted in minor additional inhibition of aggregation and tyrosine phosphorylation, likely reflecting inhibition of Tec. No effect on G protein-coupled receptor-mediated platelet function was observed. PRN473 significantly reduced the number of thrombi in podoplanin-positive vessels after Salmonella infection and the presence of IVC thrombosis after vein stenosis. The potent inhibition of human platelet CLEC-2 and reduced thrombosis in in vivo models, together with the lack of off-target SFK inhibition and absence of bleeding reported in rilzabrutinib-treated patients with immune thrombocytopenia, suggest Btk inhibition as a promising antithrombotic strategy.

01 Nov 2024·American Journal of Hematology

2025 update on clinical trials in immune thrombocytopenia

Review

Author: Al‐Samkari, Hanny

AbstractAlthough the development and regulatory approval of the thrombopoietin receptor agonists revolutionized aspects of the immune thrombocytopenia (ITP) treatment landscape over the past two decades, there remain many areas of high unmet need. Therefore, a number of investigational and repurposed agents are currently undergoing clinical development in ITP. In a departure from historical trials, which largely focused on the indefinite treatment of persistent or chronic ITP, ongoing trials run the gamut of disease phases, and include novel agents being evaluated in early phases of the disease to attempt to modify the disease course. Many agents in development target disease pathophysiologic mechanisms not previously targeted by agents in current use, including platelet autoantibody recycling, B‐cell maturation and differentiation, long‐lived plasma cells, and the complement system, among others. These agents represent promising treatment options for patients with otherwise refractory disease or who are intolerant of currently available therapies. Additionally, with our increasing understanding of the diverse immune mechanisms at play in ITP, the expansion of the therapeutic armamentarium to include agents targeting diverse pathophysiologic mechanisms may allow a more personalized therapeutic selection in the future. This manuscript provides an up‐to‐date, in‐depth overview of recently completed and ongoing clinical trials in ITP.

News (Medical) associated with Rilzabrutinib

30 Jan 2025

·www.globenewswire.com

Press Release: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025

Sanofi: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 Paris, January 30, 2025 Q4: sales growth of 10.3% at CER1 and business EPS2 of €1.31 Pharma launches up 56.5%, reaching sales of €0.8 billion, 8% of total sales, led by ALTUVIIIODupixent sales up 16.0% to €3.5 billionVaccines sales up 10.8% to €2.2 billion, driven by Beyfortus sales in EuropeBusiness EPS of €1.31, -11.0% at CER and -14.9% reported; IFRS EPS of €0.54 FY: double-digit sales growth and business EPS guidance exceeded Sales totaled €41.1 billion, an increase of 11.3% at CERSales targets exceeded: Dupixent >€13 billion and Beyfortus blockbuster status (€1.7 billion) in its first full yearResearch and Development expenses reached €7.4 billion, up 14.6%, in line with commitmentsBusiness EPS of €7.12, +4.1% at CER, above guidance, and -1.8% reported; IFRS EPS of €4.59The Board of Directors met on January 29, 2025; proposes a dividend of €3.92 for 2024, 30th year of consecutive increases Pipeline: increased investment and progress Q4: four regulatory approvals: Dupixent EoE (children) (EU), Kevzara PMR (EU), Cerdelga GD1 (children) (EU), Efluelda flu (JP)3FY: 14 regulatory approvals of medicines and vaccines, 21 regulatory submission acceptances, and eight positive phase 3 readouts emphasize a positive and improving pipeline momentum Further progress towards a focused biopharma business Intention to sell a controlling stake in Opella consumer health at an attractive valuation; closing in Q2 2025 at the earliest4 Guidance In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5. Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback).6Sanofi intends to execute a share buyback program in 2025 of €5 billion. Shares will be purchased preferably through block trades and in the open market with the purpose of cancellation. Paul Hudson, Chief Executive Officer: “We achieved double-digit sales growth in 2024 while pursuing the transformation of the company. Innovation was a key driver of our growth as launches already contributed 11 percent of sales, with Beyfortus becoming a blockbuster in its first full year of sales. We exceeded our business EPS guidance. In 2024, we announced an intention to sell a controlling stake in Opella consumer health, which will make Sanofi a focused, science-driven biopharma company. We increased R&D investments and achieved significant progress with our pipeline in 2024, including positive phase 3 study results for new medicines such as rilzabrutinib in rare diseases and tolebrutinib in multiple sclerosis. As we enter 2025, we expect continued, solid growth in sales and a strong rebound in earnings. We are also confident in the mid to long-term growth prospects of Sanofi, supported by ongoing launches, Dupixent (currently expected to reach sales of around €22 billion in 20307, in line with the current ambition), and expected future launches from our pipeline.” Q4 2024 Change Change at CER FY 2024 Change Change at CER IFRS net sales reported €10,564m +9.1% +10.3% €41,081m +8.6% +11.3% IFRS net income reported €683m — — €5,744m +6.4% — IFRS EPS reported €0.54 — — €4.59 +6.5% — Free cash flow8 €2,340m -25.5% — €5,955m -19.6% — Business operating income €2,078m -11.8% -7.7 % €11,343m +1.5% +7.6% Business net income €1,642m -15.1% -11.2 % €8,912m -1.8% +4.1% Business EPS €1.31 -14.9% -11.0% €7.12 -1.8% +4.1% 1 Changes in net sales are at constant exchange rates (CER) unless stated otherwise (definition in Appendix 9).2 To facilitate an understanding of operational performance, Sanofi comments on the business net income statement which is a non-IFRS financial measure (definition in Appendix 9). The income statement is in Appendix 3 and a reconciliation of reported IFRS to business net income is in Appendix 4.3 For the definition of medical and scientific terms, please see the first use of the word in the Pipeline update section.4 Subject to finalization of definitive agreements and subject to obtaining regulatory approvals from the competent authorities.5 In 2025, sales growth will exclude any impact from hyperinflation. In 2024, it is estimated that sales growth benefited by 1.8 percentage points.6 Applying average January 2025 exchange rates, the currency impacts are estimated between +2% and +3% on sales and +2% and +3% on business EPS.7 At CER.8 Free cash flow is a non-IFRS financial measure (definition in Appendix 9). Attachment Press_Release

Phase 3Clinical ResultFinancial StatementBiosimilarDrug Approval

31 Dec 2024

·www.echemi.com

Sanofi Submits Market Authorization Application for BTK Inhibitor Rilzabrutinib

According to information published on the CDE (Center for Drug Evaluation) website on December 30, Sanofi’s market authorization application for its BTK inhibitor Rilzabrutinib has been officially accepted. Sanofi has conducted several clinical trials in China for Rilzabrutinib to treat autoimmune diseases, including a Phase III study (CTR20220447) for immune thrombocytopenia (ITP) and a Phase IIb study (CTR20212864) for warm autoimmune hemolytic anemia. In April 2024, Sanofi announced that its Phase III LUNA 3 study achieved positive results in treating adult patients with persistent or chronic immune thrombocytopenia (ITP), meeting its primary endpoint. Based on these results, Sanofi planned to submit the market authorization application for Rilzabrutinib. If approved, Rilzabrutinib will become the first BTK inhibitor approved for the ITP indication. The LUNA 3 study was a randomized, multicenter, double-blind, placebo-controlled clinical trial. It evaluated the efficacy and safety of Rilzabrutinib (400 mg twice daily) versus placebo in treating adult and adolescent patients with persistent or chronic ITP who had previously received treatment. The double-blind treatment phase lasted 12 to 24 weeks, followed by a 28-week open-label treatment period with Rilzabrutinib, and concluded with a 4-week safety follow-up or a long-term extension study. The primary endpoint of the study was the proportion of patients achieving a platelet count of ≥50,000/μL for at least 8 weeks during the final 12 weeks of the 24-week double-blind treatment phase without requiring rescue therapy. The baseline platelet count of patients in the study was 15,000/μL, while the normal range is 150,000–450,000/μL. The study results showed that the proportion of patients achieving sustained platelet response was significantly higher in the Rilzabrutinib group compared to the placebo group, with both clinical and statistical significance. Furthermore, the study met its key secondary endpoints. Regarding safety, Rilzabrutinib’s safety profile was consistent with previous studies. Rilzabrutinib, developed by Principia Biopharma, is an oral, reversible, covalent BTK inhibitor. In August 2020, Sanofi acquired Principia Biopharma for $3.68 billion, gaining access to multiple products, including Rilzabrutinib. BTK is expressed in B cells, mast cells, and other cells involved in innate immune responses and plays a role in the development of various autoimmune diseases. Rilzabrutinib helps treat ITP complications by reducing the production of pathogenic autoantibodies and macrophage-mediated platelet destruction. Immune thrombocytopenia (ITP) is a serious acquired autoimmune hematologic disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, resulting in reduced platelet counts (<100,000/μL) and an increased risk of life-threatening bleeding, such as intracranial hemorrhage. ITP also significantly impacts patients’ quality of life, including fatigue and cognitive dysfunction. In addition to the ITP indication, Sanofi is exploring Rilzabrutinib’s therapeutic potential for other autoimmune diseases, such as IgG4-related disease, warm autoimmune hemolytic anemia, chronic spontaneous urticaria, and prurigo nodularis.

Clinical ResultPhase 3ImmunotherapyDrug ApprovalAcquisition

17 Dec 2024

·www.echemi.com

Eli Lilly’s Pirtobrutinib Joins the Race as BTK Competition Heats Up

On December 16, Innovent Biologics and Eli Lilly announced a collaboration agreement for the non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, pirtobrutinib, in mainland China. Under this agreement, Innovent Biologics will handle the import, sales, promotion, and distribution, while Eli Lilly will manage R&D and post-market medical affairs. On October 29, Eli Lilly’s pirtobrutinib received approval from the National Medical Products Administration (NMPA) for treating relapsed or refractory mantle cell lymphoma (MCL) in adults who have previously received BTK inhibitor treatments. Currently, the domestic market has five approved BTK inhibitors, including ibrutinib, zanubrutinib, ocatabrutinib, and acabrutinib. Sanofi’s Tolebrutinib and Rilzabrutinib are in Phase III clinical trials, while CT-1530 from Shouyao Holdings is in Phase II. The robust development of BTK inhibitors indicates potential market changes. BTK inhibitors work by targeting the BCR signaling pathway, binding to BTK, inhibiting its phosphorylation, and inducing apoptosis, effectively managing B-cell malignancies. Before BTK inhibitors, lymphoma treatments were limited to chemotherapy, anti-CD20 antibodies, and radiotherapy. Ibrutinib, the first BTK inhibitor, revolutionized B-cell cancer treatment since its 2013 debut and was approved in China in 2017. However, sales of ibrutinib have slowed due to competition from similar drugs. Zanubrutinib, developed by BeiGene, reached $1.297 billion in global sales in 2023, marking the first domestic drug to achieve such success, but it now faces increasing competition. Pirtobrutinib, as the first and only non-covalent BTK inhibitor, intensifies competition in this niche market. It shows potential to overcome resistance to covalent BTK inhibitors and offers a new option for relapsed/refractory MCL patients. To highlight its efficacy, Eli Lilly conducted a head-to-head study in the BRUIN MCL-321 trial. By 2030, pirtobrutinib is projected to capture 60% of the chronic lymphocytic leukemia market, equating to $3 billion in annual sales. With advancing technology and new drug development, the BTK market is expanding rapidly. According to Frost & Sullivan, the global BTK market could reach $20 billion by 2025 and $26.1 billion by 2030. In China, the market size is expected to reach RMB 13.1 billion by 2025 and RMB 22.5 billion by 2030. The growing BTK market has attracted numerous pharmaceutical companies. At least 20 BTK inhibitors are in clinical trials domestically, with Shouyao Holdings, Hengrui Medicine, and Hezheng Pharmaceutical leading the way. Ibrutinib’s core patent will expire on December 28, 2026, and at least 10 companies are preparing generics. This will lead to fierce competition among original drugs, domestic innovations, and generics. BeiGene’s zanubrutinib remains a key product, but new competitors like pirtobrutinib pose challenges. The success of pirtobrutinib in China’s market is worth monitoring. Originally developed by Redx Pharma and acquired by Loxo Oncology, pirtobrutinib was purchased by Eli Lilly for $8 billion in 2019. In March 2022, Innovent Biologics secured Chinese commercialization rights for pirtobrutinib with an initial payment of $45 million. The partnership between Innovent Biologics and Eli Lilly began in 2015 and has expanded through multiple projects. Despite setbacks like sintilimab’s rejection by the U.S. FDA in 2022, their collaboration continues with other initiatives. Their 2019 cooperation on IBI362, a dual GLP-1R and GCGR agonist, is in Phase II/III trials for Type 2 diabetes and weight loss. In March 2022, Eli Lilly’s ramucirumab was approved in China, granting Innovent Biologics exclusive commercialization rights. Additionally, they collaborate on selpercatinib, a RET inhibitor for gene fusion tumors. The cooperation and competition between domestic and multinational pharmaceutical companies are becoming a norm. This model offers a win-win strategy for navigating the global market.

Drug ApprovalAcquisitionPhase 3Phase 2License out/in

100 Deals associated with Rilzabrutinib

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	NDA/BLA	China	Sanofi Srl	30 Dec 2024
Purpura, Thrombocytopenic, Idiopathic	NDA/BLA	China	Genzyme Corp.	30 Dec 2024
Pemphigus	Preclinical	Greece	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Israel	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Canada	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Croatia	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Bulgaria	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Turkey	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Taiwan Province	Principia Biopharma, Inc.	08 Jan 2019
Pemphigus	Preclinical	Germany	Principia Biopharma, Inc.	08 Jan 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Warm autoimmune hemolytic anemia	-	Rilzabrutinib 400 mg bid	zucdsufrts(hzwrcrhkyq) = 23% rfuzrjzkfj (apfrjygvjn ) View more	-	09 Dec 2024
				Concomitant CS
NCT04562766 (LUNA 3, ASH2024) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic	202	rilzabrutinib	(bjwrxhtydg) = dhoxejivrw nyexbgvhmw (hcmhpybcmg ) Met View more	Positive	08 Dec 2024
				placebo	(bjwrxhtydg) = mrdfwjoxei nyexbgvhmw (hcmhpybcmg ) Met View more
ASH2024	Not Applicable	Purpura, Thrombocytopenic, Idiopathic	-	Rilzabrutinib 400 mg bid	ccjnlmmtri(wkxhsmiwls) = dwnsrudruu fbriekpjqh (ibtqicdaex ) View more	-	08 Dec 2024
				Placebo	cwguzbyzut(oykzvslmvz) = hqpxbhcbag kiufptduyj (tbttnmzmkb, 2.9) View more
NCT05104892 (ATS2024) Manual	Phase 2	Asthma	64	Rilzabrutinib 400 mg BID	(gsviubverp) = cbmybmflyy kucnlpvuri (jbdptpcmjs ) View more	Positive	22 May 2024
NCT03395210 (LUNA 2, EHA2024) Manual	Phase 2	Purpura, Thrombocytopenic, Idiopathic Second line	71	Rilzabrutinib 400 mg bid	lshftpkdnd(itwsqycfrv) = hgwmtkilxv vvkprhrfdh (nxbqcgjelv ) View more	Positive	14 May 2024
				Rilzabrutinibhrombopoietin-receptor agonists (TPO-RA) or corticosteroids (CS)	bggzsjklfp(nznrnrhrrp) = wextbougcc deblzfmlgq (zvoyrcumvy ) View more
NCT04562766 (LUNA 3, EHA2024)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	202	Rilzabrutinib 400 mg bid	bhbchbgkml(wmaavipgyf) = ylmvsdtbrn mzrxtyqxaz (flkfggpagj ) View more	Positive	14 May 2024
NCT03395210 (EHA2024)	Phase 2	Purpura, Thrombocytopenic, Idiopathic	-	Rilzabrutinib 400 mg bid	uygcgbcerw(qbtmhhfjin) = In the main and LTE periods, 11 (41%) patients had treatment-related adverse events (TRAEs). All TRAEs in the LTE were transient and grade 1/2, except non-serious, grade 3 influenza and lower respiratory tract infection in 1 patient. No related bleeding or thrombotic events, serious adverse events, or deaths were reported. hzlfkvdvqo (cnyjbsafkq )	-	14 May 2024
				Concomitant ITP therapy
NCT03395210 (Pubmed) Manual	Phase 1/2	Purpura, Thrombocytopenic, Idiopathic	16	Rilzabrutinib 400 mg	(jeplufjjvs) = Adverse events related to treatment were grade 1 or 2 and transient, with no bleeding, thrombotic, or serious adverse events. tjzzlyiepn (ralejxcvlx )	Positive	09 Apr 2024
NCT05107115 (RILECSU, AAAAI2024) Manual	Phase 2	Chronic Urticaria	160	rilzabrutinib 400mg once-every-evening	(xnzfcreqrv) = Rilzabrutinib was well tolerated; adverse events occurring at a higher frequency with rilzabrutinib vs placebo included headache, nausea, and diarrhea. krapgymcjg (rihjxjubof )	Positive	24 Feb 2024
				rilzabrutinib 400mg twice-a-day
NCT03395210 (Part B, ASH2023)	Phase 1/2	Purpura, Thrombocytopenic, Idiopathic	9	Rilzabrutinib 400 mg bid	etpnvxrthy(koaysqhrme) = uvexymkcva fwylfwedlh (gnzyrpmlpd, 17% - 56)	-	11 Dec 2023

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