A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.

Start Date24 Oct 2025

Sponsor / Collaborator

Sanofi

NCT07216079

/ Active, not recruitingPhase 3

An Open-label Extension Study for Oral Rilzabrutinib in Adults With Chronic Immune Thrombocytopenia (ITP) Who Have Completed the Long-term Extension (LTE) of the LUNA 3 Study (PRN1008 018/EFC17093) in Japan

This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib.
The purpose of this study is to provide continuation of rilzabrutinib treatment to adult participants with ITP who have completed the LTE of the LUNA 3 study in Japan, demonstrating clinically meaningful benefit as judged by the Investigator.

Start Date15 Oct 2025

Sponsor / Collaborator

Sanofi

NCT07190196

/ RecruitingPhase 3

A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active IgG4-related Disease

This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.
The purpose of this study is to measure time to IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period.
Study details include:
The study duration will be up to 60 weeks, including a 4-6-week screening period, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks).
The number of visits will be 16 (plus an optional 9 visits during the OLE).

Start Date26 Sep 2025

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Rilzabrutinib

100 Translational Medicine associated with Rilzabrutinib

100 Patents (Medical) associated with Rilzabrutinib

Literatures (Medical) associated with Rilzabrutinib

24 Oct 2025·JOURNAL OF ORGANIC CHEMISTRY

An Alternative Synthetic Route to Rilzabrutinib via an E-Configured Cyanoacrylic Acid Intermediate

Article

Author: Qin, Hongjian ; Shen, Jingshan ; Sun, Changliang ; Yang, Peng ; Zhu, Fuqiang ; Wei, Daibao ; Guo, Jinbo ; Bonku, Emmanuel Mintah

In this manuscript, an alternative route of synthesis for making rilzabrutinib via amide formation was described. The two segments for the amide formation are pyrazolopyrimidine-piperidine 20 and E-cyanoacrylic acid 21. The yield of 20 from Mitsunobu reaction was doubled compared with the existing route, and the Knoevenagel-derived 21 exhibited exclusive E-configuration. This route, in contrast to Sanofi's medicinal chemistry route, avoids Z/E isomer separation, achieves a 20-fold increase in overall yield, and improves sustainability through transition-metal-free catalysis and chromatography-free intermediates purification.

01 Dec 2025·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Bruton tyrosine kinase modulates systemic immune activation to bacterial translocation in primary antibody deficiencies

Article

Author: Ho, Hsi-En ; Fuleihan, Ramsay ; Radigan, Lin ; Cunningham-Rundles, Charlotte ; Sullivan, Kathleen ; Storek, Michael J ; Roudko, Vladimir ; Lee, Jo Hsuan ; Kim-Schulze, Seunghee ; Qi, Jingjing

BACKGROUND:

Bacterial translocation is a shared phenomenon in common variable immunodeficiency (CVID) and X-linked agammaglobulinemia (XLA). In CVID, bacterial translocation is linked to systemic immune activation and chronic inflammatory manifestations.

OBJECTIVE:

We investigated whether the absence of functional Bruton tyrosine kinase (BTK) in XLA is associated with protection against systemic inflammation driven by bacterial translocation, and to assess whether BTK inhibition could modulate these inflammatory responses in CVID.

METHODS:

Clinical data from the US national registry were analyzed to compare the incidence of inflammatory complications between CVID and XLA. Serum immune profiling was conducted to assess systemic immune activation associated with bacterial translocation in both disorders. In parallel, ex vivo stimulation assays were used to evaluate the effects of BTK inhibition on microbial translocation-driven inflammatory responses in CVID.

RESULTS:

XLA patients, who lack BTK, were significantly protected from the inflammatory complications commonly observed in CVID. Despite comparable levels of bacterial translocation, serum cytokine profiling revealed that XLA patients exhibited markedly reduced immune activation, with lower levels of IFN-γ pathway mediators (IFN-γ, IL-12b, IL-18, CXCL9), proinflammatory cytokines (TNF-α, TNF-β, IL-6), chemokines related to host-commensal junctures (CCL19, CCL23, CCL3), and markers of monocyte and T-cell activation. XLA and CVID exhibited differential host responses to bacterial translocation stimuli in vivo and ex vivo, with reduced IFN-γ, proinflammatory cytokines, and monocyte responses in XLA. Translating these findings, we showed that the use of BTK inhibitors (rilzabrutinib, PCI-29732) in inflammatory CVID peripheral blood mononuclear cells recapitulated the in vivo differences between CVID and XLA, and effectively attenuated pathogenic immune responses to bacterial translocation stimuli.

CONCLUSIONS:

These findings identify BTK as a key host modifier mediating the systemic effects of bacterial translocation. Inhibiting BTK activity in CVID may provide a novel therapeutic strategy to mitigate chronic inflammatory complications in this primary antibody deficiency.

01 Sep 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Next generation Bruton's tyrosine kinase inhibitors – characterization of in vitro potency and selectivity

Article

Author: Angst, Daniela ; Cenni, Bruno ; Pulz, Robert

Bruton's tyrosine kinase (BTK) mediates B cell receptor and Fc receptor signaling and is a key regulator of autoimmunity and allergy. A series of novel BTK inhibitors (BTKi) are currently in development for non-oncologic indications with covalent-irreversible (remibrutinib, evobrutinib, tolebrutinib, orelabrutinib), covalent-reversible (rilzabrutinib), and non-covalent reversible (fenebrutinib) binding modes. This study characterizes their in vitro potency and selectivity profiles under the same conditions to minimize assay differences across the different binding modes. Covalent BTKi showed human in vitro blood BTK binding in a time- and concentration-dependent manner with remibrutinib being the most potent and fastest in onset of action. Cellular BTK pathway inhibition was determined in human blood B cells and basophils, and for covalent BTKi correlated well with BTK binding. In contrast to the covalent-irreversible remibrutinib, the non-covalent reversible fenebrutinib showed rapid loss of cellular BTK inhibition after washout. Kinase selectivity was assessed in a binding screen across the human kinome, followed by quantification of binding affinities for a selection of kinases. BTKi ranked in their selectivity as follows (most selective to least): remibrutinib, fenebrutinib, evobrutinib, orelabrutinib, rilzabrutinib and tolebrutinib. These data suggest that next generation BTKi show important differences in their in vitro target binding and selectivity when compared under the same conditions.

News (Medical) associated with Rilzabrutinib

15 Dec 2025

·www.biopharmadive.com

Sanofi MS drug hits two setbacks

Sanofi is scrapping plans to get one of its more advanced experimental medicines approved for a certain kind of multiple sclerosis, following negative results from a clinical trial disclosed Monday.The French pharmaceutical giant didnt release any specific data, only that its drug, tolebrutinib, failed to meet the main goal of a late-stage trial titled PERSEUS. The study enrolled 767 participants with a rarer form of MS known as primary progressive, and looked at whether tolebrutinib was any better at delaying the disabilities that typically worsen over the course of the disease.Based on these results, Sanofi will not attempt to get the drug approved in this setting. The company is also evaluating if it needs to take an impairment charge related to tolebrutinibs intangible value, given that the drug was the centerpiece of a $3.7 billion buyout. Sanofi intends to provide an update on this evaluation in January though it noted that, either way, the outcome wont impact net income or earnings per share. Its 2025 financial guidance remains unchanged.We are disappointed by todays results; however, we do believe [they] will improve our understanding of the underlying disease biology of multiple sclerosis, said Houman Ashrafian, head of Sanofis research and development, in a statement.Separately, Sanofi on Monday revealed that an approval verdict for tolebrutinib as a treatment for non-relapsing secondary progressive MS will likely come later than expected.The Food and Drug Administration had previously aimed to make a decision by Sept. 28, but pushed that deadline back by three months after Sanofi made a major amendment to its application. Now, the company suspects recent discussions with the FDA indicate a ruling wont come by the revised date of Dec. 28. Sanofi anticipates more guidance from the agency sometime in the first three months of next year.The company said it strongly believes in tolebrutinibs risk-benefit profile. In response to an FDA request, it has submitted an expanded access protocol so eligible patients with non-relapsing secondary progressive MS can get ahold of the drug.The fact that the FDA has requested an extended access program suggests the agency is comfortable with the risk/benefit for now, wrote analysts at the investment bank Jefferies, in a note to clients.The market may well write the asset off, but that seems a bit premature, the analysts added. We wonder if more share price pressure will mean more pressure on management.Tolebrutinib comes as a tablet, and is part of a class of drugs designed to inhibit Brutons tyrosine kinase, an immune system-regulating enzyme that plays a key role in the development of B cells.Those cells make antibodies that alert the body to potential threats. Research suggests a root cause of MS is antibodies mistakenly attacking the protective myelin sheaths that cloak nerve fibers.Sanofi already has one BTK-blocking drug, Wayrilz, on the market for a different autoimmune condition. So does Novartis. BTK inhibitors like Imbruvica, Calquence and Brukinsa are used to treat certain blood cancers as well. The class as a whole carries safety concerns, namely the potential for liver injury, which in recent years led the FDA to issue partial clinical holds on tolebrutinib and similar drugs from Roche, Merck KGaA and InnoCare Pharma.This fall, that Roche drug, fenebrutinib,succeeded in two large MS trials. One recruited primary progressive patients, while the other focused on the far more common relapsing form of the disease. Jefferies analysts described those readouts as a positive surprise, though they also questioned whether Roche had collected enough supportive evidence to file for approval. '

09 Dec 2025

·www.fiercebiotech.com

ASH: Novartis details ianalumab\'s phase 3 win in rare blood disease

Novartis plans to submit ianalumab for FDA approval in primary immune thrombocytopenia in 2027, using data from both the VAYHIT2 and VAYHIT1 phase 3 trials.\n ORLANDO, Fla.—Novartis is divulging details from ianalumab’s summertime phase 3 win in a rare autoimmune blood disorder, and the data suggest the treatment could delay the progression of patients to more serious forms of the disease.Patients with primary immune thrombocytopenia (ITP) given ianalumab alongside Novartis’ Promacta (eltrombopag) saw their low platelet counts boosted to safe levels for 13 months after treatment, compared to just 4.7 months for patients given eltrombopag and placebo, translating into an extension of ITP disease control by 45%.This benefit was seen in patients given four monthly 9-mg/kg doses of Novartis’ combo therapy. A 3-mg/kg dose of the combo also achieved a statistically significant 42% improvement compared with the control group, even though the specific length of the measure—known as time to treatment failure—couldn’t be determined yet because the experimental treatment was still working in too many patients. Patients given the investigational combo also reported greater improvements in fatigue, a common symptom of ITP and a secondary endpoint in the trial.“The study achieved my high hopes and expectations,” Hanny Al-Samkari, M.D., a hematologist at Massachusetts General Hospital and Harvard Medical School who is an investigator for the trial, told Fierce Biotech.Al-Samkari presented the results from the trial, called VAYHIT2, at the American Society of Hematology (ASH) meeting in Orlando, Florida, on Dec. 9. Novartis announced the results in a press release on the same day.The results were also published in the New England Journal of Medicine on Dec. 9. Patients given ianalumab had slightly more infusion reactions than those given eltrombopag and placebo, Al-Samkari said, but most of these were mild to moderate in severity. A bigger safety question was whether patients given ianalumab would develop more infections, because the antibody is designed to deplete B cells to combat the autoimmune activity that destroys ITP patients’ platelets.Infections were no worse or more common in either ianalumab arm compared to placebo, Al-Samkari said. “That really helps us to feel comfortable that this is a safe medication to use.”ITP, which increases the risk of bruising and dangerous bleeding, can vary greatly. Of adults who develop the disease, 20% go into remission after one year, Al-Samkari explained, while 80% become chronic patients. And, of those with chronic disease, some experience only mild symptoms while others are frequently in and out of the hospital.The VAYHIT2 trial focused on patients who had been diagnosed in the last three or four months and been given first-line treatment—corticosteroids—and not had success. This design is bold and unusual in the field, Al-Samkari said, where other trials often focus on controlling disease in patients who have had ITP for years and failed multiple lines of treatment.“There was an ASH plenary last year for rilzabrutinib that is now approved in ITP as a chronic controller medication,” he added, referring to Sanofi’s late-line BTK inhibitor Wayrilz. “This drug is being evaluated totally differently.”Al-Samkari’s hope is that by resetting patients’ B cells, the ianalumab-eltrombopag combo can “defang” the disease, preventing recently diagnosed patients from progressing to more severe disease.“It’s promising what we’ve seen so far, but we need more time, another couple years,” he said. If the therapy proves successful at staving off disease progression, and if another trial testing the combo in first-line ITP, VAYHIT1, also scores a win, “it will be very strong evidence to change the treatment paradigm for this disease.”Novartis plans to submit ianalumab for FDA approval in ITP in 2027, according to the company’s Dec. 9 release, using data from both VAYHIT2 and VAYHIT1.The Swiss pharma originally announced its VAYHIT2 success in August, the day after sharing that ianalumab also succeeded in a pair of phase 3 trials for Sjögren’s syndrome, another B-cell-driven autoimmune disease. The company originally developed the antibody with MorphoSys, a German biotech Novartis went on to buy in 2024.The Big Pharma is also testing ianalumab in a host of other indications, including ongoing phase 3 trials in systemic lupus erythematosus, lupus nephritis and other diseases where rogue B cells target blood cells.Editor\'s note: This story was updated at 8:40 a.m. ET on Dec. 9 to include a link to the published study.

Phase 3Clinical ResultASHDrug Approval

24 Oct 2025

·www.globenewswire.com

Press release: Q3: continued sales and earnings progress

Q3: continued sales and earnings progress Paris, October 24, 2025 Q3 sales growth of 7.0% at CER1 and business earnings per share (EPS)2 of €2.91 Pharma launches increased sales by 57.1%, reaching €1.0 billion, driven by ALTUVIIIO and Ayvakit Dupixent sales increased by 26.2% to €4.2 billion, first time above €4 billion in a quarter Vaccines sales decreased by 7.8% to €3.4 billion, from lower influenza sales Research and Development expenses were €1.8 billion, an increase of 4.9% Selling, general and administrative expenses were €2.3 billion, up 7.1% to support launches Business EPS was €2.91, up 13.2% at CER and 7.0% at actual exchange rates, delivering profitable growth; IFRS EPS was €2.30 Pipeline progress Two regulatory approvals: Wayrilz (US) in ITP, a rare disease, and Tzield (China) for delaying onset of stage 3, type 1 diabetes Two positive phase 3 readouts: amlitelimab’s first phase 3 study in atopic dermatitis and Fluzone HD in influenza 50+ years Eight regulatory submission acceptances, three phase 3 study starts, and three regulatory designations (fast track, orphan) Capital allocation Completion of the Vigil Neuroscience acquisition, adding to the early-stage pipeline Additional commitment of $625 million to Sanofi Ventures, investing in innovative biotech and digital health companies Sanofi intends to complete its €5 billion share buyback program in 2025. 86.1% has been executed to date Sustainability Global Health Unit: one million patients have now received treatments for non-communicable diseases since 2021 Insulins Valyou Savings Program: improving access to reliable and affordable supply of critical medicines in the US Guidance unchanged In 2025, sales are anticipated to grow by a high single-digit percentage at CER. Sanofi confirms the expectation of a strong business EPS rebound with growth at a low double-digit percentage at CER (before share buyback)3 Paul Hudson, Chief Executive Officer: “We continued executing on our strategy and the growth momentum continued in Q3 with sales up by 7.0% over a high base of comparison last year. Newly launched medicines and vaccines grew by 40.8%. Dupixent grew by 26.2% and exceeded for the first time both four billion euros in quarterly global sales and three billion euros in the US, despite an unfavorable currency impact. As expected, our flu vaccines business declined because of increased price competition and lower vaccination rate. Business EPS increased by 13.2%, supported by disciplined spending, R&D prioritization, and operational efficiency. After three quarters of profitable growth, we reiterate our 2025 guidance. Our strategic focus on science, patients, and pipeline delivered important milestones in the quarter, including positive phase 3 data for amlitelimab in atopic dermatitis with all primary and key secondary endpoints met, increasing efficacy over time, and a patient-friendly quarterly dosing. We obtained two regulatory approvals: Wayrilz in the US for the rare disease immune thrombocytopenia and Tzield in China to delay the onset of stage 3, type 1 diabetes. We submitted eight regulatory applications, initiated three new phase 3 studies, and received three new regulatory designations. The acquisition of Vigil Neuroscience closed in August, and we will complete our share buyback program by the end of the year. Sanofi will strategically deploy capital towards growth and differentiated science with expected attractive financial returns. As we are looking forward to 2026, we are confident in our ability to pursue our current trajectory of profitable growth.” Q3 2025 Change Change at CER YTD 2025 Change Change at CER IFRS net sales reported €12,434m +2.3% +7.0% €32,323m +5.9% +8.7% IFRS net income reported €2,802m -0.5% — €8,614m +70.2% — IFRS EPS reported €2.30 +2.2% — €7.04 +73.8% — Free cash flow4 €2,994m -6.1% — €5,452m +50.8% — Business operating income €4,445m +2.7% +8.5 % €9,808m +5.9% +9.7% Business net income €3,547m +4.0% +9.8 % €7,699m +5.9% +9.8% Business EPS €2.91 +7.0% +13.2% €6.30 +8.4% +12.4% 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, a non-IFRS financial measure (definition in Appendix 9). The income statement is in Appendix 3 and a reconciliation of net income as reported under IFRS to business net income is in Appendix 4. 3 Applying October 2025 average currency exchange rates, the currency impacts are estimated at c.-4% on sales and at c.-6% on business EPS. 4 Free cash flow is a non-IFRS financial measure (definition in Appendix 9). Attachment Press release

Phase 3Breakthrough TherapyDrug ApprovalVaccineClinical Result

100 Deals associated with Rilzabrutinib

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D11873	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	United States	Genzyme Corp.	29 Aug 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immunoglobulin G4-Related Disease	Phase 3	United States	Sanofi	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	China	Sanofi	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Japan	Sanofi Srl	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Japan	Sanofi-Aventis Recherche & Développement SA	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Argentina	Sanofi Srl	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Argentina	Sanofi-Aventis Recherche & Développement SA	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Belgium	Sanofi-Aventis Recherche & Développement SA	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Belgium	Sanofi Srl	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Canada	Sanofi	26 Sep 2025
Immunoglobulin G4-Related Disease	Phase 3	Chile	Sanofi	26 Sep 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


LUMINA2 part B (ASH2025)	Phase 2	Warm autoimmune hemolytic anemia	15	Rilzabrutinib	wdmxukgnrr(pwtdjgdyoc) = dfynjrjizh nwbigjacke (ulapnsnxny ) View more	Positive	06 Dec 2025
NCT04562766 (LUNA3, ASH2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	202	Rilzabrutinib	mmycydhovq(uhgfwkjflp) = Two pts (3%) had grade ≥2 related TEAE of infection eqqojyoukr (xxonhswsyx ) View more	Positive	06 Dec 2025
				Rilzabrutinib
NCT04562766 (LUNA3, ASH2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	180	Rilzabrutinib 400 mg bid	ecfsvwodyw(lpzcwiklhf) = qhwhgyidag hcvvzswyys (kxwngwslfw ) View more	Positive	06 Dec 2025
				Placebo	uforhsmgev(jkhmyhnkyn) = obhnncekqt xepkxzvpay (rgyvqzrcri ) View more
NCT06975865 (LIBRA, ASH2025)	Phase 3	Anemia, Sickle Cell	192	Rilzabrutinib	iuwskultjf(whgrfpddew) = jsncnbshgs ccljxajnvi (mwgwedppzv )	Positive	06 Dec 2025
				Placebo	iuwskultjf(whgrfpddew) = nnbeomkcjm ccljxajnvi (mwgwedppzv )
NCT04520451 (ACR2025)	Phase 2	Immunoglobulin G4-Related Disease	27	Rilzabrutinib	vvkrvbzslt(dcrimftrut) = zkmmqrpewm dtbnkavljs (shlsnjipit ) View more	Positive	24 Oct 2025
NCT05104892 (Phase 2 Study, ATS2025)	Phase 2	Asthma	196	Rilzabrutinib 800mg	yekdrfzxcm(ltstndckdf) = tfenaubqdy xmesmlfvmb (drisjtslln )	Positive	16 May 2025
				Placebo	yekdrfzxcm(ltstndckdf) = hzxqnwnfgw xmesmlfvmb (drisjtslln )
NCT04562766 (LUNA3, EHA2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	174	Rilzabrutinib 400 mg bid	tfqtqwlxyw(kbbqpmlwaj) = tlkvngwhve fnwuxjtlqu (jpqqknibeu ) View more	Positive	14 May 2025
NCT04562766 (LUNA3, EHA2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	202	Rilzabrutinib 400 mg bid	isftrutmib(atdvzrobqx) = maahvkvkbi rtahvvcgdf (qfwaffuuus ) View more	Positive	14 May 2025
NCT05002777 (LUMINA 2, EHA2025)	Phase 2	Warm autoimmune hemolytic anemia	22	Rilzabrutinib 400 mg bid	ipkpbqslim(lqyqocvilc) = dflpxuymzj wxokcvoenb (cjykdvpujm )	Positive	14 May 2025
				Concomitant CS + Rilzabrutinib	ipkpbqslim(lqyqocvilc) = habkwdhtgj wxokcvoenb (cjykdvpujm )
NCT05107115 (RILECSU, Pubmed) Manual	Phase 2	Chronic Urticaria	160	rilzabrutinib 1200 mg/drilzabrutinib 1200 mg/d	grweruuckh(xklncvjgjc) = syidbbbqdr egavtmicsh (hhhsvvrqdv ) View more	Positive	23 Apr 2025
				placebo	grweruuckh(xklncvjgjc) = uhuoodjyga egavtmicsh (hhhsvvrqdv ) View more

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