The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients

At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.

Start Date01 Sep 2025

Sponsor / Collaborator

Affiliated Hospital of Xuzhou Medical University

NCT06372145

/ RecruitingPhase 3

An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).
SUBSTUDY: ToleDYNAMIC substudy

Start Date16 Apr 2024

Sponsor / Collaborator

Sanofi

ChiCTR2300074720

/ RecruitingPhase 2IIT

stratified treatment for diffuse large B cell lymphoma in the elderly

Start Date01 Aug 2023

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Tolebrutinib

100 Translational Medicine associated with Tolebrutinib

100 Patents (Medical) associated with Tolebrutinib

428

Literatures (Medical) associated with Tolebrutinib

31 Dec 2025·ANNALS OF MEDICINE

Clinical outcomes and therapeutic modalities in older Chinese patients with MCL: a multi-center real-world retrospective study

Article

Author: Zhang, Weilong ; Wang, Shuye ; Jing, Hongmei ; Liu, Hui ; Wang, Jing ; Liu, Shuozi ; Li, Lihong ; Li, Zhenling ; Sun, Xiuhua ; He, Juan ; Wang, Jingwen ; Cai, Qingqing ; Yang, Yuan ; Li, Chunyuan ; Yang, Ping ; Li, Xiaoling ; Zhang, Wei ; Chen, Yingtong ; Xiao, Xiubin

BACKGROUND AND AIMS:

Mantle cell lymphoma (MCL), an uncommon lymphoma subtype, is clinically characterized by its heterogenous behavior. Established prediction system including several clinical and biological parameters can help in determining the aggressiveness of MCL in younger patients. However, there are limited parameters on predicting the clinical outcome of older patients. The present study was performed to identify the prognostic factors and optimal treatment modalities in older Chinese MCL patients.

METHODS:

Patients (age ≥ 65 yrs) with MCL from 19 comprehensive hospitals in China were included. Clinical characteristics, therapeutic strategies, progression-free survival (PFS) and overall survival (OS) time of these patients were collected.

RESULTS:

Totally, 259 eligible patients were enrolled. The median age of patients was 69 years (range, 65-88). The median of PFS and OS were 29 months (95%CI: 26-37) and 76 months (95%CI: 61-96) months, respectively. Multivariate regression analysis determined that ECOG score ≥ 2, high MIPI score and absence of maintenance treatment were independently associated with poorer PFS of MCL patients; while ECOG score ≥ 2 and absence of maintenance treatment were independently correlated with a poorer OS. Patients with MCL who received BTKi-containing regimens or maintenance therapy showed significantly longer PFS and OS than those who did not receive these therapies. Maintenance treatment can improve the survival rate of older patients with MCL regardless of TP53 status.

CONCLUSIONS:

ECOG ≥ 2, high MIPI score, and absence of maintenance therapy were associated with poorer survival outcomes for older Chinese MCL patients. Maintenance therapy and BTKi-containing regimens have been shown to increase the survival rate of older Chinese MCL patients.

01 Dec 2025·Blood Research

Hepatitis B virus reactivation in patients with hematologic malignancies treated with Bruton tyrosine kinase inhibitors

Article

Author: Park, Hyunkyung ; Choi, Yunsuk ; Yoon, Sang Eun ; Kim, Seok Jin ; Park, Han-Seung ; Lee, Jung-Hee ; Hur, Joon Young ; Won, Young-Woong ; Choi, Jung Hye ; Lee, Je-Hwan ; Kim, Won Seog

Abstract:

Purpose:

Bruton tyrosine kinase inhibitors (BTKis) are effective and well-tolerated treatments for chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Here, we describe the clinical characteristics of hepatitis B virus (HBV) reactivation in patients with hematological malignancies treated with BTKis.

Methods:

Patients were required to have a pathologically confirmed diagnosis of CLL or MCL, receive at least one cycle of ibrutinib or zanubrutinib, and have either positive hepatitis B surface antigen or hepatitis B core antibody at diagnosis. Patients were excluded if they had received rituximab or obinutuzumab within the previous 12 months.

Results:

We identified five patients with CLL and one with MCL who had resolved HBV infections and received BTKis during the study period. None of the patients received anti-HBV prophylaxis after CLL diagnosis. The patient with MCL who received zanubrutinib was confirmed to have HBV reactivation even after prophylactic entecavir administration followed by tenofovir. All five patients with CLL received ibrutinib as second-line therapy. A 62-year-old man died of hepatorenal syndrome associated with HBV reactivation despite entecavir treatment.

Conclusion:

To the best of our knowledge, this is the first description of HBV-related death in patients receiving BTKis from HBV-endemic areas, and the first case of HBV reactivation associated with zanubrutinib despite previous entecavir prophylaxis. Further prospective studies are warranted to develop useful guidelines for monitoring HBV DNA and antiviral prophylaxis to prevent HBV reactivation after BTKi therapy.

01 Nov 2025·Blood neoplasia

Shelter in place: live CLL cells inside the bone marrow fibroblasts and its implication in residual disease persistence

Article

Author: Cukierman, Edna ; Franco-Barraza, Janusz ; Ma, Shuo ; Wang, Shengchun ; Wang, Y Lynn ; Vistarop, Aldana ; Shahriyar, Sk Abrar ; Lu, Pin ; Nakhoda, Shazia ; Franzen, Carrie A ; Gao, Juehua ; Efimov, Andrey ; Messmer, Marcus ; Rao, Shilpa

Bruton tyrosine kinase inhibitors (BTKis) have been successful in treating B-cell malignancies including chronic lymphocytic leukemia (CLL). However, a deep response to BTK inhibition is uncommon. It is unknown what mechanism results in minimal residual disease (MRD) persistence. Cell-in-cell (CIC) describes the microscopic observations of embodiment of an intact cell by another whole cell. CIC has been sporadically described by pathologists in human fixed tissues for over a century. However, its biological, pathological, and clinical significance remains obscure. In this study, we investigated human primary CLL samples using a clinically faithful ex vivo model system that accurately recapitulates the lymphoma tumor microenvironment. We observed that CLL cells were actively internalized by Bone marrow fibroblasts (BMF) and remained alive and mobile for days. We hypothesized that live CIC may represent a new mechanism for tumor cells to evade therapies and survive as residual disease. Indeed, CIC events were identified directly in the bone marrow of patients being treated with BTKis. Using confocal microscopy, we demonstrated that the ex vivo exposure to BTKi drove CLL cells into BMF. We further showed that CIC inside the BMF were indeed protected from drug-induced apoptosis compared to cells that stayed outside. Mechanistically, we identified that CXCR4 receptor was required for CIC because CXCR4 antagonists and CRISPR-mediated genetic depletion completely abrogated CIC. Altogether, human direct evidence and ex vivo data implicate CIC in disease persistence. Targeting tumor-stroma interaction via CXCR4 inhibition could constitute a new therapeutic approach to minimize MRD and future relapses.

252

News (Medical) associated with Tolebrutinib

10 Dec 2025

·www.globenewswire.com

Over 20 Studies of InnoCare’s Orelabrutinib Presented at the 67th Annual Meeting of the American Society of Hematology (ASH)

BEIJING, Dec. 09, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), primary central nervous system lymphoma (PCNSL), and diffuse large B-cell lymphoma (DLBCL). Oral Presentation Mid-treatment CSF ctdna and MYD88 clearance outperform PET-CT in predicting response and survival to orelabrutinib-based induction in newly diagnosed PCNSL: A prospective biomarker study (Publication No.: 59) The orelabrutinib, rituximab, and high-dose methotrexate (ORM) induction is effective and well tolerated in newly diagnosed PCNSL. Early cerebrospinal fluid (CSF) ctDNA and MYD88 clearance at mid-treatment offer superior predictive and prognostic value compared to PET-CT. These molecular biomarkers enable real-time risk stratification and may guide early treatment adaptation. Incorporating CSF ctDNA monitoring into clinical workflows has the potential to improve response prediction and long-term outcomes in PCNSL. Post-cycle 6, objective response rate (ORR) was 89.5%, with 78.9% complete response rate (CR). Median time to response was 2.6 months; 2-year duration of response (DoR) 72.4%. Median follow-up was 18.9 months; estimated 2-year progression-free survival (PFS) and overall survival (OS) were 62.5% and 75.2%, respectively. Treatment was generally well tolerated. Poster 1. Preliminary analysis of orelabrutinib combined with obinutuzumab in the treatment of marginal zone lymphoma (Orion Study) (Publication No.: 5379) Orelabrutinib combined with obinutuzumab demonstrated promising antitumor activity in treatment-naïve MZL with no severe toxicities observed. These early results support orelabrutinib combined with obinutuzumab regimen as a potential chemotherapy-free first-line option for MZL. Among 27 efficacy-evaluable patients: 25 patients completed interim assessment: ORR 96.0%, CR rate 72.0%; 10 patients completed 6 cycles assessment: ORR 100%, CR rate 70.0%. 2. Preliminary study results of orelabrutinib in combination with rituximab for treatment-Naïve marginal zone lymphoma: A prospective single-arm clinical trial (Publication No.: 3580) Orelabrutinib combined with rituximab demonstrates promising preliminary efficacy in treatment-naïve MZL patients who failed or were unsuitable for local therapy, with an ORR of 81.8% and a CRR of 72.7%. Despite current limitations of small sample size and short median follow-up, the orelabrutinib in combination with rituximab regimen represents a promising chemotherapy-free option for these patients. 3. Orelabrutinib plus bendamustine-rituximab (OBR) versus bendamustine-rituximab (BR) in transplant-ineligible, intermediate- to high-risk Mantle Cell Lymphoma (MCL) (Publication No.: 3599) The orelabrutinib plus bendamustine-rituximab regimen demonstrated a promising tumor response and favorable survival outcomes compared to the bendamustine-rituximab regimen. These findings suggest that the OBR regimen may serve as a promising treatment option for patients with transplant-ineligible, intermediate- to high-risk MCL. 4. Practice pattern and outcomes in DLBCL by Genetic Subtypes: Preliminary results from a large-scale real-world study in China (Publication No.: 3689) This large-scale real-world study provides treatment patterns and outcomes across DLBCL genetic subtypes in China. Rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) plus BTKi demonstrated enhanced efficacy in MCD-like patients, supporting subtype-directed therapy. Updated survival and safety data will be presented. R-CHOP plus orelabrutinib achieved a CR rate of 81.4% in MCD-like subgroup. 5. Pomalidomide, rituximab, and orelabrutinib in combination with polatuzumab vedotin for newly diagnosed diffuse large B-cell lymphoma in elderly, unfit, or frail patients: a prospective phase II study (Publication No.: 1912) The preliminary results suggest that the PRO-Pola regimen is a potential treatment option for elderly, unfit, or frail patients with DLBCL, exhibiting promising efficacy and an acceptable safety profile - particularly in those who responded to PRO induction therapy. Among the patients completed ≥3 cycles of treatment, CRR and ORR reached 77.8% and 100.0% respectively. Among the patients who completed all 6 cycles of treatment, both the CRR and ORR reached 100.0%. Publication Only: Efficacy and safety of orelabrutinib monotherapy in patients with chronic lymphocytic leukemia: A retrospective real-world study (Abstract ID: abs25-8605) This real-world study suggested that orelabrutinib monotherapy showed promising efficacy and a favorable safety profile in patients with CLL, both as first-line and subsequent therapy. Patients receiving first-line orelabrutinib achieved both an ORR and DCR of 100%. More studies on orelabrutinib have been selected for poster presentation and publication only at the 2025 ASH Annual Meeting. The other studies selected for poster presentation are as follows: Efficacy and safety of orelabrutinib, obinutuzumab, and lenalidomide in previously untreated marginal zone lymphoma: Preliminary results from a prospective, single-arm, multicenter, Phase II study (Publication No.: 5383)Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance in untreated marginal zone lymphoma (Optimize): A multicenter, single-arm, phase II study (Publication No.: 3596)Real-world efficacy and safety of orelabrutinib-based regimens in the treatment of marginal zone lymphoma (Publication No.: 1817)Single-cell transcriptomic profiling reveals tumor-intrinsic heterogeneity and immunemicro environment dynamics in the order trial for mantle-cell lymphoma (Publication No.: 1792)Orelabrutinib combined with R-CDOP regimen for first-line treatment of diffuse large Bcell lymphoma with high-risk CNS-IPI (Publication No.: 5460)Preliminary result of first-line orelabrutinib plus R-CHOP in CD5-positive diffuse large B-cell lymphoma (Rocket trial): A single-arm, phase II trial (Publication No.: 3690)Exploration of optimal high-dose methotrexate-based therapy for patients with primary CNS lymphoma: A real-world study in China (Publication No.: 3693)Chemotherapy-free induction with pomalidomide, orelabrutinib, and rituximab (POR) followed by high-dose methotrexate,rituximab and orelabrutinin (ROM) in newly diagnosed primary CNS lymphoma: Interim analysis of a phase II study (Publication No.: 5471)Orelabrutinib plus anti-PD-1 antibody and fotemustine for newly diagnosed primary central nervous system lymphoma: Phase I/II results (Publication No.: 5465)Orelabrutinib, rituximab, and thiotepa (ORT) in combination with or without high-dose methotrexate in untreated primary central nervous system lymphoma (Publication No.: 1911)Primary efficacy and safety of first-line R-MTO regimen (rituximab, methotrexate, thiotepa, and orelabrutinib) followed by autologous hematopoietic stem cell transplantation in PCNSL (Publication No.: 3687)Orelabrutinib, sintilimab, and temozolomide (OST) in relapsed/refractory primary central nervous system lymphoma (Publication No.: 5461) About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. Contact Media InvestorsChunhua Lu 86-10-66609879 86-10-66609999chunhua.lu@innocarepharma.com ir@innocarepharma.com

Clinical ResultPhase 2ASH

09 Dec 2025

·firstwordpharma.com

Liver signals again trigger partial FDA hold on Roche's fenebrutinib MS studies

In what must feel like a case of déjà vu for Roche, the FDA is once again intervening in the late-stage development of fenebrutinib for multiple sclerosis (MS), placing a partial clinical hold on the US arm of the programme following new reports of liver enzyme abnormalities in ongoing Phase III trials.As a result, new patient enrollment in the US for the FENhance I relapsing MS (RMS) study has been paused as regulators investigate the cases and whether they perhaps point to a broader liver-safety signal for the BTK inhibitor class. Enrollment outside the US continues uninterrupted.Asymptomatic and transientIn a statement Tuesday, Roche said the FDA's action follows two recent cases of elevated hepatic transaminases accompanied by increased bilirubin in the blinded Phase III FENhance RMS programme, patterns it described as "suggestive of drug-induced liver injury." Both patients were asymptomatic, and lab values normalised after treatment was discontinued, according to Roche.Fenebrutinib's development programme also includes FENhance II – which like FENhance I, compares the oral non-covalent BTK inhibitor to Sanofi's Aubagio (teriflunomide) in RMS – and FENtrepid, evaluating fenebrutinib against Roche's Ocrevus (ocrelizumab) in primary progressive MS. Both of those studies are fully enrolled, though while US participants treated for more than 70 days will continue therapy, Roche says a "small number" who started within the past 70 days will discontinue.Repeat holdThis isn't the first time fenebrutinib has drawn the regulator's attention. In late 2023, the FDA imposed a similar partial hold on the programme after two comparable liver-safety cases were reported. As with Tuesday's announcement, that earlier action had also paused US enrollment in FENhance I while allowing the fully enrolled FENhance II and FENtrepid trials to proceed, again with the exception for a handful of patients.Roche last month released topline results showing that FENhance II met its primary endpoint of significantly lowering annualised relapse rate compared to Aubagio over at least 96 weeks, succeeding where two competing BTK inhibitors – Sanofi's tolebrutinib and Merck KGaA's evobrutinib – had previously failed. Meanwhile, FENtrepid has shown non-inferiority to Ocrevus in delaying composite confirmed disability progression over at least 120 weeks.In both those trials, Roche noted that fenebrutinib's liver safety remained consistent with previous studies.Speaking to FirstWord following the readouts, neurologist Robert Naismith of Washington University School of Medicine suggested that liver safety will be watched closely. "There are a lot of patients being enrolled in the Phase III programme, which is a good thing, but it is not the same as being out in the real world. We need to see, once this is used more broadly, whether the liver safety holds up," he said (see – KOL Views Q&A: Roche's fenebrutinib raises BTK hopes in MS but displacing anti-CD20s far from certain).For additional analysis, see – KOL Views Q&A: How fenebrutinib could reshape the MS treatment landscape.

Phase 3Clinical ResultPhase 2Clinical Trial Failure

09 Dec 2025

·www.globenewswire.com

Latest Data of InnoCare’s Novel BCL2 Inhibitor Presented at the 67th Annual Meeting of the American Society of Hematology (ASH)

BEIJING, Dec. 08, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that three studies of its novel BCL2 inhibitor, Mesutoclax (ICP-248), were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Mesutoclax demonstrated remarkable efficacy and a favorable safety profile in the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML). The study of mesutoclax in the treatment of relapsed/refractory MCL was selected for oral presentation, while the CLL/SLL and AML studies were chosen for poster presentations. Oral Presentation Title: Efficacy and tolerability of mesutoclax monotherapy in Relapsed/Refractory MCL patients: High remission rates even in prior BTKi-refractory patients (Publication No.: 887) The clinical data from mesutoclax (ICP-248) monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitors refractory. The overall response rate (ORR) of MCL patients treated with 125 mg mesutoclax monotherapy was 87.5%, with a complete response rate (CRR) of 46.9%. Among MCL patients who were BTK inhibitor refractory, the ORR was 84.0% and the CRR was 36.0%. Mesutoclax was well tolerated through all dose levels (50-150mg), with no dose-limiting toxicities (DLTs) observed, and maximum tolerated dose (MTD) not reached. The clinical data of mesutoclax monotherapy showed promising safety and potential Best-in-class efficacy in MCL patients, especially for those who had received multiple prior treatments and were resistant to BTK inhibitors. Poster 1: Title: Mesutoclax monotherapy or combined with orelabrutinib demonstrates encouraging activity and safety in patients with CLL/SLL (Publication No.: 5677) Mesutoclax monotherapy or in combination with orelabrutinib demonstrated a tolerable safety profile across all dose levels tested. Substantial efficacy and deep remission were observed in both treatment-naive (TN) CLL/SLL patients receiving mesutoclax 125mg combined with orelabrutinib and R/R CLL/SLL treated with mesutoclax alone. In both TN CLL/SLL and R/R CLL/SLL patients (including those who had previously failed BTK inhibitor), the ORR was 100% in the 125 mg mesutoclax dose group. At week 36, when combined with orelabrutinib, the peripheral blood (PB) uMRD rate was 65% at 125 mg. T Mesutoclax is well tolerated with good safety profile. No DLTs were observed up to 150 mg QD, and MTD was not reached. Most treatment emergent adverse events (TEAEs) were grade 1-2. Poster 2: Title: Safety, tolerability and efficacy of mesutoclax to treat patients with myeloid malignancies (Publication No.: 3417) The combination of mesutoclax and azacitidine (AZA) demonstrated encouraging antitumor activity. The composite CR (CR+CRi, cCR) rate was achieved in 92% of TN AML patients. 82.6% of the patients achieved uMR. Most CR+CRi in TN AML was achieved by the end of cycle 1. Notably, 44% of the treatment naive AML were classified as adverse risk group and median age is 68 years old. The combination of mesutoclax and AZA also demonstrated well tolerated safety profile. There is no DLT or TLS events during the whole study. The mortality rate within 90 days was 0%. Mesutoclax further strengthens InnoCare's pipeline of hematologic oncology products. Two registrational clinical trials are ongoing: one is the combination of mesutoclax and orelabrutinib for the treatment of TN CLL/SLL; the other is for the treatment of MCL that is refractory to BTK inhibitors. In addition, the clinical study of mesutoclax as first-line treatment for AML has entered the dose expansion phase in China and globally, and the clinical study for the treatment of myelodysplastic syndrome (MDS) is being launched globally. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. Media InvestorsChunhua Lu 86-10-6660987986-10-66609999chunhua.lu@innocarepharma.com ir@innocarepharma.com

Clinical ResultASH

100 Deals associated with Tolebrutinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis, Secondary Progressive	United Arab Emirates	-	27 Aug 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	NDA/BLA	Canada	Sanofi-Aventis Recherche & Développement SA	01 Aug 2025
Myasthenia Gravis	NDA/BLA	Canada	Sanofi	01 Aug 2025
Multiple Sclerosis, Chronic Progressive	Phase 3	United States	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	United States	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	China	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	Japan	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	Argentina	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	Australia	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	Austria	Sanofi	13 Aug 2020
Multiple Sclerosis, Primary Progressive	Phase 3	Belarus	Sanofi	13 Aug 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04411641 (HERCULES, CTgov)	Phase 3	Multiple Sclerosis, Secondary Progressive	1,131	placebo+tolebrutinib (DB: Placebo)	nvgslkxdaf(bekyftaxaa) = gdfdspyirt svvllalcfl (uxaqrbhlyy, lwhusgvdsk - qxuvshtugz) View more	-	18 Jun 2025
				Tolebrutinib (DB: Tolebrutinib 60 mg)	nvgslkxdaf(bekyftaxaa) = gmyseqssxy svvllalcfl (uxaqrbhlyy, mpusrxthzs - bcucatdchk) View more
NCT04410991 (GEMINI 2, CTgov)	Phase 3	Multiple sclerosis relapse	899	Teriflunomide (Teriflunomide 14 mg)	pwzbrbquyh = prmrihjzhl klkonqikhb (qpvenlyfdb, aqaajrfylh - fkunxryjde) View more	-	18 Jun 2025
				Tolebrutinib (Tolebrutinib 60 mg)	pwzbrbquyh = ugjrgmykao klkonqikhb (qpvenlyfdb, pmzpbpckla - jiznfyfqli) View more
NCT04410978 (GEMINI 1, CTgov)	Phase 3	Multiple sclerosis relapse	974	Teriflunomide (Teriflunomide 14 mg)	ncgiuzcdij = jscqsqhoht sjgeyeicpl (iecvtmjsmx, ggxnestiac - ikpaxjgfuw) View more	-	18 Jun 2025
				Tolebrutinib (Tolebrutinib 60 mg)	ncgiuzcdij = hpstpigdgk sjgeyeicpl (iecvtmjsmx, emtqqwdstg - aabxeedrqe) View more
NCT04411641 (HERCULES, Pubmed \| N Engl J Med)	Phase 3	Multiple Sclerosis, Secondary Progressive	1,131	Tolebrutinib 60 mg once daily	dbgetontcu(juwsffpsgm) = qbxmzdkmfd duvfyhzfyr (xbyjkriojz )	Positive	15 May 2025
				Placebo	dbgetontcu(juwsffpsgm) = nhyzvfxbxz duvfyhzfyr (xbyjkriojz )
NCT04410978 \| NCT04410991 (GEMINI 1, Pubmed \| N Engl J Med) Manual	Phase 3	Multiple sclerosis relapse	-	Tolebrutinib 60 mg once dailyTolebrutinib 60 mg once daily	cdexzaqqvh(kblggvgswo) = aidbtiomqt rwbpgbqpvf (yuvtzldscf ) View more	Negative	08 Apr 2025
				Teriflunomide 14 mg once daily	cdexzaqqvh(kblggvgswo) = jeecwbjzms rwbpgbqpvf (yuvtzldscf ) View more
ASH2024	Not Applicable	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	-	BTKi	pxdmxfzlsg(uxwryogqfh) = oarfntkvwj dbwuvernor (feaukzyrub )	-	09 Dec 2024
				Anticoagulant/Antiplatelet	pxdmxfzlsg(uxwryogqfh) = aygpvduumo dbwuvernor (feaukzyrub )
ASH2024	Not Applicable	Small Lymphocytic Lymphoma	-	BTKi (Ibrutinib)	mxbobznvzb(zypwcwhcft) = A quarter of all pts experienced a non-fatal bleed, resulting in <15% of the pts discontinuing and >50% pts interrupting their BTKi tx abfcbzymge (rknuhhgivt )	-	09 Dec 2024
				Prescription Anticoagulants or Antiplatelets
GEMINI 1，GEMINI 2 (NEWS)	-	Multiple Sclerosis	1,872	Tolebrutinib	sikuohgoni(weohrcdwbi) = suowjrezaz alaeqitcxi (guiwcssgfp )	Negative	20 Sep 2024
				特立氟胺	sikuohgoni(weohrcdwbi) = aluerjlico alaeqitcxi (guiwcssgfp )
NCT04411641 (HERCULES, NEWS) Manual	Phase 3	Multiple Sclerosis, Secondary Progressive	-	Tolebrutinib	huhdfhxapa(jbcsuzvhgc): HR = 0.69 (95% CI, 0.55 - 0.88), P-Value = 0.0026 Met View more	Positive	02 Sep 2024
				placebo
PINC AI Healthcare Database (ASCO2024)	Not Applicable	Chronic Lymphocytic Leukemia	2,091	Ibrutinib	paxhdysfpm(ixerlzmrqg) = vzwllfykrd slpdtdxlba (vheixljvyv )	Positive	24 May 2024
				Acalabrutinib	paxhdysfpm(ixerlzmrqg) = olqvsxfivc slpdtdxlba (vheixljvyv )

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Chemical Structures Search & Analysis

Tolebrutinib

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation