The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML.
The goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.

Start Date01 Dec 2025

Sponsor / Collaborator-

CTIS2025-522252-74-00

/ Not yet recruitingPhase 1

Single dose oral bioequivalence study of Cladribine 10 mg Tablets and Mavenclad® 10 mg tablets (Cladribine) in healthy adult human subjects under fed conditions

Start Date22 Sep 2025

Sponsor / Collaborator-

100 Clinical Results associated with Cladribine

100 Translational Medicine associated with Cladribine

100 Patents (Medical) associated with Cladribine

3,247

Literatures (Medical) associated with Cladribine

31 Dec 2025·CNS oncology

Multiple brain lesions in a patient with relapsed hairy cell leukemia: a case report and review of the literature

Review

Author: Quilichini, Benoît ; Voldoire, Maud ; Dubreuil, Julien ; Sadot-Lebouvier, Sophie ; Le Dû, Katell ; Wafflart, Eric ; Delaunay, Jacques ; Cuvier, Thomas ; Renard, Pierre-Yves

Cerebral lesions are rare in hairy cell leukemia (HCL), and its incidence remains to be determined. Identifying the cause can be challenging. In this report, we present a case of brain lesions occurring several years after diagnosis. A 76-year-old male patient presented to the Emergency Department with confusion. He had been diagnosed with HCL in 1999 and had received five lines of treatment. Cerebral imaging revealed multiple nodular lesions, with edema and a hemorrhagic appearance. Cerebrospinal fluid tests were negative. The tumor origin was retained due to concomitant relapse (blood, lymph nodes). Despite the partial efficacy of rituximab-cladribine treatment, the patient died of Candida pneumonia. A review of the literature (PubMed, CrossRef, Google Scholar) identified seventeen cases between 1966 and 2024, with a median age of 59 years (33-80). Cladribine, with or without rituximab, was the most widely prescribed treatment regimen with a complete response rate of 57%. Four (23.5%) patients died (two from infection, one from gastrointestinal bleeding and one from an unknown cause). These atypical presentations suggest that brain imaging and advanced biological investigations should be performed to guide management.

01 Dec 2025·Multiple Sclerosis and Related Disorders

Progression independent of relapse activity (PIRA) in the Era of high-efficacy treatments

Article

Author: Liguori, Nora Fernandez ; Miguez, Jimena ; Alonso, Ricardo ; Liwacki, Susana ; Piedrabuena, Raul ; Mainella, Carolina ; Rojas, Juan Ignacio ; Zanga, Gisela ; Cabrera, Lorena Mariela ; Silva, Berenice ; Cohen, Leila ; Patrucco, Liliana ; Eizaguirre, Maria Barbara ; Lazaro, Luciana ; Casas, Magdalena ; Tizio, Santiago ; Leguizamon, Felisa ; Pita, Cecilia ; Carnero Contentti, Edgar ; Tkachuk, Veronica

BACKGROUND:

Progression independent of relapse activity (PIRA) is a key marker of chronic neurodegeneration in multiple sclerosis (MS), reflecting sustained disability progression unrelated to inflammatory relapses. While high-efficacy therapies (HETs) have significantly reduced relapse-associated worsening (RAW), the contribution of PIRA to disability progression has increased in recent diagnostic periods.

OBJECTIVES:

This study aimed to evaluate the prevalence and predictors of PIRA in Argentine patients with relapsing-remitting MS (RRMS) receiving HETs and to explore the impact of early treatment initiation on disease progression.

METHODS:

A post hoc analysis of the Argentine MS registry (RelevarEM) was conducted, including RRMS patients treated with natalizumab, alemtuzumab, cladribine (Cladribine), rituximab, or ocrelizumab. Patients required ≥1 relapse in the preceding 12 months, biannual EDSS assessments, and annual MRI scans. PIRA was defined as EDSS progression (≥1.0 or ≥0.5 points, depending on baseline score) confirmed 24 weeks apart, outside the relapse period. Logistic regression identified predictors of PIRA.

RESULTS:

Among 287 patients (68.2 % female, mean age 37.33±11.10 years), 22 (7.7 %) developed PIRA. PIRA patients were older (42.58±13.46 vs. 36.85±10.79 years, p = 0.015) and had longer disease duration (6.87±6.18 vs. 4.41±4.96 years, p = 0.023). Treatment-naïve patients showed lower PIRA risk (OR=0.10, p = 0.0049), while absence of prior relapses increased risk (OR=8.17, p = 0.0087).

CONCLUSIONS:

PIRA prevalence was lower in this cohort compared to prior studies, reflecting the effectiveness of HETs in RRMS. Early initiation of HETs is critical to mitigating PIRA and long-term disability. These findings underscore the need for timely diagnosis and treatment to alter MS progression.

01 Dec 2025·Multiple Sclerosis and Related Disorders

Evolution of high-efficacy treatment strategy for relapsing-remitting multiple sclerosis: A real-life observational study

Article

Author: Kremer, Laurent ; Didierjean, Judicaelle ; Lanotte, Livia ; Collongues, Nicolas ; Courtois, Sylvie ; Carré, Germain ; De Seze, Jerome ; Bigaut, Kévin

BACKGROUND:

The evolution of the therapeutic arsenal, diagnostic criteria and recommendations concerning treatment in multiple sclerosis (MS) have led to a change in the practices of neurologists in this disease. Our study focuses on the evolution of the prescriptions of a disease-modifying treatment (DMT) in relapsing-remitting (RR) MS by neurologists with a private practice, hospital, or MS center activity, between 2007 (introduction of natalizumab) and 2022 (current practice).

METHODS:

We conducted a multicenter, descriptive retrospective study, focusing on the prescription of DMTs for patients with RRMS in the Alsace region in France. The study encompassed prescriptions initiated between January 2007 and July 2022, for patients who had undergone a brain MRI within 6 months of disease onset. The DMTs considered as high efficacy included fingolimod, cladribine, rituximab, ocrelizumab, ofatumumab, and natalizumab.

MAIN RESULTS:

In our study, focused on the initial prescription of DMTs for RRMS involving a cohort of 1155 patients, we observed a significant time reduction before the first DMT was prescribed, from approximately 1 year during the 2007-2010 period to less than 4 months in the more recent 2018-2022 timeframe. The proportion of high-efficacy treatments (HET) increased notably during the later period interval compared to the earlier ones and there was a discernible change in the profiles of patients initiating HET. These disparities in treatment and patient profiles were particularly pronounced among neurologists practicing within specialized centers or hospitals, in contrast to those engaged in private practices.

CONCLUSIONS:

These results witness a change in decision-making regarding the prescription of the initial DMT in RR-MS by neurologists between 2007 and 2022.

110

News (Medical) associated with Cladribine

25 Nov 2025

·pmlive.com

Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

Merck KGaA has received US FDA Fast Track designation for its generalised myasthenia gravis (gMG) drug treatment. Current treatments for gMG have limited efficacy and Merck’s cladribine capsules could become the first oral treatment for gMG, if approved. gMG is a rare autoimmune neuromuscular disorder characterised by severe muscle weakness. It can affect any part of the body, but often presents in the voluntary muscles that control the eyes, eyelids, face and mouth. It can cause difficult moving, chewing, swallowing and occasionally even breathing. Cladribine is designed to selectively target the B and T cells, which are believed to contribute to the production of harmful autoantibodies, causing inflammation and damage to the neuromuscular junction. The cladribine capsules are currently being studied in the global phase 3 MyClad trial. As part of the MyClad trial, Merck KGaA formed a patient council and works with more than 20 MG patient advocacy groups around the world. “The FDA’s Fast Track designation, together with Orphan Drug designation, affirms that more treatments are needed for the gMG community,” said David Weinreich, global head of R&D and chief medical officer for Merck’s healthcare business. “Patient insights will continue to be instrumental to ensure we meet the needs of patients to deliver therapeutic innovation for this rare, chronic autoimmune neuromuscular disorder.” The FDA also granted Orphan Drug designation to the cladribine capsules in June 2023, a special status granted to drugs which treat very rare diseases. The FDA’s Fast Track programme is designed to prioritise and accelerate the development of treatments for conditions with high unmet need. Merck will announce results from the MyClad trial following its completion. In addition to the MyClad trial, Merck is also partnering with medical equipment manufacturing company Ad Scientiam to launch a prospective gMG-related study. The study will investigate the possible applications of wearable technologies, smartphone-based tests and electronic patient-reported outcomes in the management of gMG.

Fast TrackPhase 3Orphan Drug

24 Nov 2025

·www.businesswire.com

EMD Serono Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis

BOSTON--(BUSINESS WIRE)--EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for cladribine capsules for the treatment of the rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia Gravis (gMG). In June 2023, the FDA granted Orphan Drug Designation for cladribine capsules for the treatment of gMG. In addition, the Company is actively collaborating with patient organizations and Ad Scientiam, a medical technology company, to support a patient-directed approach to the future management of gMG. If approved, cladribine capsules, currently being studied in the global Phase 3 MyClad trial, could become the first oral treatment for gMG, a rare autoimmune neuromuscular disorder that causes severe muscle weakness and significantly impacts patients’ lives. The FDA’s Fast Track program is designed to facilitate the development and accelerate the review of therapies for serious conditions with unmet medical needs, potentially bringing treatments to patients sooner. The FDA Orphan Drug Designation is designed to encourage the development of treatments for rare diseases or conditions, often defined as those affecting fewer than 200,000 patients in the U.S. “The FDA’s Fast Track designation, together with Orphan Drug Designation, affirms that more treatments are needed for the gMG community,” said David Weinreich, MD, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck KGaA, Darmstadt, Germany. “As a patient-directed company, we are prioritizing the voices of MG patients in shaping our clinical program. Their insights will continue to be instrumental to ensure we meet the needs of patients to deliver therapeutic innovation for this rare, chronic autoimmune neuromuscular disorder.” To shape the MyClad trial and ensure it meets the needs of patients, EMD Serono developed a patient council and collaborates with more than 20 MG patient advocacy groups around the world. Insights from the council have informed study protocols, recruitment materials and potential future product packaging options for the clinical trial program. In addition, the company is collaborating with Ad Scientiam, a medical equipment manufacturing company, to launch a prospective, multi-center pilot study exploring an investigational software as a medical device designed to support the management of people living with gMG. The study will investigate how wearable technologies, smartphone-based functional tests, and electronic patient-reported outcomes (ePROs) could detect changes in disease trajectory in real-world conditions. The MyClad trial (NCT06463587) is a global Phase 3, randomized, double-blind and placebo-controlled study designed to assess the efficacy and safety of cladribine capsules in 264 patients with gMG. Cladribine is proposed to target selectively the B and T cells believed to contribute to the production of harmful autoantibodies that cause inflammation and damage to the neuromuscular junction. This mechanism of action, combined with a short-course infrequently-administered oral regimen taken at home, that if approved, may help reduce the burden of the disease by addressing its underlying cause. EMD Serono will announce results from the MyClad trial following its completion and remains committed to ongoing collaboration with the gMG community to ensure patient needs continue to guide clinical developments. About generalized Myasthenia Gravis Generalized Myasthenia Gravis (gMG) is a rare, chronic autoimmune neuromuscular disorder characterized by muscle weakness and fatigue, impacting an estimated 700,000 people worldwide. The disease can strike anyone at any age but is more frequently seen in young women (age 20 to 30) and men aged 50 and older. In gMG, the communication between the nerves and the muscles, particularly at the neuromuscular junction (NMJ), is disrupted causing muscle weakness. This can result in the loss of control in the eye muscles and a variable combination of the arms, legs, and respiratory muscles. The unpredictable severity and frequency of symptoms in gMG patients can be debilitating, significantly impacting various aspects of day-to-day life. About the MyClad Phase 3 Clinical Trial Program The MyClad trial (NCT06463587) is a global Phase 3, randomized, double-blind and placebo-controlled study designed to assess the efficacy and safety of cladribine capsules in 264 patients with gMG. In the study patients will be randomized to receive either two short courses of cladribine (low-dose or high-dose) or matched oral placebo, with courses separated by 4 weeks, followed by a blinded extension period and a retreatment period to assess sustained benefit, need for retreatment and long-term safety. The primary endpoint is change from baseline in the MG-Activities of Daily Living (MG-ADL) score at Week 24 of the double-blind placebo-controlled period. About EMD Serono, Inc. EMD Serono - the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada - aspires to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer. The business is imagining the future of healthcare by working to translate the discovery of molecules into potentially meaningful outcomes for people with serious unmet medical needs. EMD Serono’s global roots go back more than 350 years with Merck KGaA, Darmstadt, Germany. Today, the business has approximately 1,050 employees around the country with commercial, clinical and research operations in Massachusetts. www.emdserono.com. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck KGaA, Darmstadt, Germany, generated sales of € 21.2 billion in 65 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service.

Phase 3Fast TrackOrphan Drug

17 Sep 2025

·www.businesswire.com

Merck to Present New Data Highlighting Durable Effects of MAVENCLAD ® in Relapsing Multiple Sclerosis (RMS) at ECTRIMS 2025

DARMSTADT, Germany--(BUSINESS WIRE)--Not intended for UK-, US- or Canada-based media Merck, a leading science and technology company, today announced the presentation of over 30 abstracts from its multiple sclerosis (MS) portfolio. New four-year data from two large Phase 4 studies highlight the long-term efficacy, favorable disability outcomes and durable impact of MAVENCLAD® (cladribine tablets) in people living with relapsing multiple sclerosis (RMS). These findings are to be presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26 in Barcelona. “As the only high-efficacy short-course oral treatment, MAVENCLAD has demonstrated sustained benefits across a variety of outcomes—extending beyond relapses and MRI—without requiring continuous immunosuppression,” said Alex Kulla, Senior Vice President & Global Head of the Neurology & Immunology Medical Unit for the Healthcare business of Merck. “With over two decades of clinical experience and substantial real-world data, MAVENCLAD has been utilized to treat more than 130,000 individuals, amounting to over 360,000 patient-years of exposure. The comprehensive data presented at ECTRIMS 2025 reinforces its role in delivering durable, effective care for individuals with RMS—supporting them from early diagnosis through later stages of life.” Key MAVENCLAD data: An integrated analysis of four-year data from CLARIFY-MS (n=482) and MAGNIFY-MS (n=270), including their extension studies, showed low rates of disability accumulation and progression independent of relapse activity (PIRA) in patients treated with MAVENCLAD, especially those who initiated treatment in the early stages of their disease. At Year 4, 83.4% of patients were free from confirmed disability progression (CDP) and 89.2% were free from PIRA. 15.4% experienced confirmed disability improvement (CDI). Patients aged ≤40 experienced lower rates of PIRA compared to those over 40 (7.6% vs. 15.4%, respectively). The analysis demonstrated that MAVENCLAD provided durable efficacy after short-course treatment, with long-term control over both inflammatory and non-inflammatory components of MS-related disability. At Year 4, 83.4% of patients were free from confirmed disability progression (CDP) and 89.2% were free from PIRA. 15.4% experienced confirmed disability improvement (CDI). Patients aged ≤40 experienced lower rates of PIRA compared to those over 40 (7.6% vs. 15.4%, respectively). The analysis demonstrated that MAVENCLAD provided durable efficacy after short-course treatment, with long-term control over both inflammatory and non-inflammatory components of MS-related disability. Data from MAGNIFY-MS showed MAVENCLAD reduced serum and cerebrospinal fluid (CSF) biomarkers of neuroinflammation, suggesting a broader central nervous system (CNS) benefit. At Year 2, reductions were observed in key biomarkers, including serum glial fibrillary acidic protein (GFAP), immunoglobulin G (IgG) index, and C-X-C motif chemokine ligand 13 (CXCL-13) levels. At Year 2, reductions were observed in key biomarkers, including serum glial fibrillary acidic protein (GFAP), immunoglobulin G (IgG) index, and C-X-C motif chemokine ligand 13 (CXCL-13) levels. Brain imaging data from MAGNIFY-MS indicated that the brain atrophy rate in MAVENCLAD-treated patients was comparable to that observed in the healthy population, reinforcing the importance of brain volume (BV) preservation as a therapeutic goal in MS. From Years 2 to 4, annualized percent BV change remained below 0.4%, across all subgroups. Patients with low brain atrophy rates at Year 4 had markedly lower annualized relapse rate (ARR) (0.04 ±0.12 vs. 0.16 ±0.26) and less clinical deterioration compared to those with annualized percentage BV change exceeding -0.4%. From Years 2 to 4, annualized percent BV change remained below 0.4%, across all subgroups. Patients with low brain atrophy rates at Year 4 had markedly lower annualized relapse rate (ARR) (0.04 ±0.12 vs. 0.16 ±0.26) and less clinical deterioration compared to those with annualized percentage BV change exceeding -0.4%. Additional MAVENCLAD presentations: Poster Presentation Title: Treatment Continuation With Cladribine Tablets Beyond Year 4: Analysis of Longitudinal Prescription Data From Germany Lead Author: David Kormann, Real World Data Analytics, IQVIA Commercial GmbH & Co. OHG, Frankfurt, Germany Lead Author: David Kormann, Real World Data Analytics, IQVIA Commercial GmbH & Co. OHG, Frankfurt, Germany Poster Presentation Title: Treatment continuation with cladribine tablets (CladT) beyond year 4– second interim analysis of the CLIP-5 study Lead Author: Catharina Korsukewitz, University Hospital Muenster, Muenster, Germany Lead Author: Catharina Korsukewitz, University Hospital Muenster, Muenster, Germany Poster Presentation Title: Incidence Rate of Malignancies in People with Multiple Sclerosis Newly Initiating Cladribine Tablets or Fingolimod: Second Interim Results from CLARION Lead Author: Anna Glaser, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden Lead Author: Anna Glaser, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden Poster Presentation Title: Clinical Outcomes of Cladribine Tablets in Aging (≥50 years) Patients with Relapsing Multiple Sclerosis in a Real-World Setting: Insights From the ‘Aging’ Study Lead Author: Joshua Katz, Elliot Lewis Center for Multiple Sclerosis Care, Wellesley, MA, United States Lead Author: Joshua Katz, Elliot Lewis Center for Multiple Sclerosis Care, Wellesley, MA, United States Below is the full list of MAVENCLAD abstracts accepted for presentation at ECTRIMS 2025: The Effect of Cladribine Tablets on Brain Volume over 4 Years in the MAGNIFY-MS Extension Study Barkhof F, Schmierer K, Vermersch P, et al. Poster: P687 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Barkhof F Impact of Cladribine Tablets on GFAP Levels and Intrathecal Biomarkers in RMS: Results from the MAGNIFY-MS Study Wiendl H, Derfuss T, Sponton L, et al. Poster: P1694 Session: ePoster Date: September 24-26, 2025 Presenter: Wiendl H Long-Term Effect of Cladribine Tablets on Disability Progression and Improvement: Insights from Pooled Analyses of CLARIFY-MS and MAGNIFY-MS Studies Vermersch P, Wiendl H, Leocani L, et al. Poster: P335 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Vermersch P Cladribine Tablets Show Low 4-Year PIRA Rates in MS: Insights from Pooled Analyses of CLARIFY-MS and MAGNIFY-MS Studies Montalban X, De Stefano N, Hodgkinson S, et al. Poster: P1707 Session: ePoster Date: September 24-26, 2025 Presenter: Montalban X Comparing Changes in Brain Tissue Damage Between the Two-year Active Dosing Treatment Period and the Following Two Years Extension Period in Cladribine-treated MS Patients Stratified by MRI Phenotypes De Stefano N, Sforazzini F, Luchetti L, et al. Poster: P208 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: De Stefano N Cladribine Tablets-treated Multiple Sclerosis Patients Show Different Spatio-temporal Patterns of Acute, Chronic and Resolving Brain Inflammatory Activity Gentile G, Smyk A, Ben-Amor A-F, et al. Poster: P1450 Session: ePoster Date: September 24-26, 2025 Presenter: Gentile G Using Deep Learning on Baseline MRI Data for Highly Accurate Prediction of Cladribine Tablets-treated MS Patients who Improve Physical and Cognitive Disability in 4 Years Battaglini M, Sforazzini F, Luchetti L, et al. Poster: P672 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Battaglini M Incidence Rate of Malignancies in People with Multiple Sclerosis Newly Initiating Cladribine Tablets or Fingolimod: Second Interim Results from CLARION Glaser A, Ziemssen T, Butzkueven H, et al. Poster: P856 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Glaser A Real-world Experience with Cladribine (Mavenclad) in the MSBase Registry 2025 Spelman T, van der Walt A, Ozakbas S, et al. Poster: P875 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Butzkueven H Treatment Continuation With Cladribine Tablets Beyond Year 4: Analysis of Longitudinal Prescription Data From Germany Kormann D, Parekh M, von der Maßen K, et al. Poster: P1773 Session: ePoster Date: September 24-26, 2025 Presenter: Kormann D Real-world Experience with Cladribine Tablets in Older Age Groups in the MSBase Registry Spelman T, van der Walt A, Havrdova E, et al. Poster: P1985 Session: ePoster Date: September 24-26, 2025 Presenter: Butzkueven H Cladribine Tablets Reduce Pathological Brain Ageing Gap in MS Patients Leoncini M, Battaglini M, Sforazzini F, et al. Poster: P432 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Leoncini M Clinical Outcomes of Cladribine Tablets in Aging (≥50 years) Patients with Relapsing Multiple Sclerosis in a Real-World Setting: Insights From the ‘Aging’ Study Katz J, Hughes B, Gutierrez A, et al. Poster: P332 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Katz J Relationship Between CSF Cellular Populations and MRI Biomarkers of MS Disease Severity: Insights from the CLOCK-MS Study Samara A, Judge B, Salter A, et al. Poster: P1471 Session: ePoster Date: September 24-26, 2025 Presenter: Brier MR Three-Year Effectiveness and Safety Data for Cladribine Tablets in Patients with Relapsing Multiple Sclerosis after Transitioning from Natalizumab (CLADRINA Study) Sguigna P, Okai A, Kaplan J, et al. Poster: P1947 Session: ePoster Date: September 24-26, 2025 Presenter: Sguigna P Treatment Continuation with Cladribine Tablets (CladT) Beyond Year 4– Second Interim Analysis of the CLIP-5 Study Korsukewitz C, Richter N, Klehmet J, et al. Poster: P1803 Session: ePoster Date: September 24-26, 2025 Presenter: Korsukewitz C Long-term Effects of Treatment with Cladribine Tablets on Cognition and Treatment Satisfaction in People with Relapsing Multiple Sclerosis: 4‑year Results from the Noninterventional CLADQoL Study Penner I-K, Chudecka A, Refik P, et al. Poster: P1820 Session: ePoster Date: September 24-26, 2025 Presenter: Penner I-K 48 Month Follow-up of Maven4: a Phase IV Non-interventional, Prospective, Spanish Multicenter Study to Assess the Long Term Effectiveness of Cladribine Tablets in Real-world Clinical Practice Aladro-Benito Y, Costa-Frossard L, Sánchez Magro MI, et al. Poster: P346 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Aladro-Benito Y Design and Baseline Characteristics of the Real-world MAVENAGE Study in Relapsing MS Patients Older and Younger Than 50 Years Treated with Cladribine Tablets Meca-Lallana JE, Eichau S, Oreja-Guevara C, Meca V, et al. Poster: P1649 Session: ePoster Date: September 24-26, 2025 Presenter: Meca-Lallana JE Retrospective Analysis of Multiple Sclerosis Patients Who Initiated Oral Cladribine 5-8 Years Ago – Data from a German Cladribine Cohort Woitschach L, Cepek L, Kowarik M, et al. Poster: P357 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Ernst M Clinical Effectiveness of Cladribine Tablets for PwMS Switching from Natalizumab, AntiCD20 Treatment or “Other”; Data from the Swedish Post-market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10) Forsberg L, Larsson V, Hillert J, et al. Poster: P1762 Session: ePoster Date: September 24-26, 2025 Presenter: Forsberg L Clinical Effectiveness and Safety of Cladribine Tablets for PwMS Treated at Least 36 Months in the Swedish Post-market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10) Forsberg L, Larsson V, Hillert J, et al. Poster: P344 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Forsberg L Clinical Effectiveness of Cladribine Tablets for Patients Below or Above 50 Years of Age at Treatment Start in the Swedish Post-market Surveillance Study "Immunomodulation and Multiple Sclerosis Epidemiology 10" (IMSE 10) Larsson V, Forsberg L, Hillert J, et al. Poster: P861 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Larsson V CLADCOMS - CLADribine Tablets Long-term Control of MS – a Post-Marketing Investigator Driven Study Larsson V, Forsberg L, Nilsson P, et al. Poster: P865 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Larsson V Clinical Effectiveness of Cladribine Tablets for Patients with Few vs Many Treatments Prior CladT Initiation in the CLADCOMS Study -CLADribine Tablets Long-term Control Of MS – a Post-marketing Investigator Driven Study Larsson V, Forsberg L, Nilsson P, et al. Poster: P1804 Session: ePoster Date: September 24-26, 2025 Presenter: Larsson V Recurrent Effects on the Clonal Composition of Peripheral B Cells in MS Patients During the Second Year of Cladribine Treatment Tieck MP, Vasilenko N, Stadelmaier J, et al. Poster: P813 Session: Poster Session 2 Date: September 25, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Tieck MP Preliminary Data of Paramagnetic Rim Lesion Dynamic at 7 Tesla Magnetic Resonance Imaging in Cladribine Tablets-Treated People with Multiple Sclerosis Dal-Bianco A, Hametner S, Grabner G, et al. Poster: P216 Session: Poster Session 1 Date: September 24, 2025 Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT Presenter: Dal-Bianco A Baseline and Early Safety Data Following Full Recruitment of ChariotMS, the First DMT trial for People with Advanced MS (EDSS 6.5-8.5) Schmierer K, Mattoscio M, De Angelis F, et al. Poster: P1633 Session: ePoster Date: September 24-26, 2025 Presenter: Schmierer K Breaking Inflammatory Cycles: Cladribine Targets Pathogenic B Cell Subsets in Multiple Sclerosis Pirronello M, Picozza M, Corbisiero S, et al. Poster: P1374 Session: ePoster Date: September 24-26, 2025 Presenter: Battistini L Circulating MicroRNAs as Potential Biomarkers for Treatment Response in Cladribine-Treated Multiple Sclerosis Patients Vigiser I, Zeevi Y, Piura Y, Kolb H, Golan M, Karni A, Regev K Poster: P762 Session: ePoster Date: September 24-26, 2025 Presenter: Vigiser I Integrin β1 Demarks Circulating Precursors of Brain-residing Antibody-secreting Cells in People with MS Kuiper K, Bogers L, Rip J, et al. Oral presentation: O123 Session: Scientific Session 14: Antibody-mediated pathology Date: September 26, 2025 Time: 12:26-12:33 am PDT/03:26-03:33 am EDT Presenter: Smolders J Early Lymphocyte Reduction as a Potential Marker of Cladribine Efficacy Celius E, et al. Poster: P2028 Session: ePoster Date: September 24-26, 2025 Presenter: Celius E About MAVENCLAD® MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception, and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery. Because cladribine is cytotoxic, special handling and disposal instructions should be followed. More than 130,000 patients have been treated with MAVENCLAD since its launch in 2019. MAVENCLAD has been approved in over 80 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information. About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.9 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. Merck in Neurology and Immunology Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company’s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and generalized myasthenia gravis (gMG). About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck generated sales of € 21.2 billion in 65 countries. Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Clinical ResultPhase 3Phase 2

100 Deals associated with Cladribine

External Link

KEGG	Wiki	ATC	Drug Bank
D01370	Cladribine	L04AA40 L01BB04	DB00242

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis	United States	EMD Serono, Inc.	29 Mar 2019
Multiple Sclerosis, Relapsing-Remitting	Canada	EMD Serono, Inc.	30 Nov 2017
Multiple sclerosis relapse	European Union	Merck Europe BV	22 Aug 2017
Multiple sclerosis relapse	Iceland	Merck Europe BV	22 Aug 2017
Multiple sclerosis relapse	Liechtenstein	Merck Europe BV	22 Aug 2017
Multiple sclerosis relapse	Norway	Merck Europe BV	22 Aug 2017
Anemia	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	15 Nov 2005
Neutropenia	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	15 Nov 2005
Thrombocytopenia	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	15 Nov 2005
Mantle-Cell Lymphoma	Japan	Clinigen KK	16 Dec 2002
Non-Hodgkin Lymphoma	Japan	Clinigen KK	16 Dec 2002
Hairy Cell Leukemia	United States	Janssen Pharmaceuticals, Inc.	26 Feb 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis	Phase 3	United States	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	China	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Japan	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Argentina	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Australia	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Bulgaria	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	France	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	India	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Poland	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Romania	Merck Healthcare KGaA	25 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Hairy Cell Leukemia First line	279	Cladribine	qxwpnwprmh(vtmstaqfam) = eeulwwvlxk ncaymdiumd (urnwkmalym ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Acute Myeloid Leukemia	33	CLAG-M	dhawnztlrg(apzwcoquxs) = uomvmohxbs rhpcteuhvp (tzofqfduau ) View more	Positive	06 Dec 2025
				Cladribine-LDAC	jdcqrurqll(ebpksopufl) = djucpgqese ulhtcomwyb (zxnvwhrtzk )
NCT04050280 (ASH2025)	Phase 2	Refractory acute myeloid leukemia	19	CLAG-GO	hwjgicveyd(hmssbrmtmr) = hematologic: febrile neutropenia (95%), thrombocytopenia (79%), and anemia (47%). ibciafmqor (kpzhagalrz ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Acute Myeloid Leukemia with FLT3/ITD Mutation First line FLT3-mutated	48	CLIA + Gilteritinib	dhtbmyiyuc(fyyigxyyse) = 17 cases for CLIA/gilt kuhydnmfaq (awlntwphoo ) View more	Positive	06 Dec 2025
				CLIA + Sorafenib
NCT03257241 (PALG-AML1/2016, ASH2025)	Phase 3	Acute Myeloid Leukemia First line	439	Daunorubicin+Ara-C (DA-90)	ffpvigasak(jmdkbitfig) = fhgphocthe mkflcpiyui (ynkudtjrot ) View more	Positive	06 Dec 2025
				Daunorubicin+Ara-C+Cladribine (DAC)	ffpvigasak(myxyjgwcea) = momnfhkfbn lmbwpcwnyp (tguzzwjacz ) View more
ASH2025	Not Applicable	Blast Phase Chronic Granulocytic Leukemia	13	CLIA + TKI (frontline)	wzlzsaured(qvxkxgjvuy) = Eight of 13 patients (62%) experienced at least one adverse event, most commonly infections, febrile neutropenia, or laboratory evidence of renal or hepatic dysfunction. Three patients required hospitalization for infection-related complications. Non-infectious AEs were generally mild and often unrelated to study treatment. No unexpected or treatment-related deaths occurred. wevzjfklzm (whmqvymqvp )	Positive	06 Dec 2025
				CLIA + TKI (R/R)
NCT02115295 (ASH2025)	Phase 2	Acute Myeloid Leukemia First line KMT2A rearrangement	22	Cladribine, Idarubicin, Cytarabine (CLIA)	cxhxrlfsjw(nlbrjmgjah) = adrbsqgvae bnlsjncgpf (pqffuyxxpf ) View more	Positive	06 Dec 2025
				Cladribine, Idarubicin, Cytarabine + Venetoclax (CLIA-Ven)	cxhxrlfsjw(nlbrjmgjah) = mxmsqduhws bnlsjncgpf (pqffuyxxpf ) View more
ASH2025	Not Applicable	ANKRD26 pathogenic variants	27	Venetoclax combined with cladribine, idarubicin, and cytarabine	xpxeijbozn(lexxuhuehy) = kwbvfhvrkb lhrkqtlzny (fucszjivas ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Refractory acute myeloid leukemia	16	CLIA-venetoclax	ylklqmjplt(gqwctjkdhm) = qlpxmspqul obbgiaekvu (lzdoofgwng ) View more	Positive	06 Dec 2025
NCT04848974 (2922 \| Phase II Study of Uproleselan Combined with Cladribine and Low-Dose Cytarabine, CTgov)	Phase 1/2	Relapsing acute myeloid leukemia	37	Cladribine+Uproleselan+Cytarabine (Ph 1 Treatment Dose Level -1 Cladaribine 3.75mg/m^2)	gvejkkuzjo = dmqejieeqo sanxmwoxuc (cbpohlybkb, jwkoqsmydk - hyuzlshxno) View more	-	20 Oct 2025
				Cladribine+Uproleselan+Cytarabine (Ph 1 Treatment Dose Level 1 Cladaribine 5 mg/m^2)	gvejkkuzjo = idoktvyoug sanxmwoxuc (cbpohlybkb, gjwxbegmxm - ugbhkodaht) View more

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