Mavenclad (cladribine) / EMD Serono - LARVOL DELTA

Comparative assessment of treatment switching in patients with multiple sclerosis receiving cladribine tablets versus fingolimod, dimethyl fumarate, and teriflunomide. (PubMed, Mult Scler Relat Disord) - "This real-world study revealed significantly lower treatment switching rates in CladT-treated patients than in fingolimod-, dimethyl fumarate- and teriflunomide-treated patients with MS."

Journal • CNS Disorders • Multiple Sclerosis

Long-term outcomes of cladribine tablets in multiple sclerosis: Treatment completion, persistence, and subsequent therapy transitions in Southeast Europe. (PubMed, Mult Scler Relat Disord) - "A substantial proportion of pwMS treated with cladribine tablets remain treatment-free for over four years. In selected cases, a third course of cladribine tablets may be beneficial."

Journal • CNS Disorders • Multiple Sclerosis

EFFICACY AND SAFETY OF MELPHALAN/TBI-BASED CONDITIONING REGIMENS (MCAC/TCAC) FOR AUTOLOGOUS HSCT IN ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: A MULTICENTER, PROSPECTIVE COHORT STUDY (EBMT 2026) - P=N/A | "The MCAC regimen comprised melphalan (70 mg/m², days -8, -7), cyclophosphamide (40 mg/kg, days -6, -5), and cladribine (5 mg/m²) plus cytarabine (2 g/m²) on days -4 to -2. These preliminary findings suggest that the MCAC regimen appears to be a viable and safe alternative to TBI-based conditioning for auto-HSCT in adult ALL patients who achieve and sustain early MRD negativity. However, as enrollment in the TBI-based conditioning arm is not yet complete and the follow-up duration for both groups remains short, long-term efficacy and safety require further investigation."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Cerebral Hemorrhage • Gastroenterology • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Liver Failure • Mucositis • Stomatitis • T Acute Lymphoblastic Leukemia

EFFICACY AND SAFETY OF MELPHALAN/TBI-BASED CONDITIONING REGIMENS (MCAC/TCAC) FOR AUTOLOGOUS HSCT IN ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: A MULTICENTER, PROSPECTIVE COHORT STUDY (EBMT 2026) - P=N/A | "The MCAC regimen comprised melphalan (70 mg/m², days -8, -7), cyclophosphamide (40 mg/kg, days -6, -5), and cladribine (5 mg/m²) plus cytarabine (2 g/m²) on days -4 to -2. These preliminary findings suggest that the MCAC regimen appears to be a viable and safe alternative to TBI-based conditioning for auto-HSCT in adult ALL patients who achieve and sustain early MRD negativity. However, as enrollment in the TBI-based conditioning arm is not yet complete and the follow-up duration for both groups remains short, long-term efficacy and safety require further investigation."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Cerebral Hemorrhage • Gastroenterology • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Liver Failure • Mucositis • Stomatitis • T Acute Lymphoblastic Leukemia

Portuguese consensus for the use of cladribine tablets in multiple sclerosis. (PubMed, Neurodegener Dis Manag) - "Experts also defined monitoring schedules, treatment assessments, safety recommendations, and family planning. This study guides the use of cladribine tablets in clinical practice, supporting treatment decision-making in patients with RRMS, and summarizes the current knowledge from clinical trials and real-world studies of the efficacy and safety of cladribine tablets."

Journal • CNS Disorders • Multiple Sclerosis

Advancements in Pharmacotherapy and Mobile Health Applications for Self-Management in Multiple Sclerosis: A Comprehensive Review. (PubMed, Recent Pat Biotechnol) - "Monoclonal antibodies define the upper limit of efficacy in current MS therapy, but sustainability depends on safety oversight and patient engagement. Oral formulations remain clinically pragmatic first-line options. The synergy between pharmacotherapy and mobile health technology offers a pathway to transform adherence, monitoring, and outcome optimization in future MS management."

Journal • CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis

International Expert Opinion on Optimal Switching to Cladribine Tablets from Other High-Efficacy Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Opportunities and Challenges. (PubMed, Neurol Ther) - "An international group of experts in the care of RMS reviewed the current evidence and their clinical practice in order to provide recommendations on the optimal therapeutic use of cladribine tablets (CladT, an immune reconstitution therapy for RMS) in patients previously managed on anti-trafficking agents (S1P modulators, natalizumab) or an anti-CD20 agent. It is important to keep the interval between withdrawal of a previous anti-trafficking DMT (especially S1P modulators) and initiation of CladT as short as possible if the switch is intended to address breakthrough RMS disease activity, especially with regard to the prevention of rebound RMS disease activity. Immune reconstitution therapy with CladT may also provide an opportunity to plan for pregnancy in the absence of continuous DMT."

Journal • Review • CNS Disorders • Inflammation • Multiple Sclerosis

Treatment-free remission in MS: long-term disease control with cladribine tablets. (PubMed, J Neurol) - "Unrestricted long-term management options associated with cladribine tablets include a switch to other DMTs in cases of insufficient disease control. Overall, cladribine tablets show potential of a paradigmatic shift in MS management that may enable treatment-free remission over 6 years as an achievable treatment goal in a substantial proportion of RMS patients."

Journal • Review • CNS Disorders • Multiple Sclerosis

Fusarium on the Surface: Cutaneous Clues to a Deadly Disseminated Infection (AAD 2026) - "Patient History: Here we present a 68-year-old man with past medical history of acute myeloid leukemia (AML) treated with an allogeneic stem cell transplant, chronic hepatic graft-versus-host disease (GVHD), and cutaneous and pulmonary mucormycosis, which had been successfully managed for two years with posaconazole, who was admitted for chemotherapy with cladribine, cytarabine, and venetoclax...Treatment: Management included surgical nasal sinus debridement and near-total ethmoidectomy, in addition to aggressive systemic antifungal therapy with voriconazole, liposomal amphotericin B, micafungin, and oral terbinafine. Supportive treatment included meropenem and filgrastim to address concurrent neutropenia... In immunocompromised patients with hematologic malignancies, dermatologists should have a low threshold to perform biopsies and tissue cultures on even non-specific skin findings. Prompt dermatologic evaluation, biopsy, and tissue culture are essential for early..."

Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Leukemia • Liver Failure • Neutropenia • Otorhinolaryngology

Analysis of herpes zoster cases in multiple sclerosis patients treated with disease-modifying drugs: insights from the EudraVigilance database. (PubMed, Neurol Neurochir Pol) - "While treating MS patient with DMTs the risk of adverse HZ should be evaluated. Vaccination against HZ should be recommended for patients to benefit the most from the available treatment."

Journal • CNS Disorders • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Neuralgia • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Varicella Zoster

OCR_CLAD: Consolidation Therapy With Cladribine in Relapsing Multiple Sclerosis Patients (clinicaltrials.gov) - P=N/A | N=70 | Active, not recruiting | Sponsor: Ente Ospedaliero Cantonale, Bellinzona | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

The efficacy of disease-modifying therapies in patients with clinically isolated syndrome: a systematic review and network meta-analysis. (PubMed, Sci Rep) - "DMTs, including cladribine, teriflunomide, IFN beta-1a, IFN beta-1b, and GA, showed evidence of reducing conversion to CDMS compared with placebo. Cladribine and GA showed the strongest evidence for a high probability of reducing CDMS conversion."

Journal • Retrospective data • CNS Disorders • Multiple Sclerosis

The Exit Strategy: Clinical Outcomes and Safety of De-escalating High-efficacy Therapies in Multiple Sclerosis (AAN 2026) - ""Stable" PwMS transitioned from natalizumab (50%), ocrelizumab (49%) or alemtuzumab (1%). Most PwMS were de-escalated to cladribine (49%) or a fumarate (41%)... These findings suggest that age may be an influential factor in determining stability after de-escalation and de-escalation from ocrelizumab appears to be safer than from natalizumab. Therefore, the decision to de-escalate should be based on individual patients' characteristics."

Clinical • Clinical data • CNS Disorders • Multiple Sclerosis

Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system. (PubMed, Mult Scler Relat Disord) - "Patient counseling on early appendicitis warning signs and indications for urgent evaluation may be warranted for people with MS on DMTs."

Adverse events • Journal • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Multiple Sclerosis

Real-world Utilization of a Novel Multi-analyte Blood-based Biomarker Panel, the Octave® Multiple Sclerosis Disease Activity (MSDA) Test in Clinical Practice Across the United States (AAN 2026) - "Baseline demographics include mean age of 52.0 years, 77.0% female, 76.8% White, 14.7% Black, and 4.4% Hispanic.Among patients with DMT data, 44.4% were on high-efficacy DMTs (anti-CD20s, natalizumab, cladribine, alemtuzumab) at their latest test; 34.2% were not on a DMT. This report highlights the growing use of the MSDA Test in US clinical practice and its clinical utility for tracking meaningful change. Ongoing research is essential to fully realize the Octave® MSDA test's impact and ensure smooth integration into clinical workflows."

Biomarker • Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

Herpes Zoster Reports in Multiple Sclerosis Patients Treated With Disease Modifying Drugs – An Analysis of EudraVigilance Database (AAN 2026) - "Values form 0.2% (glatiramer acetate), to 3.9% (cladribine) of all adverse reports, mark HZ as a relevant complication during MS treatment. The highest ROR values were noted for fingolimod (4,09), cladribine (3,33) and alemtuzumab (2,27), followed by siponimod (1,97). The lowest RORs were calculated for glatiramer acetate (0,17), interferons (≈0,21) and teriflunomide (0,35)... Our study shows that some DMTs used in MS might be linked with significant increase in the risk of HZ infection development. While treating MS patient with DMTs, clinicians should always carefully evaluate the risk of adverse HZ. Moreover, vaccination against HZ should be recommended, to reduce the risk of HZ infection, enabling patients to benefit fully form the available MS treatment."

Clinical • CNS Disorders • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Neuralgia • Ophthalmology • Varicella Zoster

Association Between Disease-modifying Therapies for Multiple Sclerosis and Cancer Reporting: A Disproportionality Analysis Using the U.S. Food and Drug Administration Adverse Event Reporting System Database (AAN 2026) - "Subgroup analyses identified positive safety signals for specific malignancy subgroups with ROR (95% confidence intervals) values as follows: for alemtuzumab, non-Hodgkin B-cell lymphoma 6.49 (2.67–15.81), endocrine neoplasms malignant and unspecified (NMU) 3.63 (2.09–6.28), and skin NMU 2.99 (2.00–4.49); for fingolimod, skin NMU 4.33 (4.02–4.66) and non-Hodgkin T-cell lymphoma 2.15 (1.57–2.97); for cladribine, leukemias 2.43 (1.43–4.13) and renal and urinary tract NMU 2.18 (1.23–3.86); for rituximab, gastrointestinal NMU 3.13 (1.93–5.06); for other S1P modulators, skin NMU 2.04 (1.54–2.68); for interferon beta-1a, nervous system NMU 2.82 (2.56–3.10) and endocrine NMU 2.45 (2.23–2.69); and for interferon beta-1b, endocrine NMU 2.30 (1.78–2.98). No association was found between DMTs and overall cancer reporting. However, several subgroup analyses demonstrated positive safety signals, underscoring the need for population-based studies to provide more definitive evidence."

Adverse events • B Cell Lymphoma • CNS Disorders • Endocrine Cancer • Lymphoma • Multiple Sclerosis • Oncology • T Cell Non-Hodgkin Lymphoma

Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study. (PubMed, Neurol Ther) - P4 | "Most CLARIFY-MS participants had increased or stable information processing speed at M24 (vs baseline), as determined using clinically meaningful 4- and 8-point changes in SDMT scores. Overall, the cognitive function and employment status of CladT-treated participants with highly active RMS remained stable over 2 years."

Journal • P4 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Multiple Sclerosis

A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2 | N=58 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center | Initiation date: Dec 2025 ➔ Dec 2027

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CPO25001: Single dose oral bioequivalence study of Cladribine 10 mg Tablets and Mavenclad 10 mg tablets (Cladribine) in healthy adult human subjects under fed conditions (clinicaltrialsregister.eu) - P1 | N=40 | Not yet recruiting | Sponsor: PharOS Pharmaceutical Oriented Servises Ltd., CCDRD Cooperative Clinical Drug Research and Development AG

New P1 trial

Effects of Cladribine on Immune Cell Subsets and Autoantibody Responses in Generalized Myasthenia Gravis Peripheral Blood Mononuclear Cells in Vitro (AAN 2026) - P3 | "Cladribine, at concentrations intended to mimic the plasma exposure of people with gMG treated with oral cladribine, depletes B and T cell subsets, inhibits plasma cell differentiation, and reduces IgG and anti-AChR IgG production in gMG PBMCs in vitro. These data suggest that cladribine targets drivers of autoimmunity in gMG, supporting the upstream mechanism of cladribine in reducing autoantibody production in gMG."

Immune cell • Preclinical • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis • CD20

Neurofibromatosis and Multiple Sclerosis Under Cladribine Therapy: An Illustrative Unique Case and Systematic Review (AAN 2026) - "This case presentation and review highlights a previously unreported association between cladribine therapy and neurofibroma proliferation in NF1. While causality cannot be established, immunosuppression may play a contributory role in tumor growth in genetically susceptible individuals. Further research is warranted to elucidate the biological mechanisms linking NF and MS and to guide therapeutic decisions in this rare comorbidity."

Clinical • Review • CNS Disorders • Genetic Disorders • Immunology • Multiple Sclerosis • Neurofibromatosis • Solid Tumor • NF1

A Comparative Effectiveness Analysis of Fumarates versus Cladribine in People With MS Transitioning From Anti-CD20 Therapies (AAN 2026) - "Strategies to mitigate risks with anti-CD20s include switching to oral DMTs such as FUM (dimethyl fumarate; diroximel fumarate) or oral CLAD... These results indicate that relapse rates were comparable between FUM and CLAD and suggest FUM may be as effective as CLAD in controlling disease activity in PwMS transitioning from anti-CD20 therapies."

HEOR • CNS Disorders • Infectious Disease • Multiple Sclerosis

Cladribine Holds its Weight: Comparable Lymphocyte Dynamics in People With Multiple Sclerosis Above and Below 110 kg (AAN 2026) - "Lymphocyte dynamics were comparable between weight groups, indicating that cladribine's capped dosing strategy remains effective at higher body weights. This finding supports the use of cladribine in patients weighing over 110 kg, thereby expanding confidence in prescribing cladribine to a broader patient population."

CNS Disorders • Inflammation • Multiple Sclerosis