fingolimod / Generic mfg. - LARVOL DELTA

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

Repeatedly occurring retrograde menstruation intensifies central sensitization driven by neuroinflammation in endometriosis models. (PubMed, J Clin Invest) - "Furthermore, dienogest (a synthetic progestin) and fingolimod (a selective immunosuppressor) reduced hyperalgesia and neuroinflammation. The circuits of neuroplasticity and stimulation of peripheral organs via a feedback loop of neuroinflammation may mediate widespread endometriosis-associated CPP. These findings in mice were further supported by results from the spontaneously developed advanced endometriosis in rhesus macaques via recurrent retrograde menstruation."

Journal • Endometriosis • Gynecology • Immunology • Inflammation • Musculoskeletal Pain • Pain • Women's Health • TRPV1

VOYAGE: A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (clinicaltrials.gov) - P3 | N=185 | Not yet recruiting | Sponsor: Biogen

New P3 trial • CNS Disorders • Multiple Sclerosis • Pediatrics

Cognitive Ability in Pediatric-Onset Multiple Sclerosis: A Case Series. (PubMed, Pediatr Neurol) - "Children with POMS presenting at a younger age are at increased risk of cognitive impairment, especially during the early stages of the disease. Some clinical and radiological factors can predict worse intellectual performance, while high-efficacy disease-modifying treatment like Fingolimod and its precocious initiation is associated with better cognitive prognosis."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Multiple Sclerosis • Pediatrics

AEROBIC EXERCISE ATTENUATES PRESSURE-OVERLOAD CARDIOMYOPATHY VIA MICROBIOTA-BILE ACID-DEPENDENT RECRUITMENT OF GUT RORγT⁺ TREGS (ACC 2026) - "Mice underwent exercise, antibiotic-mediated microbiota depletion, bile acid supplementation (DCA/LCA), or S1PR1 inhibition (FTY720)... Aerobic exercise counteracts immune-inflammatory injury and pathological remodeling in POH-PT by expanding gut-derived Helios⁻RORγt⁺ Tregs via microbiota-derived bile acids and facilitating their S1PR1-dependent cardiac recruitment, unveiling a gut-heart immunometabolic axis as a therapeutic target."

Cardiomyopathy • Cardiovascular • Fibrosis • Immunology • Inflammation • MAF • S1PR1

MMR SEROLOGIC STATUS IN MULTIPLE SCLEROSIS AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION (EBMT 2026) - "Background: Multiple sclerosis (MS) patients undergoing autologous stem cell transplantation (ASCT) after carmustine, cytarabine, etoposide, melphalan (BEAM) or cyclophosphamide (Cy) chemotherapy plus rabbit anti-thymocyte globulin (rATG) are considered as naïve to vaccines and offered revaccination; live vaccines as measles/mumps/rubella (MMR) are not recommended before 24 months from ASCT with concern about vaccine-induced infectious disease...The two patients who lost either MMR (ID23) or rubella immunity (ID35) had both low titles at baseline; prior to ASCT, they had received interferon and 3 lines of therapy (interferon, fingolimod, ocrelizumab), respectively... In our real-life population of ASCT-treated MS, the vast majority of patients retained MMR immunity with a slight decline of vaccine titres over time confirming that MMR revaccination could be safely postponed after 24 months from ASCT and probably offered only in selected patients at high risk (i.e...."

CNS Disorders • Infectious Disease • Measles • Multiple Sclerosis • Mumps • Rubella • Transplantation

MMR SEROLOGIC STATUS IN MULTIPLE SCLEROSIS AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION (EBMT 2026) - "Background: Multiple sclerosis (MS) patients undergoing autologous stem cell transplantation (ASCT) after carmustine, cytarabine, etoposide, melphalan (BEAM) or cyclophosphamide (Cy) chemotherapy plus rabbit anti-thymocyte globulin (rATG) are considered as naïve to vaccines and offered revaccination; live vaccines as measles/mumps/rubella (MMR) are not recommended before 24 months from ASCT with concern about vaccine-induced infectious disease...The two patients who lost either MMR (ID23) or rubella immunity (ID35) had both low titles at baseline; prior to ASCT, they had received interferon and 3 lines of therapy (interferon, fingolimod, ocrelizumab), respectively... In our real-life population of ASCT-treated MS, the vast majority of patients retained MMR immunity with a slight decline of vaccine titres over time confirming that MMR revaccination could be safely postponed after 24 months from ASCT and probably offered only in selected patients at high risk (i.e...."

CNS Disorders • Infectious Disease • Measles • Multiple Sclerosis • Mumps • Rubella • Transplantation

Sidaxue ameliorates rheumatoid arthritis by inhibiting synovial neutrophil migration: Insights from an integrated multi-omics analysis. (PubMed, Phytomedicine) - "SX ameliorates RA by inhibiting neutrophil migration and activation via the RAC1/PAK1/LIMK1/Cofilin1 pathway. This work unveils the immune-regulatory mechanism of SX, supporting its development as a natural therapeutic for RA."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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

Pharmacologic Blockade of Lymphocyte Trafficking with FTY720 Disrupts CD8+ T Cell and cDC1 Activation Required for PD-1 Efficacy in Bladder Cancer (AUA 2026) - No abstract available

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-1

Adjunctive Therapies for Prevention of Intracranial Hemorrhage Associated with Tenecteplase in Acute Ischemic Stroke: A Systematic Review and Evidence Synthesis (AAN 2026) - "Otaplimastat showed no significant reduction in hemorrhage rates,while meta-analysis of 7 RCTs of minocycline (n≈426) showed a non-significant trend toward improved outcomes without excess bleeding...Other agents (edaravone, imatinib, uric acid): Small studies suggested possible neurovascular protection but lacked clear evidence of hemorrhage reduction... Current evidence suggests that adjunctive neuroprotective and vasculoprotective agents can be safely co-administered with thrombolytics such as tenecteplase or alteplase, but none have definitively reduced intracranial hemorrhage risk. Fingolimod and 3K3A-APC show the most promise and warrant further investigation in larger, TNK-specific randomized trials."

Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Preclinical Evidence Supporting Pilavapadin as a Novel Oral Therapy for Spasticity (AAN 2026) - "Objective: To evaluate the effects of the adapter protein-2 associated kinase 1 (AAK1) inhibitor pilavapadin on spasticity endpoints in preclinical models of central nervous system injury.Background: Current oral therapies for spasticity, such as baclofen and tizanidine, provide only partial benefit and are often limited by sedation... In mice, pilavapadin significantly improved tcMEP latency (5.55 ± 0.22ms at 10 mg/kg; 5.32 ± 0.22ms at 3 mg/kg vs. 10.05 ± 2.59ms for vehicle; both p<0.05) and peak-to-peak amplitude (11,613.75 ± 1154.41 µV at 10 mg/kg; 11,321.67 ± 1321.68 µV at 3 mg/kg vs. 7681.17 ± 1505.12 µV for vehicle; both p<0.001) on day 10, with effects comparable to fingolimod and tizanidine... Pilavapadin demonstrated significant, sustained effects measures of spasticity in two validated preclinical models. These findings support further development of pilavapadin as a potential oral therapy for spasticity with a..."

Preclinical • CNS Disorders • Depression • Movement Disorders • Multiple Sclerosis

Pediatric-Onset Multiple Sclerosis at Age 10 Following Nephrotic Syndrome: Early Recognition and Successful Treatment With Fingolimod. (PubMed, Cureus) - "This case highlights the value of advanced MRI biomarkers in very early-onset multiple sclerosis, the importance of systematically excluding disease mimics in prepubertal children, and the effectiveness of early initiation of high-efficacy disease-modifying therapy. Early recognition and prompt treatment are essential to optimize outcomes in pediatric multiple sclerosis."

Journal • CNS Disorders • Glomerulonephritis • Multiple Sclerosis • Nephrology • Ophthalmology • Otorhinolaryngology • Pediatrics • Renal Disease • Solid Tumor • Vertigo

Hypoxia-responsive hybrid nanoparticles loaded with fingolimod and colistin against multidrug-resistant Klebsiella pneumoniae with mature biofilm. (PubMed, Asian J Pharm Sci) - "Bacterial loads eliminated by 4 Log10 CFU and 2 Log10 CFU, respectively. The strategy provides a valuable reference for the treatment of refractory infections caused by MDR-KP."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

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

Early life viral infection generates pathologic tissue resident memory cells that contribute to asthma-like disease. (PubMed, JCI Insight) - "FTY720-mediated disruption of lymphocyte circulation demonstrated TRMs contribute to pathology. Local depletion of lung CD4+ T cells and JAK2-inhibition mitigated pathology. These findings suggest TRMs uniquely generated after early life viral infection can contribute to Th2-driven asthma pathology."

Journal • Asthma • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • CD4

The gut microbiota composition is shaped by disease activity and individual treatment responses in patients with multiple sclerosis. (PubMed, Front Immunol) - "In this cross-sectional study, we investigated the potential role of gut microbiota in treatment response by analyzing its composition using 16S rRNA sequencing in treatment-naïve patients and those receiving disease-modifying therapies (interferon-beta (IFN-β), fingolimod, or cladribine), compared to healthy controls (HC). In summary, we found that the treatment influences gut microbiota. Similar profile of gut microbiota and higher levels of molecules associated with microbial translocation were observed in patients with active disease (CIS and NR), suggesting the higher permeability of their gut barrier leading to pro-inflammatory tunning of their immune system."

Biomarker • Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • IFNB1 • LBP

Fingolimod normalizes metabolic signatures associated with synaptic plasticity and memory in APP/PS1 model: Sphingosine-1-phosphate receptor a therapeutic target for Alzheimer's. (PubMed, Sci Rep) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Visceral leishmaniasis in a multiple sclerosis patient: a rare complication of fingolimod-induced lymphopenia. (PubMed, Rev Esp Quimioter) - No abstract available

Journal • CNS Disorders • Infectious Disease • Multiple Sclerosis

Therapeutic Potential of Fingolimod and Dimethyl Fumarate in Preclinical Pancreatic Cancer Models. (PubMed, Oncol Res) - "Although the responses observed with Fingolimod and DMF were similar to those of Gemcitabine and Erlotinib, these findings indicate a potential emerging interest in Fingolimod and DMF for the treatment of pancreatic cancer. However, further work is still necessary to fully characterize how these drugs affect tumor progression."

Journal • Preclinical • CNS Disorders • Multiple Sclerosis • Oncology • Pancreatic Cancer • Solid Tumor

Therapeutic effects of fingolimod through sphingosine-1-phosphate signaling in pulmonary arterial hypertension. (PubMed, J Pharmacol Sci) - "Collectively, these findings indicate that fingolimod ameliorates pulmonary vascular remodeling by inhibiting abnormal PASMC proliferation and CD163-positive macrophage viability, thereby improving survival in experimental PAH rats. Targeting the S1P signaling pathway with fingolimod may represent a promising repositioning strategy for PAH therapy."

Journal • Cardiovascular • CNS Disorders • Hypertension • Multiple Sclerosis • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CD163

FORMULARY EXCLUSIONS AND NON-ADHERENCE TO DISEASE-MODIFYING THERAPIES FOR MULTIPLE SCLEROSIS IN MEDICARE PART D (ISPOR 2026) - "Off-formulary use varied across DMTs, ranging from 1.6% among all fingolimod users to 86.9% among peginterferon beta-1a users. Off-formulary use was associated with lower odds of adherence to several DMTs, including teriflunomide (OR 0.80; 95% CI, 0.66-0.96), interferon beta-1a (subcutaneous) (OR 0.71; 95% CI, 0.56-0.92), interferon beta-1a (intramuscular) (OR 0.84; 95% CI, 0.71-0.98), glatiramer acetate (generic) (OR 0.63; 95% CI, 0.42-0.93), and glatiramer acetate (brand) (OR 0.53; 95% CI, 0.46-0.62). Over one-third of Medicare beneficiaries with MS used DMTs that were off-formulary. Over one-third of Medicare beneficiaries with MS used DMTs that were off-formulary. Off-formulary use was associated with reduced adherence across several DMTs. Future research should elucidate the mechanisms by which formulary exclusions contribute to non-adherence to DMTs."

Adherence • Medicare • Reimbursement • US reimbursement • CNS Disorders • Multiple Sclerosis

ECONOMIC VALUE OF RELAPSE RATE REDUCTION WITH OFATUMUMAB VERSUS COMPARATOR DISEASE-MODIFYING THERAPIES IN RELAPSING MULTIPLE SCLEROSIS: A FIVE-YEAR BUDGET IMPACT ANALYSIS WITH CLINICAL OUTCOME OFFSETS (ISPOR 2026) - "Comparator ARRs from phase III trials and literature: ofatumumab 0.11 (ASCLEPIOS I/II, Hauser NEJM 2020); interferon β-1a IM 0.61; interferon β-1a SC 0.86; teriflunomide 0.37; fingolimod 0.18; natalizumab 0.25; rituximab 0.20... Ofatumumab's superior ARR profile (0.11, lowest in class) generates substantial clinical value through relapse avoidance, translating into quantifiable cost offsets that reduce net budget impact by approximately one-quarter. These findings support value-based pricing negotiations incorporating ARR-driven outcomes"

Clinical • Clinical data • HEOR • CNS Disorders • Multiple Sclerosis • IFNB1

Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Pediatric-onset Relapsing-remitting MS: Results of the Phase III OPERETTA Two Study (AAN 2026) - P2, P3 | "Ocrelizumab was noninferior to fingolimod on relapse activity and superior on MRI endpoints, and the safety profile was consistent with studies in adults, making ocrelizumab a potential high‑efficacy treatment option for POMS."

Clinical • P3 data • CNS Disorders • Multiple Sclerosis • Pediatrics