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\nMultiple Sclerosis Journal 2026, Vol. 32(1) 57–59 DOI: 10. 1177/ 13524585251396275  \n© The Author(s), 2025.  \nArticle reuse guidelines: [sagepub.com/journals](sagepub.com/journals)permissions  \nOver the past three decades, drug development and approval for patients with multiple sclerosis (MS) have been very dynamic. However, there are currently no therapies that restore neurological function in individuals with MS who have already accumulated substantial disability. Remyelination therapies may have the potential to address this unmet need, but they face major challenges, some of which are discussed below.  \nComplex biology of MS  \nThe pathogenesis of MS remains incompletely understood. It is established that inflammation, demyelination, and axonal loss throughout the central nervous system (CNS) are features of all disease stages, 1 but the sequence and interrelationship of these pathological events are unclear. It is also unknown whether these processes are causally related. Perhaps most pertinent to the question of the feasibility of remyelination therapies is the fact that the critical biological events triggering demyelination and remyelination failure are still being investigated.2 Failure to fully comprehend why oligodendrocyte precursor cells (OPCs) do not differentiate and completely myelinate axons, as well as to identify all inhibitory signals within the CNS, constitutes major obstacles for remyelination therapy.  \nAdditional hurdles to introduce remyelination therapies in MS may arise from unknown disease stagespecific biological events, which will likely complicate clinical trial designs. Most approved disease-modifying therapies (DMTs) either sequester bone marrowderived leukocytes outside the CNS or reduce their abundance. These therapies are no longer effective in secondary progressive MS (SPMS), indicating that the biology that drives CNS disease towards compartmentalized inflammation has fundamentally changed.3 However, even in the early relapsing-remitting stage of MS (RRMS), targeting activated leukocytes may reduce disease relapse frequency, but may not significantly benefit the progressive demyelination. For instance, leukocytes subsets secrete trophic factors, including insulin-like growth factor 1 (IGF-1) that  \npromote the formation of OPC.4 Consequently, combining anti-inflammatory therapy with re-myelinating agents could offer both opportunities and challenges.  \nA comprehensive understanding of these biological mechanisms-and their interplay across disease stageswill be essential for the successful development of remyelination therapies in MS.  \nPreclinical-to-clinic translation gaps  \nNumerous remyelination therapies have shown limited effectiveness in clinical trials. One approach targeted LINGO-1 (leucine-rich repeat and immunoglobulin domain-containing Nogo receptor–interacting protein-1), a key inhibitor of oligodendrocyte differentiation and myelination. Opicinumab, a monoclonal antibody against LINGO-1, demonstrated early promise in preclinical and phase 1 studies; however, it failed to show significant clinical benefit in larger phase 2 trials.5,6 Clemastine (a muscarinic receptor antagonist) modestly improved electrophysiological measures in patients with MS but had limited impact on neurological function.7  \nImportantly, negative trial outcomes should not be equated with a complete failure to re-myelinate CNSaxons. Advanced magnetic resonance imaging (MRI) modalities and visual evoked potentials may suggest evidence of partial myelin repair even when no clinical improvement is observed. However, meaningful therapeutic success must translate into functional improvement. This disconnect suggests remyelinationalone may be insufficient, especially in the presence of irreversible axonal damage or complex neural network disruptions. Future therapies must pair myelin repair with neuroprotection and s","cbCailOEhH8J2uhh","https://ap.wps.com/l/cbCailOEhH8J2uhh","pdf",535475,"English","# Complex biology of MS\n## Preclinical-to-clinic translation gaps\n## Pharmacological challenges and potential side effects of re-myelinating therapies\n## Lack of validated biomarkers for remyelination","[{\"question\":\"What unmet need do remyelination therapies aim to address in multiple sclerosis?\",\"answer\":\"They aim to address the lack of therapies that restore neurological function in MS patients who have already accumulated substantial disability.\"},{\"question\":\"Why are remyelination therapies difficult to develop and translate into clinical practice?\",\"answer\":\"Major obstacles include incomplete understanding of MS pathogenesis, especially the triggers of demyelination and remyelination failure, and limited effectiveness of candidate treatments in larger clinical trials.\"},{\"question\":\"What pharmacological challenges affect remyelinating therapies in the CNS?\",\"answer\":\"Effective delivery across the blood-brain barrier is difficult, often requiring high systemic doses that can increase off-target effects and systemic toxicity.\"}]","Remyelination therapies are achievable in clinical practice - No - in Multiple Sclerosis Journal 2026 | PDF",1790588089]