Rozebalamin mecobalamin
Drug Class
Ultrahigh-dose vitamin B12 analog / Neuroprotective agent超大剂量维生素 B12 类似物 / 神经保护剂
Mechanism
Ultrahigh-dose mecobalamin acts as a neuroprotectant by promoting axonal regeneration, myelination, and reducing neurotoxic homocysteine levels in patients with ALS.超大剂量甲钴胺通过促进轴突再生、髓鞘形成以及降低肌萎缩侧索硬化症（ALS）患者体内的神经毒性同型半胱氨酸水平，发挥神经保护作用。
Approved Indication
Slowing the progression of functional impairment in patients with early-stage amyotrophic lateral sclerosis (ALS), per its PMDA approval.用于延缓早期肌萎缩侧索硬化症（ALS）患者功能障碍的进展，基于其日本PMDA批准。
What This Means For Patients
Rozebalamin is an ultrahigh-dose formulation of mecobalamin (50 mg injection) approved in Japan to slow functional decline in patients with early-stage amyotrophic lateral sclerosis (ALS). Developed by Eisai, it represents a targeted approach using megadose vitamin B12 therapy for neuroprotection. It is accessible in the Hainan Boao Lecheng pilot zone under special import pathways for neurodegenerative conditions.Rozebalamin（超大剂量甲钴胺）是日本批准用于延缓早期肌萎缩侧索硬化症（ALS，渐冻症）患者功能退化进程的50毫克注射剂。该药由卫材（Eisai）开发，代表了使用超大剂量维生素B12进行神经保护的疗法。该药已引入海南博鳌乐城特许通道供临床使用。
Regulatory Approvals
- PMDA — approved (2024) — source
Pivotal Clinical Evidence
- JETALS — Oki et al., JAMA Neurol 2022 (NCT03548311) — DOI
Sources
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.