Rozebalamin (mecobalamin) / Eisai - LARVOL DELTA

ROZEBALAMIN FOR INJECTION 25 MG (MECOBALAMIN) FOR AMYOTROPHIC LATERAL SCLEROSIS LAUNCHED IN JAPAN (Eisai Press Release) - "Eisai...announced today that the amyotrophic lateral sclerosis (ALS) treatment 'Rozebalamin for Injection 25 mg' (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. The product received manufacturing and marketing approval in Japan on September 24, 2024, and was published in Japan’s National Health Insurance Drug Price List today....This approval is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), multicenter, placebo-controlled, double-blind, randomized Phase III clinical trial..."

Launch Japan • Amyotrophic Lateral Sclerosis

AMYOTROPHIC LATERAL SCLEROSIS TREATMENT 'ROZEBALAMIN FOR INJECTION 25 MG' RECEIVES THE GOOD DESIGN AWARD 2024 FOR LIGHTPROOF VIAL PACKAGING (Eisai Press Release) - "Eisai Co., Ltd...announced today that amyotrophic lateral sclerosis (ALS) treatment 'Rozebalamin for Injection 25 mg' (mecobalamin) has received the Good Design Award 2024 (by the Japan Institute of Design Promotion) for its light-proof vial packaging."

Commercial • Amyotrophic Lateral Sclerosis • CNS Disorders

ROZEBALAMIN FOR INJECTION 25 MG (MECOBALAMIN) APPROVED IN JAPAN FOR AMYOTROPHIC LATERAL SCLEROSIS (Eisai Press Release) - "Eisai Co., Ltd...announced today that it has obtained manufacturing and marketing authorization approval for amyotrophic lateral sclerosis (ALS) treatment 'Rozebalamin for Injection 25 mg' (mecobalamin) in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis....This approval is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), multicenter, placebo-controlled, double-blind, randomized Phase III clinical trial in 130 patients with ALS..."

Japan approval • Amyotrophic Lateral Sclerosis

EISAI SUBMITS NEW DRUG APPLICATION FOR MECOBALAMIN ULTRAHIGH-DOSE FORMULATION IN JAPAN FOR THE INDICATION OF AMYOTROPHIC LATERAL SCLEROSIS (Eisai Press Release) - "Eisai...announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan....This application is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), a Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients..."

Japanese regulatory • Amyotrophic Lateral Sclerosis

A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2/3; N=300; Active, not recruiting; Sponsor: Eisai Co., Ltd.; Trial primary completion date: Feb 2016 ➔ Mar 2017

Trial primary completion date • Biosimilar • Complement-mediated Rare Disorders • Pain

A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Eisai Co., Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Eisai Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Eisai Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Eisai Co., Ltd.

Clinical • New P1 trial