Rozebalamin (Mecobalamin)

Rozebalamin (mecobalamin, also known as methylcobalamin) was approved in Japan on 24 September 2024 for slowing the progression of functional impairment in amyotrophic lateral sclerosis (ALS). It is an intramuscular injection: the approved adult dose is 50 mg twice a week. The Japanese label asks doctors to choose patients with the trial population in mind, which was people with early ALS (within one year of onset) who could still breathe well (%FVC above 60%).

Its exact mechanism in ALS is not known; mecobalamin, an active form of vitamin B12, acts as a coenzyme of methionine synthase and is thought to protect nerves from damage linked to homocysteine. Rozebalamin gives it at a far higher dose than ordinary vitamin B12 products. In the Japanese JETALS trial (130 patients, 16 weeks), the ALS functional rating score (ALSFRS-R) fell by 2.7 points with Rozebalamin compared with 4.6 points with placebo.

• Do not use in anyone who has had an allergic reaction to any ingredient. Anaphylaxis (for example a sudden drop in blood pressure or difficulty breathing) is the main serious risk; stop treatment and seek help immediately if it occurs.
• For intramuscular use only, never into a vein or under the skin. Change the injection site each time and avoid nerve paths.
• Treatment should begin in a hospital or clinic under a doctor. Home self-injection is allowed only if the doctor decides it is safe after training the patient or family.
• The medicine is sensitive to light: inject within 60 minutes of dissolving it and throw away any leftover solution. Red-coloured urine can occur and is caused by the drug being excreted.
• It has not been studied in children.

Can Rozebalamin be imported to India?

Rozebalamin is approved only in Japan. A patient in India whose neurologist recommends it can ask for it to be imported in their own name under the named-patient route. Because it comes only from Japan, we confirm current supply and expiry dates before quoting.

How many vials are needed?

Each box contains 8 vials of 25 mg. One 50 mg dose uses 2 vials: each vial is dissolved in 2.3 mL of saline and 2.0 mL is injected. At two doses a week that is 4 vials a week, so one box lasts 2 weeks and a month needs about 2 boxes. The saline used to dissolve it is not listed as part of the pack.

What documents do we need?

• A prescription from the treating neurologist
• The neurologist’s ALS diagnosis summary, ideally with a recent ALSFRS-R score and breathing test (%FVC)
• Government-issued photo ID of the patient

We confirm the order only after the prescription has been checked.

How is Rozebalamin stored and prepared?

Store at room temperature, in the outer box to protect from light. The shelf life is 5 years. After dissolving, protect the solution from light and inject it within 60 minutes. Treatment should be started in a clinic, and home injection only after the doctor has trained the patient or family.

Because Rozebalamin is a Japan-only medicine, we check stock and expiry dates with authorised Japanese channels for each request. Ongoing treatment also needs regular boxes, so we plan monthly quantities with the family.

For Rozebalamin price in India and expected delivery time, call +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• Japan: Approved on 24 September 2024 (Eisai); launched on 20 November 2024. It holds orphan drug designation in Japan.
• United States / European Union: Not approved.

Sources:

• Rozebalamin for Injection 25 mg – Japanese package insert (PMDA, December 2025)
• Eisai news release: approval in Japan for ALS (24 September 2024)
• Eisai news release: launch in Japan (20 November 2024)

Information last checked: October 2026.

Why is Rozebalamin prescribed?

Doctors prescribe Rozebalamin for slowing the progression of functional impairment in ALS. It is an ultra-high-dose methylcobalamin (vitamin B12) injection.

Who is the maker of Rozebalamin?

It is made by Eisai Co., Ltd. (Japan).

How does Mecobalamin act in the body?

Its exact mechanism in ALS is not known; mecobalamin, an active form of vitamin B12, acts as a coenzyme of methionine synthase and is thought to protect nerves from damage linked to homocysteine.

Is Rozebalamin the same as ordinary vitamin B12 injections?

It contains the same substance, mecobalamin, but at a much higher dose (50 mg twice a week) and is approved in Japan specifically for ALS. Ordinary B12 products are not a substitute.

How is Rozebalamin given?

As an injection into the muscle, 50 mg twice a week. It must not be given into a vein or under the skin. The first doses are given in a clinic by or under a doctor.

Is Rozebalamin FDA approved?

No. Rozebalamin is not approved by the US FDA; it is approved only in Japan.