Drugs / E0302
E0302
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03885882 | Apr → Jun 2019 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00444613 | Apr 2007 → Mar 2014 | amyotrophic lateral sclerosis | Eisai Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-11-20 | Eisai Inc. | Regulatory ROZEBALAMIN® FOR INJECTION 25 MG (MECOBALAMIN) FOR AMYOTROPHIC LATERAL SCLEROSIS LAUNCHED IN JAPAN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “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. |
| 2024-09-24 | Eisai Inc. | Regulatory ROZEBALAMIN® FOR INJECTION 25 MG (MECOBALAMIN) APPROVED IN JAPAN FOR AMYOTROPHIC LATERAL SCLEROSIS eisai.com ↗ |
| 2024-01-26 | Eisai Inc. | Regulatory EISAI SUBMITS NEW DRUG APPLICATION FOR MECOBALAMIN ULTRAHIGH-DOSE FORMULATION IN JAPAN FOR THE INDICATION OF AMYOTROPHIC LATERAL SCLEROSIS eisai.com ↗ |
| 2022-05-27 | Eisai Inc. | Regulatory MINISTRY OF HEALTH, LABOUR AND WELFARE GRANTS ORPHAN DRUG DESIGNATION IN JAPAN TO MECOBALAMIN ULTRAHIGH-DOSE FORMULATION WITH PROSPECTIVE INDICATION FOR DELAYING THE PROGRESSION OF DISEASE AND FUNCTIONAL IMPAIRMENT OF AMYOTROPHIC LATERAL SCLEROSIS eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW). |
| 2022-05-10 | Eisai Inc. | Results EISAI INITIATES PREPARATION FOR NEW DRUG APPLICATION, BASED ON THE RESULTS OF AN INVESTIGATOR-INITIATED CLINICAL TRIAL OF ULTRAHIGH-DOSE MECOBALAMIN FOR AMYOTROPHIC LATERAL SCLEROSIS IN JAPAN eisai.com ↗
However, an additional analysis of Study 761 suggested that ultrahigh-dose mecobalamin prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset. |
| 2016-03-22 | Eisai Inc. | Regulatory EISAI WITHDRAWS NEW DRUG APPLICATION FOR MECOBALAMIN ULTRA-HIGH DOSE PREPARATION AS TREATMENT FOR AMYOTROPHIC LATERAL SCLEROSIS eisai.com ↗ |
| 2015-05-27 | Eisai Inc. | Regulatory EISAI SUBMITS NEW DRUG APPLICATION FOR MECOBALAMIN ULTRA-HIGH DOSE PREPARATION AS TREATMENT FOR AMYOTROPHIC LATERAL SCLEROSIS IN JAPAN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted a new drug application for mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan. |
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | E0302 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03885882 ↗ |
| Known as | E0302 IR | “E0302 IR, oral tablet.” NCT03885882 ↗ |
| Known as | E0302 SR1 | “E0302 SR1, oral tablet.” NCT03885882 ↗ |
| Known as | E0302 SR2 | “E0302 SR2, oral tablet.” NCT03885882 ↗ |
| Known as | E0302 SR3 | “E0302 SR3, oral tablet.” NCT03885882 ↗ |
| Route | Intramuscular | “Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.” NCT00444613 ↗ |