Drugs / methylcobalamin
methylcobalamin
also known as
Mecobalamin · methylB12 · vitamin B12 · E0302 · Mecobalamin tablets · Vit. B12 · MeCbl
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | amyotrophic lateral sclerosis 28 | 2024-01-26 | “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” eisai.com ↗ |
| Filed | Japan (PMDA) | — | amyotrophic lateral sclerosis 28 | 2015-05-27 | “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.” eisai.com ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07853053 | Jan 2027 → Dec 2029 expected | urinary bladder cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05366933 | Aug 2022 → Jul 2027 expected | optic nerve disorder | National Aeronautics and Space Administration (NASA) | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02696512 | Mar 2016 → Mar 2017 | brain injury | International Brain Research Foundation | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06568185 | May → Oct 2024 overdue | diabetic polyneuropathy | Universiti Sains Malaysia | Recruiting | No outcome recorded |
| Phase 2 | NCT00699478 | Apr → Sep 2008 | vitamin B12 deficiency | Yonsei University | Completed | No outcome recorded |
| Phase 2/33 trials · 1 met primary | ||||||
| Phase 2/3 | NCT06940557 | Dec 2023 → Sep 2024 | carpal tunnel syndrome | Universiti Putra Malaysia | Completed | No outcome recorded |
| Phase 2/3 | NCT01039792 | Jan 2010 → Oct 2013 | autism | University of California, San Francisco | Completed | Met primary |
| Phase 2/3 | NCT00445172 | Feb 2008 → Mar 2017 | amyotrophic lateral sclerosis | Eisai Inc. | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT07423390 | Feb 2026 → Mar 2029 expected | chemotherapy-induced neuropathy | Qinghai Red Cross Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT07274696 | Dec 2025 → Dec 2027 expected | postsurgical hypothyroidism | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05165069 | Jan 2022 → Aug 2024 overdue | hand-foot syndrome | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active not recruiting | Met primary |
| Phase 3 | NCT03548311 | Nov 2017 → Feb 2020 | amyotrophic lateral sclerosis | Eisai Inc. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07133438 | Aug 2025 → May 2027 expected | retinal vein occlusion | First Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT06220929 | Jan → Dec 2024 | infectious disease with sepsis, liver disorder | Sichuan Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01192113 | Apr 2010 → May 2011 | peripheral neuropathy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00165711 | Mar 2003 → ? | vitamin B12 deficiency | Eisai Inc. | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06241638 | Jul 2022 → Jun 2023 | diabetes mellitus | Al-Balqa Applied University | Completed | No outcome recorded |
| — | NCT04800666 | Mar 2021 → Mar 2022 | facial paralysis | Zhuan Zhang | Completed | No outcome recorded |
| — | NCT03485404 | Jan 2019 → Jul 2021 | — | Xijing Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT04083560 | Sep 2018 → Sep 2022 | vitamin B12 deficiency | Sitaram Bhartia Institute of Science and Research | Completed | No outcome recorded |
| — | NCT00692315 | Sep 2006 → Jun 2007 | autism | Arkansas Children's Hospital Research Institute | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT07626528 Comparator | Jul 2026 → Dec 2027 expected | chemotherapy-induced neuropathy | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT02853942 Background | Oct 2016 → Oct 2017 | facial nerve disorder | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 1/2 | NCT05008042 Comparator | Feb 2019 → Mar 2024 | fibromyalgia | Linnaeus University | Completed | No outcome recorded |
| Phase 2 | NCT06813274 Background | Jan → Nov 2026 expected | cognitive disorder, diabetes mellitus, diabetic retinopathy | Hejiang Ye | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04372316 Comparator | Dec 2017 → Jul 2020 | diabetic neuropathy | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT03593304 Comparator | Mar → Dec 2018 | acute lymphoblastic leukemia, chemotherapy-induced neuropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 2/3 | NCT03167918 Background | Jul 2014 → Apr 2017 | type 2 diabetes mellitus | Liaoning University of Traditional Chinese Medicine | Completed | No outcome recorded |
| Phase 2/3 | NCT00273650 Comparator | Jul 2005 → Jun 2009 | autism spectrum disorder | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT07344974 Comparator | Feb 2026 → Feb 2027 expected | breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06985589 Background | Jan → Aug 2024 | herpes zoster | Second Affiliated Hospital of Xi'an Jiaotong University | Completed | No outcome recorded |
| Phase 4 | NCT05184049 Background | Jan 2022 → Oct 2023 | diabetes mellitus | Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 4 | NCT02923388 Comparator | Oct 2016 → Jun 2018 | chemotherapy-induced neuropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT02270749 Comparator | Oct 2014 → Jun 2016 | vitamin B12 deficiency | Rijnstate Hospital | Completed | No outcome recorded |
| — | NCT07515885 Background | Sep 2025 → Dec 2028 expected | herpes zoster | Dexiong Han | Recruiting | No outcome recorded |
| — | NCT06990854 Background | Jul 2025 → Dec 2026 expected | postherpetic neuralgia | Dexiong Han | Not yet recruiting | No outcome recorded |
| — | NCT06643247 Background | Nov 2024 → Dec 2027 expected | herpes zoster | First People's Hospital of Hangzhou | Recruiting | No outcome recorded |
| — | NCT07283562 Comparator | Jan 2023 → Oct 2025 | sensorineural hearing loss disorder | The First Hospital of Hebei Medical University | Completed | No outcome recorded |
| — | NCT05623384 Background | Nov 2022 → Sep 2023 | sudden sensorineural hearing loss | Zhuan Zhang | Unknown | No outcome recorded |
| — | NCT03983200 Background | Jun → Nov 2019 | diabetic polyneuropathy | Majianhua | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “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. |
| 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 ↗
it has received orphan drug designation for ultrahigh-dose mecobalamin |
| 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 ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has withdrawn its new drug application for ultra-high dose mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan. |
| 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 8 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Methylcobalamin | “Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given...” PMID 32457078 ↗ May 202013“Each tablet contains 4 active ingredients as follows: Alpha lipoic acid 300mg, Vitamin B12 (methylcobalamin) 500mcg, Vitamin B6 (pyridoxine) 8mg, Vitamin B1 (thiamine) 39mg.” NCT06568185 ↗ “Vitamin B-Complex Supplement containing: 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin” NCT05366933 ↗ “Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for twelve months.” NCT06241638 ↗ “Methylcobalamin (MeCbl) is a vitamin B12 analog that is necessary for the maintenance of the peripheral nervous system.” PMID 26300733 ↗ Aug 2015 “alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg” NCT06940557 ↗ “The second group (oral B-12) received daily doses of oral methylcobalamin (1000 µg).” PMID 29931179 ↗ Jul 2018 |
| Known as | E0302 | “Exploratory analyses in our previous study (study ID #E0302-J081-761) have suggested that high-dose methylcobalamin (E0302) prolonged the overall survival of ALS patients and...” PMID 30578206 ↗ Dec 20181“E0302 (mecobalamin)” NCT00445172 ↗ |
| Known as | MeCbl | “Methylcobalamin (MeCbl) is a vitamin B12 analog that is necessary for the maintenance of the peripheral nervous system.” PMID 26300733 ↗ Aug 2015 |
| Known as | Mecobalamin | “The basic treatment consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days.” NCT06985589 ↗24“Both groups received a standard regimen (Dextran-40, Ginkgo Biloba Extract, Mecobalamin, and Yufeng Ningxin Dripping Pills).” NCT07283562 ↗ “All participants will receive Valacyclovir Hydrochloride tablets and Mecobalamin tablets.” NCT06643247 ↗ |
| Known as | Mecobalamin tablets | “Pharmacotherapy：① Pregabalin ( Lyrica™ ，Pfizer Inc. America) ② Methylcobalamin ( Mecobalamin tablets， Weicai (China) Pharmaceutical Co., Ltd， China）” NCT06990854 ↗1“Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment.” NCT03167918 ↗ |
| Known as | methylB12 | “Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ |
| Known as | Vit. B12 | “Vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for...” NCT06241638 ↗1“Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia” NCT05008042 ↗ |
| Known as | vitamin B12 | “Vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for...” NCT06241638 ↗2“The study is a randomised, placebo-controlled, single-blind, clinical trial with two parallel groups which are administered mecobalamin (vitamin B12) or placebo over 12 weeks.” PMID 36997252 ↗ Mar 2023 “Each tablet contains 4 active ingredients as follows: Alpha lipoic acid 300mg, Vitamin B12 (methylcobalamin) 500mcg, Vitamin B6 (pyridoxine) 8mg, Vitamin B1 (thiamine) 39mg.” NCT06568185 ↗ |
| Modality | Other / unclassified | “daily nutraceutical supplement containing bioactive B vitamins” NCT05366933 ↗ |
| Modality | Small molecule | — CHEMBL4297672 ↗ |
| Route | Subcutaneous | “administered subcutaneously” NCT00273650 ↗ |