Multiple clinical trials evaluate the therapeutic utility and supplementation efficacy of methylcobalamin across Phase 1 through Phase 4, as well as early phase and unassigned protocols. Sponsored primarily by academic institutions and hospital systems, these studies investigate conditions including post-bariatric vitamin B12 deficiency, diabetic peripheral neuropathy, end-stage renal disease with renal hypertension, autistic disorder, post-operative cognitive dysfunction, and chemotherapy-induced peripheral neurotoxicity in breast cancer. The trial landscape encompasses diverse recruitment statuses, including completed, currently recruiting, terminated, and upcoming studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07344974 | NOT_YET_RECRUITING | Breast Cancer |
Peking University Cancer Hospital & Institute |
2026-02-01 | PHASE4 |
| NCT06990854 | NOT_YET_RECRUITING | Postherpetic Neuralgia ( PHN ) |
Dexiong Han |
2025-07-01 | |
| NCT07281872 | COMPLETED | Therapeutic Equivalency, Healthy |
Wanbangde Pharmaceutical Group Co., LTD |
2025-10-29 | PHASE1 |
| NCT05785585 | RECRUITING | Vitamin B12 Nutritional Deficiency |
Fundació Eurecat |
2023-09-09 | |
| NCT05807711 | COMPLETED | End Stage Renal Disease; Hypertension, Renal |
Alexandria University |
2023-04-01 | PHASE4 |
| NCT06241638 | COMPLETED | Diabetes Mellitus |
Al-Balqa Applied University |
2022-07-01 | |
| NCT04711980 | UNKNOWN | Diabetic Peripheral Neuropathy Type 2 |
Fengmei Lian |
2021-06 | EARLY_PHASE1 |
| NCT03485404 | TERMINATED | Post Operative Cognitive Dysfunction |
Xijing Hospital |
2019-01-10 | |
| NCT04372316 | UNKNOWN | Diabetic Neuropathies |
Peking University Third Hospital |
2017-12-25 | PHASE2 |
| NCT03548311 | COMPLETED | Amyotrophic Lateral Sclerosis |
Eisai Co., Ltd. |
2017-11-01 | PHASE3 |
| NCT03360435 | Completed | Bariatric Surgery Candidate|Vitamin Deficiency|Mineral Deficiency |
University of Florida |
2017-12-15 | -- |
| NCT02540642 | COMPLETED | Type 2 Diabetes; Vitamin B12 Deficiency; Hyperhomocysteinemia |
Smt. Kashibai Navale Medical College and General Hospital |
2010-10 | |
| NCT01661309 | COMPLETED | Vitamin B12 Deficiency |
University of West London |
2012-03 | |
| NCT00273650 | COMPLETED | Autistic Disorder |
University of California, San Francisco |
2005-07 | PHASE2; PHASE3 |
| NCT00933998 | COMPLETED | Diabetic Peripheral Neuropathy |
Carolina Musculoskeletal Institute |
2006-06 | |
| NCT00692315 | COMPLETED | Autistic Disorder |
Arkansas Children's Hospital Research Institute |
2006-09 |
(data from https://clinicaltrials.gov, updated on 2026-01-20)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).