Clinical Trials
Several clinical trials investigate 3-Methylbutanoic acid or related metabolomic profiling across diverse research domains, including chronic obstructive pulmonary disease, prediabetes, gut dysbiosis, endotoxemia, systemic inflammation, and sensory perception in non-smoking individuals. Sponsored by academic and research organizations such as Asan Medical Center, Seoul National University College of Medicine, HEM Pharma Inc., Ohio State University, the USDA Beltsville Human Nutrition Research Center, and Rockefeller University, these studies operate under Not Applicable or unclassified trial phases. Their recruitment statuses range from not yet recruiting and active, not recruiting, to completed.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06101459 | Not yet recruiting | Chronic Obstructive Pulmonary Disease |
Asan Medical Center|Seoul National University College of Medicine|HEM Pharma Inc. |
2023-12-01 | -- |
| NCT05318183 | Active not recruiting | PreDiabetes|Dysbiosis|Endotoxemia|Inflammation |
Ohio State University|USDA Beltsville Human Nutrition Research Center |
2022-01-27 | Not Applicable |
| NCT01039935 | Completed | Non-smokers |
Rockefeller University |
2009-11 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).