Multiple clinical trials are evaluating isoleucine across metabolic, gastrointestinal, and neuromuscular conditions, including type 2 diabetes, maple syrup urine disease, prediabetes, pediatric acute infectious diarrhea, obesity, and perinatal tumors. Spanning Phase 2 as well as unassigned or non-applicable trial phases, these protocols feature varied recruitment statuses ranging from completed evaluations to active or upcoming studies. This research is supported by international academic and medical institutions, including Texas A&M University, the International Centre for Diarrhoeal Disease Research, Bangladesh, and Assistance Publique - Hôpitaux de Paris.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07329088 | WITHDRAWN | Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Metabolic Syndrome (MetS); Obesity & Overweight |
Jean L. Fry |
2026-05-04 | |
| NCT06372314 | RECRUITING | Neonates on TPN; Stable Neonates; Neonates Managed in the ICU |
The Hospital for Sick Children |
2026-01-01 | |
| NCT06581991 | NOT_YET_RECRUITING | Maple Syrup Urine Disease |
Meta Healthcare Ltd |
2024-10 | |
| NCT05682339 | COMPLETED | Healthy |
University of Adelaide |
2023-06-19 | |
| NCT06365268 | Not yet recruiting | Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region |
Assistance Publique - Hôpitaux de Paris |
2024-05 | -- |
| NCT06142513 | Not yet recruiting | Obesity Hypoventilation Syndrome|Obesity|Hypoventilation|Respiration Disorders|Sleep Disorder; Breathing-Related |
Istanbul University|Istanbul University - Cerrahpasa (IUC) |
2024-04-10 | -- |
| NCT05026047 | Not yet recruiting | Papillomavirus Infection |
Assistance Publique - Hôpitaux de Paris |
2023-05 | Not Applicable |
| NCT05812144 | Recruiting | Type 1 Facioscapulohumeral Muscular Dystrophy |
Centre Hospitalier Universitaire de Nice |
2023-05-23 | Not Applicable |
| NCT04461236 | COMPLETED | Type 2 Diabetes |
Texas A&M University |
2019-05-30 | |
| NCT03180775 | UNKNOWN | Atherosclerosis; Diet Modification; Serum; Disease |
Rambam Health Care Campus |
2017-07-01 | |
| NCT02634164 | COMPLETED | Hyperglycemia |
Texas Woman's University |
2015-12 | |
| NCT01034228 | COMPLETED | Acute Infectious Diarrhoea in Children |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2007-07 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-04-15)
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>).