BAM (8-22) and related therapeutic research regimens have been evaluated across multiple clinical trials. These studies investigate diverse conditions, including bile acid malabsorption, irritable bowel syndrome with diarrhea, chronic diarrhea, COVID-19, multiple myeloma, and itch. The clinical landscape features Phase 2 and Phase 4 trials sponsored by academic entities such as the University of Chicago and the University of Virginia, as well as industry sponsors like Allergan and Eli Lilly and Company. Most of these trials have reached completed recruitment status, as demonstrated by studies such as NCT05130047 focusing on chronic diarrhea and NCT00317811 evaluating plasma cell neoplasms.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05610111 | COMPLETED | Type 1 Diabetes |
Sue Brown |
2023-01-18 | |
| NCT05130047 | COMPLETED | Chronic Diarrhea; Irritable Bowel Syndrome With Diarrhea; Bile Acid Malabsorption; Bile Acid Diarrhea; Bile Acid Malabsorption Syndrome Type II; Functional Diarrhea |
Michael Camilleri, MD |
2021-12-01 | PHASE2 |
| NCT04784637 | COMPLETED | Type 1 Diabetes Mellitus |
University of Virginia |
2021-07-23 | |
| NCT04634409 | COMPLETED | COVID-19 |
Eli Lilly and Company |
2020-10-29 | PHASE2 |
| NCT04588532 | COMPLETED | Itch |
Aalborg University |
2020-10-01 | |
| NCT04197440 | UNKNOWN | Itch |
Aalborg University |
2020-01-15 | |
| NCT03441581 | COMPLETED | Irritable Bowel Syndrome With Diarrhea |
Allergan |
2018-02-23 | PHASE4 |
| NCT03367858 | COMPLETED | Alcohol Use, Unspecified |
University of Rhode Island |
2017-01 | |
| NCT01927523 | UNKNOWN | Youth Violence; Crime; Educational Achievement |
University of Chicago |
2013-08 | |
| NCT02078856 | COMPLETED | Bile Acid Malabsorption |
Albireo |
2014-03 | PHASE2 |
| NCT00317811 | COMPLETED | Multiple Myeloma and Plasma Cell Neoplasm |
Oncotherapeutics |
2005-11 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-07)
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>).