Clinical Trials

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)

Check the BAM (8-22) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAM (8-22) selectively binds to and activates Mas-related G-protein-coupled receptors, specifically hMrgprX1 and MrgprC11, triggering downstream G-protein signaling cascades within sensory neurons. This cellular stimulation induces neuronal excitation and pruritic signal transduction, directly linking its mechanism to clinical trial research targeting itch mechanisms and sensory neuropathies.

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>).

Note: Technical data last updated: Sep 1, 2026.