Clinical Trials

The clinical evaluation of BPC157 encompasses several clinical trials investigating its therapeutic potential across musculoskeletal injuries and safe administration parameters. Clinical research spans early-stage Phase 1 and Phase 2 trials focusing on conditions such as hamstring muscle strain, skeletal muscle injury, and rotator cuff tears, alongside safety studies in healthy volunteers. Trial sponsors include academic research entities like the University of Arkansas, commercial biotechnology firms such as Hudson Biotech, and pharmaceutical developers including PharmaCotherapia d.o.o. Specific active and planned investigations include NCT07437547 assessing acute hamstring strain recovery, NCT07803250 examining post-surgical rotator cuff healing, and NCT02637284 evaluating baseline safety and pharmacokinetics. Currently, recruitment statuses across these studies range from actively recruiting and not yet recruiting to unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07803250 NOT_YET_RECRUITING
Rotator Cuff Tear
University of Arkansas
 2027-01-01 PHASE1
NCT07437547 RECRUITING
Hamstring Muscle Strain; Skeletal Muscle Injury
Hudson Biotech
 2026-02-02 PHASE2
NCT02637284 UNKNOWN
Healthy Volunteers
PharmaCotherapia d.o.o.
 2015-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the BPC157 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BPC157, a synthetic pentadecapeptide derived from human gastric juice protein, modulates nitric oxide synthases and growth factor signaling pathways to stimulate endothelial cell migration, promote extracellular matrix synthesis, and accelerate localized angiogenesis. This enhancement of cellular proliferation and tissue reorganization facilitates structural remodeling, underlying its clinical application for accelerating recovery in acute skeletal muscle injuries, rotator cuff tears, and hamstring strains.

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>).

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