Clinical Trials

Numerous clinical trials investigate the therapeutic and diagnostic applications of muramyl dipeptide across diverse indications, including skeletal injury, HIV infection, chronic obstructive pulmonary disease, prediabetes, and dental conditions. These studies span Phase 1 through Phase 4 interventions alongside observational designs, supported by government agencies such as the National Institute of Allergy and Infectious Diseases and prominent academic centers like Boston Children's Hospital. Current recruitment statuses range from completed evaluations, including pediatric biokinetic studies, to actively recruiting and upcoming trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02993029 RECRUITING
Treatment Outcome
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
 2017-09-01
NCT07505745 RECRUITING
Prediabetes; Insulin Resistance; Overweight/Obesity
Hudson Biotech
 2026-02-02 PHASE2
NCT06012006 UNKNOWN
COPD
Assistance Publique - Hôpitaux de Paris
 2024-09
NCT05927376 COMPLETED
Depression, Anxiety
University of East Anglia
 2023-08-01
NCT04090671 UNKNOWN
COPD Exacerbation; CHF; OSA; COPD
Institut für Pneumologie Hagen Ambrock eV
 2018-12-19
NCT06079567 Recruiting
Facioscapulohumeral Muscular Dystrophy Type 2
Centre Hospitalier Universitaire de Nice
 2023-10-03 Not Applicable
NCT06045338 Not yet recruiting
Long COVID|Post-Acute Sequelae of COVID-19|COVID Long-Haul
Beth Israel Deaconess Medical Center
 2023-10 Not Applicable
NCT06110403 Recruiting
Copd
University Hospital Lille|AstraZeneca
 2023-09-29 Phase 1|Phase 2
NCT06012006 Not yet recruiting
COPD
Assistance Publique - Hôpitaux de Paris
 2023-08 Not Applicable
NCT01376505 COMPLETED
Malignant Solid Tumour; Breast Cancer; Malignant Tumor of Colon; GIST; Ovarian Cancer
Robert Wesolowski
 2011-06-21 PHASE1
NCT04928820 TERMINATED
Biochemically Recurrent Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
Jonsson Comprehensive Cancer Center
 2021-06-16 PHASE2
NCT05614518 COMPLETED
Bone Metastases
HTA Co., Ltd.
 2021-03-29 PHASE3
NCT05973292 COMPLETED
Endodontically Treated Teeth; Anterior Teeth
Kafrelsheikh University
 2021-04-01 PHASE2
NCT03673722 COMPLETED
Dementia
University of East Anglia
 2019-04-01
NCT04756349 COMPLETED
Non Carious Cervical Lesion
Universidade Federal do Para
 2020-02-12
NCT02304757 COMPLETED
Differentiated Thyroid Cancer; Osteoporosis
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
 2015-01
NCT03948191 COMPLETED
Thyroid-Associated Ophthalmopathy
Dalian University
 2017-10-16 PHASE4
NCT03298854 UNKNOWN
Low Back Pain, Mechanical
Mohamed Fathy
 2017-11-01
NCT03002454 TERMINATED
Cancer of Bone
University of Manitoba
 2016-08 PHASE3
NCT00882609 UNKNOWN
Bone Metastases
American College of Radiology - Image Metrix
 2009-01 PHASE3
NCT00001042 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-28)

Check the Muramyl dipeptide (MDP) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a core peptidoglycan structural motif, muramyl dipeptide activates downstream signaling cascades that induce the expression of the essential osteogenic transcription factor Runx2. This molecular induction drives osteoblast differentiation and bone formation, providing a mechanism relevant to clinical studies involving skeletal injury and bone tissue remodeling.

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>).

Jump to

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