Numerous clinical trials evaluate D-mannose across healthy cohorts and diverse medical conditions, most prominently urinary tract infections, coronary artery disease, hyperlipidemias, and periodontal diseases. Spanning Phase 1 through Phase 4 alongside non-interventional protocols, these studies are supported by academic medical centers and biopharmaceutical entities, including Washington University, Peking University Third Hospital, and KEB Nutraceuticals. Across active, completed, terminated, and withdrawn statuses, these evaluations assess specific endpoints such as urinary tract infection symptoms and pharmacokinetic interactions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06940622 | RECRUITING | Recurrent UTIs; Recurrent Urinary Tract Infections; Recurrent Urinary Tract Infections in Women; Recurrent Urinary Tract Infection; Cystitis Recurrent; Cystitis Chronic; UTI; UTI - Urinary Tract Infection; UTI - Lower Urinary Tract Infection |
University of Texas Southwestern Medical Center |
2025-08-01 | |
| NCT07637903 | COMPLETED | Recurrent Urinary Tract Infection; Catheter-Related Infections |
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
2022-05-04 | |
| NCT06360055 | UNKNOWN | Health |
Peking University Third Hospital |
2024-04-01 | |
| NCT06719115 | COMPLETED | Urinary Tract Infection(UTI) |
KEB Nutraceuticals USA, Inc. |
2023-05-03 | PHASE2 |
| NCT06360055 | Recruiting | Health |
Peking University Third Hospital |
2024-04-01 | Not Applicable |
| NCT04880343 | SUSPENDED | Lower Urinary Tract Infection |
Carmen Gonzalez Enguita |
2021-01-26 | |
| NCT06268483 | COMPLETED | Urinary Tract Infections, Recurrent |
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
2022-03-01 | |
| NCT03996057 | WITHDRAWN | UTI; Female Urogenital Diseases; UTI - Lower Urinary Tract Infection |
Washington University School of Medicine |
2018-06-20 | PHASE4 |
| NCT05186285 | Unknown status | Healthy |
Keymed Biosciences Co.Ltd |
2021-12-11 | Phase 1 |
| NCT04505982 | Unknown status | Rheumatoid Polyarthritis |
BADOT Valerie|Brugmann University Hospital |
2020-07-14 | -- |
| NCT03497598 | TERMINATED | Urinary Tract Infections |
Kantonsspital Aarau |
2018-05-09 | PHASE4 |
| NCT03395288 | TERMINATED | Urinary Tract Infections |
Washington University School of Medicine |
2018-03-22 | PHASE2; PHASE3 |
| NCT02702765 | COMPLETED | Wilsons Disease |
University of Aarhus |
2016-02 | |
| NCT03404869 | UNKNOWN | CDG Ib |
Orpha Labs |
2015-03-31 | PHASE1; PHASE2 |
| NCT03753451 | COMPLETED | Periodontal Diseases |
InCor Heart Institute |
2016-10-01 | |
| NCT03395288 | Terminated | Urinary Tract Infections |
Washington University School of Medicine |
2018-03-22 | Phase 2|Phase 3 |
| NCT04888260 | Completed | Coronary Artery Disease|Hyperlipidemias |
Kafkas University |
2018-01-10 | -- |
| NCT02397291 | TERMINATED | IUGR; Pregnancy |
University of Colorado, Denver |
2001-01 | |
| NCT02490046 | UNKNOWN | Multiple Sclerosis; Recurrent Urinary Tract Infections |
University College, London |
2015-02 | PHASE1 |
| NCT01808755 | COMPLETED | Recurrent Urinary Tract Infection |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2012-01 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-09-22)
Check the
D-Mannose
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.