Clinical Trials

Numerous clinical trials evaluate polyvinylpyrrolidone across diverse medical indications, ranging from SARS-CoV-2 acute respiratory disease and bacterial MRSA infections to osteoporotic vertebral compression fractures, benign prostatic hyperplasia, lower urinary tract symptoms, and knee osteoarthritis. Spanning Early Phase 1 through Phase 4 alongside non-interventional and device-based classifications, these studies are sponsored by academic institutions, university hospitals, and medical research centers worldwide. Current trial recruitment statuses encompass completed, active, recruiting, and withdrawn studies assessing various patient outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07378423 RECRUITING
Cancer Predisposition Syndromes; Pediatric Cancer; Childhood Neoplasms; Hereditary Cancer Syndromes
Insel Gruppe AG, University Hospital Bern
 2026-04-01
NCT07460297 ENROLLING_BY_INVITATION
Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate; Seroma Following Procedure
Jianyi Li
 2025-04-16
NCT06463678 NOT_YET_RECRUITING
Fungal Keratitis
IVIEW Therapeutics Inc.
 2026-08-01 PHASE2
NCT03297281 RECRUITING
Benign Prostatic Hyperplasia; Anticoagulant Adverse Reaction
Clinique Pasteur
 2017-10-30
NCT06379243 RECRUITING
Osteoporosis Fracture; Osteoporosis Vertebral; Compression Fracture; Perform PVP / PKP Treatment
The Seventh Affiliated Hospital of Sun Yat-sen University
 2023-12-01
NCT07616583 RECRUITING
Osteoporotic Vertebral Compression Fractures; Vertebroplasty
Beijing Friendship Hospital
 2024-01-01
NCT07692009 COMPLETED
Osteoarthritis (OA) of the Knee
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.
 2024-01-23 PHASE4
NCT03674151 UNKNOWN
Split-skin Grafted Third-degree Burn Wound
University Hospital Schleswig-Holstein
 2015-07
NCT04725396 COMPLETED
Oropharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma
UNICANCER
 2021-04-20
NCT04529369 NOT_YET_RECRUITING
Benign Prostatic Hyperplasia
Jewish General Hospital
 2020-10
NCT06880445 COMPLETED
Perineal Infection; Maternal Infections Affecting Fetus or Newborn; Cost Effectiveness
Tzu-Ying Huang
 2024-11-30
NCT06864858 COMPLETED
Visual Acuity
Johnson & Johnson Vision Care, Inc.
 2025-03-30
NCT06610331 COMPLETED
Palatal Wound
Abant Izzet Baysal University
 2024-02-01
NCT05745467 Withdrawn
SARS-CoV-2 Acute Respiratory Disease
University of Iowa|3M
 2024-07-03 Phase 4
NCT05354986 COMPLETED
Tooth Staining; Periodontitis
Universidad Complutense de Madrid
 2022-10-01
NCT06379243 Recruiting
Osteoporosis Fracture|Osteoporosis Vertebral|Compression Fracture|Perform PVP / PKP Treatment
The Seventh Affiliated Hospital of Sun Yat-sen University|The Fourth Affiliated Hospital of Guangzhou Medical University|Huizhou Municipal Central Hospital|Dongguan Hospital of Traditional Chinese Medicine
 2023-12-01 Not Applicable
NCT06275880 COMPLETED
Gonarthrosis
Instituto Mexicano del Seguro Social
 2023-04-01
NCT05696132 Not yet recruiting
MRSA
Nantes University Hospital
 2023-02 Phase 2
NCT05587179 Completed
Unconsciousness
Centre for Evidence-Based Practice Belgium|University Hospital Antwerp
 2022-12-21 Not Applicable
NCT04457765 WITHDRAWN
Rhinoplasty
Boston Medical Center
 2021-04 EARLY_PHASE1
NCT05375773 UNKNOWN
2019 Novel Coronavirus Infection
Ruijin Hospital
 2022-04-16
NCT04260412 UNKNOWN
End Stage Renal Disease; Haemodialysis; Diet, Healthy; Chronic Inflammation
University Medical Centre Ljubljana
 2020-08-31
NCT05049213 COMPLETED
Covid19; SARS-CoV 2 Infection
National Taiwan University Hospital
 2022-06-24 PHASE4
NCT05200754 UNKNOWN
SARS-CoV-2 Infection
Carsten Müller-Tidow
 2020-09-03 PHASE2
NCT04568382 COMPLETED
Diabetes Mellitus, Type 2; Multiple Chronic Conditions
University of California, Davis
 2020-10-12
NCT06585319 COMPLETED
COVID 19
Materno-Perinatal Hospital of the State of Mexico
 2020-02-01 PHASE2; PHASE3
NCT04872686 COMPLETED
Virus Infection, RNA; Effect of Drug; Efficacy, Self
DR. MALA KHAN
 2021-04-10 PHASE3
NCT04721457 COMPLETED
SARS-CoV-2; COVID-19; Mouthwashes; Viral Load; Polymerase Chain Reaction; Coronavirus; Covid19; Saliva
King Abdulaziz University
 2021-01-03 PHASE4
NCT04019782 UNKNOWN
Knee Osteoarthritis; Gonarthrosis
Coordinación de Investigación en Salud, Mexico
 2019-08-01 PHASE3
NCT04517162 UNKNOWN
Covid19; Cytokine Storm; Regulation of Inflammatory Response; Pulmonary Fibrosis
Janette Furuzawa Carballeda
 2020-08-19 PHASE1; PHASE2
NCT04510402 UNKNOWN
Covid19; Povidone Iodine Adverse Reaction
Brigham and Women's Hospital
 2020-08 PHASE1; PHASE2
NCT04347954 COMPLETED
COVID-19
Stanford University
 2020-08-15 PHASE1; PHASE2
NCT03685604 COMPLETED
Surgical Site Infections
University Hospital, Basel, Switzerland
 2018-09-10 PHASE4
NCT03654820 UNKNOWN
Root Caries
The University of Hong Kong
 2017-08-03
NCT03490396 TERMINATED
Oral Mucositis
Midatech Pharma US Inc.
 2018-05-15 PHASE4
NCT03846700 UNKNOWN
Benign Prostatic Hyperplasia (BPH)
University of Bari
 2019-03-01
NCT02998554 TERMINATED
Adenoviral Conjunctivitis
Shire
 2017-03-28 PHASE3
NCT02998541 TERMINATED
Adenoviral Conjunctivitis
Shire
 2017-03-27 PHASE3
NCT03004924 COMPLETED
Bacterial Conjunctivitis
Shire
 2017-03-29 PHASE3
NCT03894722 COMPLETED
Impacted Third Molar Tooth
Cansu Gül Koca
 2016-10-03 PHASE4
NCT03348917 COMPLETED
Skin Health
Mundipharma Manufacturing Pte Ltd.
 2017-12-28 PHASE4
NCT05342272 COMPLETED
Xerostomia
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
 2017-09-22 PHASE3
NCT03001102 COMPLETED
Surgical Wound Infection
Federal University of Minas Gerais
 2015-08
NCT02749604 UNKNOWN
Prostatic Hyperplasia
Mansoura University
 2016-03 PHASE4
NCT03141554 COMPLETED
Oral Health
Mundipharma Manufacturing Pte Ltd.
 2017-05-05 PHASE4
NCT02293759 UNKNOWN
Benign Prostatic Hyperplasia
Mansoura University
 2014-10 PHASE4
NCT02006303 UNKNOWN
Benign Prostate Hyperplasia; Urinary Retention
Royal Victoria Hospital, Canada
 2013-12 PHASE4
NCT02283684 COMPLETED
Benign Prostatic Hyperplasia
Mansoura University
 2014-09 PHASE4
NCT02345720 COMPLETED
Visual Acuity
Johnson & Johnson Vision Care, Inc.
 2014-12
NCT01732991 COMPLETED
Prostatic Hypertrophy, Benign
University Hospital, Tours
 2012-09
NCT02036320 COMPLETED
Vision Correction
Johnson & Johnson Vision Care, Inc.
 2014-01
NCT01747577 COMPLETED
Overactive Bladder; Benign Prostate Hyperplasia; Transurethral Resection of Prostate; Photoselective Vaporization Prostatectomy
Astellas Pharma Korea, Inc.
 2012-12-04 PHASE4
NCT01647347 COMPLETED
Bacteraemia Post Debridement
University of Zurich
 2012-08 PHASE4
NCT00527371 COMPLETED
Benign Prostatic Hyperplasia
St. Joseph's Healthcare Hamilton
 2008-01
NCT01484054 COMPLETED
Refractive Ametropia
Johnson & Johnson Vision Care, Inc.
 2011-11
NCT01484028 COMPLETED
Refractive Ametropia
Johnson & Johnson Vision Care, Inc.
 2011-11
NCT03249363 COMPLETED
Spinal Diseases; Spinal Fusion; Spine Injury; Infection, Hospital
University of Rome Tor Vergata
 2010-01-01
NCT01180777 COMPLETED
Myopia
Johnson & Johnson Vision Care, Inc.
 2010-07-01
NCT00941486 TERMINATED
Acute Adenoviral Conjunctivitis
Shire
 2009-06-30 PHASE2
NCT01043588 COMPLETED
Benign Prostatic Hyperplasia
Assistance Publique - Hôpitaux de Paris
 2007-11
NCT00826527 UNKNOWN
Urinary Frequency; Urinary Urgency; Nocturia
Seattle Urology Research Center
 2007-01 PHASE4
NCT00349024 UNKNOWN
Brain and Central Nervous System Tumors; Chordoma; Kidney Cancer; Leukemia; Lymphoma; Mucositis; Neuroblastoma; Pain; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
Children's Cancer and Leukaemia Group
 2005-07
NCT00612768 COMPLETED
Dermatitis, Contact
Allerderm
 2008-01 PHASE2
NCT00908427 COMPLETED
Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
Samsung Medical Center
 2004-06

(data from https://clinicaltrials.gov, updated on 2026-05-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Polyvinylpyrrolidone functions as a biocompatible, synthetic polymer matrix that encapsulates both hydrophilic and lipophilic substances to establish a stabilized protective barrier at physiological interfaces. By regulating sustained solute release and maintaining microenvironmental stability, this material accelerates localized tissue regeneration and cellular healing, providing critical therapeutic efficacy in wound management, intra-articular treatments for knee osteoarthritis, and surgical repair interventions.

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.