Clinical Trials

Numerous clinical trials evaluate this compound across diverse indications, including Vitamin D deficiency, human papillomavirus (HPV) infection, osteoporosis, schizophrenia, gastroenteritis, and metabolic risk factors in hemodialysis patients. Spanning Early Phase 1 through Phase 4, these protocols are supported by major pharmaceutical sponsors like GlaxoSmithKline and Takeda alongside academic institutions such as Cornell University. Recruitment statuses range from active and recruiting to completed, with studies addressing outcomes such as bone mineral metabolism and viral vaccine immunogenicity.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07598032 NOT_YET_RECRUITING
Prostate Cancer (Adenocarcinoma); Vitamin D on Tumor Response and Inflammatory Markers
University of Ilorin Teaching Hospital
 2026-06-01 PHASE3
NCT07495605 NOT_YET_RECRUITING
Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp
Cairo University
 2026-03-22
NCT05644522 RECRUITING
Cerebrovascular Accident; Post-polio Syndrome; Spinal Cord Injuries; Multiple Sclerosis; Muscular Dystrophy; Paralysis
Shirley Ryan AbilityLab
 2024-03-01
NCT07661329 RECRUITING
Primary Open Angle Glaucoma (POAG); Ocular Hypertension (OH)
YS Life Science Co., Ltd.
 2026-06-02 PHASE3
NCT07641933 RECRUITING
Intervention Studies; ASA Physical Status I; Intracanal Medication; Periapical Abscess; Retreatment
Ain Shams University
 2026-06-01 PHASE1
NCT06791044 RECRUITING
Vitamin D Insufficiency
Dionyssiotis, Yannis, M.D.
 2025-09-01
NCT07142759 ENROLLING_BY_INVITATION
Vitamin D Insufficiency
Quadram Institute Bioscience
 2025-09-01
NCT07567417 NOT_YET_RECRUITING
Assessment of Some Hormone Levels in Children With Dilated Cardiomyopathy
Sohag University
 2026-06-01
NCT07775456 ACTIVE_NOT_RECRUITING
Bacterial Load Reduction; Postoperative Pain
Future University in Egypt
 2026-06-01 PHASE2
NCT07194837 RECRUITING
This Study Will be Performed to Evaluate the Efficiency of 810 nm Diode Laser Disinfection on Periapical Healing in Root Canal Retreatment Cases
Al-Azhar University
 2025-09-19
NCT07585721 NOT_YET_RECRUITING
Symptomatic Apical Periodontitis
Future University in Egypt
 2026-06-01
NCT07388888 NOT_YET_RECRUITING
Pulp Necrosis
Ain Shams University
 2026-02 PHASE4
NCT06206226 RECRUITING
Depression; Depressive Disorder; Depressive Symptoms
University of Wisconsin, Madison
 2026-09
NCT07371416 ACTIVE_NOT_RECRUITING
Immature Permanent Teeth With Open Apex; Pulp Necrosis
Mansoura University
 2025-10-01
NCT07239739 NOT_YET_RECRUITING
Periapical Lesion; Periapical Periodontitis
Faiz ur rahman
 2026-06-15
NCT06831500 RECRUITING
Multi-system Atrophy - Parkinsonian Type; Orthostatic Hypotension, Dysautonomic; Parkinson Disease
Julien Bally
 2025-07-18 PHASE1; PHASE2
NCT06447519 ACTIVE_NOT_RECRUITING
Endodontically Treated Teeth; Calcium Hydroxide
Aristotle University Of Thessaloniki
 2024-09-12
NCT07683520 COMPLETED
Chronic Apical Periodontitis
Ain Shams University
 2025-10-04 PHASE4
NCT07262554 ACTIVE_NOT_RECRUITING
Apical Periodontitis
Alexandria University
 2025-11-15 PHASE2
NCT06395688 WITHDRAWN
Cannabis Abuse
Aelis Farma
 2025-12 PHASE1
NCT05860699 RECRUITING
Severe Alcohol Use Disorder (DSM 5)
Assistance Publique - Hôpitaux de Paris
 2024-04-08 PHASE2
NCT06683833 RECRUITING
Deep Caries; Indirect Pulp Capping; Mineral Trioxide Aggregate (MTA); Calcium Hydroxide; Biodentine; Patient Reported Outcome Measures
Cairo University
 2025-09-03 PHASE4
NCT05018988 UNKNOWN
Vitamin D Deficiency; Musculoskeletal Diseases; Cognitive Delay, Mild
University of Ulster
 2019-11-01
NCT06939608 COMPLETED
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2025-04-28
NCT05857267 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Laboratorios Poen
 2023-03-07 PHASE4
NCT06101589 UNKNOWN
Mental Health Issue
University of the Punjab
 2024-05-15
NCT05901636 COMPLETED
Influenza Prevention
Janssen Vaccines & Prevention B.V.
 2023-05-17 PHASE1; PHASE2
NCT06398236 COMPLETED
Menopause
Nutrition & Sante Iberia
 2023-03-17
NCT04495608 COMPLETED
Nephrolithiasis; Nephrocalcinosis; Hypercalciuria
Hospices Civils de Lyon
 2021-01-13 PHASE2
NCT07332936 COMPLETED
Symptomatic Irreversible Pulpitis; Postoperative Endodontic Pain Following Emergency Root Canal Treatment
Umm Al-Qura University
 2023-07-01
NCT04262934 UNKNOWN
hemoDIALysis Patients
Institut Phoceen de Nephrologie
 2018-01-08 PHASE3
NCT06807320 COMPLETED
Indirect Pulp Cap
Shaheed Zulfiqar Ali Bhutto Medical University
 2022-01-01 PHASE4
NCT06054919 UNKNOWN
Vitamin D Deficiency
Indonesia University
 2021-04-01 PHASE2; PHASE3
NCT04346394 WITHDRAWN
Parkinson Disease
Nathaniel M. Robbins
 2021-05-11 EARLY_PHASE1
NCT05340985 UNKNOWN
Multiple Sclerosis, Relapsing-Remitting; Adult ALL; Vitamin D3 Deficiency
Tehran University of Medical Sciences
 2022-07 PHASE4
NCT05184595 UNKNOWN
Multiple Myeloma
Central Hospital, Nancy, France
 2022-01-01
NCT04224246 COMPLETED
Weaning from Mechanical Ventilation
Poitiers University Hospital
 2020-02-27 PHASE2
NCT05618899 UNKNOWN
Obesity
Riphah International University
 2022-05-01
NCT07340944 COMPLETED
Chronic Apical Periodontitis
Ataturk University
 2022-09-10
NCT04939792 COMPLETED
Vitamin D Deficiency
Louisiana State University Health Sciences Center Shreveport
 2020-11-06 EARLY_PHASE1
NCT05935254 COMPLETED
Attention Deficit and Hyperactivity Disorder; Dental Plaque
Aydin Adnan Menderes University
 2022-01-29
NCT05044052 COMPLETED
Infection
Women's College Hospital
 2021-12-15
NCT04095793 TERMINATED
Symptomatic Neurogenic Orthostatic Hypotension
Theravance Biopharma
 2019-09-19 PHASE3
NCT04160767 UNKNOWN
Celiac Disease
University of Milan
 2019-01-30 PHASE4
NCT04885803 COMPLETED
Vitamin D Deficiency
Inspired Life Medical, Inc.
 2021-03-26
NCT03848351 COMPLETED
Gingivitis
University of Pisa
 2019-04-01
NCT05502068 COMPLETED
COVID-19; Vitamin D Deficiency
Pauls Stradins Clinical University Hospital
 2021-02-01
NCT03849833 UNKNOWN
Healthy Volunteers
Bispebjerg Hospital
 2019-01-31
NCT03852888 COMPLETED
Rheumatoid Arthritis
CHU de Reims
 2018-11-14
NCT04134065 UNKNOWN
Vitamin D Deficiency; Crohn Disease
Nanjing University School of Medicine
 2019-12-01 EARLY_PHASE1
NCT03940157 COMPLETED
Depression; Awareness; Self-management
University of Wisconsin, Madison
 2019-07-01
NCT04351490 WITHDRAWN
SARS-CoV 2
University Hospital, Lille
 2020-04
NCT04488042 COMPLETED
Obesity, Morbid; Suture, Complication; Suture Rupture
University of Campania Luigi Vanvitelli
 2020-01-01
NCT04655664 COMPLETED
Nutritional Deficiency
Universitas Sumatera Utara
 2020-04-11
NCT03469271 COMPLETED
Cancer
Mayo Clinic
 2018-05-25 PHASE4
NCT04822038 COMPLETED
Vitamin D Deficiency; Scleroderma, Systemic
Coordinación de Investigación en Salud, Mexico
 2017-06-01
NCT03284710 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-06-19 PHASE1; PHASE2
NCT02091219 COMPLETED
Vitamin D Deficiency
University of California, Los Angeles
 2014-06 EARLY_PHASE1
NCT04100226 UNKNOWN
Lung Diseases, Interstitial; Vitamin D Deficiency
Cairo University
 2019-03-01
NCT04613258 COMPLETED
Tuberculosis
Universitas Sumatera Utara
 2019-05-11
NCT04527913 COMPLETED
Periodontitis
University of Pisa
 2011-09
NCT03481426 COMPLETED
Back Pain
Finnish Institute of Occupational Health
 2017-02-01
NCT03766074 UNKNOWN
Depression
Tirang R. Neyestani, Ph.D.
 2018-05-06
NCT03496246 UNKNOWN
Vitamin D Deficiency; Inflammatory Bowel Diseases
Assiut University
 2018-04
NCT03199963 TERMINATED
Mammographic Breast Density
BHR Pharma, LLC
 2017-08-21 PHASE3
NCT03855501 COMPLETED
Immature Teeth
Ege University
 2015-01
NCT06096194 COMPLETED
Vitamin D Deficiency; 25-Hydroxyvitamin D3 Deficiency, Selective
Instituto Nacional de Salud Publica, Mexico
 2018-07-15
NCT02460211 COMPLETED
Cardiovascular Disease; Vitamin D Deficiency
Intermountain Health Care, Inc.
 2015-07
NCT02067741 TERMINATED
Metastatic Breast Adenocarcinoma; Breast Cancer
Swiss Cancer Institute
 2016-06-14 PHASE2
NCT02553044 COMPLETED
Vitamin D Deficiency; Osteoporosis
Sheffield Teaching Hospitals NHS Foundation Trust
 2015-10
NCT01342536 COMPLETED
Major Depressive Disorder
University of Wisconsin, Madison
 2011-12-14 PHASE3
NCT02818660 COMPLETED
Adrenal Insufficiency
Haukeland University Hospital
 2016-05-21
NCT02158598 COMPLETED
Vitamin D Deficiency
CHU de Quebec-Universite Laval
 2014-06 PHASE4
NCT03284697 COMPLETED
Reversible Pulpitis
Postgraduate Institute of Dental Sciences Rohtak
 2016-10-14
NCT03035084 COMPLETED
Vitamin D Deficiency; 25-Hydroxyvitamin D Concentration
King Faisal Specialist Hospital & Research Center
 2017-02-15 PHASE4
NCT03268083 COMPLETED
Enterovirus Infections
Enimmune Corporation
 2016-07 PHASE2
NCT02658357 COMPLETED
Schizophrenia; Schizo-affective Disorder
Braeburn Pharmaceuticals
 2015-10 PHASE2
NCT02787109 COMPLETED
Chlamydia Trachomatis
Statens Serum Institut
 2016-07 PHASE1
NCT03403985 UNKNOWN
Dental Pulp Capping; Dental Caries Extending to Pulp
Jordan University of Science and Technology
 2017-06-01
NCT03544671 COMPLETED
Vitamin D Deficiency; 25-Hydroxyvitamin D3 Deficiency, Selective
Instituto Nacional de Salud Publica, Mexico
 2016-09-15
NCT03099759 COMPLETED
Vitamin D Deficiency
The Cleveland Clinic
 2016-06-27
NCT01535196 TERMINATED
Chronic Heart Failure; Vitamin D Adverse Reaction
Semmelweis University
 2012-12 PHASE3
NCT03463642 COMPLETED
Vitamin D Deficiency
University of Wolverhampton
 2017-02-02
NCT01518959 TERMINATED
Chronic Lymphoid Leukemia
Semmelweis University
 2012-01 PHASE3
NCT01457001 TERMINATED
Chronic Renal Failure
Italian Society of Nephrology
 2012-11 PHASE3
NCT01170507 WITHDRAWN
Vitamin D Deficiency
King Faisal Specialist Hospital & Research Center
 2011-12 PHASE1; PHASE2
NCT01202994 COMPLETED
Alzheimer's Disease
University of Utah
 2011-05 PHASE2
NCT03849222 COMPLETED
Pulp Necrosis; Apexification
Al-Azhar University
 2013-08-20 PHASE2; PHASE3
NCT01170494 COMPLETED
Vitamin D Deficiency
King Faisal Specialist Hospital & Research Center
 2013-02
NCT02802449 COMPLETED
Hypovitaminosis D
Charles Drew University of Medicine and Science
 2013-09
NCT02518763 UNKNOWN
Osteoporosis
University Hospital, Caen
 2011-06 PHASE3
NCT02005302 UNKNOWN
Vitamin D Deficiency; Malnutrition
Wenhu Liu
 2013-01 PHASE4
NCT02333682 COMPLETED
Osteoporosis
dsm-firmenich Switzerland AG
 2014-11
NCT02535910 UNKNOWN
Hypovitaminosis D; Cardiovascular Diseases
University of Reading
 2015-08
NCT01633853 COMPLETED
Vitamin D Deficiency
Dongliang Zhang, MD
 2012-07 PHASE4
NCT01976481 COMPLETED
Skin Toxicity
University of Zurich
 2013-11
NCT01741181 COMPLETED
Diabetes Mellitus Type 2; Vitamin D Deficiency
Tan Tock Seng Hospital
 2012-09 PHASE4
NCT02247011 COMPLETED
Osteoporotic Fractures; Osteoporosis, Postmenopausal
Peking Union Medical College Hospital
 2013-03
NCT01025128 COMPLETED
Vitamin D Deficiency; Secondary Hyperparathyroidism; Osteomalacia
Clalit Health Services
 2010-01 PHASE4
NCT01868945 COMPLETED
Pre-frail Elderly; Frail Elderly
dsm-firmenich Switzerland AG
 2013-04 PHASE1
NCT02334592 COMPLETED
Healthy
Vitamin D Society
 2014-01
NCT01403103 WITHDRAWN
Mucinous Adenocarcinoma of the Colon; Mucinous Adenocarcinoma of the Rectum; Signet Ring Adenocarcinoma of the Colon; Signet Ring Adenocarcinoma of the Rectum; Stage I Colon Cancer; Stage I Rectal Cancer
Case Comprehensive Cancer Center
 2012-04 EARLY_PHASE1
NCT01633658 WITHDRAWN
Vitamin D Deficiency
Creighton University
 2012-11
NCT01774435 COMPLETED
Schizophrenia
Endo USA Inc., a Keenova Therapeutics Company
 2012-10 PHASE1
NCT00750529 COMPLETED
Alzheimer's Disease
University Hospital, Clermont-Ferrand
 2008-11 PHASE1
NCT02186106 COMPLETED
Deficiency, Vitamin D; Obesity
Bispebjerg Hospital
 2012-01 PHASE4
NCT00217477 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2004-08 PHASE1
NCT01168401 COMPLETED
Gastroenteritis
Takeda
 2010-09-03 PHASE1
NCT01469650 COMPLETED
Premature Infants
University of Nebraska
 2012-01
NCT01594970 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Allergan
 2012-03 PHASE4
NCT02621827 COMPLETED
Pregnancy; Lactation
Medical Research Council
 2011-11
NCT01481051 COMPLETED
Glaucoma; Ocular Hypertension (OH)
Mati Therapeutics Inc.
 2011-11 PHASE2
NCT01481077 COMPLETED
Glaucoma; Ocular Hypertension (OH)
Mati Therapeutics Inc.
 2011-11 PHASE2
NCT01369771 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma
FinnMedi Oy
 2010-08 PHASE4
NCT01323218 UNKNOWN
Obstructive Sleep Apnea-hypopnea Syndrome
University Hospital, Clermont-Ferrand
 2011-03 PHASE2
NCT01488227 COMPLETED
Healthy
University of Kentucky
 2011-08 PHASE3
NCT01758601 COMPLETED
Cardiovascular Risk Factors; Metabolic Syndrome
Hospital Universitario Ramon y Cajal
 2010-01 PHASE3
NCT01229982 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Mati Therapeutics Inc.
 2010-10 PHASE2
NCT00524680 COMPLETED
Prostate Cancer
Roswell Park Cancer Institute
 2007-06 PHASE2
NCT01425775 COMPLETED
Systemic Lupus Erythematosus
University of Alexandria
 2010-04
NCT01585051 COMPLETED
Diabetes Mellitus Type 2
Kantonsspital Baselland Bruderholz
 2009-01 PHASE3
NCT00967811 COMPLETED
Glaucoma; Ocular Hypertension
Mati Therapeutics Inc.
 2009-08 PHASE2
NCT01037036 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma
Mati Therapeutics Inc.
 2009-12 PHASE2
NCT00481767 COMPLETED
Human Papillomavirus (HPV) Infection
GlaxoSmithKline
 2007-10-01 PHASE3
NCT00889629 COMPLETED
Chronic Kidney Disease; Kidney Transplantation
Mariana Markell
 2008-11 PHASE4
NCT00437177 UNKNOWN
Alcoholism
Hospital Universitari Vall d'Hebron Research Institute
 2007-01 PHASE2
NCT00845299 COMPLETED
Glaucoma; Ocular Hypertension
Mati Therapeutics Inc.
 2009-01 PHASE2
NCT00820300 COMPLETED
Glaucoma; Ocular Hypertension
Mati Therapeutics Inc.
 2009-01 PHASE2
NCT00821002 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Mati Therapeutics Inc.
 2009-01 PHASE2
NCT00678756 UNKNOWN
Psoriasis Vulgaris
Technische Universität Dresden
 2008-03 PHASE2
NCT00855517 WITHDRAWN
Glaucoma; Ocular Hypertension
Mati Therapeutics Inc.
 2009-03 PHASE2
NCT00258258 TERMINATED
Multiple Myeloma and Plasma Cell Neoplasm
Roswell Park Cancer Institute
 2005-08 PHASE1
NCT00717834 COMPLETED
Ross River Virus Disease (RRVD)
Alachua Government Services, Inc.
 2008-06 PHASE1; PHASE2
NCT00659204 TERMINATED
Healthy
Madigan Army Medical Center
 2008-01 PHASE3
NCT00718276 COMPLETED
Healthy
University of Zurich
 2008-03 PHASE1
NCT00585442 TERMINATED
Hypertension; Vitamin D Deficiency
University of Utah
 2007-05 EARLY_PHASE1
NCT00383019 COMPLETED
Glaucoma; Ocular Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-11-14 PHASE3
NCT00546286 COMPLETED
Glaucoma; Ocular Hypertension
Merck Sharp & Dohme LLC
 2006-05-31 PHASE3
NCT00248833 COMPLETED
Meningitis, Meningococcal, Serogroup B
U.S. Army Medical Research and Development Command
 2005-12-05 PHASE1
NCT00009802 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
University of Pittsburgh
 1998-06 PHASE1
NCT00693615 COMPLETED
Infections, Papillomavirus
GlaxoSmithKline
 2000-10 PHASE2
NCT00693966 COMPLETED
Infections, Papillomavirus
GlaxoSmithKline
 1999-10 PHASE2
NCT00143208 COMPLETED
Glaucoma; Ocular Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-05 PHASE4
NCT00647101 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-12 PHASE4
NCT01120119 COMPLETED
Diabetes Mellitus, Type 1
Campus Bio-Medico University
 PHASE2
NCT00138983 COMPLETED
Rheumatoid Arthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Wegener's Granulomatosis
UMC Utrecht
 2000-05 PHASE3
NCT00542074 COMPLETED
Bacterial Vaginosis
University of Washington
 2003-06

(data from https://clinicaltrials.gov, updated on 2026-05-20)

Check the Z-VAD(OH)-FMK product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Z-VAD(OH)-FMK acts by irreversibly binding to the catalytic domain of pan-caspase enzymes, effectively blocking downstream proteolytic cascades and preventing apoptotic cellular destruction. By suppressing caspase-dependent cell death pathways, this inhibition maintains cellular integrity and mitigates pathological cell loss, offering therapeutic relevance in experimental models of inflammatory and degenerative conditions investigated across clinical settings.

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.