Clinical Trials

Numerous clinical trials evaluate a diverse array of conditions, including hepatobiliary malignancies, postoperative pain, dry eye disease, essential tremor, and dietary deficiencies. Spanning Early Phase 1 through Phase 4, these investigations encompass completed studies, actively recruiting cohorts, and pending protocols. They are supported by academic institutions such as Sun Yat-sen University, governmental agencies like the National Institute of Neurological Disorders and Stroke, and private sponsors including VivaVision Biotech.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07329569 NOT_YET_RECRUITING
Chemical Burns; Ocular Burns
Fondation Ophtalmologique Adolphe de Rothschild
 2026-03 PHASE2
NCT04580368 RECRUITING
Cystic Fibrosis
Children's Hospital Medical Center, Cincinnati
 2021-05-01
NCT07321691 NOT_YET_RECRUITING
Deafness
University Hospital, Toulouse
 2026-09
NCT07668856 RECRUITING
Refractory Epilepsy in Children; Refractory Epilepsy; Epilepsy
UMC Utrecht
 2025-02-06 PHASE3
NCT07497568 RECRUITING
Dental Implant; Stability
University of Baghdad
 2025-11-01
NCT01687127 NOT_YET_RECRUITING
One-carbon Metabolism in Healthy Individuals
University of British Columbia
 2024-01-01
NCT07150026 RECRUITING
Pitt Hopkins Syndrome
Unravel Biosciences, Inc.
 2026-03-15 PHASE1
NCT07242430 ACTIVE_NOT_RECRUITING
Perimenopause; Perimenopausal Women; Perimenopause, Climacteric Syndrome
Northumbria University
 2026-04-07
NCT07294482 RECRUITING
Sleep
Efforia, Inc
 2025-09-10
NCT07023146 ENROLLING_BY_INVITATION
Investigating the Effects of Power Training in the Elderly
Federal University of Rio Grande do Sul
 2025-04-02
NCT06958276 COMPLETED
Nonspecific Shoulder Pain; Shoulder Pain Syndrome
Universidad de Zaragoza
 2025-05-01
NCT04856176 TERMINATED
Advanced Lung Non-Small Cell Carcinoma; Non-Small Cell Carcinoma of Lung, TNM Stage 4
Tufts Medical Center
 2022-01-03 PHASE2
NCT06406816 Not yet recruiting
Intrahepatic Cholangiocarcinoma
Yongyi Zeng|Meng Chao Hepatobiliary Hospital of Fujian Medical University
 2024-05 Early Phase 1
NCT06407518 Not yet recruiting
Preoperative|Sleep Disturbance|Anxiety|Midazolam|Pain Postoperative
Sixth Affiliated Hospital Sun Yat-sen University
 2024-05 Not Applicable
NCT06402110 Recruiting
Femoral Triangle Block|Adductor Canal Block|Anterior Cruciate Ligament Reconstruction
Tanta University
 2024-05-07 Not Applicable
NCT06429228 COMPLETED
Catheter Related Complication; Anterior Vaginal Wall Prolapse
IRCCS San Raffaele
 2020-04-20
NCT05509920 UNKNOWN
Root Caries
Cairo University
 2022-10
NCT05214287 COMPLETED
Parkinson Disease; Effect of Drug
Radboud University Medical Center
 2022-02-22 PHASE1; PHASE2
NCT04968522 UNKNOWN
Fetal Alcohol Spectrum Disorders
Monash Medical Centre
 2022-02-14 PHASE4
NCT05489094 UNKNOWN
Iron-deficiency
Danone Specialized Nutrition Indonesia
 2022-08-31 PHASE4
NCT05415748 COMPLETED
Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
University of California, San Francisco
 2021-09-18 PHASE4
NCT05343715 COMPLETED
Fabry Disease
Bio Sidus SA
 2021-10-23 PHASE1
NCT04601792 UNKNOWN
Bronchiectasis; Quality of Life; Traditional Chinese Medicine; Sputum; Symptoms; Individuality
Shanghai University of Traditional Chinese Medicine
 2019-12-01 PHASE4
NCT04556838 COMPLETED
Dry Eye
VivaVision Biotech, Inc
 2020-12-03 PHASE2
NCT02333149 WITHDRAWN
Attention Deficit/Hyperactivity Disorder; Initial Insomnia
University of Alberta
 2019-01-01 PHASE3
NCT03843541 COMPLETED
Respiratory Tract Diseases; Abnormal Mucus Secretions
Zambon SpA
 2019-06-25 PHASE3
NCT04427852 COMPLETED
Cognitive Change; Nutrient Deficiency; Nutritional Anemia; Visual Spatial Processing; Diet, Healthy; Diet; Deficiency; Dietary Deficiency; Dietary B12 Deficiency; Dietary Zinc Deficiency; Dietary Vitamin B12 Deficiency Anemia; Dietary Deficiency of Selenium and Vitamin E
Texas A&M University
 2020-01-20
NCT03301311 COMPLETED
Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Indeterminate Colitis
Children's Hospital Medical Center, Cincinnati
 2018-04-10
NCT03347188 COMPLETED
Post-Traumatic Headache
Teva Branded Pharmaceutical Products R&D, Inc.
 2017-12-18 PHASE2
NCT02781064 COMPLETED
Cardiovascular Disease
London School of Hygiene and Tropical Medicine
 2016-09-01 PHASE4
NCT04018950 COMPLETED
Acinetobacter Baumannii-calcoaceticus Complex Infections
Entasis Therapeutics
 2019-06-21 PHASE1
NCT02158663 COMPLETED
Posttraumatic Stress Disorder; Depression
James A. Haley Veterans Administration Hospital
 2014-06-06
NCT03456713 COMPLETED
Healthy
Eli Lilly and Company
 2018-03-06 PHASE1
NCT02946788 COMPLETED
Acne Vulgaris
BioPharmX, Inc.
 2017-03-13 PHASE2
NCT02743143 COMPLETED
Schizophrenia
St. Olavs Hospital
 2015-12
NCT02995083 WITHDRAWN
Symptomatic Osteoarthritis of the Knee
Rush University Medical Center
 2017-06 EARLY_PHASE1
NCT03158038 COMPLETED
Influenza; Healthy
MedImmune LLC
 2017-05-30 PHASE4
NCT02744456 COMPLETED
Hypertension; High Blood Pressure
Columbia University
 2014-08-01 EARLY_PHASE1
NCT01838681 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2013-06 PHASE3
NCT03207698 COMPLETED
Furcation Defects
Government Dental College and Research Institute, Bangalore
 2015-09 PHASE2; PHASE3
NCT02161354 TERMINATED
Dental Pain
NanoSHIFT LLC
 2014-06 PHASE2
NCT02006875 COMPLETED
Stroke
Taipei Medical University WanFang Hospital
 2013-01 PHASE3
NCT05095493 COMPLETED
Dystonia, Focal
University of Texas Southwestern Medical Center
 2013-01-01
NCT02255812 COMPLETED
Exploratory Behavior
University Hospital, Basel, Switzerland
 2013-03
NCT02707172 COMPLETED
Environmental Exposure; Exposure to Pollution
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2013-05
NCT01480297 COMPLETED
Peripheral Neuropathy; Type 1 Diabetes
University of Michigan
 2011-11 PHASE2
NCT01065051 TERMINATED
Hypertension, Pulmonary; Ventricular Dysfunction, Left
Bayer
 2010-11 PHASE2
NCT00594412 COMPLETED
Fatty Liver; Hepatitis
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-12-20
NCT00102596 COMPLETED
Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)
 2005-01 PHASE2
NCT00502268 WITHDRAWN
Coronary Calcification; Endstage Renal Disease; Parathyroid Hormone
Southeast Renal Research Institute
 2008-02 PHASE4
NCT00308152 COMPLETED
Colonic Diseases
The Canberra Hospital
 2006-02 PHASE2
NCT00535743 COMPLETED
Anesthesia, General
Merck Sharp & Dohme LLC
 2004-03-04 PHASE2
NCT01282814 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2003-02 PHASE1
NCT02259985 COMPLETED
Healthy
Boehringer Ingelheim
 1998-03 PHASE1
NCT00016679 COMPLETED
Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)
 2001-05 PHASE1
NCT00393653 TERMINATED
Osteoarthritis; Gastroesophageal Reflux Disease
American Academy of Family Physicians
 2006-10
NCT00121498 COMPLETED
Pain
Rambam Health Care Campus
 2002-11
NCT00371696 COMPLETED
Osteoarthritis
University of Bristol
 2001-12 PHASE2
NCT01058603 UNKNOWN
Infertility
Laboratoires Genévrier
 2008-02 PHASE3
NCT00299169 TERMINATED
Diabetes; Cardiovascular Disease; Hyperlipidemia
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2006-09 PHASE4
NCT00080366 COMPLETED
Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)
 2004-03 PHASE2
NCT00002324 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-09)

Check the OF-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OF-1 potently binds to the bromodomains of BRPF1B and BRPF2 with dissociation constants of 100 nM and 500 nM, respectively, thereby blocking their interaction with acetylated histones and disrupting chromatin-remodeling complex activity. This molecular blockade downregulates transcriptional programs necessary for aberrant cell proliferation and inflammatory cascades, providing target rationale for conditions studied in clinical settings such as intrahepatic cholangiocarcinoma and inflammatory ocular diseases.

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.