Clinical Trials

Numerous clinical trials evaluate the therapeutic utility and safety of lipid fat emulsions across conditions such as parenteral nutrition-induced cholestasis, systemic sepsis, acute drug poisoning, inflammatory responses, and perioperative nutritional support in gastric cancer. Spanning Early Phase 1 through Phase 4, these studies encompass completed, active not recruiting, unknown, and terminated recruitment statuses. Supported by academic medical centers, university hospitals, and pharmaceutical sponsors, these investigations examine critical interventions ranging from drug detoxification kinetics to inflammatory marker modulation in critically ill patients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06126380 ENROLLING_BY_INVITATION
Kidney Transplant Rejection
Eledon Pharmaceuticals
 2023-10-25 PHASE2
NCT05683132 ACTIVE_NOT_RECRUITING
Insomnia; PTSD; Women Veterans
VA Office of Research and Development
 2023-06-01
NCT05612594 RECRUITING
Sleep Apnea
Yale University
 2024-03-27 PHASE4
NCT05941520 RECRUITING
Breast Atypical Hyperplasia; Breast Carcinoma; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ
National Cancer Institute (NCI)
 2024-10-10 PHASE2
NCT07065656 NOT_YET_RECRUITING
Respiratory Failure; Hypoxia; Hypercapnia
National University Hospital, Singapore
 2025-11-01
NCT05973773 ACTIVE_NOT_RECRUITING
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation
Taiho Oncology, Inc.
 2023-12-18 PHASE3
NCT07790549 NOT_YET_RECRUITING
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Liaquat University of Medical & Health Sciences
 2026-09-07
NCT07798258 ACTIVE_NOT_RECRUITING
TMD
Cairo University
 2025-10-10 PHASE2
NCT07327931 RECRUITING
Hip Osteoarthritis; Hip Pain Chronic
Poznan University of Medical Sciences
 2026-02-13
NCT07035652 NOT_YET_RECRUITING
Chronic Obstructive Pulmonary Disease (COPD)
S-INFINITY Pharmaceuticals Co., Ltd
 2025-07-15 PHASE1
NCT07738926 NOT_YET_RECRUITING
Fibromyalgia; Fibromyalgia Syndrome
Istituto Giannina Gaslini
 2026-08-01
NCT07439120 RECRUITING
Urothelial Carcinoma (UC)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
 2026-04-13 EARLY_PHASE1
NCT06034977 UNKNOWN
Hepatocellular Carcinoma
Chang Gung Memorial Hospital
 2023-12-01 PHASE2
NCT05815485 ACTIVE_NOT_RECRUITING
COVID-19
The University of Texas Medical Branch, Galveston
 2023-05-04 PHASE2; PHASE3
NCT06748937 RECRUITING
Tuberculosis
TASK Applied Science
 2025-03-03 PHASE2
NCT07202390 NOT_YET_RECRUITING
Knee Osteoarthritis
Northern Orthopaedic Division, Denmark
 2026-02-01
NCT06126354 WITHDRAWN
Insulin Resistance; Prediabetic State; Non-Alcoholic Fatty Liver Disease; Overweight and Obesity
Columbia University
 2024-07-01 PHASE1
NCT04021368 UNKNOWN
Acute Myeloid Leukemia; High-risk Myelodysplastic Syndrome
Ryvu Therapeutics SA
 2019-09-04 PHASE1
NCT06224842 UNKNOWN
Angioimmunoblastic T-cell Lymphoma
Huijing Wu
 2023-12-12 PHASE1; PHASE2
NCT06222294 COMPLETED
Sedation in the ICU
Jiangsu HengRui Medicine Co., Ltd.
 2024-03-12 PHASE3
NCT05139563 COMPLETED
Acceptability
RTI International
 2022-07-12
NCT04958382 UNKNOWN
Chronic Insomnia
Sichuan Provincial People's Hospital
 2021-12-01
NCT03493542 COMPLETED
Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ
Merck Sharp & Dohme LLC
 2018-08-31 PHASE3
NCT05441878 UNKNOWN
Cirrhosis, Liver; Acute-On-Chronic Liver Failure; Shock, Septic; Shock Hypovolemic
Post Graduate Institute of Medical Education and Research, Chandigarh
 2020-08-15 PHASE4
NCT05132777 UNKNOWN
Locally Advanced or Metastatic Non-Small Cell Lung Cancer; EGFR Exon20 Insertion Mutations
Shanghai JMT-Bio Inc.
 2021-11-20 PHASE2
NCT01093326 COMPLETED
Multiple Sclerosis
Actelion
 2010-05-12 PHASE2
NCT02240498 COMPLETED
Abscess
University of Rochester
 2014-09 PHASE1
NCT05752864 COMPLETED
Primary Dysmenorrhea
Sahmyook University
 2023-04-30
NCT04404127 UNKNOWN
Kidney Transplantation
King Faisal Specialist Hospital & Research Center
 2020-09-01 PHASE4
NCT05677867 COMPLETED
Overweight; Obesity
Pfizer
 2023-01-18 PHASE1
NCT05711810 COMPLETED
Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral
Yang I. Pachankis
 2023-01-02 PHASE4
NCT04991688 TERMINATED
Low Anterior Resection Syndrome (LARS>20); Refractory Medical Treatment After Rectal Resection
University Hospital, Bordeaux
 2021-09-01 PHASE2
NCT03727724 COMPLETED
Carcinoma, Non-Small-Cell Lung
The Netherlands Cancer Institute
 2018-12-04 PHASE2
NCT05506540 COMPLETED
Healthy
EnnovaBio
 2021-02-17 PHASE1
NCT05060913 COMPLETED
Effect of Drug
Dow University of Health Sciences
 2021-11-17 EARLY_PHASE1
NCT04565392 WITHDRAWN
Covid19
drpykessupplements.com
 2021-05-01 PHASE4
NCT04277923 UNKNOWN
Preterm Infant
Shanghai Jiao Tong University School of Medicine
 2020-02 PHASE4
NCT03975283 UNKNOWN
Post Operative Pain
McMaster University
 2019-08 PHASE4
NCT05976100 COMPLETED
Smallpox; Monkeypox; Cowpox; Vaccinia Virus Infection
Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
 2020-09-04 PHASE1
NCT04365270 COMPLETED
Reversible Pulpitis; Pulpitis; Caries,Dental; Caries Class I; Caries; Dentin; Caries
Ain Shams University
 2019-01-15 PHASE3
NCT04451447 COMPLETED
Bile Leak
Amr Abdelaal
 2019-03-20
NCT03543774 UNKNOWN
Hypercholesterolemia; Chronic Kidney Diseases
Hue University of Medicine and Pharmacy
 2018-06-15 PHASE4
NCT03024580 UNKNOWN
Breast Neoplasm
Instituto Nacional de Cancer, Brazil
 2017-03-06 PHASE2
NCT04586608 COMPLETED
Premature Birth
Iaso Maternity Hospital, Athens, Greece
 2018-02-15
NCT03568604 COMPLETED
Dyspareunia
San Diego Sexual Medicine
 2018-08-07 PHASE4
NCT01720225 COMPLETED
Leukemia
M.D. Anderson Cancer Center
 2012-11-06 PHASE2
NCT00862446 COMPLETED
Parenteral Nutrition Associated Liver Disease
Vanderbilt University Medical Center
 2009-03 PHASE4
NCT02915016 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-12-07 PHASE1; PHASE2
NCT03122886 COMPLETED
Advanced Malignant Neoplasm
Mayo Clinic
 2017-07-14
NCT03694821 TERMINATED
Osteoarthritis
UConn Health
 2018-07-05 PHASE4
NCT01089426 COMPLETED
Liver Injury
Children's Hospital Los Angeles
 2008-09
NCT00738101 COMPLETED
Cholestasis; Cholestasis of Parenteral Nutrition
Baylor College of Medicine
 2008-09
NCT01323907 WITHDRAWN
Total Parenteral Nutrition-induced Cholestasis
Sivan Kinberg
 2011-01
NCT03190369 COMPLETED
Osteoarthritis
Genzyme, a Sanofi Company
 2017-08-21 PHASE3
NCT07057609 COMPLETED
Healthy
Haisco Pharmaceutical Group Co., Ltd.
 2018-10-16 PHASE1
NCT01173159 COMPLETED
Cholestasis
Children's Hospital Medical Center, Cincinnati
 2010-07
NCT03015194 COMPLETED
Mitral Valve Failure
National Heart, Lung, and Blood Institute (NHLBI)
 2017-06-20
NCT03372850 UNKNOWN
Healthy
Hanmi Pharmaceutical Company Limited
 2018-02-15 PHASE1
NCT03136068 COMPLETED
Abortion
University of California, San Francisco
 2017-02-23 PHASE4
NCT07671495 COMPLETED
Melanoma Stage I; Melanoma Stage III; Melanoma Stage II; Skin Melanoma
MIPO Clinic
 2014-01 PHASE2
NCT06337604 COMPLETED
Helicobacter Pylori Infection
TenNor Therapeutics Inc.
 2017-10-10 PHASE1
NCT02357576 COMPLETED
Cholestasis
University of Michigan
 2016-05-21 PHASE3
NCT02550860 TERMINATED
Intestinal Diseases
Hospices Civils de Lyon
 2015-01 PHASE3
NCT03536598 COMPLETED
Hypertension With Hyperlipidemia
HK inno.N Corporation
 2016-10-14 PHASE3
NCT02721277 TERMINATED
Cholestasis; Jaundice, Obstructive
University of Florida
 2016-05 PHASE1; PHASE2
NCT02775942 COMPLETED
Poliomyelitis
National Institute of Hygiene and Epidemiology, Vietnam
 2015-11 PHASE2
NCT02153398 COMPLETED
Gastric Ulcer (GU); Duodenal Ulcer (DU); Anastomotic Ulcer (AU); Non-erosive Reflux Esophagitis Disease (NERD); Reflux Esophagitis (RE); Zollinger-Ellison Syndrome
AstraZeneca
 2014-06 PHASE3
NCT02112006 COMPLETED
Hand Injury; Wrist Injury; Finger Injury
Jose Soberon, MD
 2014-04
NCT02458417 COMPLETED
Segmental Vitiligo; Piebaldism
Netherlands Institute for Pigment Disorders
 2015-05 PHASE4
NCT02467543 COMPLETED
Dysmenorrhea
University of Johannesburg
 2015-02 PHASE2
NCT02349282 COMPLETED
Deficiency, Vitamin D; Elderly, Frail
Wageningen University
 2014-12
NCT01908543 TERMINATED
Hereditary Haemorrhagic Telangiectasia
Imperial College London
 2013-07
NCT02141737 UNKNOWN
General Anesthesia
Tang-Du Hospital
 2014-05 PHASE4
NCT02255513 COMPLETED
Attention Deficit Hyperactivity Disorder
Ironshore Pharmaceuticals and Development, Inc
 2014-05 PHASE3
NCT01918202 COMPLETED
Healthy
Pfizer
 2014-03 PHASE1
NCT02446483 COMPLETED
Gastrointestinal Diseases
GlaxoSmithKline
 2014-03-19 PHASE4
NCT00816348 TERMINATED
Cholestasis; Total Parenteral Nutrition-induced Cholestasis
Cindy Haller
 2008-12 PHASE2
NCT01913054 UNKNOWN
Safety of Gastroscopy
Jiangsu Nhwa Pharmaceutical Co., Ltd.
 2013-08 PHASE4
NCT01874574 COMPLETED
Knee Osteoarthritis
Thammasat University
 2011-01 PHASE4
NCT01152996 COMPLETED
Depressive Disorder, Major
Takeda
 2010-09 PHASE3
NCT02299258 COMPLETED
Gastric Outlet Obstruction
The First People's Hospital of Yuhang District
 2009-05
NCT01050660 COMPLETED
Parenteral Nutrition-Associated Liver Disease
Yale University
 2009-06
NCT01582477 COMPLETED
Postsurgical Pain; Analgesia; Prostatectomy
Pacira Pharmaceuticals, Inc
 2012-03 PHASE4
NCT01314885 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Pfizer
 2011-01 PHASE1
NCT02389452 COMPLETED
Osteoarthritis
Genzyme, a Sanofi Company
 2010-02 PHASE4
NCT01376817 UNKNOWN
Severe Acute Pancreatitis
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2008-07 PHASE4
NCT01347203 COMPLETED
Deep Vein Thrombosis Leg
Diakron Pharmaceuticals
 2011-04 PHASE1
NCT01167426 COMPLETED
Multiple Sclerosis
Teva Neuroscience, Inc.
 2010-07 PHASE3
NCT01028040 COMPLETED
Healthy
AstraZeneca
 2009-12 PHASE1
NCT01133379 COMPLETED
Dentin Sensitivity
Johnson & Johnson Consumer and Personal Products Worldwide
 2010-05
NCT00811889 COMPLETED
Chronic Kidney Disease; Type 2 Diabetes; Diabetic Nephropathy
Biogen
 2009-04-30 PHASE2
NCT01096446 TERMINATED
Hypertriglyceridemia; Hyperglycemia
OSF Healthcare System
 2008-04
NCT01052584 COMPLETED
Malaria
Centers for Disease Control and Prevention
 2009-10
NCT00885781 COMPLETED
Gastrectomy; Malnutrition
National Taiwan University Hospital
 2008-11 PHASE4
NCT00531427 COMPLETED
Chronic Pain; Osteoarthritis of the Knee
Purdue Pharma LP
 2007-09 PHASE3
NCT00776009 COMPLETED
Attention-Deficit/Hyperactivity Disorder (ADHD)
Novartis Pharmaceuticals
 2008-10 PHASE4
NCT00451646 COMPLETED
Parenteral Nutrition
Fresenius Kabi
 2007-10 PHASE3
NCT00497601 COMPLETED
Visceral Leishmaniasis
Banaras Hindu University
 2007-02 PHASE2
NCT01996475 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
 PHASE1
NCT01258660 COMPLETED
Contraception
Bayer
 2006-12 PHASE1
NCT00503659 COMPLETED
Bronchial Hyperreactivity; Bronchial Asthma
Johann Wolfgang Goethe University Hospital
 2007-02
NCT00562549 COMPLETED
Hypertension
Retension Pharmaceuticals. Inc.
 2007-07 PHASE2
NCT00361790 COMPLETED
Healthy
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2006-08 PHASE1
NCT00702767 COMPLETED
Low Birth Weight
OSF Healthcare System
 2005-07
NCT00330980 COMPLETED
Dyslipidemias
University of California, San Diego
 2000-04 PHASE4
NCT00053417 COMPLETED
Multiple Sclerosis
Acorda Therapeutics
 2003-02 PHASE2
NCT00292279 COMPLETED
Carcinoma Surgery; Parenteral Nutrition; Post-Operative Hospital Stay
Sino-Swed Pharmaceutical Corporation
 2002-06 PHASE3
NCT00274092 COMPLETED
Pulmonary Disease, Chronic Obstructive
Boehringer Ingelheim
 2002-09 PHASE3
NCT00002275 COMPLETED
HIV Infections
Abbott
NCT00002029 COMPLETED
HIV Infections
Abbott
NCT00336908 COMPLETED
Inflammation; Cardiac Surgical Procedures
University of Alberta
 2005-11 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2025-12-10)

Check the Fat Emulsion（20%） product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fat Emulsion (20%) inhibits the opening of the mitochondrial permeability transition pore, preventing the collapse of mitochondrial membrane potential and halting downstream necrotic cell death cascades. By preserving mitochondrial structural integrity and modulating innate immune cell responses, this lipid formulation limits ischemic tissue damage and attenuates systemic inflammatory responses associated with conditions such as cardiac surgical procedures and sepsis.

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.