Active Ingredient History
Melatonin (5-methoxy N-acetyltryptamine) is a hormone synthesized and released from the pineal gland at night, which acts on specific high affinity G-protein coupled receptors to regulate various aspects of physiology and behaviour, including circadian and seasonal responses, and some retinal, cardiovascular and immunological functions. Melatonin is also made synthetically and available without a prescription as an over-the-counter (OTC) dietary supplement in the U.S. Melatonin supplementation has many uses, however, it has been widely studied for treatment of jet lag and sleep disorders. Parents may consider using melatonin to help their child who has a trouble falling asleep. A medical professional should always evaluate insomnia or other sleeping disorders in children. Additionally, melatonin has been shown to protect against oxidative stress in various, highly divergent experimental systems. There are many reasons for its remarkable protective potential. In mammals, melatonin binds to a number of receptor subtypes including high-affinity (MT1 and MT2) and low-affinity (MT3, nuclear orphan receptors) binding sites, which are distributed throughout the central nervous system and periphery. NCATS
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Abdominal Pain (Phase 1)
Acute Coronary Syndrome (Phase 2/Phase 3)
Acute Febrile Encephalopathy (Phase 1)
Acute Kidney Injury (Phase 3)
Air Travel (Phase 2/Phase 3)
Alcohol-Related Disorders (Phase 2)
Altitude Sickness (Early Phase 1)
Alveolar Bone Loss (Phase 3)
Alzheimer Disease (Phase 3)
Analgesia (Phase 2/Phase 3)
Anesthesia (Phase 4)
Anxiety (Phase 4)
Anxiety Disorders (Phase 3)
Aortic Aneurysm (Phase 2/Phase 3)
Arthritis, Rheumatoid (Phase 1)
Arthroplasty (Phase 4)
Asphyxia (Phase 1/Phase 2)
Atrial Fibrillation (Phase 2)
Autism Spectrum Disorder (Phase 3)
Autistic Disorder (Phase 1)
Autoimmune Diseases (Phase 1/Phase 2)
Autoimmune Diseases of the Nervous System (Phase 1/Phase 2)
Autonomic Nervous System Diseases (Early Phase 1)
Bariatric Surgery (Phase 4)
Barrett Esophagus (Phase 3)
Benzodiazepines (Phase 3)
Binge-Eating Disorder (Phase 1/Phase 2)
Biological Availability (Phase 2)
Bipolar Disorder (Phase 4)
Blindness (Phase 2)
Blood Glucose (Phase 3)
Blood Pressure (Phase 3)
Bone Diseases, Metabolic (Phase 1)
Brain Concussion (Phase 2/Phase 3)
Brain Injuries (Phase 2)
Brain Injuries, Traumatic (Phase 4)
Breast Neoplasms (Phase 3)
Burns (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 3)
Carotid Stenosis (Phase 4)
Cesarean Section (Phase 1/Phase 2)
Child (Phase 3)
Chromosome Deletion (Phase 1)
Chronic Periodontitis (Phase 2)
Chronobiology Disorders (Phase 1/Phase 2)
Cognition Disorders (Phase 2)
Cognitive Aging (Phase 2)
Colitis, Ulcerative (Phase 2)
Colostomy (Phase 2)
Conscious Sedation (Phase 3)
Coronavirus Infections (Phase 2/Phase 3)
COVID-19 (Phase 2/Phase 3)
Critical Illness (Phase 4)
Delirium (Phase 4)
Dementia (Phase 4)
Dengue Virus (Phase 2)
Dental Implantation (Phase 4)
Dentofacial Deformities (Phase 2)
Depression (Phase 4)
Depressive Disorder, Major (Phase 2)
Dermatitis, Atopic (Phase 2/Phase 3)
Dermatology (Phase 1)
Developmental Disabilities (Phase 3)
Diabetes Mellitus (Phase 4)
Diabetes Mellitus, Type 1 (Early Phase 1)
Diabetes Mellitus, Type 2 (Phase 2)
Diabetic Retinopathy (Phase 3)
Dialysis (Phase 3)
DNA Repair-Deficiency Disorders (Phase 4)
Dysmenorrhea (Phase 2)
Dyspepsia (Phase 1)
Dyssomnias (Phase 3)
Electroencephalography (Phase 3)
Emergence Delirium (Phase 4)
Endometriosis (Phase 2)
Endotoxemia (Phase 4)
Enterocolitis, Necrotizing (Phase 4)
Epilepsy (Phase 3)
Epilepsy, Generalized (Phase 4)
Essential Hypertension (Phase 2)
Fatigue (Phase 2/Phase 3)
Fatigue Syndrome, Chronic (Phase 4)
Feeding and Eating Disorders (Phase 4)
Fertilization in Vitro (Phase 2/Phase 3)
Fetal Growth Retardation (Phase 4)
Fibromyalgia (Phase 2/Phase 3)
Gastroesophageal Reflux (Phase 3)
Gastrointestinal Neoplasms (Phase 3)
General Surgery (Early Phase 1)
Glucose Metabolism Disorders (Phase 1/Phase 2)
Head and Neck Neoplasms (Phase 2)
Healthy Volunteers (Phase 4)
Heart (Phase 1)
Heart Arrest (Phase 4)
Heart Failure (Phase 2)
Heart Failure, Systolic (Phase 2)
Hematoma (Phase 1)
Hemodialysis, Home (Phase 3)
Herpes Genitalis (Phase 4)
Hot Flashes (Phase 1/Phase 2)
Hypertension (Phase 2)
Hypotension, Orthostatic (Early Phase 1)
Hypoxia-Ischemia, Brain (Early Phase 1)
Infant, Premature (Phase 4)
Infant, Premature, Diseases (Phase 1)
Infertility (Phase 4)
Inflammation (Phase 3)
Insulin Resistance (Phase 1)
Intellectual Disability (Phase 1)
Irritable Bowel Syndrome (Phase 3)
Ischemia (Early Phase 1)
Ischemic Stroke (Phase 4)
Jet Lag Syndrome (Phase 2)
Keratosis, Actinic (Phase 2)
Kidney Failure, Chronic (Phase 2/Phase 3)
Lennox Gastaut Syndrome (Phase 4)
Leukemia, Lymphoid (Phase 1)
Liver Diseases (Phase 4)
Liver Transplantation (Phase 3)
Lung Neoplasms (Phase 3)
Lymphoma (Phase 2)
Matrix Metalloproteinases (Phase 4)
Melanoma (Phase 3)
Melatonin (Phase 4)
Menopause (Phase 2/Phase 3)
Mental Disorders (Phase 2/Phase 3)
Mental Health (Phase 3)
Metabolic Diseases (Phase 1)
Metabolic Syndrome (Phase 2)
Migraine Disorders (Phase 3)
Motor Activity (Early Phase 1)
Mucositis (Phase 2)
Multiple Sclerosis (Phase 1/Phase 2)
Multiple Sclerosis, Relapsing-Remitting (Phase 2)
Myocardial Infarction (Phase 2)
Myocardial Ischemia (Phase 2)
Narcotics (Phase 2)
Neoadjuvant Therapy (Phase 3)
Neonatal Sepsis (Phase 1/Phase 2)
Neoplasms (Phase 3)
Nervous System Diseases (Phase 1/Phase 2)
Neurodevelopmental Disorders (Phase 3)
Nocturia (Phase 2)
Nocturnal Enuresis (Phase 2)
Obesity (Phase 3)
Optic Nerve Hypoplasia (Early Phase 1)
Orthognathic Surgery (Phase 2/Phase 3)
Orthopedic Procedures (Phase 3)
Orthostatic Intolerance (Phase 1/Phase 2)
Osteoporosis (Phase 1)
Osteoporosis, Postmenopausal (Phase 4)
Ovarian Diseases (Phase 2/Phase 3)
Oxidative Stress (Phase 4)
Pain (Phase 4)
Pain, Postoperative (Phase 4)
Parkinson Disease (Phase 4)
Periodontal Diseases (Phase 4)
Periodontitis (Phase 4)
Peritoneal Dialysis (Phase 3)
Pharmacokinetics (Phase 1/Phase 2)
Pinealoma (Early Phase 1)
Polycystic Ovary Syndrome (Phase 4)
Post-Concussion Syndrome (Phase 2/Phase 3)
Postoperative Complications (Phase 2/Phase 3)
Posture (Phase 4)
Prediabetic State (Phase 3)
Pregnancy Complications (Phase 3)
Premature Birth (Phase 2/Phase 3)
Premedication (Phase 4)
Prognathism (Phase 2/Phase 3)
Psychophysiologic Disorders (Phase 3)
Psychotic Disorders (Phase 4)
Quality of Life (Phase 1/Phase 2)
Radiodermatitis (Phase 2)
REM Sleep Behavior Disorder (Phase 4)
Renal Dialysis (Phase 3)
Renal Insufficiency, Chronic (Phase 2/Phase 3)
Reperfusion Injury (Phase 2)
Retrognathia (Phase 2/Phase 3)
Safety (Phase 1)
Schizophrenia (Phase 4)
Seizures, Febrile (Phase 4)
Self-Injurious Behavior (Phase 1)
Sepsis (Phase 3)
Shock, Septic (Phase 4)
Sleep (Phase 2/Phase 3)
Sleep Apnea, Obstructive (Early Phase 1)
Sleep Deprivation (Phase 3)
Sleep Disorders, Circadian Rhythm (Phase 4)
Sleep Disorders, Intrinsic (Phase 4)
Sleep Quality (Phase 4)
Sleep Wake Disorders (Phase 4)
Smoking (Phase 4)
Somatosensory Disorders (Phase 2/Phase 3)
Spinal Cord Injuries (Phase 1)
Squamous Cell Carcinoma of Head and Neck (Phase 3)
Stillbirth (Phase 3)
Stomatitis (Phase 1/Phase 2)
Stroke (Phase 4)
Substance Withdrawal Syndrome (Phase 1/Phase 2)
Sunburn (Phase 1)
Tachycardia (Phase 1/Phase 2)
Thrombotic Stroke (Phase 4)
Tooth Abnormalities (Phase 3)
Vascular Calcification (Phase 4)
Vascular System Injuries (Phase 4)
Ventilation (Phase 4)
Wound Healing (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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