Active Ingredient History
Ramelteon was approved by the United States (U.S.) in July 2005, and the Japanese Ministry of Health, Labour and Welfare in April 2010. It is currently available in the USA and Japan as ROZEREM and is indicated for the treatment of insomnia characterized by difficulty with sleep onset. In October 7, 2011, Takeda has decided to discontinue the development of ramelteon in Europe for the treatment of insomnia in order to best optimize Takeda’s resources for its research and development activities. Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and selectivity over the MT3 receptor. Ramelteon demonstrates full agonist activity in vitro in cells expressing human MT1 or MT2 receptors, and high selectivity for human MT1 and MT2 receptors compared to the MT3 receptor. The activity of ramelteon at the MT1 and MT2 receptors is believed to contribute to its sleep-promoting properties since these receptors are acted upon by endogenous melatonin and are thought to be involved in the maintenance of the circadian rhythm underlying normal sleep-wake cycles. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine, and opiates. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Sleep Disorders, Intrinsic (approved 2005)
Acne Vulgaris (Phase 3)
Asthma (Phase 3)
Bipolar Disorder (Phase 4)
Brain Injuries (Phase 4)
Burns (Phase 2)
Chronobiology Disorders (Phase 4)
Cognition Disorders (Phase 2)
Cognitive Aging (Phase 4)
COVID-19 (Phase 2)
Delayed Emergence from Anesthesia (Phase 2)
Delirium (Phase 4)
Depression (Phase 3)
Depressive Disorder, Major (Phase 4)
Fibrosis (Phase 4)
Gastroesophageal Reflux (Phase 3)
Hypertension (Phase 4)
Lung Injury (Phase 2)
Marijuana Abuse (Phase 1/Phase 2)
Migraine Disorders (Phase 4)
Migraine with Aura (Phase 2)
Migraine without Aura (Phase 2)
Neurocognitive Disorders (Phase 2)
Parkinson Disease (Phase 4)
Psychotic Disorders (Phase 4)
Pulmonary Disease, Chronic Obstructive (Phase 4)
Quadriplegia (Phase 4)
REM Sleep Behavior Disorder (Phase 4)
Schizophrenia (Phase 4)
Seasonal Affective Disorder (Phase 4)
Sleep (Phase 2)
Sleep Apnea, Obstructive (Phase 3)
Sleep Deprivation (Phase 4)
Sleep Disorders, Circadian Rhythm (Phase 2)
Sleep Wake Disorders (Phase 4)
Spinal Cord Injuries (Phase 4)
Substance-Related Disorders (Phase 2)
Tobacco Use Disorder (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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