Balance

3
Pipeline Programs
2
Companies
37
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
1
2
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

U
RAMELTEONApproved
ramelteon
Unknown Company
Melatonin Receptor Agonist [EPC]oral2020
Takeda
ROZEREMApproved
ramelteon
Takeda
Melatonin Receptor Agonist [EPC]oral2005

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
1 program
1
1
ROZEREM(Ramelteon)Phase 35 trials
Active Trials
NCT05414864Terminated5Est. Sep 2022
NCT01685151Withdrawn0Est. Nov 2015
NCT01467700Terminated490Est. Mar 2015
+2 more trials
Design Therapeutics
1 program
experimental foot deviceN/A1 trial
Active Trials
NCT03663816CompletedEst. Mar 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TakedaRamelteon
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TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon
TakedaRamelteon

Showing 15 of 37 trials with date data

Clinical Trials (37)

Total enrollment: 8,549 patients across 37 trials

Insomnia Prevalence and Treatment Impact on Systemic Hypertension

Start: May 2022Est. completion: Sep 20225 patients
Phase 4Terminated

Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Start: Feb 2008Est. completion: Dec 201032 patients
Phase 4Completed

Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

Start: Jan 2008Est. completion: Mar 201025 patients
Phase 4Completed

Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

Start: Nov 2007Est. completion: May 201090 patients
Phase 4Completed

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Start: Jul 2007Est. completion: Jul 201112 patients
Phase 4Completed

Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

Start: Apr 2007Est. completion: May 2008135 patients
Phase 4Completed

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

Start: Feb 2007Est. completion: Aug 2007110 patients
Phase 4Completed

Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

Start: Oct 2006Est. completion: Sep 2007552 patients
Phase 4Completed

Treating Chronic Insomnia in Breast Cancer Patients

Start: Aug 2006Est. completion: Jan 200916 patients
Phase 4Terminated

A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder

Start: Sep 2012Est. completion: Nov 20150
Phase 3Withdrawn

Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

Start: Dec 2011Est. completion: Mar 2015642 patients
Phase 3Terminated

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

Start: Dec 2011Est. completion: Mar 2015490 patients
Phase 3Terminated

Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

Start: Dec 2007Est. completion: Dec 201021 patients
Phase 3Terminated

Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia

Start: Aug 2007Est. completion: Mar 2008259 patients
Phase 3Completed

Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

Start: Jul 2006Est. completion: Mar 200927 patients
Phase 3Completed

Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia

Start: Jul 2005Est. completion: Oct 2006275 patients
Phase 3Completed

Efficacy of Ramelteon in Adults With Chronic Insomnia

Start: Feb 2005Est. completion: Aug 20051,081 patients
Phase 3Terminated

Efficacy of Ramelteon in Subjects With Chronic Insomnia

Start: Feb 2003Est. completion: Sep 20041,213 patients
Phase 3Completed

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

Start: Jan 2003Est. completion: Sep 2003405 patients
Phase 3Completed

Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

Start: Dec 2002Est. completion: May 2003289 patients
Phase 3Completed

Ramelteon in Adults With Chronic Insomnia

Start: Dec 2002Est. completion: Sep 2003848 patients
Phase 3Completed

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

Start: Dec 2002Est. completion: Jan 2004829 patients
Phase 3Completed

A Study of a Melatonin Receptor Agonist to Prevent Migraine

Start: Apr 2008Est. completion: Sep 201018 patients
Phase 2Terminated

Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

Start: Oct 2007Est. completion: May 2008132 patients
Phase 2Completed

Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia

Start: Jul 2006Est. completion: Mar 2007472 patients
Phase 2Completed

Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

Start: Mar 2006Est. completion: Aug 200774 patients
Phase 2Completed

Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea

Start: Jul 2003Est. completion: Dec 200326 patients
Phase 2Completed

Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse

Start: Jun 2003Est. completion: Dec 200314 patients
Phase 2Completed

Efficacy and Safety of Ramelteon on Chronic Insomnia

Start: May 2002Est. completion: Dec 200366 patients
Phase 2Completed

Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults

Start: Nov 2009Est. completion: Apr 201156 patients
Phase 1Completed

Effects of Ramelteon on Driving Ability

Start: Mar 2006Est. completion: Jul 200630 patients
Phase 1Completed
NCT03663816Design Therapeuticsexperimental foot device

Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking

Start: Oct 2018Est. completion: Mar 2019
N/ACompleted

Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -

Start: Mar 2011Est. completion: Jun 2014236 patients
N/ACompleted

Clinical Management of Neuropathic Pain With Ramelteon

Start: Sep 2008Est. completion: Dec 201123 patients
N/ATerminated

Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety

Start: Aug 2008Est. completion: Jul 201011 patients
N/ATerminated

Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Start: May 2008Est. completion: Mar 201024 patients
N/ACompleted

Ramelteon for a Nap Prior to a Night Shift

Start: Dec 2007Est. completion: Nov 200811 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
2 companies competing in this space