CLINICAL TRIALS PROFILE FOR RAMELTEON

505(b)(2) Clinical Trials for ramelteon

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02840591 ↗	Ramelteon and Citicoline for Delirium	Withdrawn	University of Texas Southwestern Medical Center	Phase 4	2016-07-01	Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.

All Clinical Trials for ramelteon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00237497 ↗	Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia	Completed	Takeda	Phase 3	2005-07-01	The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
NCT00247390 ↗	Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.	Completed	Takeda	Phase 3	2005-07-01	The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
NCT00316992 ↗	Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease	Completed	Takeda	Phase 4	2006-04-01	The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
NCT00319215 ↗	Effects of Ramelteon on Driving Ability	Completed	Takeda	Phase 1	2006-03-01	The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
NCT00319215 ↗	Effects of Ramelteon on Driving Ability	Completed	Utrecht Institute for Pharmaceutical Sciences	Phase 1	2006-03-01	The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
NCT00325728 ↗	Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease	Completed	Takeda	Phase 2	2006-03-21	The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance
NCT00337272 ↗	Treating Chronic Insomnia in Breast Cancer Patients	Terminated	Takeda Pharmaceuticals North America, Inc.	Phase 4	2006-08-01	This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Clinical Trial Conditions for ramelteon

Condition Name

Condition Name for ramelteon
Intervention	Trials
Insomnia	20
Chronic Insomnia	13
Delirium	6
Bipolar Disorder	5

Condition MeSH

Condition MeSH for ramelteon
Intervention	Trials
Sleep Initiation and Maintenance Disorders	40
Disease	13
Delirium	7
Parasomnias	6

Clinical Trial Locations for ramelteon

Trials by Country

Trials by Country for ramelteon
Location	Trials
United States	453
Mexico	11
Japan	10
Canada	7
Russian Federation	5

Trials by US State

Trials by US State for ramelteon
Location	Trials
California	25
Florida	22
Ohio	22
New York	19
Pennsylvania	18

Clinical Trial Progress for ramelteon

Clinical Trial Phase

Clinical Trial Phase for ramelteon
Clinical Trial Phase	Trials
Phase 4	30
Phase 3	22
Phase 2	15

Clinical Trial Status

Clinical Trial Status for ramelteon
Clinical Trial Phase	Trials
Completed	48
Terminated	14
Unknown status	6

Clinical Trial Sponsors for ramelteon

Sponsor Name

Sponsor Name for ramelteon
Sponsor	Trials
Takeda	45
Takeda Pharmaceuticals North America, Inc.	6
National Institute on Drug Abuse (NIDA)	3

Sponsor Type

Sponsor Type for ramelteon
Sponsor	Trials
Industry	53
Other	53
NIH	7

Ramelteon Market Analysis and Financial Projection

Ramelteon: Clinical Trials, Market Analysis, and Projections

Introduction to Ramelteon

Ramelteon, a melatonin receptor agonist, is primarily used for the treatment of insomnia, particularly in individuals who have difficulty falling asleep. It mimics the action of melatonin, a hormone that regulates the sleep-wake cycle, without the addictive potential associated with many traditional sleep aids.

Clinical Trials and Efficacy

Prevention of Delirium

Several clinical trials have investigated the efficacy of ramelteon in preventing delirium, especially in elderly patients and those in intensive care units (ICUs).

• A multicenter, rater-blinded, randomized placebo-controlled trial found that ramelteon significantly reduced the risk of delirium in elderly patients admitted for acute care. The study showed a lower incidence of delirium in the ramelteon group (3%) compared to the placebo group (32%)[1].
• Another study conducted in ICUs demonstrated that ramelteon reduced the occurrence and duration of delirium. The ramelteon group had a lower incidence of delirium (24.4% vs 46.5%) and shorter duration of delirium (0.78 days vs 1.4 days) compared to the placebo group[3].

Postoperative Delirium

Clinical trials in Japan have shown promising results for ramelteon in preventing postoperative delirium in cancer patients.

• A phase II study in Japan found that ramelteon was effective in preventing delirium after gastrectomy in gastric cancer patients aged 75 years and older. This study suggested the feasibility of a phase III trial to further evaluate its efficacy and safety[4].
• However, studies in the USA have reported conflicting results, highlighting the need for more comprehensive trials to establish ramelteon's efficacy in different populations[4].

ICU Length of Stay

A single-center, randomized, triple-blind, placebo-controlled trial examined the effect of ramelteon on the duration of ICU stay. The study found that patients receiving ramelteon had a shorter ICU length of stay (4.56 days vs 5.86 days) compared to those receiving a placebo, although the difference was not statistically significant without multivariate analysis[3].

Market Analysis

Current Market Outlook

The global market for insomnia medications, including ramelteon, is projected to grow significantly.

• The market size for insomnia medications is expected to reach approximately $6 billion by 2025, with a compound annual growth rate (CAGR) of over 7%[5].
• Ramelteon's market is driven by increasing awareness of sleep disorders, rising stress levels, changing lifestyles, and the impact of technology on sleep quality. Healthcare systems' emphasis on non-benzodiazepine sleep solutions also contributes to its growing demand[5].

Market Segmentation

The ramelteon market is segmented by types and regions:

• Types: Ramelteon is available under the brand name Rozerem and as generic formulations. The market is further segmented into hospital and retail pharmacy markets, reflecting its versatility in addressing both clinical and consumer needs[5].
• Regions: The market is analyzed across North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Key players operate in these regions, with significant presence in countries like the United States, Japan, and India[5].

Key Players

• Takeda Pharmaceuticals: Originally founded in 1781 in Japan, Takeda has a strong global presence and markets ramelteon under the brand name Rozerem. The company has invested significantly in research and development and has a diverse portfolio that includes sleep disorder treatments[5].
• Dr. Reddy's Laboratories: Founded in 1984 in India, Dr. Reddy's is a global healthcare company that produces generics and proprietary medications. The company has entered the ramelteon market with its generic formulations, capitalizing on the growing demand for cost-effective alternatives[5].

Market Projections

Growth Trends

The ramelteon market is expected to experience robust growth driven by several factors:

• Increasing Awareness: Growing awareness of sleep disorders and the importance of sleep health is driving demand for effective sleep aids like ramelteon[5].
• Expanding Distribution Channels: Potential expansions in distribution channels and the introduction of new formulations are expected to enhance market access and patient adherence[5].
• Innovation: The pharmaceutical sector's focus on innovation, particularly in non-benzodiazepine sleep solutions, is projected to further boost the market for ramelteon[5].

Regional Growth

The market is expected to grow across various regions, with Asia-Pacific, particularly Japan, playing a significant role due to the drug's approval and established efficacy in preventing delirium and treating insomnia.

• The CAGR for the ramelteon market is projected to be around 35.10% during the forecast period from 2025 to 2031, reflecting strong demand and innovation in the sector[5].

Key Takeaways

• Ramelteon has shown significant efficacy in preventing delirium in elderly patients and those in ICUs.
• Clinical trials in Japan have demonstrated its effectiveness in preventing postoperative delirium in cancer patients.
• The global market for ramelteon is projected to grow substantially, driven by increasing awareness of sleep disorders and the need for non-benzodiazepine sleep solutions.
• Key players like Takeda Pharmaceuticals and Dr. Reddy's Laboratories are well-positioned to capture a larger share of the market.

FAQs

Q1: What is ramelteon primarily used for?

Ramelteon is primarily used for the treatment of insomnia, particularly for individuals who have difficulty falling asleep.

Q2: How does ramelteon prevent delirium?

Ramelteon, as a melatonin receptor agonist, helps regulate the sleep-wake cycle, which is crucial in preventing delirium, especially in elderly patients and those in ICUs.

Q3: What are the key findings from clinical trials on ramelteon?

Clinical trials have shown that ramelteon significantly reduces the risk of delirium in elderly patients and those in ICUs. It also reduces the occurrence and duration of delirium in postoperative settings.

Q4: Who are the key players in the ramelteon market?

The key players in the ramelteon market include Takeda Pharmaceuticals, which markets ramelteon under the brand name Rozerem, and Dr. Reddy's Laboratories, which offers generic formulations.

Q5: What is the projected growth rate for the ramelteon market?

The ramelteon market is expected to grow at a CAGR of around 35.10% during the forecast period from 2025 to 2031.

Sources

1. Hatta, K., et al. "Preventive Effects of Ramelteon on Delirium: A Randomized, Placebo-Controlled Trial in Patients with Acute Care." JAMA Psychiatry, vol. 71, no. 4, 2014, pp. 397-403.
2. Cognitive Market Research. "Ramelteon Market Report 2024 (Global Edition)." Cognitive Market Research, 2022.
3. Society of Critical Care Medicine. "The Effect of Ramelteon Administration on the Duration of ICU Stay." SCCM Blog, 2018.
4. Ozaki, A., et al. "A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of Oral Ramelteon for Postoperative Delirium Prevention in Elderly Cancer Patients." Japanese Journal of Clinical Oncology, vol. 53, no. 9, 2023, pp. 851-858.
5. OpenPR. "Ramelteon Market Share & Market Analysis - Growth Trends & Forecasts for period from (2024 - 2031)." OpenPR, 2024.