Drugs / Ramelteon
Ramelteon
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ROZEREM | — | 2008-10-20 | fda.gov ↗ |
| Approved | US (FDA) | ROZEREM | — | 2005-07-22 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 2005
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 missed | ||||||
| Phase 1 | NCT06890715 | Jun → Jul 2024 | insomnia | Overseas Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00914862 | Nov 2009 → Mar 2011 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00893269 | Oct 2008 → Oct 2010 | cannabis dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00319215 | Mar → Jul 2006 | insomnia | Utrecht Institute for Pharmaceutical Sciences | Completed | Missed primary |
| Phase 212 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT04470297 | Sep → Nov 2020 | COVID-19, lung disorder | Associação Fundo de Incentivo à Pesquisa | Unknown | No outcome recorded |
| Phase 2 | NCT02324153 | Mar 2017 → Jun 2019 | delirium | Johns Hopkins University | Completed | Missed primary |
| Phase 2 | NCT02560324 | Sep 2015 → Aug 2018 | nicotine dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00593736 | Oct 2007 → May 2008 | circadian rhythm sleep disorder, delayed sleep phase type | Takeda | Completed | Missed primary |
| Phase 2 | NCT00755495 | Jul 2006 → Mar 2007 | sleep disorder, initiating and maintaining sleep | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00325728 | Mar 2006 → Aug 2007 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00755508 | Nov 2005 → Sep 2006 | sleep disorder, initiating and maintaining sleep | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00671190 | Mar → May 2005 | sleep disorder | Takeda | Completed | Met primary |
| Phase 2 | NCT00672802 | Aug 2003 → Mar 2004 | chronic obstructive pulmonary disease | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00672061 | Jul → Dec 2003 | obstructive sleep apnea syndrome | Takeda | Completed | Missed primary |
| Phase 2 | NCT00671632 | Jun → Dec 2003 | substance abuse | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00915135 | May 2002 → Dec 2003 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 319 trials · 5 met primary · 4 missed | ||||||
| Phase 3 | NCT06512363 | Aug 2024 → Dec 2026 expected | insomnia | Nanjing Chia-tai Tianqing Pharmaceutical | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01685151 | Sep 2012 → Nov 2015 | bipolar disorder | Takeda | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT01677182 | Aug 2012 → Aug 2014 | bipolar disorder | Takeda | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT01467713 | Dec 2011 → Mar 2015 | bipolar I disorder | Takeda | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT01467700 | Dec 2011 → Mar 2015 | bipolar depression | Takeda | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT00869167 | Mar 2008 → Jun 2009 | asthma, insomnia | Northwestern University | Terminated | No outcome recorded |
| Phase 3 | NCT00756002 | Aug 2007 → Mar 2008 | sleep disorder, initiating and maintaining sleep | Takeda | Completed | Met primary |
| Phase 3 | NCT00642694 | May 2007 → May 2010 | insomnia, major depressive disorder | University of Texas Southwestern Medical Center | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT01048242 | Jul 2006 → Mar 2009 | insomnia, obstructive sleep apnea syndrome | University of Pennsylvania | Completed | No outcome recorded |
| Phase 3 | NCT00237497 | Jul 2005 → Oct 2006 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00247390 | Jul 2005 → Dec 2006 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00672724 | Feb → Aug 2005 | insomnia | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00671086 | Feb 2003 → Sep 2004 | sleep disorder, initiating and maintaining sleep | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00671125 | Jan → Sep 2003 | insomnia | Takeda | Completed | Met primary |
| Phase 3 | NCT00656994 | Jan 2003 → Jul 2004 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00671255 | Dec 2002 → Jan 2004 | insomnia | Takeda | Completed | Met primary |
| Phase 3 | NCT00671567 | Dec 2002 → Sep 2003 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00671398 | Dec 2002 → May 2003 | insomnia | Takeda | Completed | Met primary |
| Phase 3 | NCT00671294 | Oct 2002 → Jul 2003 | insomnia | Takeda | Completed | Met primary |
| Phase 424 trials · 4 missed | ||||||
| Phase 4 | NCT07598734 | Jun 2026 → Jun 2028 expected | — | University of Washington | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07382843 | Mar 2024 → Dec 2025 | circadian rhythm sleep disorder | Tri-Service General Hospital (TSGH) | Completed | No outcome recorded |
| Phase 4 | NCT05069428 | Mar 2023 → Mar 2025 overdue | delirium | Centennial Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05414864 | May → Jul 2022 | hypertensive disorder, insomnia | University of Sao Paulo | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03165695 | Dec 2019 | delirium | Brigham and Women's Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03931070 | May 2019 → Feb 2022 | delirium | Rhode Island Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03461042 | Feb 2018 → Jul 2019 | insomnia | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 4 | NCT02669082 | May 2017 → Jan 2018 | insomnia, major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03075657 | May 2017 → Jun 2018 | schizophrenia | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT03091738 | Feb 2017 → Oct 2018 | cirrhosis of liver | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 4 | NCT02840591 | Jul 2016 → Nov 2017 | delirium | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01207050 | Sep 2010 → Dec 2014 | insomnia, traumatic brain injury | Kessler Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT00622427 | Feb 2008 → Feb 2010 | attention deficit-hyperactivity disorder 8 | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT00595504 | Jan 2008 → Mar 2010 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00552760 | Nov 2007 → Mar 2010 | bipolar disorder | Lehigh Valley Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00576927 | Oct 2007 → Feb 2010 | — | Emory University | Completed | Missed primary |
| Phase 4 | NCT00507546 | Jul 2007 → Dec 2010 | insomnia, quadriplegia, spinal cord injury | US Department of Veterans Affairs | Completed | Missed primary |
| Phase 4 | NCT00462254 | Jun 2007 → Jun 2008 | Parkinson disease | Southern California Institute for Research and Education | Terminated | No outcome recorded |
| Phase 4 | NCT00492232 | Apr 2007 → Mar 2008 | insomnia | Takeda | Completed | Missed primary |
| Phase 4 | NCT00492011 | Feb → Aug 2007 | circadian rhythm sleep disorder, jet lag type | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00414102 | Oct 2006 → Sep 2007 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00502320 | Sep 2006 → Apr 2008 | seasonal affective disorder | Lehigh Valley Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00568789 | Jun → Sep 2006 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00316992 | Apr → Nov 2006 | chronic obstructive pulmonary disease | Takeda | Completed | Missed primary |
| Phase not applicable3 trials | ||||||
| — | NCT00811746 | Dec 2008 → Sep 2010 | obstructive sleep apnea syndrome | Southern California Institute for Research and Education | Completed | No outcome recorded |
| — | NCT00745030 | Jun 2008 → Dec 2009 | REM sleep behavior disorder, parkinsonian disorder | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00595075 | Dec 2007 → Nov 2008 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 2 | NCT00539110 Comparator | Dec 2009 → Dec 2012 | — | Shriners Hospitals for Children | Completed | No outcome recorded |
| Phase 2 | NCT00739024 Comparator | Apr 2008 → Apr 2009 | migraine with aura, migraine without aura | Swedish Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01128582 Comparator | Mar 2009 → Dec 2011 | gastroesophageal reflux disease, insomnia | Southern Arizona VA Health Care System | Unknown | No outcome recorded |
| Phase 3 | NCT00585208 Comparator | Dec 2007 → Sep 2010 | bipolar disorder, insomnia | Lindner Center of HOPE | Terminated | No outcome recorded |
| Phase 4 | NCT03265951 Comparator | Jan 2018 → Sep 2019 | insomnia | State University of New York at Buffalo | Withdrawn | No outcome recorded |
| Phase 4 | NCT02564939 Comparator | Feb 2017 → Dec 2018 | delirium | Hartford Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01401413 Comparator | Jan 2008 → Sep 2010 | REM sleep behavior disorder | Sleep Medicine Centers of WNY | Completed | No outcome recorded |
| Phase 4 | NCT01180855 Comparator | Aug 2007 → Sep 2010 | insomnia | University of Arizona | Unknown | No outcome recorded |
| Phase 4 | NCT02156271 Comparator | Jul 2007 → Jun 2008 | insomnia | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00391755 Comparator | Oct 2006 → Oct 2009 | migraine disorder | Charlottesville Neuroscience | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00337272 Comparator | Aug 2006 → Aug 2008 | insomnia | Accelerated Community Oncology Research Network | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02691013 Comparator | Feb 2016 → Dec 2017 | delirium | University of California, San Diego | Unknown | No outcome recorded |
| — | NCT00907595 Comparator | May 2009 → Mar 2010 | Huntington disease, Lewy body dementia, Parkinson disease, circadian rhythm sleep disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00753623 Comparator | Sep 2008 → Dec 2010 | neuropathy, painful | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00746239 Comparator | Aug 2008 → Jul 2010 | insomnia, panic disorder | Milton S. Hershey Medical Center | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-07-24 | Zydus Lifesciences Limited | Regulatory Zydus has launched Ramelteon Tablets in the US upon receiving final approval from the USFDA zyduslife.com ↗
Zydus Cadila announced the Day – 1 launch of Ramelteon Tablets (US RLD – Rozerem Tablets), 8 mg upon receiving the final approval from the USFDA. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-29 | Xiromed LLC | Xiromed LLC Launches Ramelteon Tablets xiromed.com ↗ |
| 2020-12-15 | Upsher-Smith Laboratories | Upsher-Smith Launches Ramelteon Tablets upsher-smith.com ↗ |
| 2019-07-24 | Zydus Lifesciences Limited | Zydus has launched Ramelteon Tablets in the US upon receiving final approval from the USFDA zyduslife.com ↗ |
| 2014-09-05 | Takeda | Meiji and Takeda Announce Co-Promotion Agreement for "ROZEREM ® " For the Treatment of Insomnia in Japan takeda.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 79 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ramelteon | “Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease” NCT00462254 ↗75“ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans” NCT01180855 ↗ “Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG” NCT00811746 ↗ “Ramelteon” NCT01048242 ↗ |
| Known as | Ramelteon SL | “Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.” NCT01467713 ↗ |
| Known as | Remeron | “medication called ramelteon (Brand Name: Remeron)” NCT02560324 ↗ |
| Known as | Rozerem | “using Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Ramelteon Tablets (trade name: Rozerem®,...” NCT06890715 ↗8“Ramelteon is under global development by Takeda Pharmaceuticals as a nonscheduled sleep agent for the treatment of difficulty with sleep initiation, and is marketed under the...” NCT00756002 ↗ “Ramelteon (Rozerem; Takeda Pharmaceutical Company Limited, Osaka, Japan) is an orally active, highly selective melatonin MT(1)/MT(2) receptor agonist.” PMID 19228178 ↗ 2009 “Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease” NCT00462254 ↗ “ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans” NCT01180855 ↗ “Rozerem” NCT00915135 ↗ |
| Known as | Rozerem (Ramelteon) | “Rozerem (Ramelteon)” NCT00642694 ↗ |
| Known as | RozeremR | “Ramelteon (RozeremR)” NCT05414864 ↗ |
| Known as | TAK-375 | “Ramelteon (TAK-375), approved by the Food and Drug Administration for the treatment of insomnia with sleep onset abnormalities” NCT03265951 ↗2“ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans” NCT01180855 ↗ “TAK-375” NCT00915135 ↗ |
| Action | Activate | “ramelteon, a selective MT1/MT2 melatonin-receptor agonist used for insomnia treatment.” PMID 19294955 ↗ Mar 2009 |
| Route | Oral | “Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.” NCT00237497 ↗ |