Drugs / Trazodone
Trazodone
also known as
trazodone hydrochloride · Desyrel · Trazodone HCl · AF-1161 · Beneficat · Deprax · J10.767K · Molipaxin · +13 more
Small molecule targets HTR2A, HTR2C, SLC6A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DESYREL | — | 1986-09-02 – 1988-11-07 | fda.gov ↗ |
| Approved | US (FDA) | DESYREL | — | 1981-12-24 | fda.gov ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02699138 | Oct 2021 → Dec 2022 | obstructive sleep apnea syndrome, post-traumatic stress disorder | University of California, San Diego | Withdrawn | No outcome recorded |
| Phase 18 trials | ||||||
| Phase 1 | NCT05299398 | Apr → Aug 2025 | postpartum depression | Verinder Sharma | Withdrawn | No outcome recorded |
| Phase 1 | NCT06773767 | May → Aug 2024 | — | Angelini Pharma | Completed | No outcome recorded |
| Phase 1 | NCT05136521 | Feb → Jul 2020 | — | Angelini Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02785601 | May → Nov 2017 | depressive disorder | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 1 | NCT02785614 | May → Nov 2017 | depressive disorder | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 1 | NCT03516630 | Mar → May 2017 | — | Angelini Pharma | Completed | Mixed |
| Phase 1 | NCT00839072 | Feb 2009 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00270959 | Jun 2006 → Sep 2010 | post-traumatic stress disorder | University of Washington | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06286189 | Jan 2024 → Jan 2026 overdue | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01857596 | Apr 2013 → Oct 2014 | hypoactive sexual desire disorder | S1 Biopharma, Inc. | Completed | No outcome recorded |
| Phase 27 trials · 3 missed | ||||||
| Phase 2 | NCT07210112 | Jun 2026 → Dec 2029 expected | major depressive disorder | Centre Hospitalier St Anne | Recruiting | No outcome recorded |
| Phase 2 | NCT06983080 | Nov 2025 → Jul 2027 expected | insomnia | University of Montreal Hospital Centre (CHUM) | Recruiting | No outcome recorded |
| Phase 2 | NCT06517797 | Oct 2025 → Jun 2027 expected | obesity disorder | S1 Biopharma, Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04082806 | Aug 2020 → Apr 2022 | major depressive disorder | Erich Seifritz | Completed | No outcome recorded |
| Phase 2 | NCT03749642 | Nov 2018 → Jun 2020 | diabetic polyneuropathy | Angelini Pharma | Completed | Missed primary |
| Phase 2 | NCT03202979 | May 2017 → Aug 2018 | diabetic polyneuropathy | Angelini Pharma | Completed | Missed primary |
| Phase 2 | NCT00027053 | Jun 2002 → Jan 2006 | alcohol dependence | Rhode Island Hospital | Completed | Missed primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT04302870 | Feb 2020 → Dec 2030 expected | amyotrophic lateral sclerosis | University of Edinburgh | Recruiting | Missed primary |
| Phase 35 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02086929 | Dec 2012 → Apr 2014 | major depressive disorder | Angelini Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01142258 | Mar 2010 → Apr 2012 | Alzheimer disease, insomnia | Brasilia University Hospital | Completed | Met primary |
| Phase 3 | NCT00775203 | Jun → Nov 2007 | major depressive disorder | Labopharm Inc. | Completed | Met primary |
| Phase 3 | NCT00000179 | — | Alzheimer disease | National Institute on Aging (NIA) | Completed | Missed primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT05085808 | Mar 2028 → Jul 2029 | delirium | University of Southern California | Withdrawn | No outcome recorded |
| Phase 4 | NCT07542756 | May 2026 → Jan 2032 expected | insomnia | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 4 | NCT06740188 | Jan 2025 → Dec 2026 expected | — | Tongji University | Recruiting | No outcome recorded |
| Phase 4 | NCT06295562 | Nov 2024 → Oct 2025 | obstructive sleep apnea syndrome | China Medical University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04468776 | Feb 2022 → Jun 2024 | insomnia | California Pacific Medical Center Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT03522207 | Oct 2018 → Jan 2020 | bruxism, chronic pain syndrome, temporomandibular joint dysfunction syndrome | University of Montreal Hospital Centre (CHUM) | Terminated | No outcome recorded |
| Phase 4 | NCT02922894 | Jun 2017 → Dec 2026 expected | sleep apnea syndrome, spinal cord injury | John D. Dingell VA Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT00791739 | Apr 2008 → Jul 2009 | fibromyalgia | University of Granada | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01097980 | Apr 2010 → Jan 2012 | post-selective serotonin reuptake inhibitor sexual dysfunction | Beitou Armed Forces Hospital, Taipei, Taiwan | Completed | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 0 | NCT06546358 Comparator | Sep 2024 → Sep 2025 overdue | postpartum depression | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06281756 Comparator | Mar 2024 → Nov 2027 expected | hypertensive disorder, insomnia | Milton S. Hershey Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT02945644 Comparator | Feb 2017 → Sep 2020 | obstructive sleep apnea syndrome | Louis Stokes VA Medical Center | Suspended | No outcome recorded |
| Phase 1 | NCT01400165 Comparator | Jul → Dec 2011 | — | University of Ottawa | Unknown | No outcome recorded |
| Phase 1 | NCT01347541 Background | Jan → Nov 2011 | post-traumatic stress disorder | University of Washington | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01121900 Comparator | Jun → Jul 2008 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01121926 Comparator | Jan → Mar 2008 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01121913 Comparator | Mar → Apr 2005 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05293600 Comparator | Jul 2023 → Oct 2026 expected | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05282550 Comparator | Feb 2023 → Jul 2027 expected | cognitive impairment with or without cerebellar ataxia, sleep disorder | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT02458469 Comparator | May 2015 → Apr 2019 | sleep apnea syndrome, spinal cord injury | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2/3 | NCT01524497 Comparator | Nov 2011 → Aug 2013 | depressive disorder | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 3 | NCT03668041 Comparator | Feb 2021 → Mar 2026 | insomnia | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT03534284 Comparator | Sep 2018 → Oct 2022 | end stage renal failure, insomnia | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT01468038 Comparator | Apr → Oct 2008 | sleep disorder | Targeted Medical Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00253890 Comparator | Oct 2005 → May 2010 | opiate dependence | Butler Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07210606 Comparator | Oct 2026 → Jun 2030 expected | central sleep apnea syndrome | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07136415 Comparator | Feb 2026 → Feb 2031 expected | insomnia | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05209035 Comparator | May 2022 → May 2025 overdue | cognitive impairment with or without cerebellar ataxia, obstructive sleep apnea syndrome | Chinese University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04162743 Comparator | Feb 2019 → Mar 2020 | cerebral infarction, obstructive sleep apnea syndrome | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01662297 Comparator | Jul 2012 → Oct 2015 | insomnia, mental disorder, substance-related disorder | VA Connecticut Healthcare System | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01764867 Comparator | Jun 2012 → Oct 2014 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT02118688 Comparator | Mar 2011 → Mar 2016 | delirium | Rochester General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00659919 Comparator | Nov 2000 → Dec 2003 | schizophrenia | BeerYaakov Mental Health Center | Completed | No outcome recorded |
| — | NCT05125146 Comparator | Nov 2021 → May 2025 overdue | insomnia | Dr. Nazanin Alavi | Recruiting | No outcome recorded |
| — | NCT02655354 Background | Oct 2015 → Nov 2019 | alcohol-related disorders, brain injury, cognitive impairment with or without cerebellar ataxia, depressive disorder +1 | University of Washington | Completed | No outcome recorded |
| — | NCT01943435 Comparator | Nov 2013 → Jun 2016 | lumbar spinal stenosis | Michael Schneider, DC, PhD | Completed | No outcome recorded |
| — | NCT01896349 Background | Apr 2013 → Aug 2014 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT01817907 Comparator | Mar 2013 → Apr 2014 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| — | NCT01651442 Comparator | Aug 2012 → Mar 2017 | insomnia | Jack Edinger, PhD | Completed | No outcome recorded |
| — | NCT01348542 Comparator | Apr 2011 → Jun 2018 | insomnia | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT00817011 Comparator | Apr 2006 → Dec 2016 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-01-19 | Lee's Pharmaceutical Limited | Inclusion of Treprostinil Injection, Teglutik® and Trittico® in the National Reimbursement Drug List leespharm.com ↗ |
| 2022-08-22 | Lee's Pharmaceutical Limited | New “Excellent” Treatment for Depression ― Lee’s Pharm successfully held Satellite Meeting for Trittico® leespharm.com ↗ |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trazodone | “Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline;...” NCT00270959 ↗61“Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline,...” NCT01347541 ↗ “Adjunctive antidepressant agents: nortriptyline, duloxetine, sertraline, trazodone, or mirtazapine” NCT01943435 ↗ “S1B-509 (proprietary combination of trazodone and bupropion) low dose” NCT06517797 ↗ “trazodone_Desyrel, Beneficat, Deprax” NCT00817011 ↗ “Lorexys is bupropion plus trazodone” NCT01857596 ↗ |
| Known as | AF-1161 | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Beneficat | “trazodone_Desyrel, Beneficat, Deprax” NCT00817011 ↗ |
| Known as | Deprax | “trazodone_Desyrel, Beneficat, Deprax” NCT00817011 ↗ |
| Known as | Desyrel | “This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge...” NCT00027053 ↗2“Trazodone (Desyrel) will be given in a crossover order with placebo.” NCT03522207 ↗ “trazodone_Desyrel, Beneficat, Deprax” NCT00817011 ↗ |
| Known as | J10.767K | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Molipaxin | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Molipaxin cr | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | NSC-292811 | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Oleptro | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Trazodona | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Trazodone Contramid OAD | “The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).” NCT00775203 ↗ |
| Known as | Trazodone Contramid(R) once-a-day | “Trazodone Contramid(R) once-a-day (TzCOAD) is a reformulation of trazodone hydrochloride that controls the release of trazodone over 24 hours.” PMID 20581790 ↗ 2009 |
| Known as | Trazodone HCl | “Drug: Trazodone HCl” NCT01121913 ↗ |
| Known as | trazodone hydrochloride | “two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg...” NCT01121913 ↗5“The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.” NCT02785601 ↗ “Trazodone Contramid(R) once-a-day (TzCOAD) is a reformulation of trazodone hydrochloride that controls the release of trazodone over 24 hours.” PMID 20581790 ↗ 2009 “This study evaluated the effect of 3 doses of a trazodone hydrochloride 6% oral drops solution.” PMID 32488885 ↗ Jun 2020 “Drug: Trazodone Hydrochloride” NCT06286189 ↗ |
| Known as | Trazodone Hydrochloride (HCl) | “Trazodone Hydrochloride (HCl) Extended-Release Tablets” NCT00775203 ↗ |
| Known as | trazodone hydrochloride prolonged-release tablet | “T group: the subjects will be provided trazodone hydrochloride prolonged-release tablet 150mg at about8:00am each day.” NCT02785614 ↗ |
| Known as | trazodone hydrochloride tablet | “R group: The subjects will receive 50mg trazodone hydrochloride tablet 50mg for 3 times after receiving standard light breakfast at 6:00am, standard meal at 14:00 and 22:00.” NCT02785614 ↗ |
| Known as | Trialodine | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | Trittico | ChEMBL registry synonym — accepted as the source's own label CHEMBL621 ↗ |
| Known as | TRZ | “Trazodone (TRZ) is a compound with a multi-modal mechanism of action, being a serotonin-2 antagonist/reuptake inhibitor developed and approved for the treatment of depression...” PMID 32936427 ↗ Nov 2020 |
| Known as | TzCOAD | “Trazodone Contramid(R) once-a-day (TzCOAD) is a reformulation of trazodone hydrochloride that controls the release of trazodone over 24 hours.” PMID 20581790 ↗ 2009 |
| Action | Inhibit | “The 5-HT2 antagonist, trazodone, may be beneficial in the” PMID 18978492 ↗ Mar 20093“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL621 ↗ “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL621 ↗ “Serotonin transporter inhibitor” CHEMBL621 ↗ |
| Modality | Small molecule | — CHEMBL621 ↗ |
| Route | Oral | “single oral dose of 300 mg” NCT01121913 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL621 ↗ |
| Target | HTR2C | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL621 ↗ |
| Target | SLC6A4 | “Serotonin transporter inhibitor” CHEMBL621 ↗ |