Drugs / Vortioxetine
Vortioxetine
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | TRINTELLIX | — | 2017-03-10 – 2023-08-23 | fda.gov ↗ |
| Approved | EU (EMA) | Brintellix | — | 2013-12-18 | europa.eu ↗ |
| Approved | US (FDA) | TRINTELLIX | — | 2013-09-30 | fda.gov ↗ |
Trials 94 · started per year
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US approved 2013
EU approved 2013
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04456777 | Jul 2020 → Jul 2022 | cognitive disorder | Alen Greš | Unknown | No outcome recorded |
| Phase 0 | NCT02454426 | Apr → Jun 2016 | coronary artery disorder, major depressive disorder | Thomas Jefferson University | Withdrawn | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT05416762 | Sep → Nov 2022 | major depressive disorder | Seasons Biotechnology (Taizhou) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05416957 | Sep → Oct 2022 | major depressive disorder | Seasons Biotechnology (Taizhou) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03884491 | Mar → Jun 2019 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02386488 | Mar → May 2015 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02170220 | Jul → Nov 2014 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02112903 | Apr → Sep 2014 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02072278 | Feb → Nov 2014 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT01676571 | Oct → Nov 2012 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT01607125 | Jul 2012 → Sep 2013 | depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT01299805 | Mar → Jun 2011 | — | Takeda | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05814640 | Feb 2023 → Dec 2026 expected | major depressive disorder, splenic sequestration | First Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07284628 | Jun 2026 → Jun 2029 expected | glioblastoma | University of Zurich | Recruiting | No outcome recorded |
| Phase 2 | NCT07000734 | Jul 2025 → Apr 2026 | cardiovascular disorder, cognitive disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT06604520 | Mar 2025 → May 2029 expected | behavioral variant of frontotemporal dementia | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT05047952 | Sep 2021 → Feb 2023 | cognitive disorder, post-COVID-19 disorder | Brain and Cognition Discovery Foundation | Completed | No outcome recorded |
| Phase 2 | NCT03766867 | Dec 2018 → Jul 2019 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 2 | NCT03598868 | Aug 2018 → Sep 2021 | bipolar depression | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02919501 | Sep 2016 → Apr 2017 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 2 | NCT02528409 | Jun 2016 → Nov 2018 | binge eating disorder | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT02327013 | Dec 2014 → Sep 2016 | attention deficit-hyperactivity disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 2 | NCT01491035 | Apr 2012 → Dec 2014 | anxiety disorder, depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 2 | NCT01564862 | Apr 2012 → Feb 2014 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00761306 | Jun 2007 → Sep 2008 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 2 | NCT00839423 | Aug 2006 → Aug 2007 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT04895488 | Jan 2022 → Dec 2024 | cognitive impairment with or without cerebellar ataxia | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 2/3 | NCT03053362 | May 2017 → Aug 2018 | major depressive disorder | Brain and Cognition Discovery Foundation | Completed | No outcome recorded |
| Phase 2/3 | NCT01255787 | Nov 2010 → Mar 2012 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 341 trials | ||||||
| Phase 3 | NCT07204314 | Oct 2025 → Sep 2029 expected | major depressive disorder | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06561438 | Aug 2024 → Jun 2025 | — | Future University in Egypt | Completed | No outcome recorded |
| Phase 3 | NCT06025474 | Jan → Oct 2023 | burning mouth syndrome | Federico II University | Unknown | No outcome recorded |
| Phase 3 | NCT05104918 | Feb → Apr 2022 | major depressive disorder | Scotmann Pharmaceuticals | Unknown | No outcome recorded |
| Phase 3 | NCT05014919 | Aug 2021 → Mar 2022 | depressive disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase 3 | NCT04818099 | Oct 2020 → Oct 2023 | radiation-induced disorder | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 3 | NCT04035850 | Aug 2019 → Aug 2021 | — | Noam Soreni | Withdrawn | No outcome recorded |
| Phase 3 | NCT03108625 | Mar 2017 → Apr 2020 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT02845349 | Oct 2016 → Oct 2018 | major depressive disorder, traumatic brain injury | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 3 | NCT02871297 | Aug 2016 → Mar 2022 | major depressive disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase 3 | NCT02709655 | May 2016 → Jan 2022 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT02709746 | May 2016 → Jul 2019 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT02389816 | Apr 2015 → Mar 2018 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02272517 | Dec 2014 → Mar 2016 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT02279953 | Oct 2014 → Apr 2016 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT02279966 | Oct 2014 → Feb 2016 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01571453 | May 2012 → Oct 2013 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01488071 | Jan → Dec 2012 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01422213 | Dec 2011 → May 2013 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01395147 | Jul 2011 → May 2013 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01364649 | Jun 2011 → Dec 2013 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01355081 | May 2011 → Dec 2012 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01323478 | Apr 2011 → Sep 2012 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01152996 | Sep 2010 → May 2013 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01179516 | Aug 2010 → May 2012 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01163266 | Jul 2010 → Jan 2012 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01153009 | Jun 2010 → Mar 2012 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01140906 | May 2010 → Sep 2011 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00811252 | Jan 2009 → Feb 2010 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00788034 | Oct 2008 → Jun 2010 | generalized anxiety disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00744627 | Sep 2008 → Jul 2009 | generalized anxiety disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00735709 | Aug 2008 → Jul 2009 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00731120 | Jun 2008 → Jan 2009 | generalized anxiety disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00707980 | Jun 2008 → Jul 2010 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00734071 | Jun 2008 → Jan 2009 | generalized anxiety disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00730691 | Jun 2008 → Feb 2009 | generalized anxiety disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00694304 | May 2008 → Mar 2010 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00672958 | Apr → Nov 2008 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00672620 | Apr → Nov 2008 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00635219 | Feb 2008 → Apr 2009 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00596817 | Dec 2007 → Sep 2009 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 424 trials | ||||||
| Phase 4 | NCT07266545 | Feb 2026 → Dec 2028 expected | bipolar depression, major depressive disorder | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT06805266 | Feb 2025 → Dec 2026 expected | Parkinson disease, depressive disorder | Marianna Amboni | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05481957 | Mar 2022 → Jun 2023 | bipolar depression | First Affiliated Hospital of Zhejiang University | Completed | No outcome recorded |
| Phase 4 | NCT03830827 | Sep 2020 → Apr 2021 | cognitive impairment with or without cerebellar ataxia, depressive disorder | Sir Run Run Shaw Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04448431 | Jun 2020 → Jan 2022 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT04294654 | Feb 2020 → Jul 2022 | dementia, major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT04288895 | Feb 2020 → Feb 2022 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT04220996 | Dec 2019 → Mar 2021 | anxiety disorder, major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT04301492 | Nov 2019 → Jul 2023 | depressive disorder | IRCCS San Raffaele Roma | Unknown | No outcome recorded |
| Phase 4 | NCT03580967 | Jul 2019 → Jul 2021 | major depressive disorder, type 2 diabetes mellitus | Todd Doyle | Withdrawn | No outcome recorded |
| Phase 4 | NCT03835715 | Feb 2019 → Feb 2020 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT03779789 | Feb 2019 → Feb 2023 | major depressive disorder | Azienda Ospedaliera Universitaria Integrata Verona | Completed | No outcome recorded |
| Phase 4 | NCT02969876 | Aug 2017 → Aug 2018 | major depressive disorder | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02972632 | Dec 2016 → Feb 2018 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02749721 | Dec 2016 → Jan 2019 | major depressive disorder | Rush University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02932904 | Nov 2016 → May 2017 | — | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03272711 | Aug 2016 → Jan 2019 | subjective cognitive decline | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT02637466 | Jul 2016 → Jul 2018 | female breast carcinoma, major depressive disorder | University of Miami | Withdrawn | No outcome recorded |
| Phase 4 | NCT03978286 | Jun 2016 → Jun 2017 | depressive disorder, type 2 diabetes mellitus | Universidad Juárez Autónoma de Tabasco | Completed | No outcome recorded |
| Phase 4 | NCT02234362 | Jun 2015 → Sep 2016 | major depressive disorder, vascular disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02395510 | May 2015 → Jun 2016 | panic disorder | Siyan Clinical Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02371980 | Feb 2015 → Mar 2019 | major depressive disorder | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02332954 | Feb 2015 → Jul 2017 | major depressive disorder | Lundbeck Canada Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02294305 | Dec 2014 → Nov 2016 | major depressive disorder, social phobia | The Medical Research Network | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04498897 Comparator | Jan 2019 → Apr 2021 | alcohol dependence, major depressive disorder | Hanyang University Seoul Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03321526 Background | Dec 2017 → Jun 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03485274 Comparator | Jul 2018 → Feb 2023 | anxiety, cannabis dependence, depressive disorder | The University of Hong Kong | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03855865 Comparator | Jul 2019 → Dec 2020 | major depressive disorder | Naurex, Inc | Withdrawn | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02637895 Comparator | Dec 2016 → Jan 2020 | post-traumatic stress disorder | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT03187093 Comparator | Oct 2016 → Apr 2019 | major depressive disorder | Oleg Levada | Unknown | No outcome recorded |
| Phase 4 | NCT02357797 Comparator | Feb 2016 → Oct 2023 | schizophrenia | Northwell Health | Unknown | No outcome recorded |
Press releases naming this drug 13 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-09-20 | Takeda | Takeda and Lundbeck announce Ministry of Health, Labour and Welfare (MHLW) approval of Trintellix ® in Japan takeda.com ↗ |
| 2018-09-28 | Takeda | Takeda and Lundbeck Submit New Drug Application (NDA) for Vortioxetine in Japan for the Treatment of Major Depressive Disorder (MDD) takeda.com ↗ |
| 2018-06-08 | Takeda | Positive clinical phase III results of vortioxetine in Japanese patients takeda.com ↗ |
| 2018-05-02 | Takeda | TRINTELLIX ® (vortioxetine) Prescribing Information Now Includes New Data Showing Improvement in Processing Speed, an Important Aspect of Cognitive Function in Acute Major Depressive Disorder (MDD) takeda.com ↗ |
| 2017-06-23 | Takeda | Lundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix® (vortioxetine) sNDA takeda.com ↗ |
| 2016-06-02 | Takeda | Trintellix (vortioxetine) Now Available in U.S. Pharmacies takeda.com ↗ |
| 2016-05-03 | Takeda | Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in U.S. to Avoid Name Confusion takeda.com ↗ |
| 2016-03-29 | Takeda | Takeda and Lundbeck Receive Complete Response Letter for Brintellix® (vortioxetine) sNDA takeda.com ↗ |
| 2016-02-04 | Takeda | FDA Psychopharmacologic Drug Advisory Committee Supports the Effectiveness of Brintellix® (vortioxetine) in Treating Certain Aspects of Cognitive Dysfunction in Major Depressive Disorder (MDD) takeda.com ↗ |
| 2015-08-11 | Takeda | FDA Accepts a Supplemental New Drug Application for Review of Brintellix ® (vortioxetine) Clinical Trial Data That Assessed Cognitive Function in Patients with Major Depressive Disorder takeda.com ↗ |
| 2014-06-18 | Takeda | Results of a New Study of Brintellix ® (vortioxetine) vs. Escitalopram on Sexual Functioning in Well Treated MDD Patients Experiencing Treatment-Emergent Sexual Dysfunction takeda.com ↗ |
| 2014-06-17 | Takeda | New CONNECT Study Presents data on Measures of Cognitive Performance in Adult Patients Treated with Brintellix ® (vortioxetine) for Major Depressive Disorder takeda.com ↗ |
| 2014-01-22 | Takeda | Brintellix ® (vortioxetine) for the treatment of major depressive disorder in adults is now available in U.S. pharmacies takeda.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vortioxetine | “Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of...” NCT03321526 ↗97“Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes” NCT00596817 ↗ |
| Known as | Brintellix | “Vortioxetine (Brintellix®), a novel antidepressant for the treatment of adult with major depressive disorder, has been approved by the Chinese Food and Drug Administration in...” NCT03830827 ↗2“Vortioxetine is approved by the U.S. Food and Drug Administration as a treatment for depression, and also goes by the name Trintellix (formerly known as Brintellix).” NCT03272711 ↗ “to receive study drug (Brintellix drops 20 mg/ml).” NCT04301492 ↗ |
| Known as | Lu AA21004 | “Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu...” NCT02072278 ↗15“A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication” NCT01488071 ↗ “Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study” PMID 24257717 ↗ May 2014 “Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder” NCT01491035 ↗ “Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes” NCT00596817 ↗ “Drug: Vortioxetine (Lu AA21004)” NCT01422213 ↗ “Vortioxetine (Lu AA21004)” NCT00694304 ↗ “Vortioxetine (Lu AA21004)” NCT00761306 ↗ “Vortioxetine (Lu AA21004)” NCT01607125 ↗ “Vortioxetine (Lu AA21004)” NCT01323478 ↗ “Vortioxetine (Lu AA21004)” NCT00635219 ↗ “Vortioxetine (Lu AA21004)” NCT00811252 ↗ “vortioxetine (Lu AA21004)” NCT01564862 ↗ |
| Known as | Trintellix | “This study will look at an anti-depressant medication called vortioxetine (Trintellix).” NCT03580967 ↗ |
| Known as | Vortioxetine Hemihydrobromide | “Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg” NCT05416762 ↗ |
| Action | Inhibit | “inhibitor of the 5-HT transporter” PMID 23252878 ↗ Jan 2013 |
| Route | Oral | “encapsulated tablets, daily, orally” NCT00596817 ↗ |