Drugs / Vortioxetine
last change Jun 2026 re-read 9 days ago

Vortioxetine

Developed for
major depressive disorder · depressive disorder · generalized anxiety disorder · bipolar depression · cognitive disorder · anxiety disorder · cognitive impairment with or without cerebellar ataxia · type 2 diabetes mellitus
+18 more · attention deficit-hyperactivity disorder · behavioral variant of frontotemporal dementia · binge eating disorder · burning mouth syndrome · dementia · glioblastoma · panic disorder · post-COVID-19 disorder · radiation-induced disorder · social phobia · subjective cognitive decline · traumatic brain injury · alcohol dependence · anxiety · cannabis dependence · parkinsonian disorder · post-traumatic stress disorder · schizophrenia
Investigated by
H. Lundbeck A/S · Takeda · Brain and Cognition Discovery Foundation · Johns Hopkins University · Massachusetts General Hospital · Seasons Biotechnology (Taizhou) Co., Ltd.
+48 more · Takeda Pharmaceuticals North America, Inc. · Washington University School of Medicine · Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Alen Greš · Andalusian Public Foundation for Health Research in Seville · Azienda Ospedaliera Universitaria Integrata Verona · Brain Hospital Affiliated to Guangzhou Medical University · Cantonal Hospital of Lucerne, Switzerland · Cantonal Hospital of St. Gallen · Children's Hospital of Chongqing Medical University · ElMindA Ltd · Federico II University · First Affiliated Hospital of Chongqing Medical University · First Affiliated Hospital of Zhejiang University · Future University in Egypt · Huazhong University of Science and Technology · ICON plc · IRCCS San Raffaele Roma · Kantonsspital Aarau · Lundbeck Canada Inc. · Lundbeck LLC · Marianna Amboni · Mayo Clinic · National Institute on Aging (NIA) · Noam Soreni · Queen's University · Rawalpindi Medical College · Rush University Medical Center · Scotmann Pharmaceuticals · Second Xiangya Hospital of Central South University · Seoul National University Hospital · Shenzhen Mental Health Center · Sir Run Run Shaw Hospital · Siyan Clinical Corporation · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University · The Medical Research Network · The Second Affiliated Hospital of Chongqing Medical University · Thomas Jefferson University · Todd Doyle · Universidad Juárez Autónoma de Tabasco · University Hospital, Basel, Switzerland · University Hospital, Zürich · University of Catania · University of Chicago · University of Miami · University of Zurich · Zhejiang University

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed major depressive disorder 1 milestone
Filed Japan (PMDA) — major depressive disorder 2018-09-28

“today announced the submission of a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for vortioxetine” takeda.com ↗

Approved Indication not stated 3 milestones
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

today
US approved 2013
EU approved 2013
1
2
11
1
6
6
6
8
6
13
3
2
7
6
2
5
2
1
4
2
20062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 · 2 met primary · 3 missed
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 Missed primary
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 Missed primary
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 Missed primary
Phase 2 NCT01491035 Apr 2012 → Dec 2014 anxiety disorder, depressive disorder H. Lundbeck A/S Completed No outcome recorded
Phase 2/33 trials · 1 missed
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 Missed primary
Phase 341 trials · 12 met primary · 10 missed
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 Stop: Business
Phase 3 NCT02871297 Aug 2016 → Mar 2022 major depressive disorder H. Lundbeck A/S Terminated No outcome recorded
Phase 424 trials · 3 met primary · 1 missed
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 Met primary
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 Stop: Enrollment
Comparator or background therapy7 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 Missed primary
Phase 2/3 NCT03485274 Comparator Jul 2018 → Feb 2023 anxiety, cannabis dependence, depressive disorder The University of Hong Kong Completed No outcome recorded
Phase 3 NCT03855865 Comparator Jul 2019 → Dec 2020 major depressive disorder Naurex, Inc Withdrawn No outcome recorded Stop: Business
Phase 4 NCT02637895 Comparator Dec 2016 → Jan 2020 post-traumatic stress disorder University of Miami Completed No outcome recorded

News releases announcing trial results or a regulatory action · 13

DateIssuerRelease
2022-01-01 Alembic Pharmaceuticals Ltd. Regulatory 7th January, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg.
2021-09-18 Zydus Lifesciences Limited Regulatory Zydus Cadila receives final approval from USFDA for Vortioxetine Tablets zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Vortioxetine Tablets in the strengths of 5 mg, 10 mg, 20 mg (US RLD: Trintellix Tablets).
2019-09-20 Takeda Regulatory Takeda and Lundbeck announce Ministry of Health, Labour and Welfare (MHLW) approval of Trintellix ® in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE: 4502/NYSE: TAK ) (“Takeda”) and H. Lundbeck A/S (“Lundbeck”) jointly announced today that the MHLW of Japan approved Trintellix ® (vortioxetine) for the treatment of depression and depressed state.
2018-09-28 Takeda Regulatory 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 Results Positive clinical phase III results of vortioxetine in Japanese patients takeda.com ↗
Takeda Pharmaceutical Company Limited [TSE: 4502] (“Takeda”) and its partner, H. Lundbeck A/S (“Lundbeck”) today announced positive results from the pivotal study (NCT02389816) with vortioxetine in adults with Major Depressive Disorder (MDD) conducted in Japan.
2018-05-02 Takeda Regulatory 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 ↗
Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX ® (vortioxetine).
2018-05-02 H. Lundbeck A/S Regulatory Trintellix Prescribing Information Updated to Include New Data Showing Improvement in Processing Speed lundbeck.com ↗
Osaka, Japan and Deerfield, Ill. (May 2, 2018) – Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine).
2017-06-23 Takeda Regulatory Lundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix® (vortioxetine) sNDA takeda.com ↗
The CRL does not change the FDA-approved current prescribing information for Trintellix.
2016-03-29 Takeda Regulatory Takeda and Lundbeck Receive Complete Response Letter for Brintellix® (vortioxetine) sNDA takeda.com ↗
The CRL does not apply to the use of Brintellix in MDD.
2016-02-04 Takeda Regulatory 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 ↗
The panel voted 8-2 that substantial evidence has been presented to support a claim of effectiveness for Brintellix for treating certain aspects of cognitive dysfunction in MDD
2015-08-11 Takeda Regulatory 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 ↗
Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label.
2014-06-18 Takeda Results 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 ↗
Takeda and Lundbeck Announce Results at American Society of Clinical Psychopharmacology Annual Meeting Hollywood, Fla. U.S.A., June 17, 2014 and Osaka, Japan, June 18, 2014 —Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced that the companies presented results about sexual functioning from a head-to-head study of Brintellix ® (vortioxetine) vs. escitalopram in patients with well treated major depressive disorder (MDD) experiencing treatment-emergent sexual dysfunction (TESD).

All press releases naming this drug 16 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 103 sources stand behind the page.

FieldValueCited 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 ↗

NCT02637466 ↗

NCT03598868 ↗

NCT00635219 ↗

NCT02072278 ↗

NCT03187093 ↗

NCT03485274 ↗

NCT03830827 ↗

NCT05481957 ↗

NCT03580967 ↗

Show 87 more sources

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)” NCT00635219 ↗

“Vortioxetine (Lu AA21004)” NCT01607125 ↗

“vortioxetine (Lu AA21004)” NCT01564862 ↗

“Vortioxetine (Lu AA21004)” NCT00761306 ↗

Show 5 more sources

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 ↗