Evidence map›Paper›PMID 41697570›Full record

SynthesisClinical drug investigation2026

Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System.

Solomiya Gumenyuk, Ajay Ogirala, Steven T Szabo, Kenneth Koblan, Seth C Hopkins, Mike Ufer

5 registry-linked trialsAbstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Clinical drug investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01692782 phase2completednot on this map

A Randomized, Double Blind, Parallel Group, Multicenter Efficacy and Safety Study of SEP-225289 Versus Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorSumitomo Pharma America, Inc.Ran2012 to 2013Enrolled341ConditionsAdult Attention Deficit Hyperactivity DisorderArmsSEP-225289, Placebo
NCT02276209 phase3completednot on this map

A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorSumitomo Pharma America, Inc.Ran2014 to 2016Enrolled636ConditionsAdult Attention Deficit Hyperactivity DisorderArmsDasotraline, Placebo
NCT02428088 phase2 / phase3completednot on this map

A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorSumitomo Pharma America, Inc.Ran2015 to 2016Enrolled330ConditionsAttention Deficit Hyperactivity DisorderArmsDasotraline, Placebo Comparator
NCT02564588 phase2 / phase3completednot on this map

A 12-week, Randomized, Double-blind, Parallel-group, Placebo Controlled, Flexibly Dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder

TypeinterventionalSponsorSumitomo Pharma America, Inc.Ran2015 to 2016Enrolled319ConditionsBinge Eating DisorderArmsDasotraline, Placebo
NCT03107026 phase3completednot on this map

A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder

TypeinterventionalSponsorSumitomo Pharma America, Inc.Ran2017 to 2018Enrolled491ConditionsBinge Eating DisorderArmsdasotraline 4mg, dasotraline 6mg, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Solomiya GumenyukSumitomo Pharma America, Inc., Marlborough, MA, USA.
Ajay Ogirala *Sumitomo Pharma America, Inc., Marlborough, MA, USA.
Steven T Szabo *Sumitomo Pharma America, Inc., Marlborough, MA, USA.
Kenneth Koblan *Sumitomo Pharma America, Inc., Marlborough, MA, USA.
Seth C Hopkins *Sumitomo Pharma America, Inc., Marlborough, MA, USA.
Mike UferSumitomo Pharma Switzerland GmbH, Aeschengraben 27, CH-4051, Basel, Switzerland. mikeufer@web.de.ORCID http://orcid.org/0000-0002-6637-4406

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe safety profile of single or dual monoamine reuptake inhibitors (MRIs) is based on longstanding post-marketing experience but remains to be established for triple MRIs that may exhibit favorable efficacy as treatment of psychiatric disorders. Here, we characterized the safety profile of the triple MRI dasotraline based on disproportionality analyses and clinical trial data.

methodsThe Food and Drug Administration Adverse Event Reporting System was queried for adverse events of commonly prescribed selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), norepinephrine reuptake inhibitors (NRIs), and norepinephrine-dopamine reuptake inhibitors (NDRIs). Bayesian disproportionality analyses were conducted to determine the Empirical Bayes Geometric Mean (EBGM) for each Medical Dictionary for Regulatory Activities (MedDRA

resultsA total of 1087, 940, 409, and 714 PTs with an EBGM ≥3 were identified for SSRIs, SNRIs, NRIs, and NDRIs, respectively. The cumulative pooled incidence of these class-related PTs was approximately 2- to 2.5-fold higher for dasotraline than placebo (SSRIs: 24.7%/9.6%; SNRIs: 50.7%/26.3%; NRIs: 56.5%/32.2%; NDRIs: 35.2%/18.2%).

conclusionsThe safety profile of the triple MRI dasotraline was not distinct from pharmacologically related classes indicated by a consistently higher incidence of class-related adverse events compared to placebo in randomized, controlled clinical trials. Bayesian disproportionality analyses utilizing post-marketing data from established drug classes can provide meaningful information for qualitative safety evaluation of drugs in clinical development. CLINICALTRIALS: GOV IDENTIFIERS: NCT01692782, NCT02428088, NCT02276209, NCT02564588, NCT03107026.

Indexed as

Adverse Drug Reaction Reporting SystemsNeurotransmitter Uptake InhibitorsAdultBayes TheoremDouble-Blind MethodFemaleHumansMaleRandomized Controlled Trials as TopicSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake InhibitorsUnited StatesUnited States Food and Drug AdministrationNeurotransmitter Uptake InhibitorsSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake Inhibitors

Identifiers

PMID41697570

What Socratic holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.