Delving into the Latest Updates on Dasotraline Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Dasotraline

+ [4]

Target

DAT x NET x SERT

Mechanism

DAT antagonists(Dopamine transporter antagonists), NET inhibitors(Norepinephrine transporter inhibitors), SERT inhibitors(Serotonin transporter inhibitors)

Therapeutic Areas

Other Diseases

Active Indication-

Inactive Indication

Attention Deficit Disorder With HyperactivityBinge-Eating DisorderDepressive Disorder, Major

Originator Organization

Sumitomo Pharma Co., Ltd.

Active Organization-

Inactive Organization

Sumitomo Pharma America, Inc.

Drug Highest PhasePendingNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC16H15Cl2N

InChIKeySRPXSILJHWNFMK-MEDUHNTESA-N

CAS Registry675126-05-3

View All Structures (2)

INTRODUCTIONAttention-deficit/hyperactivity disorder (ADHD) is a complex neurodevelopmental disorder. It is one of the most common mental disorders in youth worldwide characterized by persistent overactivity and impulsivity/inattention symptoms associated with social and academic impairment. dasotraline has been suggested to play a pivotal role as a serotonin, norepinephrine, and dopamine reuptake inhibitor. This study aimed to create evidence from published randomized clinical trials (RCTs) about the benefits of dasotraline for ADHD patients.METHODSA computer literature search (PubMed, Scopus, Web of Science, and Cochrane CENTRAL) was conducted. We included RCTs comparing dasotraline versus placebo. The primary outcome measure was the ADHD Rating Scale-IV score, pooled as the mean difference between the two groups from baseline to the endpoint. The secondary outcome measures were the ADHD Rating Scale-IV Inattention score, ADHD Rating Scale-IV Hyperactivity score.RESULTSFive RCTs with a total of 1594 patients were included in this study. dasotraline showed a significant improvement in the primary outcome (MD -2.65, 95% CI [-4.14 to -1.17], P= 0.0004 CONCLUSION: The results showed that dasotraline demonstrated a significant improvement in both primary and secondary outcomes, establishing its efficacy as a novel treatment for ADHD symptoms. However, mild to moderate side effects were observed.

01 Aug 2024·Journal of Psychiatric Research

Efficacy and safety of monoamine reuptake inhibitors in attention deficit hyperactivity disorder: A Bayesian network meta-analysis

Article

Author: Maiti, Rituparna ; Mishra, Archana ; Ramasubbu, Mathan Kumar ; Mohapatra, Debadatta ; Maji, Shampa

The use of first-line drugs in clinical practice for attention deficit hyperactivity disorder (ADHD) is limited by their adverse effects. Many novel monoamine reuptake inhibitors (MRIs) with better safety profiles and comparable efficacy are also being tried for ADHD. This network meta-analysis (NMA) has evaluated the efficacy and safety of MRIs in ADHD. The data was extracted from 31 relevant clinical trials after a literature search on MEDLINE/PubMed, Embase, Scopus, Cochrane databases, and clinical trial registries. Quality assessment was performed using the risk of bias assessment tool (RoB2) by Cochrane Collaboration, and the random-effects model was used to estimate the effect size. Standardised mean difference (SMD) and 95% credible interval(95%CrI) were reported for the reduction in ADHD rating scale score. Network geometry was visualised, and node splitting was done for the closed triangles. Meta-regression was done for the duration of therapy. PRISMA-NMA guidelines were followed in selecting, analyzing, and reporting findings. The drugs showing significant reduction on the ADHD rating scale as compared to placebo are bupropion (SMD: 0.33; 95%CrI: 0.60,-0.059), dasotraline(SMD: 0.49; 95%CrI: 0.82,-0.16), venlafaxine(SMD: 0.71; 95%CrI: 1.3,-0.15), viloxazine(SMD: 0.45; 95%CrI: 0.77,-0.12). Other drugs (centanafadine, duloxetine, edivoxetine, reboxetine, tipepidine, vortioxetine) were no better than placebo in reducing symptom severity of ADHD. The efficacy of none of the drugs was found to be significantly different as compared to methylphenidate. Among all, duloxetine (OR:15; 95%CrI:1.8130) showed significantly more treatment-emergent adverse events than methylphenidate. In conclusion, venlafaxine, viloxazine, and bupropion are the most efficacious MRIs for ADHD symptom reduction as compared to placebo with high certainty of evidence.

23 May 2024·Expert Opinion on Pharmacotherapy

The role of adrenergic neurotransmitter reuptake inhibitors in the ADHD armamentarium

Review

Author: Arnold, L. Eugene ; Ilipilla, Geeta

INTRODUCTIONAdrenergic neurotransmitter reuptake inhibitors are gaining attention in treatment for attention-deficit hyperactivity disorder (ADHD). Due to their effects on norepinephrine, dopamine, and serotonin neurotransmission, they benefit both ADHD and comorbid disorders and have some other advantages including longer duration of action and fewer adverse effects compared to stimulants. There is continued interest in these agents with novel mechanisms of action in treatment of ADHD.AREAS COVEREDThe authors conducted a PubMed literature search using the following key words: 'ADHD' AND 'adrenergic reuptake inhibitors' OR 'nonstimulants' OR 'atomoxetine' OR 'Viloxazine' OR 'Dasotraline' OR 'Centanafadine' OR 'PDC-1421' OR 'Reboxetine' OR 'Edivoxetine' OR 'Bupropion' OR 'Venlafaxine' OR 'Duloxetine.' They reviewed FDA fact sheets of available medications for safety/tolerability studies and reviewed published clinical studies of these medications for treatment of ADHD.EXPERT OPINIONAdrenergic neurotransmitter reuptake inhibitors fit the diverse needs of children and adolescents with ADHD with 1) poor tolerability to stimulants (e.g. due to growth suppression, insomnia, rebound irritability, co-morbid depression, anxiety and tic disorders, substance abuse or diversion concerns), 2) cardiac risks, and/or 3) need for extended duration of action. Their differences in receptor affinities and modulating effects support the unique benefits of individual agents.

100 Deals associated with Dasotraline Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Dasotraline Hydrochloride	-	DB12305

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Binge-Eating Disorder	NDA/BLA	US	Sumitomo Pharma America, Inc.	11 Apr 2019
Attention Deficit Disorder With Hyperactivity	NDA/BLA	US	Sumitomo Pharma America, Inc.	01 Jun 2014
Depressive Disorder, Major	NDA/BLA	US	Sumitomo Pharma America, Inc.	01 Dec 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03231800 (Pubmed \| J Atten Disord) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	95	Dasotraline	(wmhlxwzagh) = aatawkzlte kvwkafkgdi (maxjnifnsp, 0.775)	Positive	20 Jan 2022
				placebo	(wmhlxwzagh) = gwetbipwzp kvwkafkgdi (maxjnifnsp, 0.773)
NCT02564588 (Pubmed \| J Clin Psychiatry) Manual	Phase 2/3	Binge-Eating Disorder	315	Dasotraline	ysndnuqtrq(cpmzmsidff) = txrgqjpnxg muqkblkjim (cqjlgraskw, 0.17) View more	Positive	08 Sep 2020
				Placebo	(ychuwtbzlh) = pamlehkfes ztdenxmsog (yicjorttht ) View more
NCT02684279 (CTgov)	Phase 3	Binge-Eating Disorder	533	Dasotraline	xcpcfwdahx(ychmvmyiqj) = vcyfdznyzw dothajxipq (netjgjmnyh, flowfemckv - yuiyzclywt) View more	-	12 Aug 2020
NCT03107026 (CTgov)	Phase 3	Binge-Eating Disorder	491	Placebo (Placebo)	vatnyczkge(mxfvylbvll) = wpeenyrcdt xrngzrpfqq (hgbunhwmdf, tdckxzvqab - bqpzihdfjd) View more	-	13 Jul 2020
				dasotraline 4mg (Dasotraline 4mg)	vatnyczkge(mxfvylbvll) = dvxmiwxjdn xrngzrpfqq (hgbunhwmdf, xyzcouwzuz - uinnzyqaxl) View more
NCT03231800 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	95	Placebo (Placebo)	ftzcxcqasf(dhqrriatqg) = mdaveuxiyv eipzqxsggl (tsdienooar, mjebfwyawk - fdfpfoltpe) View more	-	24 Jun 2020
				dasotraline (Dasotraline)	ftzcxcqasf(dhqrriatqg) = gtcaglyjtv eipzqxsggl (tsdienooar, xamsrwyhwf - zfjgrjjwva) View more
NCT02734693 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	132	Placebo (Placebo)	nowoqemotz(xxsvihepgr) = nekcunynsp kltjyvmkjx (qfdqokuqxy, dnmvlkinye - tnhysgazlo) View more	-	27 Mar 2020
				dasotraline 4mg (Dasotraline 4mg)	nowoqemotz(xxsvihepgr) = smmuwmtmhy kltjyvmkjx (qfdqokuqxy, tbaewyxsxc - cxhpvzsjpf) View more
NCT02457819 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	237	Dasotraline	lrpiaewxrw(krlqxmtykm) = pqdgukeldi toezdjnixw (utmlyczfzi, rafguyndqn - awzpklkkwa) View more	-	18 Jan 2020
NCT02734693 (Pubmed) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	112	dasotraline	rubvfeegdv(sdngavgcwn) = ndwzdyiblx nmqhssrkwm (uflxjxbbyl )	Positive	01 Jan 2020
				Placebo	rubvfeegdv(sdngavgcwn) = jinltyduar nmqhssrkwm (uflxjxbbyl )
NCT01692782 (CTgov)	Phase 2	Attention Deficit Disorder With Hyperactivity	341	SEP-225289 (SEP-225289 4mg)	fmwizrirbi(ilyelaokfz) = xrzfubiqna cchagwmmym (vhbxhgztbr, sqtwpgrxtu - cexbylxexz) View more	-	12 Jan 2015
				SEP-225289 (SEP-225289 8mg)	fmwizrirbi(ilyelaokfz) = gxoexghtgb cchagwmmym (vhbxhgztbr, fsdrjqvztq - xhzlldophf) View more