Delving into the Latest Updates on Edivoxetine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Edivoxetine, Edivoxetine hydrochloride (USAN)

+ [3]

Target

NET

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors)

Therapeutic Areas

Other Diseases

Active Indication

Attention Deficit Disorder With Hyperactivity

Inactive Indication

Depressive Disorder, Major

Originator Organization

Eli Lilly & Co.

Active Organization

Suzhou SIKRO Pharmaceutical Co., Ltd

Inactive Organization

Eli Lilly & Co.Catalent Pharma Solutions Ltd.

Fisher Clinical Services, Inc.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure

Molecular FormulaC18H27ClFNO4

InChIKeyWJDKGRLMNSHPON-CJRXIRLBSA-N

CAS Registry1194374-05-4

View All Structures (2)

主要研究目的评价EDP125 治疗中国儿童和青少年注意缺陷/多动障碍(ADHD)的安全性和有效性。次要研究目的 1) 确定 EDP125 的药代动力学特征及其变异性，并评价患者因素对药代动力学的可能影响。 2) 评价 EDP125 血浆浓度、药效学生物标记物 DHPG 血浆浓度与疗效之间的关系。

[Translation]

Primary study objectives To evaluate the safety and efficacy of EDP125 in the treatment of attention-deficit/hyperactivity disorder (ADHD) in Chinese children and adolescents. Secondary study objectives 1) To determine the pharmacokinetic characteristics and variability of EDP125 and to evaluate the possible effects of patient factors on pharmacokinetics. 2) To evaluate the relationship between EDP125 plasma concentration, pharmacodynamic biomarker DHPG plasma concentration and efficacy.

Start Date30 Aug 2021

Sponsor / Collaborator

Suzhou SIKRO Pharmaceutical Co., Ltd

NCT01460381 / CompletedPhase 1

A Study to Investigate the Effect of CYP2C19 Phenotype on the Pharmacokinetics of LY2216684 in Healthy Subjects

The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be documented.

Start Date01 Oct 2011

Sponsor / Collaborator

Eli Lilly & Co.

NCT01460407 / CompletedPhase 1

Effect of Clarithromycin on the Pharmacokinetics of LY2216684 in Healthy Subjects

The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of LY2216684 in healthy participants. Side effects will be documented. There will be 2 study periods (5 and 9 days) and follow up will occur at least 7 days after the last dose. Screening is required within 45 days prior to the start of the study.

Start Date01 Oct 2011

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Edivoxetine Hydrochloride

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100 Translational Medicine associated with Edivoxetine Hydrochloride

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100 Patents (Medical) associated with Edivoxetine Hydrochloride

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26

Literatures (Medical) associated with Edivoxetine Hydrochloride

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.

28 Feb 2023·Psychopharmacology bulletin

ADHD-A Clinician's Bird's Eye View of Current Status and New Vistas!

Review

Author: Alamiri, Bibi ; Elsori, Dalal ; Alwetayan, Salem ; Naguy, Ahmed ; Pridmore, Saxby

ObjectivesLiterature on ADHD has taken long strides recently as heaps of new data are pouring in through countless papers. Here, authors try to outline changing paradigms in ADHD practice. DSM-5 changes regarding the typology and diagnostic criteria are highlighted. Overview of co-morbidities, associations, developmental trajectories, and syndromic continuity across lifespan is outlined. Recent insights into aetiology and diagnostic tools are briefly discussed. New medications in the pipeline are also described.MethodsEMBASE, Ovid MEDLINE, PubMed, Scopus, Web of Science, and Cochrane Database of Systemic Reviews were searched for all relevant updates in ADHD literature as of June, 2022.ResultsDSM-5 brought about changes to the diagnostic criteria of ADHD. These included replacing types with presentations, pushing age to 12, and, incorporating adult diagnostic criteria. In the same vein, DSM-5 allows now for diagnosing concurrent ADHD and ASD. Associations of ADHD to allergy, obesity, sleep disorders, and, epilepsy have been demonstrated in recent literature. Neurocircuity underlying ADHD has been extended beyond frontal-striatal to include CTC as well as DMN accounting for ADHD heterogeneity. NEBA was FDA-approved to differentiate ADHD from hyperkinetic ID. Atypical antipsychotics use to address behavioural facets in ADHD is on the rise with no solid evidence-base. α-2 agonists are FDA-approved as monotherapy or adjunctive to stimulants. Pharmacogenetic testing is readily available for ADHD. Different formulations of stimulants abound on the market widening clinicians' repertoire. Stimulant-related exacerbation of anxiety and tics were challenged in recent studies. Drugs for ADHD in the pipeline include-dasotraline, armodafinil, tipepidine, edivoxetine, metadoxine, and memantine.ConclusionsLiterature on ADHD keeps expanding towards advancing our understanding of the complex and heterogeneous intricacies of this commonplace neurodevelopmental disorder and hence informing better decisions on how best to manage its diverse cognitive, behavioural, social and medical facets.

100 Deals associated with Edivoxetine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D09891	Edivoxetine Hydrochloride	-	DB09184

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	MX	Eli Lilly & Co.	01 Oct 2010
Depressive Disorder, Major	Phase 3	ES	Eli Lilly & Co.	01 Oct 2010
Depressive Disorder, Major	Phase 3	LT	Eli Lilly & Co.	01 Oct 2010
Depressive Disorder, Major	Phase 3	US	Eli Lilly & Co.	01 Oct 2010
Attention Deficit Disorder With Hyperactivity	Phase 3	CA	Eli Lilly & Co.	01 Jun 2009
Attention Deficit Disorder With Hyperactivity	Phase 2	US	Eli Lilly & Co.	01 Jun 2009
Attention Deficit Disorder With Hyperactivity	Phase 1	CA	Eli Lilly & Co.	01 Jun 2009
Attention Deficit Disorder With Hyperactivity	Phase 1	US	Eli Lilly & Co.	01 Jun 2009
Attention Deficit Disorder With Hyperactivity	Phase 1	PR	Eli Lilly & Co.	01 Jun 2009
Attention Deficit Disorder With Hyperactivity	Discovery	PR	Eli Lilly & Co.	01 Jun 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01389765 (CTgov)	Phase 1	Depressive Disorder, Major	24	LY2216684 (LY2216684 Administered in Fed State)	utbmcvfjaw(yimkhcfeqm) = ifogzmizdd nshkdubxgp (unrqstvxya, qqpuoyubpd - fhokmqntvl) View more	-	13 Nov 2018
				LY2216684 (LY2216684 Administered in Fasted State)	utbmcvfjaw(yimkhcfeqm) = lgicvgietj nshkdubxgp (unrqstvxya, puctbgihnb - ziifvtrupj) View more
NCT01460381 (CTgov)	Phase 1	Depressive Disorder, Major	18	LY2216684 (LY2216684 (CYP2C19 Extensive Metabolizers))	omjavmodym(pwrgxfrgmn) = qqvwkrmqyo iandfhadfp (jmvncmvzhd, hmjxeynvda - mibmaqhtze) View more	-	26 Oct 2018
				Quinidine+LY2216684 (LY2216684 + Quinidine (CYP2C19 Poor Metabolizers))	fnpollhots(hiikjsepyr) = uxlfljzrqq bscacanefr (ytxsxlymld, lbmqxpzaah - refrhtvmgv) View more
NCT01370499 (CTgov)	Phase 3	Depressive Disorder, Major	288	Placebo+LY2216684 (LY2216684 + SSRI (Placebo Prior Study))	(hlsoilbsdg) = zgvmzxysmg ujyhffmchp (zyrsqouvwc, mtspwyoact - xavmnspkli) View more	-	25 Oct 2018
				LY2216684 (LY2216684 + SSRI (LY2216684 Prior Study))	(hlsoilbsdg) = zopqasvbxe ujyhffmchp (zyrsqouvwc, levawrkjut - lhvqthgfma) View more
NCT01373931 (CTgov)	Phase 1	Depressive Disorder, Major	20	LY2216684 (OC + LY2216684)	yyyxdqnopy(nzzxadoeiy) = jrsmdpwdsm aymlokbsvp (hbvoeufjxn, ccehwvzpuf - iszvqoyntx) View more	-	23 Oct 2018
				Placebo (OC + Placebo)	yyyxdqnopy(nzzxadoeiy) = eeffekvtzy aymlokbsvp (hbvoeufjxn, hpnsykvloo - pkcyyjneia) View more
NCT01263223 (CTgov)	Phase 1	Depressive Disorder, Major	24	LY2216684 (18-mg LY2216684)	zogkhojdck(vftqrqknpq) = rakdkeljeg cefiwsudma (mvglvukpyg, jdiueinpdx - fnxmtlqidz) View more	-	23 Oct 2018
				Placebo (Placebo)	zogkhojdck(vftqrqknpq) = ryvrhrefhj cefiwsudma (mvglvukpyg, ejfztccwkn - dlyionvgdy) View more
NCT01263197 (CTgov)	Phase 1	Depressive Disorder, Major	48	LY2216684 (LY2216684 (Group 1))	gouurzdgav(qdkrptjlsh) = mplidedgri ffcblypydu (cpxkhcbpvy, yttjhgfxph - lstytbwurq) View more	-	22 Oct 2018
				Albuterol (Albuterol)	gouurzdgav(qdkrptjlsh) = hioguixoqr ffcblypydu (cpxkhcbpvy, nwotkqrojt - pxovjzhuik) View more
NCT01241435 (CTgov)	Phase 1	Depressive Disorder, Major	36	LY2216684 (Normal Hepatic Function)	lphhttgaic(qrgjcgaxbz) = eiulapqgsd qlptqzwjnd (ngvrucytkp, gndruditbg - sgbzkutbtj) View more	-	22 Oct 2018
				LY2216684 (Mild Hepatic Impairment)	lphhttgaic(qrgjcgaxbz) = gtkbdecmjt qlptqzwjnd (ngvrucytkp, ofmlnorjel - njqbilsnog) View more
NCT01243957 (CTgov)	Phase 1	Depressive Disorder, Major	20	Fluoxetine+LY2216684	bukakksfcf(xyphqduxgv) = kqmzxgouor wjvzhakxiy (bxmqhnzcgx, qrvpjcznva - wglickyljp) View more	-	22 Oct 2018
NCT01266590 (CTgov)	Phase 1	Depressive Disorder, Major	30	digoxin+LY2216684	lylvpoyimn(wtyiqlkiih) = zfzpiymuef czatatxsvi (jzabifcmjt, irplztslzq - qfqevztbie) View more	-	22 Oct 2018