Drugs in Development forDrugs in Development forDepression,Depression,Anxiety,Anxiety,Sleep disorders,Sleep disorders,Bipolar Disorder,Bipolar Disorder,Schizophrenia,Schizophrenia,and Attention-Deficit Hyperactivity Disorderand Attention-Deficit Hyperactivity Disorder (ADHD)(ADHD)

Updated 9/18/2009

*COLOR KEY: ____ - indicates update ____ - indicates discontinued

Depression/Anxiety

Drug NamePharmacologicActionCompanyIndicationDevelopmentalPhaseLinks

Vilazodone

5-HT

1A

antagonist,SSRIClinical DataOnline, Inc.Depression,Anxiety

NDA anticipatedin late-2009

1/06 pressrelease

Valdoxan™

(agomelatine,AGO 178)

Melatonin agonist,5-HT

2B/2C

antagonistServier,NovartisDepression,Anxiety

US: Phase III

delayed(results not expecteduntil 2011)EU: Approved andlaunched

Oct ’05 pressrelease

Lu AA21004

5-HT

1A

partialagonist, 5-HT

3

antagonistLundbeck,TakedaDepression,Anxiety

Phase III delayed

(results not expecteduntil 2011)

LY2216684

NorepinephrineReuptake InhibitorLillyDepression,ADHD

Phase IIIF2695,Levomilnacipran

NE/5-HT reuptakeinhibitor,enantiomer of MilnacipranForest,PierreFabreDepression,Anxiety

Phase IIISEP-227162

DA/NE/5-HTreuptake inhibitorSepracorDepression,Anxiety

Phase IILu AA24530

5-HT

3

, 5-HT2

c

antagonism,

reuptake inhibitor mechanism?

TakedaDepression,Anxiety

Phase II

June ’09 pressrelease

SEP-225289

DA/NE/5-HTreuptake inhibitorSepracorDepression,Anxiety

Phase IITC-5214

Non-selectiveNicotinic antagonistTargaceptDepression

Phase IILu AA34893

UndisclosedmonoaminemodulatorLundbeckDepression,BipolarDisorder

Phase IILosmapimod,GSK 856553

P38 kinase inhibitorGSKDepression

Phase II

Orvepitant,GW823296

NK-1 antagonistGSKDepression,Anxiety

Phase IIAZD6765

NMDA antagonistAstraZenecaDepression,Anxiety

Phase IIONO-2333Ms

CRF-1 antagonistOnoPharmaceuticalsDepression,Anxiety

Phase IIOPC-34712

OtsukaDepression

Phase IINemifitide (INN00835)

Pentapeptide of melanocyte-inhibiting factor(MIF-1)TetragenexDepression

Phase II

[Innapharma’sinfo ]

SSR 411298

FAAH inhibitorSanofi-AventisDepression[in theElderly]

Phase IIBCI-540

BrainCells, Inc.Depression

Phase IIORG 26576

AMPA modulatorMerck,Schering-PloughDepression

Phase IITIK-101/D-Cycloserine

NMDA antagonist

TikvahTherapeutics

Anxiety, OCD

Phase IIORG(34517/34850)

GR antagonistMerck,Schering-PloughDepression

Phase IIGSK561679

GSKDepression[in womenonly]

Phase IITyrima™,CX157

Reversible MAOICeNeRxDepression,Anxiety

Phase IIRO4917523,EVT101

NMDA antagonistEvotec,RocheDepression

Phase IIGSK 588045

5-HT1 antagonistGSKDepression,Anxiety

Phase IIRX-10100

Unknown 5-HT andDA modulatorRexahnDepression

Phase IIAZD7325

GABA partialagonistAstraZenecaAnxiety

Phase IIAZD2327

EnkephalinergicmodulatorAstraZenecaAnxiety

Phase IISA4503

Sigma agonistEisai,M'sScienceDepression

Phase II

(Europe)

PRE703

MgluR agonistPrescientAnxiety

Phase IJNJ-19567470,TS-041

CRF-1 antagonistJanssen (J & J), TaishoDepression,Anxiety

Phase I

Taisho’s pressrelease

SSR 125543

CRF-1 antagonistSanofi-AventisDepression,Anxiety

Phase IYKP3089

Undisclosedmechanism of actionSKPharmaceuticalsAnxiety

Phase IGSK 163090

5-HT1 antagonistGSKDepression,Anxiety

Phase I

GABA-A agonistBristol-MyersSquibbAnxiety

Phase I

DA/NE/5-HTreuptake inhibitorBristol-MyersSquibbDepression,Anxiety

Phase ITC-2216

Nicotinicalpha4beta2TargaceptDepression

Phase I

antagonist

URB597

FAAH inhibitorMerck,Schering-PloughDepression,Anxiety

Phase IAZD6280

GABA partialagonistAstraZenecaAnxiety

Phase IPSN0041

UndisclosedpolypeptidePsylinNeurosciencesDepression

Phase I

Sleep disorders

Drug NamePharmacologicActionCompanyIndicationDevelopmentalPhaseLinks

Ciltyri®(Eplivanserin)

5-HT

2A

antagonistSanofi-AventisSleepdisorders

FDA issued completeresponse (9/17/09)citing benefit-riskproblems. TalksongoingEU decision expectedin Q4’09

[SR 46349 is selective for 5-HT2A receptors]

ORG 50081(Esmirtazapine)

5-HT

2

antagonist,H

1

antagonist,alpha-adrenergicantagonistMerck,Schering-PloughSleepdisorders, hotflashes

Phase IIITasimelteon,VEC-162

Melatonin agonistVandaPharm.Sleepdisorders,Depression

Phase IIIAlmorexant,ACT-078573

Orexin antagonistGSK,ActelionSleepdisorders

Phase IIIPD-6735

Melatonin agonistPhase 2DiscoverySleepdisorders

Phase IIPimavanserin,ACP-103

5-HT

2A

inverseagonistAcadia,BiovailParkinson’s-inducedpsychosis,Sleep

Phase II

9/2004 Press release

PD 200-390

Alpha-2delta

Calcium channel

blocker

Sleep

disorders

Phase II

DISCONTINUED

EVT 201

GABA-A partialagonistEvotecSleepdisorders

Phase IILY2624803,HY10275

5-HT

2A

and H1antagonistLilly, HypnionSleepdisorders

Phase IITIK-301,LY156735

Melatonin agonist,5-HT

2B/2C

antagonist

TikvahTherapeutics,Phase 2Discovery

Sleepdisorders

Phase IIMK4305

Sleepdisorders

Phase II

Psychosis/Bipolar disorder

Drug NamePharmacologicActionCompanyIndicationDevelopmentalPhaseLinks

Fanapt®

5-HT

2A

, D

2

/D

3

, andVanda Pharm.Psychosis

APPROVED

Drugs in Development for Depression/Anxiety, Sleep disorders, Schizophrenia, Bipolar Disorder, and Attention-Deficit Hyperactivity Disorder (ADHD)

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AmySchemerleft a comment

Not current, any chance this could be updated?

03 / 04 / 2010

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