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

(ADHD)
*COLOR KEY: ____ - indicates update

Updated 9/18/2009

____ - indicates discontinued

Depression/Anxiety
Drug Name
Vilazodone Valdoxan™ (agomelatine, AGO 178)

Pharmacologic Action
5-HT1A antagonist, SSRI

Company
Clinical Data Online, Inc.

Indication
Depression, Anxiety Depression, Anxiety

Developmental Phase
NDA anticipated in late-2009

Links
1/06 press release

Melatonin agonist, Servier, 5-HT2B/2C antagonist Novartis 5-HT1A partial

US: Phase III delayed (results not expected Oct ’05 press until 2011) release EU: Approved and launched

Lu AA21004

agonist, 5-HT3

Lundbeck, Takeda Lilly Forest, Pierre Fabre Sepracor Lundbeck, Takeda Sepracor Targacept Lundbeck GSK

Depression, Anxiety Depression, ADHD Depression, Anxiety Depression, Anxiety Depression, Anxiety Depression, Anxiety Depression Depression, Bipolar Disorder Depression

Phase III delayed
(results not expected until 2011)

antagonist Norepinephrine LY2216684 Reuptake Inhibitor NE/5-HT reuptake F2695, inhibitor, Levomilnacipran enantiomer of Milnacipran DA/NE/5-HT SEP-227162 reuptake inhibitor 5-HT3, 5-HT2c antagonism, Lu AA24530 reuptake inhibitor mechanism? DA/NE/5-HT SEP-225289 reuptake inhibitor Non-selective TC-5214 Nicotinic antagonist Undisclosed Lu AA34893 monoamine modulator Losmapimod, P38 kinase inhibitor GSK 856553

Phase III

Phase III

Phase II
June ’09 press release

Phase II

Phase II Phase II Phase II Phase II

Orvepitant, GW823296 AZD6765 ONO-2333Ms OPC-34712

NK-1 antagonist NMDA antagonist CRF-1 antagonist

Depression, Anxiety Depression, AstraZeneca Anxiety Ono Depression, Pharmaceuticals Anxiety Otsuka Depression GSK Tetragenex Depression

Phase II Phase II Phase II Phase II Phase II
[Innapharma’s info]

Pentapeptide of Nemifitide (INN melanocyte00835) inhibiting factor (MIF-1) SSR 411298 BCI-540 ORG 26576 AMPA modulator FAAH inhibitor

Depression [in the Elderly] BrainCells, Inc. Depression Merck, Depression Schering-Plough Sanofi-Aventis
Tikvah Therapeutics

Phase II Phase II Phase II

TIK-101/DNMDA antagonist Cycloserine ORG GR antagonist (34517/34850) GSK561679 Tyrima™, CX157 RO4917523, EVT101 GSK 588045 RX-10100 AZD7325 AZD2327 SA4503 PRE703 JNJ-19567470, TS-041 SSR 125543 YKP3089 GSK 163090 Reversible MAOI NMDA antagonist 5-HT1 antagonist

Anxiety, OCD Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase I Phase I Phase I Phase I Phase I Phase I Phase I Phase I
Taisho’s press release
(Europe)

Merck, Depression Schering-Plough Depression GSK [in women only] Depression, CeNeRx Anxiety Evotec, Roche GSK Depression Depression, Anxiety

TC-2216

Unknown 5-HT and Rexahn Depression DA modulator GABA partial AstraZeneca Anxiety agonist Enkephalinergic AstraZeneca Anxiety modulator Eisai, M's Sigma agonist Depression Science MgluR agonist Prescient Anxiety Janssen (J & J), Depression, CRF-1 antagonist Taisho Anxiety Depression, CRF-1 antagonist Sanofi-Aventis Anxiety Undisclosed SK mechanism of Anxiety Pharmaceuticals action Depression, 5-HT1 antagonist GSK Anxiety Bristol-Myers GABA-A agonist Anxiety Squibb DA/NE/5-HT Bristol-Myers Depression, reuptake inhibitor Squibb Anxiety Nicotinic Targacept Depression alpha4beta2

antagonist URB597 AZD6280 PSN0041 FAAH inhibitor GABA partial agonist Undisclosed polypeptide Merck, Depression, Schering-Plough Anxiety AstraZeneca Psylin Neurosciences Anxiety Depression Phase I Phase I Phase I
Press release

Sleep disorders
Drug Name Pharmacologic Developmental Company Indication Action Phase
5-HT2A antagonist SanofiAventis Sleep disorders
FDA issued complete response (9/17/09) citing benefit-risk problems. Talks ongoing EU decision expected in Q4’09

Links

Ciltyri® (Eplivanserin)

[SR 46349 is selective for 5-HT2A receptors]

5-HT2 antagonist, ORG 50081 H1 antagonist, (Esmirtazapine) alpha-adrenergic antagonist Tasimelteon, VEC-162 Almorexant, ACT-078573 PD-6735 Pimavanserin, ACP-103 Melatonin agonist Orexin antagonist Melatonin agonist 5-HT2A inverse agonist Alpha-2delta Calcium channel blocker GABA-A partial agonist 5-HT2A and H1 antagonist

Merck, ScheringPlough Vanda Pharm. GSK, Actelion Phase 2 Discovery Acadia, Biovail

Sleep disorders, hot Phase III flashes Sleep disorders, Depression Sleep disorders Sleep disorders Parkinson’sinduced psychosis, Sleep Sleep disorders Sleep disorders Sleep disorders Phase III Phase III Phase II

Phase II

9/2004 Press release

PD 200-390 EVT 201 LY2624803, HY10275 TIK-301, LY156735 MK4305

Pfizer Evotec Lilly, Hypnion
Tikvah

Phase II Phase II Phase II Phase II Phase II

DISCONTINUED

Melatonin agonist, Therapeutics, Sleep 5-HT2B/2C antagonist Phase 2 disorders
Discovery Merck

Sleep disorders

Psychosis/Bipolar disorder
Drug Name
Fanapt®

Pharmacologic Action

Company

Indication
Psychosis

Developmental Phase
APPROVED

Links

5-HT2A, D2/D3, and Vanda Pharm.

(Iloperidone) Saphris™ (Asenapine, ORG 5222) Serdolect® (Sertindole)

α1 adrenergic antagonist 5-HT2 antagonist, D2 partial agonist Merck, Psychosis Schering-Plough Psychosis Psychosis Psychosis, Depression Psychosis, Parkinson’s

(5/6/09)

APPROVED
(8/14/09)

5-HT2, 5-HT6, α1 adrenergic, and D2 Lundbeck antagonist Solvay, Wyeth

Bifeprunox (DU- D2/5-HT1A partial 127090) agonist Corlux ®, CORT 108297 (mifespristone) Pardoprunox, SLV 308 LIC477D (Licarbazepine) Pimavanserin, ACP-103 ORG 34517/34850 ORG 24448 Lurasidone (SM13496) RG2417 (triacetyluridine) Lonasen (blonanserin) R1678 LY2140023 Mirapex ® (pramipexole) LU-31-130 SM 13496 (Lurasidone) Lu AA34893 Undisclosed monoaminergic modulator

NDA submitted to FDA. Approved in EU. Phase III
(resubmission planned for ’09)

Discontinued

Cortisol antagonist Corcept D2/ D3 partial agonist, 5-HT1A agonist NA+ current blocker 5-HT2A inverse agonist GR antagonist AMPA modulator D2, 5-HT2A antagonist Prodrug of uridine D2, 5-HT2A antagonist mGluR modulator mGlu2/3 prodrug D2, D3 agonist

Phase III

Corlux info

Solvay Novartis

Phase III Phase III Phase III Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II Phase II
10/21/05 press release 9/2004 Press release

Bipolar disorder Parkinson’sAcadia, Biovail induced psychosis Merck, Depression, Schering-Plough Psychosis Merck, Psychosis, ScheringDepression Plough, Cortex Merck, Psychosis Sumitomo Bipolar Repligen disorder Dainippon Psychosis Pharmaceuticals Roche Psychosis Lilly Psychosis BoehringerBipolar Ingelheim disorder Psychosis Psychosis Depression, Bipolar Disorder Bipolar Disorder, Psychosis Psychosis Psychosis, IBS Psychosis Psychosis, Alzheimer’s

D1/D2 antagonist/5Lundbeck HT2a antagonist Sumitomo Lundbeck

Lu AA39959

Undisclosed ion Lundbeck channel modulator Forest Laboratories GSK Sanofi-Aventis GSK

Phase II Phase II Phase II Phase II Phase II

Caripazine, RGHD2/D3 antagonist 188 Talnetant (SBNK-3 antagonist 223412) AVE 1625 CB1 antagonist GW742457 5-HT6 antagonist

Vabicaserin (SCA-136) P-101 Org 25935

5-HT2c agonist Alpha-2 antagonist GLYT1 inhibitor

Wyeth

Depression

Phase II Phase II Phase II Phase II Phase Phase Phase Phase Phase Phase II II II II II II

endogenous RG1068, Secretin pancreatic hormone ADX63365 MgluR agonist BL-1020 GABA agonist TS-032 mGluR modulator PF-217830 PF-2545920 SLV 313 5-HT2A antagonist Nicotinic, ABT-089 Acetylcholine agonist GW773812 D2/5-HT antagonist SSR 103800 GLYT1 inhibitor Alpha/4beta2 nicotinic TC-1827 acetylcholine receptor YKP 1358 JNJ-17305600 XY 2401 PNU 170413 RGH-188 GLYT1 inhibitor

Potomac Pharma Merck, Psychosis Schering-Plough Psychosis, Repligen Autism, Anxiety Merck Psychosis BioLineRx Psychosis Pfizer Psychosis Pfizer Psychosis Pfizer Psychosis Solvay Psychosis Abbott GSK Sanofi-Aventis Targacept Psychosis Psychosis Psychosis

Phase I Phase I Phase I

Antipsychoticinduced side Phase I effects Phase I Phase I Phase I Phase I Phase I

SK Psychosis Pharmaceuticals Johnson & Psychosis Johnson Psychosis Psychosis Psychosis

glycine-site specific Xytis modulator of NMDA Pfizer D2, D3 antagonist Forrest

Attention Deficit Hyperactivity Disorder (ADHD)
Drug Name
SPD-465 (longer acting Adderall XR®) Intuniv® (SPD503, guanfacine) Altropane

Pharmacologic Action
Long-acting amphetamine product

Company

Indication

Developmental Phase
Approvable, awaiting final FDA approval

Links
DISCO’D?? ?

Shire ADHD Pharmaceuticals

ABT-089 ABT-894

Alpha-2aadrenoceptor agonist Highly selective DA transporter radioligand nicotinic (nAChR) modulator nicotinic (nAChR) modulator

Shire ADHD Pharmaceuticals Boston Life Sciences Abbott Abbott ADHD

Approvable, expected launch for late ‘09 Phase II

ADHD ADHD

Phase II Phase II

PF03654746 MEM3454

H3 antagonist?

Pfizer Memory Pharm./ Roche PsychoGenics DOV Pharmaceuticals

ADHD ADHD ADHD ADHD, Depression

Phase II Phase II Phase II Phase I
Memory’s drug profile

Nicotinic alpha7 partial agonist Eltroprazine 5-HT1A/1B agonist DOV-102677 DA/NE/5-HT reuptake inhibitor (with preferential action on the dopamine transporter) SON-216 (bifemelane) SPD-483

Sosei

ADHD

Phase I

ATS (Amphetamine Shire ADHD Transdermal Pharmaceuticals System)

Preclinical

APPENDIX 1 Terms glossary Phase I: Phase I includes the initial introduction of an investigational new drug into humans. Phase I studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase I, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase II studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase II: Phase II includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase II studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. Phase III:

A phase III trial frequently compares a new treatment to a standard treatment or to no treatment, and treatment allocation may be randomly assigned and the data masked. These studies usually involve a large number of participants followed for longer periods of treatment exposure. Phase III studies are expanded controlled and uncontrolled trials. Phase III studies usually include from several hundred to several thousand subjects. NDA: New Drug Application. NDA refers to the data that the drug company submits to the FDA at the time of the drug’s application filing. Approvable: The term given to a drug’s tentative approval status by the FDA. Before the drug can be launched, the company has to fulfill ongoing clinical and manufacturing concerns brought up by the FDA.

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