drugs in development for depression/anxiety, sleep disorders, schizophrenia, bipolar disorder, and...
DESCRIPTION
Clinical drug compounds in research and development for Major Depressive Disorder and Anxiety, Sleep/Insomnia disorders, Schizophrenia, Bipolar Disorder, and Attention-Deficit Hyperactivity Disorder (ADHD)TRANSCRIPT
Drugs in Development for Drugs in Development for Depression, 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 NamePharmacolog
ic ActionCompany
Indication
Developmental Phase
Links
Vilazodone5-HT1A antagonist, SSRI
Clinical Data Online, Inc.
Depression, Anxiety
NDA anticipated in late-2009
1/06 press release
Valdoxan™ (agomelatine, AGO 178)
Melatonin agonist, 5-HT2B/2C
antagonist
Servier, Novartis
Depression, Anxiety
US: Phase III delayed (results not expected until 2011)EU: Approved and launched
Oct ’05 press release
Lu AA21004
5-HT1A partial
agonist, 5-HT3
antagonist
Lundbeck, Takeda
Depression, Anxiety
Phase III delayed(results not expected until 2011)
LY2216684Norepinephrine Reuptake Inhibitor
LillyDepression, ADHD Phase III
F2695, Levomilnacipran
NE/5-HT reuptake inhibitor, enantiomer of Milnacipran
Forest, Pierre Fabre
Depression, Anxiety
Phase III
SEP-227162DA/NE/5-HT reuptake inhibitor
SepracorDepression, Anxiety Phase II
Lu AA24530
5-HT3, 5-HT2c antagonism, reuptake inhibitor mechanism?
Lundbeck, Takeda
Depression, Anxiety Phase II June ’09 press
release
SEP-225289DA/NE/5-HT reuptake inhibitor
SepracorDepression, Anxiety Phase II
TC-5214Non-selective Nicotinic antagonist
Targacept Depression Phase II
Lu AA34893 Undisclosed monoamine
Lundbeck Depression, Bipolar
Phase II
modulator DisorderLosmapimod, GSK 856553
P38 kinase inhibitor
GSK Depression Phase II
Orvepitant, GW823296
NK-1 antagonist GSK Depression, Anxiety
Phase II
AZD6765 NMDA antagonist AstraZeneca Depression, Anxiety
Phase II
ONO-2333Ms CRF-1 antagonistOno Pharmaceuticals
Depression, Anxiety Phase II
OPC-34712 Otsuka Depression Phase II
Nemifitide (INN 00835)
Pentapeptide of melanocyte-inhibiting factor (MIF-1)
Tetragenex Depression Phase II [Innapharma’s info ]
SSR 411298 FAAH inhibitor Sanofi-AventisDepression [in the Elderly]
Phase II
BCI-540 BrainCells, Inc.
Depression Phase II
ORG 26576 AMPA modulatorMerck, Schering-Plough
Depression Phase II
TIK-101/D-Cycloserine
NMDA antagonist Tikvah Therapeutics
Anxiety, OCD
Phase II
ORG (34517/34850) GR antagonist
Merck, Schering-Plough
Depression Phase II
GSK561679 GSKDepression [in women only]
Phase II
Tyrima™, CX157
Reversible MAOI CeNeRx Depression, Anxiety
Phase II
RO4917523, EVT101
NMDA antagonist Evotec, Roche Depression Phase II
GSK 588045 5-HT1 antagonist GSK Depression, Anxiety
Phase II
RX-10100Unknown 5-HT and DA modulator
Rexahn Depression Phase II
AZD7325 GABA partial agonist
AstraZeneca Anxiety Phase II
AZD2327 Enkephalinergic modulator
AstraZeneca Anxiety Phase II
SA4503 Sigma agonist Eisai, M's Science
Depression Phase II (Europe)
PRE703 MgluR agonist Prescient Anxiety Phase IJNJ-19567470, TS-041
CRF-1 antagonist Janssen (J & J) , Taisho
Depression, Anxiety
Phase I Taisho’s press release
SSR 125543 CRF-1 antagonist Sanofi-Aventis Depression, Anxiety
Phase I
YKP3089Undisclosed mechanism of action
SK Pharmaceuticals
Anxiety Phase I
GSK 163090 5-HT1 antagonist GSK Depression, Anxiety
Phase I
GABA-A agonist Bristol-Myers Squibb
Anxiety Phase I
DA/NE/5-HT reuptake inhibitor
Bristol-Myers Squibb
Depression, Anxiety Phase I
TC-2216Nicotinic alpha4beta2 antagonist
Targacept Depression Phase I
URB597 FAAH inhibitorMerck, Schering-Plough
Depression, Anxiety Phase I
AZD6280 GABA partial agonist
AstraZeneca Anxiety Phase I
PSN0041 Undisclosed polypeptide
Psylin Neurosciences
Depression Phase I Press release
Sleep disorders
Drug NamePharmacologic Action
Company
Indication
Developmental Phase
Links
Ciltyri® (Eplivanserin)
5-HT2A antagonist
Sanofi-Aventis
Sleep disorders
FDA issued complete response (9/17/09) citing benefit-risk problems. Talks ongoingEU decision expected in Q4’09
[SR 46349 is selective for 5-HT2A receptors]
ORG 50081 (Esmirtazapine)
5-HT2 antagonist, H1 antagonist, alpha-adrenergic antagonist
Merck, Schering-Plough
Sleep disorders, hot flashes
Phase III
Tasimelteon, VEC-162
Melatonin agonist
Vanda Pharm.
Sleep disorders, Depression
Phase III
Almorexant, ACT-078573
Orexin antagonist
GSK, Actelion
Sleep disorders
Phase III
PD-6735 Melatonin agonist
Phase 2 Discovery
Sleep disorders
Phase II
Pimavanserin, ACP-103
5-HT2A inverse agonist
Acadia, Biovail
Parkinson’s-induced psychosis, Sleep
Phase II 9/2004 Press release
PD 200-390Alpha-2delta Calcium channel blocker
PfizerSleep disorders Phase II
DISCONTINUED
EVT 201GABA-A partial agonist Evotec
Sleep disorders Phase II
LY2624803, HY10275
5-HT2A and H1 antagonist
Lilly, Hypnion
Sleep disorders
Phase II
TIK-301, LY156735
Melatonin agonist, 5-HT2B/2C
antagonist
Tikvah Therapeutics, Phase 2 Discovery
Sleep disorders
Phase II
MK4305 MerckSleep disorders
Phase II
Psychosis/Bipolar disorder
Drug NamePharmacolog
ic ActionCompany
Indication
Developmental Phase
Links
Fanapt® (Iloperidone)
5-HT2A, D2/D3, and α1 adrenergic antagonist
Vanda Pharm. Psychosis APPROVED (5/6/09)
Saphris™ (Asenapine,ORG 5222)
5-HT2 antagonist, D2 partial agonist
Merck, Schering-Plough
Psychosis APPROVED (8/14/09)
Serdolect® (Sertindole)
5-HT2, 5-HT6, α1 adrenergic, and D2 antagonist
Lundbeck PsychosisNDA submitted to FDA. Approved in EU.
Bifeprunox (DU-127090)
D2/5-HT1A partial agonist Solvay, Wyeth Psychosis
Phase III (resubmission planned for ’09)
Discontinued
Corlux ®, CORT 108297 (mifespristone)
Cortisol antagonist Corcept
Psychosis, Depression Phase III Corlux info
Pardoprunox, SLV 308
D2/ D3 partial agonist, 5-HT1A
agonistSolvay
Psychosis, Parkinson’s Phase III
LIC477D (Licarbazepine)
NA+ current blocker
Novartis Bipolar disorder
Phase III
Pimavanserin, ACP-103
5-HT2A inverse agonist Acadia, Biovail
Parkinson’s-induced psychosis
Phase III9/2004 Press release
ORG 34517/34850 GR antagonist
Merck, Schering-Plough
Depression, Psychosis Phase II
ORG 24448 AMPA modulatorMerck, Schering-Plough, Cortex
Psychosis, Depression Phase II
Lurasidone (SM13496)
D2, 5-HT2A
antagonistMerck, Sumitomo
Psychosis Phase II
RG2417 (triacetyluridine)
Prodrug of uridine Repligen
Bipolar disorder Phase II
10/21/05 press release
Lonasen (blonanserin)
D2, 5-HT2A
antagonist
Dainippon Pharmaceuticals
Psychosis Phase II
R1678 mGluR modulator Roche Psychosis Phase IILY2140023 mGlu2/3 prodrug Lilly Psychosis Phase IIMirapex ® (pramipexole)
D2, D3 agonist Boehringer-Ingelheim
Bipolar disorder
Phase II
LU-31-130D1/D2 antagonist/5-HT2a antagonist
Lundbeck Psychosis Phase II
SM 13496 (Lurasidone)
Sumitomo Psychosis Phase II
Lu AA34893Undisclosed monoaminergic modulator
LundbeckDepression, Bipolar Disorder
Phase II
Lu AA39959 Undisclosed ion channel
Lundbeck Bipolar Disorder,
Phase II
modulator PsychosisCaripazine, RGH-188
D2/D3 antagonist Forest Laboratories
Psychosis Phase II
Talnetant (SB-223412)
NK-3 antagonist GSK Psychosis, IBS
Phase II
AVE 1625 CB1 antagonist Sanofi-Aventis Psychosis Phase II
GW742457 5-HT6 antagonist GSK Psychosis, Alzheimer’s
Phase II
Vabicaserin (SCA-136)
5-HT2c agonist Wyeth Depression Phase II
P-101 Alpha-2 antagonist
Potomac Pharma
Phase II
Org 25935 GLYT1 inhibitorMerck, Schering-Plough
Psychosis Phase II
RG1068, Secretin
endogenous pancreatic hormone
RepligenPsychosis, Autism, Anxiety
Phase II
ADX63365 MgluR agonist Merck Psychosis Phase IIBL-1020 GABA agonist BioLineRx Psychosis Phase IITS-032 mGluR modulator Pfizer Psychosis Phase IIPF-217830 Pfizer Psychosis Phase IIPF-2545920 Pfizer Psychosis Phase IISLV 313 5-HT2A antagonist Solvay Psychosis Phase II
ABT-089Nicotinic, Acetylcholine agonist
Abbott Psychosis Phase I
GW773812 D2/5-HT antagonist
GSK Psychosis Phase I
SSR 103800 GLYT1 inhibitor Sanofi-Aventis Psychosis Phase I
TC-1827
Alpha/4beta2 nicotinic acetylcholine receptor
TargaceptAntipsychotic-induced side effects
Phase I
YKP 1358SK Pharmaceuticals
Psychosis Phase I
JNJ-17305600 GLYT1 inhibitor Johnson & Johnson
Psychosis Phase I
XY 2401
glycine-site specific modulator of NMDA
Xytis Psychosis Phase I
PNU 170413 Pfizer Psychosis Phase IRGH-188 D2, D3 antagonist Forrest Psychosis Phase I
Attention Deficit Hyperactivity Disorder (ADHD)
Drug Name
Pharmacologic Action
CompanyIndicatio
nDevelopment
al PhaseLinks
SPD-465 (longer acting Adderall
Long-acting amphetamine product
Shire Pharmaceuticals
ADHD Approvable, awaiting final FDA approval
DISCO’D???
XR®)Intuniv® (SPD503, guanfacine)
Alpha-2a-adrenoceptor agonist
Shire Pharmaceuticals
ADHD Approvable, expected launch for late ‘09
Altropane Highly selective DA transporter radioligand
Boston Life Sciences
ADHD Phase II
ABT-089 nicotinic (nAChR) modulator
Abbott ADHD Phase II
ABT-894 nicotinic (nAChR) modulator
Abbott ADHD Phase II
PF-03654746
H3 antagonist? Pfizer ADHD Phase II
MEM3454 Nicotinic alpha7 partial agonist
Memory Pharm./ Roche
ADHD Phase II Memory’s drug profile
Eltroprazine 5-HT1A/1B agonist PsychoGenics ADHD Phase II
DOV-102677 DA/NE/5-HT reuptake inhibitor (with preferential action on the dopamine transporter)
DOV Pharmaceuticals
ADHD, Depression
Phase I
SON-216 (bifemelane)
Sosei ADHD Phase I
SPD-483 ATS (Amphetamine Transdermal System)
Shire Pharmaceuticals
ADHD 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.