Future Treatments for Depression, Anxiety, Sleep Disorders, Psychosis, and ADHD
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This list is regulary updated by Neurotransmitter.net's Drug Pipeline Expert, JR Becker (jrbecker76@hotmail.com). Shawn Thomas (shawn@neurotransmitter.net) is responsible for additions, editing, and fact-checking. Dr. Louis Sanfilippo, Professor of Clinical Psychiatry at Yale, is also a valued contributor to this groundbreaking and widely appreciated list.

Treatments for Depression and Anxiety

Drug Name Pharmacologic Action Company Indication Developmental Phase Links
Valdoxan (agomelatine, AGO 178) 5-HT2C antagonist, 5-HT2B antagonist, melatonin M1/M2 receptor agonist Servier, Novartis Depression, anxiety US: Phase III - submission expected in mid-2009
EU: Approved, launch expected mid-2009

[Receptor activity] [Oct 2005 press release] [ClinicalTrials.gov]
Vilazodone 5-HT1A partial agonist, serotonin reuptake inhibitor Clinical Data Online, Inc. Depression Phase III [January 2007 Press Release] [ClinicalTrials.gov]
Lu AA21004 5-HT3 antagonist, 5-HT1A partial agonist Lundbeck Depression, anxiety Phase III

[Lu AA21004: a novel potential treatment for mood disorders][ClinicalTrials.gov]
PD-332334 Alpha2delta calcium channel blocker Pfizer Anxiety, sleep Phase III [ClinicalTrials.gov]
LY2216684 Norepinephrine reuptake inhibitor Eli Lilly Depression, ADHD Phase III [ClinicalTrials.gov]
SEP-227162 DA/NE/5-HT reuptake inhibitor Sepracor Depression, anxiety Phase III [ClinicalTrials.gov]
F2695, levomilnacipran enantiomer of milnacipran Forest Labs, Pierre Fabre Depression Phase II [ClinicalTrials.gov]
Lu AA24530 Mixed serotonin modulator Lundbeck Depression, anxiety Phase II [ClinicalTrials.gov]
SEP-225289 DA/NE/5-HT reuptake inhibitor Sepracor Depression, anxiety Phase II [ClinicalTrials.gov]
Lu AA34893 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Lundbeck Bipolar depression, anxiety Phase II [ClinicalTrials.gov]
Losmapimod, GSK 856553 P38 kinase inhibitor GSK Depression Phase II [ClinicalTrials.gov]
TIK-101/d-cycloserine NMDA anatagonist Tikvah Pharmaceuticals Anxiety, OCD Phase II [ClinicalTrials.gov]
GW823296 (orvepitant) NK1 antagonist GSK Depression, anxiety Phase II [ClinicalTrials.gov]
ORG 34517/34850 Glucocorticoid receptor type II (GRII) antagonist Schering-Plough Depression, psychosis Phase II [ClinicalTrials.gov]
AZD6765 NMDA antagonist AstraZeneca Depression, anxiety Phase II [ClinicalTrials.gov]
TC-5214 Nonselective Nicotinic acetylcholine receptor antagonist Targacept Depression Phase II [ClinicalTrials.gov]
Nemifitide
(INN 00835)		 Pentapeptide analog of melanocyte-inhibiting factor (MIF-1) administered intravenously (mechanism unknown) Tetragenex Depression Phase II [Innapharma's info] [Antidepressant-like effects of a novel pentapeptide, nemifitide, in an animal model of depression] [MIF-1 may regulate ACTH secretion] [ClinicalTrials.gov]
RO4917523 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Roche Depression Phase II [ClinicalTrials.gov]
ONO-2333Ms CRF1 antagonist Ono Pharmaceuticals Depression, anxiety Phase II [ClinicalTrials.gov]
OPC-34712 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Otsuka Depression Phase II [ClinicalTrials.gov]
SSR 411298 FAAH (fatty acid amide hydrolase) inhibitor Sanofi-Aventis Depression, anxiety, hyperphagia Phase II [ClinicalTrials.gov]
BCI-540 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. BrainCells Inc. Depression Phase II [ClinicalTrials.gov]
ORG 26576 AMPA receptor modulator Schering-Plough Depression Phase II [ClinicalTrials.gov]
GSK561679 CRF1 antagonist GSK Depression (in wom Phase II [ClinicalTrials.gov]
Tyrima™, CX157 Reversible monoamine oxidase A (MAO-A) inhibitor CeNeRx Depression, anxiety Phase II [ClinicalTrials.gov]
EVT101 NMDA antagonist Roche Depression Phase II [ClinicalTrials.gov]
RX-10100 Unknown serotonin and dopamine modulator Rexahn Depression Phase II [ClinicalTrials.gov]
AZD7325 GABA receptor partial agonist AstraZeneca Anxiety Phase II [ClinicalTrials.gov]
AZD2327 Enkephalinergic modulator AstraZeneca Anxiety Phase II [ClinicalTrials.gov]
SA4503 Sigma receptor agonist Eisai, M's Science Depression, post-stroke recovery Phase II (Europe) [ClinicalTrials.gov]
PRE703 MgluR agonist Prescient Anxiety Phase I [ClinicalTrials.gov]
JNJ-19567470, TS-041 CRF1 antagonist Janssen (Johnson & Johnson), Taisho Depression, anxiety Phase I [ClinicalTrials.gov]
SSR 125543 CRF1 antagonist Sanofi-Aventis Depression, anxiety, hyperphagia Phase I [ClinicalTrials.gov]
YKP3089 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. SK Pharmaceuticals Anxiety Phase I [ClinicalTrials.gov]
GSK 588045 5-HT1 antagonist GSK Depression, anxiety Phase I [ClinicalTrials.gov]
GSK 163090 5-HT1 antagonist GSK Depression, anxiety Phase I [ClinicalTrials.gov]
TC-2216 Nicotinic acetylcholine receptor (alpha4beta2) antagonist Targacept Depression Phase I [ClinicalTrials.gov]
URB597 FAAH (fatty acid amide hydrolase) inhibitor Schering-Plough Depression Phase I [ClinicalTrials.gov]
AZD6280 GABA receptor partial agonist AstraZeneca Anxiety Phase I [ClinicalTrials.gov]
PSN0041 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Psylin Neurosciences Depression Phase I [ClinicalTrials.gov]

Treatments for Sleep Disorders

Drug Name Pharmacologic Action Company Indication Developmental Phase Links
Ciltyri®, Eplivanserin, SR 46349 5-HT2A receptor antagonist Sanofi-Aventis Sleep disorders US/EU decisions expected in 4th quarter 2009 [ClinicalTrials.gov]
ORG 50081 (esmirtazapine) 5-HT2 antagonist, H1 antagonist, alpha-2-adrenoceptor antagonist Schering-Plough Sleep disorders, hot flashes Phase III [ClinicalTrials.gov]
Tasimelte, VEC-162 Melatonin receptor agonist Vanda Pharmaceuticals Sleep disorders, depression Phase III [Vanda's info] [ClinicalTrials.gov]
Almorexant, ACT-078573 Orexen OX1 and OX2 receptor antagonist Actelion Sleep disorders Phase III [Actelion's Web Site] [ClinicalTrials.gov]
PD-6735 Melatonin receptor agonist Phase 2 Discovery Sleep Disorders Phase II [ClinicalTrials.gov]
Pimavanserin, ACP-103 Serotonin 5-HT2A receptor inverse agonist, dopamine D2/D3 receptor partial agonist, acetylcholine M1 receptor agonist Acadia Sleep disorders, Parkinson's disease psychosis, schizophrenia co-therapy Phase II [June 07 Press Release] [ClinicalTrials.gov]
PD-200,390 Voltage-gated calcium channel alpha(2)delta subunit modulator Pfizer Sleep disorders Phase II [ClinicalTrials.gov]
EVT 201 GABA-A partial agonist Evotec Sleep disorders Phase II [ClinicalTrials.gov]
LY2624803, HY10275 5-HT2A and histamine H1 receptor antagonist

Eli Lilly, Hypnion

 Depression, ADHD Phase II [ClinicalTrials.gov]
TIK-301, LY156735 Melatonin agonist, 5-HT2B/5-HT2C antagonist Tikvah Pharmaceuticals Sleep disorders Phase II [ClinicalTrials.gov]
MK4305 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Merck Sleep disorders Phase II [ClinicalTrials.gov]

Treatments for Psychosis/Bipolar Disorder

Drug Name Pharmacologic Action Company Indication Developmental Phase Links
Fanapt ® (iloperidone) 5-HT2A antagonist, D2/D3 antagonist, alpha-1-adrenoceptor antagonist Vanda Pharmaceuticals Psychosis Approved 5/7/09 [ClinicalTrials.gov]
Saphris™ (asenapine, ORG 5222) 5-HT2 antagonist, D2 partial agonist Schering-Plough Psychosis NDA Submitted, approval expected by mid-2009 [ClinicalTrials.gov]
Serdolect®, sertindole 5-H2 antagonist, 5-HT6 antagonist, D2 antagonist, afects alpha-1-adrenoceptor Lundbeck Psychosis NDA Submitted (approved in EU) [ClinicalTrials.gov]
Bifeprunox (DU-127090) Partial agonist at dopamine D2 and serotonin 5-HT1A receptors Solvay, Wyeth Psychosis Phase III (resubmission planned for 2009) [ClinicalTrials.gov]
Corlux ® (AKA mifepristone or RU-486) Glucocorticoid receptor type II (GRII) antagonist, progesterone receptor antagonist Corcept Psychosis, depression Phase III [Corcept's info] [ClinicalTrials.gov]
Pardoprunox, SLV 308 D2 partial agonist, 5-HT1A agonist Solvay Psychosis, Parkinson's disease Phase III [ClinicalTrials.gov]
LIC477D (licarbazepine) Voltage-gated sodium channel inhibitor Novartis Psychosis Phase III [ClinicalTrials.gov]
Pimavanserin, ACP-103 Serotonin 5-HT2A receptor inverse agonist, dopamine D2/D3 receptor partial agonist, acetylcholine M1 receptor agonist Acadia Antipsychotic-induced side effects, Parkinson's disease psychosis Phase III [June 07 Press Release] [ClinicalTrials.gov]
ORG 34517/34850 Glucocorticoid receptor type II (GRII) antagonist Schering-Plough Depression, psychosis Phase II [ClinicalTrials.gov]
ORG 24448 AMPA modulator Schering-Plough/Cortex Psychosis Phase II [ClinicalTrials.gov]
Lurasidone (SM 13496) D2, 5-HT2A antagonist

Merck, Dainippon Sumitomo

 Psychosis Phase II [ClinicalTrials.gov]
RG2417 (triacetyluridine) Prodrug of uridine Repligen Bipolar disorder Phase II

[Repligen's info] [ClinicalTrials.gov]
Lonasen (blonanserin) D2, 5-HT2A antagonist Dainippon Sumitomo Psychosis Phase II [ClinicalTrials.gov]
R1678 mGluR modulator Roche Psychosis Phase II [ClinicalTrials.gov]
LY2140023 Prodrug for an mGluR2/3 agonist Eli Lilly Psychosis Phase II [ClinicalTrials.gov]
Mirapex ® (pramipexole) Dopamine D2, D3 receptor agonist Boehringer-Ingelheim Bipolar Disorder Phase II [ClinicalTrials.gov]
Lu-31-130 D1 antagonist, D2 antagonist, 5-HT2A antagonist Lundbeck Psychosis Phase II [ClinicalTrials.gov]
Lu AA34893 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Lundbeck Bipolar depression, anxiety Phase II [ClinicalTrials.gov]
Lu AA39959 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Lundbeck Bipolar depression, anxiety Phase II [ClinicalTrials.gov]
Caripazine, RGH-188 D2, D3 antagonist

Forest Labs

 Psychosis Phase II [ClinicalTrials.gov]
Talnetant (SB-223412) NK-3 antagonist GSK Psychosis, IBS, overactive bladder Phase II [ClinicalTrials.gov]
AVE1625 CB1 antagonist Sanofi-Aventis Psychosis Phase II [ClinicalTrials.gov]
GW742457 5-HT6 antagonist GSK Psychosis, Alzheimer's Phase II [ClinicalTrials.gov]
vabicaserin (SCA-136) 5-HT2C agonist Wyeth Schizophrenia Phase II [ClinicalTrials.gov]
P-101 Alpha-2-adrenoceptor antagonist Potomac Pharma Schizophrenia Phase II [ClinicalTrials.gov]
ORG 25935 GLYT1 (glycine transporter) inhibitor Schering-Plough Psychosis Phase II [ClinicalTrials.gov]
RG1068, secretin Endogenous pancreatic hormone Repligen Psychosis, autism, anxiety Phase II [ClinicalTrials.gov]
ADX63365 MGluR agonist Merck Psychosis Phase II [ClinicalTrials.gov]
BL-1020 GABA-A agonist BioLineRx Psychosis Phase II [ClinicalTrials.gov]
TS-032 5-HT2A antagonist Pfizer Psychosis Phase II [ClinicalTrials.gov]
PF-217830 D3 antagonist Pfizer Psychosis Phase II [ClinicalTrials.gov]
PF-2545920 D3 antagonist Pfizer Psychosis Phase II [ClinicalTrials.gov]
SLV 313 5-HT2A antagonist Solvay Psychosis Phase II [ClinicalTrials.gov]
ABT-089 Nicotinic acetylcholine receptor agonist Abbott Laboratories Psychosis, ADHD Phase I [ClinicalTrials.gov]
GW773812 D2, 5-HT antagonist GSK Psychosis Phase I [ClinicalTrials.gov]
SSR 103800 GLYT1 (Type 1 glycine transporter) inhibitor Sanofi-Aventis Psychosis Phase I  
TC-1827 Selective alpha4beta2 nicotinic acetylcholine receptor agonist Targacept Cognitive impairment associated with schizophrenia Phase I [ClinicalTrials.gov]
YKP 1358 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. SK Pharmaceuticals Psychosis Phase I [ClinicalTrials.gov]
JNJ-17305600 GLYT1 inhibitor Johnson & Johnson Psychosis Phase I [ClinicalTrials.gov]
XY 2401 Glycine site specific NMDA modulator Xytis Psychosis Phase I [ClinicalTrials.gov]
PNU 170413 D3 antagonist Pfizer Psychosis Phase I [ClinicalTrials.gov]
RGH-188 D2, D3 antagonist Forrest Psychosis Phase I [ClinicalTrials.gov]

Treatments for Attention Deficit Hyperactivity Disorder (ADHD)

Drug Name Pharmacologic Action Company Indication Developmental Phase Links
SPD-465 (longer acting Adderall XR ®) Long-acting amphetamine product Shire Pharmaceuticals ADHD Approvable, awaiting final FDA approval [ClinicalTrials.gov]
Intuniv ® (SPD-503, guanfacine) Alpha-2A-adrenoceptor agonist Shire Pharmaceuticals ADHD Approvable, awaiting final FDA approval [ClinicalTrials.gov]
Altropane Highly selective dopamine transporter radioligand Boston Life Sciences ADHD Phase II [ClinicalTrials.gov]
ABT-089 Nicotinic acetylcholine receptor agonist Abbott Laboratories ADHD, Psychosis Phase II [ClinicalTrials.gov]
ABT-894 Nicotinic acetylcholine receptor agonist Abbott Laboratories ADHD Phase II [ClinicalTrials.gov]
PF-03654746 Histamine H3 receptor antagonist Pfizer ADHD Phase II [ClinicalTrials.gov]
MEM3454 Alpha-7 nicotinic acetylcholine receptor partial agonist Memory Pharm./ Roche ADHD Phase II [Memory's drug profile] [ClinicalTrials.gov]
Eltroprazine 5-HT1A and 5-HT1B agonist PsychoGenics ADHD Phase II [Memory's drug profile] [ClinicalTrials.gov]
DOV-102,677 DA/NE/5-HT reuptake inhibitor (with preferential action on the dopamine transporter) DOV Pharmaceuticals ADHD Phase I [ClinicalTrials.gov]
SON-216 (bifemelane) E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Sosei ADHD Phase I [ClinicalTrials.gov]
SPD-483 ATS (Amphetamine Transdermal System) Shire Pharmaceuticals ADHD Preclinical  

 

APPENDIX

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: Term giving to a drug's 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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