Phase II and Phase III Drugs in U.S. Development for Depression, Anxiety, Sleep Disorders, Psychosis, & ADHD
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Treatments for Depression and Anxiety

Drug Name Pharmacologic Action Company/Pipeline Indication Developmental Phase Links to Clinical Trials
agomelatine (AGO 178) Serotonin 5-HT2C and 5-HT2B receptor antagonist, melatonin M1 and M2 receptor agonist Novartis Depression, OCD Phase III (NDA projected 2012)

[ClinicalTrials.gov]
Lu AA21004 5-HT3, 5-HT7, and 5-HT1B antagonist; 5-HT1A agonist; and 5-HT reuptake inhibitor Lundbeck Depression, anxiety Phase III

[ClinicalTrials.gov]
LY2216684 (NERI-IV) Norepinephrine reuptake inhibitor Eli Lilly Depression, ADHD Phase III [ClinicalTrials.gov]
levomilnacipran (F2695) enantiomer of milnacipran Forest Labs Depression Phase III (NDA projected 2012) [ClinicalTrials.gov]
TC-5214 Nonselective Nicotinic acetylcholine receptor antagonist

Targacept / Astrazeneca

 Depression Phase III (adjunct)/Phase II (monotherapy) [ClinicalTrials.gov]
Lu AA24530 5-HT3 and 5-HT2C antagonist, serotonin reuptake inhibitor Lundbeck Depression, anxiety Phase II [ClinicalTrials.gov]
orvepitant (GW823296) NK1 antagonist GSK Depression, anxiety Phase II [ClinicalTrials.gov]
AZD6765 NMDA antagonist AstraZeneca Depression, anxiety Phase II [ClinicalTrials.gov]
ONO-2333Ms CRF1 antagonist Ono Pharmaceuticals Depression, anxiety Phase II [ClinicalTrials.gov]
OPC-34712 Dopamine D2 receptor partial agonist Otsuka Depression, schizophrenia, ADHD Phase II [ClinicalTrials.gov]
BCI-540 (sabcomeline) Muscarinic acetylcholine M1 and M4 receptor partial agonist BrainCells Inc. Depression (adjunct to SSRIs) Phase II [ClinicalTrials.gov]
BCI-540 (coluracetam) Glutamate AMPA receptor potentiator, choline reuptake enhancer BrainCells Inc. Depression, anxiety Phase II [ClinicalTrials.gov]
BCI-952 (combination of buspirone and melatonin) Combines the effects of buspirone and melatonin BrainCells Inc. Depression Phase II [ClinicalTrials.gov]
TIK-101/d-cycloserine NMDA glycine recognition site modulator Tikvah Pharmaceuticals Anxiety, OCD Phase II [ClinicalTrials.gov]
Tyrima™, CX157 Reversible monoamine oxidase A (MAO-A) inhibitor CeNeRx Depression, anxiety Phase II [ClinicalTrials.gov]
CXB722 CRF-1 receptor antagonist CeNeRx Anxiety Phase II [ClinicalTrials.gov]
Serdaxin (RX-10100) Unknown serotonin and dopamine modulator Rexahn Depression, Parkinson's disease Phase II [ClinicalTrials.gov]
AZD2066 Metabotropic glutamate receptor 5 antagonist AstraZeneca Depression, chronic neuropathic pain Phase II [ClinicalTrials.gov]
JNJ-18038683 Serotonin 5-HT7 receptor antagonist Johnson & Johnson Depression Phase II [ClinicalTrials.gov]
YKP3089 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. SK Pharmaceuticals Anxiety Phase II [ClinicalTrials.gov]
CP-601,927 Neuronal nicotinic receptor (alpha4beta2 subtype selective) partial agonist Pfizer Depression Phase II [ClinicalTrials.gov]
RG7090 mGluR5 antagonist Roche Treatment-resistant depression Phase II [ClinicalTrials.gov]
ADX71149 mGluR2 positive allosteric modulator Addex Anxiety, schizophrenia Phase II [ClinicalTrials.gov]
GLYX-13 NMDA glycine-site functional partial agonist Naurex Depression (adjuvant), treatment-resistant depression, bipolar depression Phase II [ClinicalTrials.gov]
GSK561679 CRF1 receptor antagonist Neurocrine / GSK PTSD Phase II [ClinicalTrials.gov]

Treatments for Sleep Disorders

Drug Name Pharmacologic Action Company/Pipeline Indication Developmental Phase Links to Clinical Trials
suvorexant (MK-4305) Orexin OX1 and OX2 receptor antagonist Merck Insomnia Phase III [ClinicalTrials.gov]
tasimelteon, VEC-162 Melatonin receptor agonist Vanda Pharmaceuticals Sleep disorders Phase III [ClinicalTrials.gov]
SB-649868 Orexin receptor antagonist GSK Sleep disorders Phase II [ClinicalTrials.gov]
EVT 201 GABA-A partial agonist Evotec Insomnia Phase II [ClinicalTrials.gov]
LY2624803, HY10275 5-HT2A and histamine H1 receptor antagonist

Eli Lilly

 Insomnia Phase II [ClinicalTrials.gov]
TIK-301, LY156735 Melatonin agonist, 5-HT2B/5-HT2C antagonist Tikvah Pharmaceuticals Sleep disorders Phase II [ClinicalTrials.gov]
MK-6096 E-mail shawn@neurotransmitter.net if you can share details about how this drug works. Merck Sleep disorders Phase II [ClinicalTrials.gov]
MK-3697 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 and Bipolar Disorder

Drug Name Pharmacologic Action Company/Pipeline Indication Developmental Phase Links to Clinical Trials
caripazine (RGH-188) D2, D3 antagonist

Forest Labs

 Schizophrenia, bipolar mania Phase III (NDA projected 2012) [ClinicalTrials.gov]
Corlux ® (mifepristone, RU-486) Glucocorticoid receptor type II (GRII) antagonist, progesterone receptor antagonist Corcept Psychotic depression Phase III [ClinicalTrials.gov]
zicronapine (Lu-31-130) D1 antagonist, D2 antagonist, 5-HT2A antagonist Lundbeck Psychosis Phase III [ClinicalTrials.gov]
RG1678 Glycine transporter-1 inhibitor Roche Schizophrenia Phase III (NDA projected 2013) [ClinicalTrials.gov]
BL-1020 GABA-A agonist, dopamine D2 receptor antagonist, serotonin 5-HT2A receptor antagonist BioLineRx Psychosis Phase II/III [ClinicalTrials.gov]
LY2140023 Prodrug for an mGluR2/3 agonist Eli Lilly Schizophrenia Phase II [ClinicalTrials.gov]
Lu AA39959 Ion channel modulator Lundbeck Psychosis, bipolar disorder Phase II [ClinicalTrials.gov]
GSK239512 H3 receptor antagonist GSK Schizophrenia, dementia Phase II [ClinicalTrials.gov]
PF-2545920 Phosphodiesterase PDE10A inhibitor Pfizer Psychosis Phase II [ClinicalTrials.gov]
TC-5619 Neuronal nicotinic receptor (alpha7 subtype selective) agonist Targacept / Astrazeneca Schizophrenia, ADHD Phase II [ClinicalTrials.gov]
ADX71149 mGluR2 positive allosteric modulator Addex Schizophrenia, anxiety Phase II [ClinicalTrials.gov]
OPC-34712 Dopamine D2 receptor partial agonist Otsuka Schizophrenia, depression, ADHD Phase II [ClinicalTrials.gov]

Treatments for Attention Deficit Hyperactivity Disorder (ADHD)

Drug Name Pharmacologic Action Company/Pipeline Indication Developmental Phase Links to Clinical Trials
LY2216684 (NERI-IV) Norepinephrine reuptake inhibitor Eli Lilly ADHD, Depression Phase III [ClinicalTrials.gov]
ABT-089 Neuronal nicotinic receptor partial (alpha4beta2 & alpha6beta2) agonist Abbott Laboratories ADHD Phase II (possibly discontinued) [ClinicalTrials.gov]
ABT-894 Neuronal nicotinic receptor (alpha4beta2 subtype selective) agonist Abbott Laboratories / NeuroSearch ADHD Phase II [ClinicalTrials.gov]
eltoprazine Serotonin 5-HT1A and 5-HT1B receptor agonist, 5-HT2C receptor antagonist PsychoGenics ADHD Phase II [ClinicalTrials.gov]
AZD3480 Neuronal nicotinic receptor (alpha4beta2 subtype selective) agonist Targacept / Astrazeneca ADHD Phase II [ClinicalTrials.gov]
AZD1446 Neuronal nicotinic receptor (alpha4beta2 subtype selective) agonist Targacept / Astrazeneca ADHD, Alzheimer's disease Phase II [ClinicalTrials.gov]
TC-5619 Neuronal nicotinic receptor (alpha7 subtype selective) agonist Targacept / Astrazeneca ADHD, schizophrenia Phase II [ClinicalTrials.gov]
OPC-34712 Dopamine D2 receptor partial agonist Otsuka ADHD, depression, schizophrenia Phase II [ClinicalTrials.gov]

 

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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