2019 Medicines in Development for Mental Illnesses · Nuplazid® ACADIA Pharmaceuticals major...

2019 Medicines in Development for Mental Illnesses

Anxiety Disorders

Product Name Sponsor Indication Development Phase

AVN 101 Avineuro Pharmaceuticals anxiety disorders Phase II

(serotonin 6 receptor antagonist) Hallandale Beach, FL www.avineuro.com

AVP-786 Avanir Pharmaceuticals agitation in Alzheimer's disease Phase III

(deudextromethorphan analogue/ Aliso Viejo, CA (Fast Track) www.avanir.com

quinidine) Concert Pharmaceuticals www.concertpharma.com

Lexington, MA

AXS-05 Axsome Therapeutics agitation in Alzheimer's disease Phase II/III

(bupropion/dextromethorphan New York, NY (Fast Track) www.axsome.com

fixed-dose combination)

BI-1358894 Boehringer Ingelheim panic disorder Phase I

(TRPC4 channel inhibitor) Ridgefield, CT www.boehringer-ingelheim.com

BTRX-335140 BlackThorn Therapeutics anxiety disorders Phase I

(opioid kappa receptor antagonist) San Francisco, CA www.blackthornrx.com

eltoprazine Amarantus BioScience (Elto Pharma) aggression in Alzheimer's disease Phase II

(serotonin 1A/1B partial agonist) New York, NY www.amarantus.com

FKW00GA Fabre-Kramer Pharmaceuticals generalized anxiety disorder, Phase II

(serotonin 1A receptor agonist, Houston, TX social phobia www.fabrekramer.com

serotonin 2A receptor antagonist)

Medicines in Development: Mental Illnesses ǀ 2019 1

http://www.avineuro.com/

http://www.avanir.com/

http://www.concertpharma.com/

http://www.axsome.com/

http://www.boehringer-ingelheim.com/

http://www.blackthornrx.com/

http://www.amarantus.com/

http://www.fabrekramer.com/

Anxiety Disorders


JNJ-42165279 Janssen Research & Development major depressive disorder with Phase II completed

(fatty acid amide hydrolase inhibitor) Raritan, NJ anxious distress, social anxiety www.janssen.com

disorder

JNJ-61393215 Janssen Research & Development anxiety Phase I completed

(orexin1 receptor inhibitor) Raritan, NJ www.janssen.com

NBTX-001 Nobilis Therapeutics post-traumatic stress disorder Phase II

(NMDA receptor antagonist) Portland, OR (PTSD) www.nobilistx.com

NYX-783 Aptinyx PTSD (Fast Track) Phase II

(NMDA receptor modulator) Evanston, IL www.aptinyx.com

PH94B VistaGen Therapeutics social anxiety disorder Phase III

(chemoreceptor cell modulator) South San Francisco, CA www.vistagen.com

Rexulti® Lundbeck agitation in Alzheimer's disease Phase III

brexpiprazole (oral) Deerfield, IL (Fast Track), PTSD www.lundbeck.com

Otsuka Pharmaceutical www.otska.com

Rockville, MD

SEP-380135 Sunovion Pharmaceuticals agitation in Alzheimer's disease Phase I

Marlborough, MA www.sunovion.com


http://www.janssen.com/


http://www.nobilistx.com/

http://www.aptinyx.com/

http://www.vistagen.com/

http://www.lundbeck.com/

http://www.otska.com/

http://www.sunovion.com/

Anxiety Disorders


SRX246 Azevan Pharmaceuticals PTSD Phase II

(vasopressin 1a receptor antagonist) Bethlehem, PA www.azevan.com

anxiety, fear Phase I

www.azevan.com

TNX-102 SL Tonix Pharmaceuticals PTSD Phase III

(cyclobenzaprine sublingual) New York, NY www.tonixpharma.com

agitation in Alzheimer's disease Phase I

(Fast Track) www.tonixpharma.com

Travivo™ Fabre-Kramer Pharmaceuticals generalized anxiety disorder Phase II

gepirone ER Houston, TX www.fabrekramer.com

troriluzole (BHV-4157) Biohaven Pharmaceutical generalized anxiety disorder Phase III

(glutamate modulator) New Haven, CT www.biohavenpharma.com

obsessive compulsive disorder Phase II/III

www.biohavenpharma.com


http://www.azevan.com/


http://www.tonixpharma.com/



http://www.biohavenpharma.com/

http://www.biohavenpharma.com/

Attention-Deficit/Hyperactivity Disorder


ATS Noven Pharmaceuticals attention-deficit/hyperactivity Phase II

(adrenergic receptor agonist) Miami, FL disorder (ADHD) www.noven.com

centanafadine Otsuka Pharmaceutical ADHD Phase III

(norepinephrine, dopamine and Rockville, MD www.otsuka.com

serotonin reuptake inhibitor)

CX-717 RespireRx Pharmaceuticals ADHD Phase II completed

(AMPA receptor modulator) Glen Rock, NJ www.respirerx.com

dasotraline (SEP-225289) Sunovion Pharmaceuticals ADHD (pediatric and adult) application submitted

(serotonin, norepinephrine and Marlborough, MA www.sunovion.com

dopamine reuptake inhibitor)

Dyanavel® XR Tris Pharma ADHD (adult) Phase III

amphetamine extended-release Monmouth Junction, NJ www.trispharma.com

eltoprazine Amarantus BioScience (Elto Pharma) ADHD (adult) Phase III

(serotonin 1A/1B partial agonist) New York, NY www.amarantus.com

Evekeo® Arbor Pharmaceuticals ADHD (adult) Phase III

amphetamine sulfate Atlanta, GA www.arborpharma.com

HLD100 Ironshore Pharmaceuticals ADHD (pediatric) Phase II completed

(dextroamphetamine sulfate Durham, NC www.ironshorepharma.com

modified release)


http://www.noven.com/

http://www.otsuka.com/

http://www.respirerx.com/


http://www.trispharma.com/

http://www.amarantus.com/

http://www.arborpharma.com/

http://www.ironshorepharma.com/



KP415 KemPharm ADHD Phase III

(serdexmethylphenidate) Celebration, FL www.kempharm.com

KP484 KemPharm ADHD (adult) Phase III

(serdexmethylphenidate) Celebration, FL www.kempharm.com

NLS-001 NLS Pharmaceutics ADHD (adult) Phase II

(mazindol controlled release) Stans, Switzerland www.nlspharma.com

OPC-64005 Otsuka Pharmaceutical ADHD (adult) Phase II

(serotonin, norepinephrine and Rockville, MD www.otsuka.com


SKL13865 SK Life Science ADHD Phase I

(adrenergic and dopamine Paramus, NJ www.sklifescienceinc.com

uptake inhibitor)

SPN-810 Supernus Pharmaceuticals impulsive aggression in ADHD Phase III

(dopamine D2 receptor antagonist) Rockville, MD (pediatric) (Fast Track) www.supernus.com

SPN-812 Supernus Pharmaceuticals ADHD Phase III

(adrenergic reuptake inhibitor) Rockville, MD www.supernus.com

TRN-110 Tris Pharma ADHD (adult and pediatric) in clinical trials

Monmouth Junction, NJ www.trispharma.com


http://www.kempharm.com/

http://www.kempharm.com/

http://www.nlspharma.com/


http://www.sklifescienceinc.com/

http://www.supernus.com/


http://www.trispharma.com/



Vyvanse® Takeda ADHD (4-5 years) Phase II completed

lisdexamfetamine Deerfield, IL www.takeda.com

Bipolar Disorders


ALKS 3831 Alkermes bipolar 1 disorder Phase III

(olanzapine/samidorphan) Waltham, MA www.alkermes.com

DLP-114 Delpor bipolar 1 disorder Phase I

(risperidone 6-12 month formulation) South San Francisco, CA www.delpor.com

Geodon® Pfizer bipolar 1 disorder (pediatric) Phase III

ziprasidone New York, NY www.pfizer.com

lumateperone (ITI-007) Intra-Cellular Therapies bipolar depression Phase III

(serotonin receptor antagonist, New York, NY www.intracellulartherapies.com

serotonin reuptake inhibitor,

DPP modulator, glutamate

receptor modulator)

NRX-100/NRX-101 NeuroRx bipolar depression in patients Phase II/III

(cycloserine/lurasidone) Wilmington, DE with acute suicidal ideation www.neurorxpharma.com

and behavior (Fast Track)


http://www.takeda.com/

http://www.alkermes.com/

http://www.delpor.com/

http://www.pfizer.com/

http://www.intracellulartherapies.com/

http://www.neurorxpharma.com/

Bipolar Disorders


Rykindo® Luye Pharma bipolar disorder application submitted

risperidone extended-release Princeton, NJ www.luye.cn

microsphere for injection

(LY03004)

SAGE-217 Sage Therapeutics bipolar depression Phase II

(GABA A receptor modulator) Cambridge, MA www.sagerx.com

SEP-4199 Sunovion Pharmaceuticals bipolar 1 depression Phase II


SEP-378608 Sunovion Pharmaceuticals bipolar disorder Phase I


SKL-PSY/FZ-016 SK Life Science bipolar disorder Phase I

(serotonin 1A receptor agonist) Paramus, NJ www.sklifescienceinc.com

SPN-604 Supernus Pharmaceuticals bipolar disorder Phase II

(sodium channel blocker) Rockville, MD www.supernus.com

Depression


AGN-241751 Allergan major depressive disorder Phase II

(NMDA receptor modulator) Madison, NJ (Fast Track) www.allergan.com


http://www.luye.cn/

http://www.sagerx.com/





http://www.allergan.com/

Depression


AV-101 VistaGen Therapeutics major depressive disorder (Fast Track), Phase II

(NMDA receptor glycine B antagonist) South San Francisco, CA major depressive disorder www.vistagen.com

(post-ketamine or esketamine)

suicidal ideation Phase I

www.vistagen.com

AXS-05 Axsome Therapeutics treatment resistant depression Phase III

(bupropion/dextromethorphan New York, NY (Fast Track) www.axsome.com


major depressive disorder Phase II

(Breakthrough Therapy) www.axsome.com

BI-1358894 Boehringer Ingelheim major depressive disorder Phase I

(TRPC4 channel inhibitor) Ridgefield, CT www.boehringer-ingelheim.com

BTRX-335140 BlackThorn Therapeutics mood disorders Phase I

(opioid kappa receptor antagonist) San Francisco, CA www.blackthornrx.com

Fetzima® Allergan major depressive disorder Phase III

levomilnacipran extended release Madison, NJ (pediatric) www.allergan.com

FKB01MD Fabre-Kramer Pharmaceuticals major depressive disorder Phase II

(serotonin reuptake inhibition, Houston, TX www.fabrekramer.com

serotonin 2/1A receptor agonism,

serotonin 1D receptor modulation)







http://www.blackthornrx.com/



Depression


ganaxolone Marinus Pharmaceuticals postpartum depression Phase II

(GABA A receptor agonist) Radnor, PA www.marinuspharma.com

JNJ-54175446 Janssen Research & Development major depressive disorder Phase I

(purinergic P2X7 receptor antagonist) Raritan, NJ www.janssen.com

JNJ 67953964 Janssen Research & Development major depressive disorder Phase II

(opioid kappa receptor antagonist) Raritan, NJ www.janssen.com

liafensine (DB104) Denovo Biopharma depression Phase I completed

(norepinephrine, dopamine, San Diego, CA www.denovobiopharma.com

serotonin reuptake inhibitor)

lumateperone (ITI-007) Intra-Cellular Therapies major depressive disorder Phase I




receptor modulator)

LY03005 Luye Pharma moderate to severe depression Phase III

(ansofaxine hydrochloride Princeton, NJ www.luye.cn

extended release)

MIJ821 Novartis Pharmaceuticals treatment-resistant depression Phase II

(NMDA negative allosteric East Hanover, NJ www.novartis.com

modulator


http://www.marinuspharma.com/



http://www.denovobiopharma.com/


http://www.luye.cn/

http://www.novartis.com/

Depression


MIN-117 Minerva Neurosciences major depressive disorder Phase II

(alpha7 adrenergic receptor Waltham, MA www.minervaneurosciences.com

modulagtor, serotonin1A/2A

receptor antagonist, serotonin

uptake inhibitor)

NSI-189 Neuralstem major depressive disorder Phase II

(benzylpiperazine-aminopyridine Germantown, MD www.neuralstem.com

neurogenic)

Nuplazid® ACADIA Pharmaceuticals major depressive disorder Phase III

pimavanserin San Diego, CA (adjunctive therapy) www.acadia-pharm.com

NV-5138 Navitor Pharmaceuticals major depressive disorder, Phase I

(MTORC1 protein stimulant) Cambridge, MA treatment resistant depression www.navitorpharma.com

PDC-1421 BioLite major depressive disorder Phase II

(NET inhibitor) Taipei, Taiwan www.biolite.com

PH10 nasal spray VistaGen Therapeutics major depressive disorder Phase II

(chemoreceptor cell stimulant) South San Francisco, CA www.vistagen.com

pramipexole Chase Therapeutics major depressive disorder Phase II

(dopamine D2/D3 receptor agonist) Washington, DC www.chasetherapeutics.com


http://www.minervaneurosciences.com/

http://www.neuralstem.com/

http://www.acadia-pharm.com/

http://www.navitorpharma.com/

http://www.biolite.com/


http://www.chasetherapeutics.com/

Depression


REL-1017 Relmada Therapeutics major depressive disorder Phase II

(dextromethadone) New York, NY (Fast Track) www.relmada.com

SAGE-217 Sage Therapeutics major depressive disorder (Fast Track), Phase III

(GABA A receptor modulator) Cambridge, MA postpartum depression www.sagerx.com

scopolamine intranasal Repurposed Therapeutics major depressive disorder Phase I

(muscarinic receptor antagonist) Tampa, FL

seltorexant (MN-202) Janssen Research & Development major depressive disorder Phase II completed

(orexin receptor type 2 antagonist) Raritan, NJ www.janssen.com

Minerva Neurosciences www.minervaneurosciences.com

Waltham, MA

SEP-378614 Sunovion Pharmaceuticals treatment resistant depression Phase I


SHX-001 Shenox Pharmaceuticals major depressive disorder Phase I

(ketamine transdermal patch) McLean, VA www.shenoxpharma.com

sirukumab Janssen Research & Development major depressive disorder Phase II completed

(interleukin 6 inhibitor) Raritan, NJ www.janssen.com

SPN-809 Supernus Pharmaceuticals depression Phase I

(adrenergic reuptake inhibitor) Rockville, MD www.supernus.com


http://www.relmada.com/





http://www.shenoxpharma.com/



Depression


Spravato® Janssen Research & Development major depressive disorder at Phase III

esketamine Raritan, NJ imminent risk for suicide www.janssen.com

major depressive disorder Phase II

(pediatric) www.janssen.com

Strada™ MSI Methylation Sciences major depressive disorder Phase II

ademetionine Burnaby, Canada www.methylationsciences.com

SUVN 911 Suven Life Sciences major depressive disorder Phase I

(alpha4beta2 nicotinic receptor Monmouth Junction, NJ www.suven.com

antagonist)

TAK-653 Takeda treatment-resistant depression Phase I

(AMPA receptor modulator) Deerfield, IL www.takeda.com

Travivo™ Fabre-Kramer Pharmaceuticals major depressive disorder application submitted


Trintellix™ Lundbeck major depressive disorder (pediatric) Phase III

vortioxetine Deerfield, IL www.lundbeck.com

Takeda www.takeda.com

Deerfield, IL




http://www.methylationsciences.com/

http://www.suven.com/





Depression


TS-121 Taisho Pharmaceutical major depressive disorder Phase II

Tokyo, Japan www.taisho.co.jp

TS-161 Taisho Pharmaceutical depression Phase I


Viibryd® Allergan major depressive disorder (pediatric) Phase III completed

vilazodone Madison, NJ www.allergan.com

Vraylar® Allergan major depressive disorder Phase III

cariprazine Madison, NJ (adjunctive therapy) www.allergan.com

Zulresso® Sage Therapeutics postpartum depression (adolescents) Phase III

brexanolone Cambridge, MA www.sagerx.com

Schizophrenia


Abilify Maintena® Lundbeck schizophrenia (2 month treatment) Phase I

aripiprazole once-monthly Deerfield, IL www.lundbeck.com

Otsuka www.otsuka.com

Rockville, MD


http://www.taisho.co.jp/







Schizophrenia


ALKS 3831 Alkermes schizophrenia Phase III

(olanzapine/samidorphan) Waltham, MA www.alkermes.com

ASP4345 Astellas Pharma US cognitive impairment associated Phase II

(dopamine D1 receptor modulator) Northbrook, IL with schizophrenia (CIAS) www.astellas.com

AVN 211 Avineuro Pharmaceuticals schizophrenia Phase II/III

(serotonin 6 receptor antagonist) Hallandale Beach, FL www.avineuro.com

AVP-786 Avanir Pharmaceuticals schizophrenia (negative symptoms) Phase II

(deudextromethorphan analogue/ Aliso Viejo, CA www.avanir.com

quinidine) Concert Pharmaceuticals www.concertpharma.com

Lexington, MA

basmisanil Roche CIAS Phase II

(GABA A alpha 5 receptor Basel, Switzerland www.roche.com

modulator)

BI 409306 Boehringer Ingelheim attenuated psychosis syndrome, Phase II

(PDE9A inhibitor) Ridgefield, CT schizophrenia, psychotic disorders www.boehringer-ingelheim.com

(pediatric)

BI 425809 Boehringer Ingelheim schizophrenia (combination with Phase II

(glycine transporter 1 inhibitor) Ridgefield, CT Computerized Cognitive Training) www.boehringer-ingelheim.com


http://www.alkermes.com/

http://www.astellas.com/

http://www.avineuro.com/



http://www.roche.com/



Schizophrenia


BIIB104 Biogen CIAS (Fast Track) Phase II

(AMPA receptor modulator) Cambridge, MA www.biogen.com

CTP-692 Concert Pharmaceuticals schizophrenia Phase I

(deuterated D-serine) Lexington, MA www.concertpharma.com

CVN058 Cerevance CIAS Phase I

Boston, MA www.cerevance.com

DB103 Denovo Biopharma schizophrenia Phase I

(pomaglumetad) San Diego, CA www.denovobiopharma.com

DLP-114 Delpor schizophrenia Phase I

(risperidone 6-12 month formulation) South San Francisco, CA www.delpor.com

DSP-6745 Sunovion Pharmaceuticals psychosis in Parkinson's disease Phase I

(serotonin 5-HT2A/c receptors Marlborough, MA www.sunovion.com

dual antagonist)

evenamide Newron Pharmaceuticals schizophrenia Phase II

(voltage-gated sodium Morristown, NJ www.newron.com

channel blocker)


http://www.biogen.com/


http://www.cerevance.com/

http://www.denovobiopharma.com/

http://www.delpor.com/


http://www.newron.com/

Schizophrenia


FKF02SC Fabre-Kramer Pharmaceuticals schizophrenia Phase II

(dopamine D2/D3 receptor Houston, TX www.fabrekramer.com

antagonist, serotonin 2C/2A receptor

antagonist, alpha-1 adrenergic

receptor antagonist)

HP-3070 Hisamitsu Pharmaceutical schizophrenia application submitted

(asenapine transdermal) Tosu, Japan www.global.hisamitsu

Noven Pharmaceuticals www.noven.com

Miami, FL

KarXT Karuna Pharmaceuticals psychosis in schizophrenia Phase II

(muscarinic M1/M4 receptor Boston, MA www.karunatx.com

agonist, muscarinic receptor

antagonist)

Lu AF11167 Lundbeck schizophrenia (negative symptoms) Phase II

(PDE10A inhibitor) Deerfield, IL www.lundbeck.com

lumateperone (ITI-007) Intra-Cellular Therapies schizophrenia (Fast Track) application submitted




receptor modulator)

LY03010 Luye Pharma schizophrenia, Phase I

(paliperidone palmitate) Princeton, NJ schizoaffective disorder www.luye.cn



http://www.global.hisamitsu/

http://www.noven.com/

http://www.karunatx.com/



http://www.luye.cn/

Schizophrenia


MK-8189 Merck schizophrenia Phase II

Kenilworth, NJ www.merck.com

NaBen® SyneuRx schizophrenia (adolescent), Phase II/III

sodium benzoate New Taipei City, Taiwan schizophrenia (adult), www.syneurx.com

ORPAHN DRUG refractory schizophrenia

Nuplazid® ACADIA Pharmaceuticals dementia-related psychosis, Phase III

pimavanserin San Diego, CA schizophrenia inadequate response www.acadia-pharm.com

(adjunctive therapy)

schizophrenia (negative symptoms) Phase II

(adjunctive therapy) www.acadia-pharm.com

paliperidone palmitate 6-month Janssen Pharmaceutical schizophrenia Phase III

long-acting injection Raritan, NJ www.janssen.com

Rexulti® Lundbeck schizophrenia (adolescents) Phase III

brexpiprazole Deerfield, IL (oral) www.lundbeck.com

Otsuka Pharmaceutical www.otsuka.com

Rockville, MD

schizophrenia Phase I

(depot injection) www.lundbeck.com

www.otsuka.com


http://www.merck.com/

http://www.syneurx.com/








Schizophrenia


RG7906 Roche negative symptoms associated with Phase II

(RO6889450) Basel, Switzerland schizophrenia and schizoaffective www.roche.com

disorder

Risperidone ISM® Rovi schizophrenia Phase III

risperidone extended release Madrid, Spain www.rovi.es

roluperidone (MIN-101) Minerva Neurosciences schizophrenia Phase III

(serotonin 2A receptor antagonist, Waltham, MA www.minervaneurosciences.com

sigma-2 receptor antagonist)

RP5063 Reviva Pharmaceuticals schizophrenia Phase II

(dopamine D2/D3/D4 receptor Cupertino, CA www.revivapharma.com

partial agonist, serotonin 1A/2A

receptor partial agonist, serotonin

2B/6/7 receptor antagonist)

Rykindo® Luye Pharma schizophrenia application submitted

risperidone extended-release Princeton, NJ www.luye.cn

microsphere for injection

(LY03004)

SEP-363856 Sunovion Pharmaceuticals schizophrenia (Breakthrough Therapy) Phase III

(serotonin 1A receptor agonist, Marlborough, MA www.sunovion.com

trace amine-associated receptor 1

agonist)

psychosis in Parkinson's disease Phase II

www.sunovion.com


http://www.roche.com/

http://www.rovi.es/


http://www.revivapharma.com/

http://www.luye.cn/



Schizophrenia


SKL20540 SK Life Science CIAS Phase I

(alpha7 nicotinic acetylcholine Paramus, NJ www.sklifescienceinc.com

receptor agonist)

TAK-041 Takeda CIAS (negative symptoms) Phase I

(GPR139 agonist) Deerfield, IL www.takeda.com

TAK-831 Takeda CIAS (negative symptoms) Phase II

(DAAO inhibitor) Deerfield, IL www.takeda.com

TS-134 Taisho Pharmaceutical schizophrenia Phase I


TV-46000 Teva North America schizophrenia Phase III

(risperidone LAI) Parsippany, NJ www.tevapharm.com

Vraylar® Allergan schizophrenia relapse prevention, Phase III

cariprazine Madison, NJ schizophrenia (adolescents) www.allergan.com

Substance Use Disorders


AD04 ADial Pharmaceuticals alcohol use disorder Phase II

(ondansetron) Charlottesville, VA www.adialpharma.com






http://www.tevapharm.com/


http://www.adialpharma.com/



AEF0117 Aelis Farma marijuana use disorder Phase II

(CB1 receptor antagonist) Bordeaux, France www.aelisfarma.com

ANS-6637 Amygdala Neurosciences alcohol use disorder, Phase I

(ALDH 2 inhibitor) Palo Alto, CA opioid use disorder www.amygns.com

APC-6000 Adamis Pharmaceuticals opioid use disorder application submitted

(naloxone injection) San Diego, CA www.adamispharmaceuticals.com

arbaclofen ER Osmotica Pharmaceuticals opioid use disorder Phase I

Bridgewater, NJ www.osmotica.com

ASP-8062 Astellas Pharma US drug use disorder Phase I

(GABA-B receptor modulator) Northbrook, IL www.astellas.com

AXS-05 Axsome Therapeutics tobacco use disorder Phase II

(bupropion/dextromethorphan New York, NY www.axsome.com


buprenorphine/naloxone INSYS Therapeutics opioid use disorder Phase I

sublingual spray Chandler, AZ www.insysrx.com

CERC-501 Janssen Research & Development tobacco use disorder Phase II completed

(opioid kappa receptor antagonist) Raritan, NJ www.janssen.com


http://www.aelisfarma.com/

http://www.amygns.com/

http://www.adamispharmaceuticals.com/

http://www.osmotica.com/

http://www.astellas.com/


http://www.insysrx.com/




cytisinicline Achieve Life Sciences tobacco use disorder Phase III

(alpha4 beta2 nicotinic Seattle, WA www.achievelifesciences.com

receptor agonist)

EMB-001 Embera NeuroTherapeutics cocaine use disorder, Phase I

(metyrapone/oxazepam) Boston, MA tobacco use disorder www.emberaneuro.com

GET73 CT Laboratories alcohol use disorder Phase II

(metabotropic glutamate Sanremo, Italy www.labct.it/en/

receptor 5 antagonist)

IXT-m200 InterveXion Therapeutics methamphetamine use disorder Phase I/II

(chimeric mAb) Little Rock, AR (Fast Track) www.intervexion.com

MDL-001 Mucodel opioid use disorder Phase I completed

(naloxone buccal gel) Greensboro, NC www.nasobain.com

MN-166 MediciNova alcohol use disorder, Phase II

(ibudilast) La Jolla, CA methamphetamine use disorder www.medicinova.com

National Institute on Drug Abuse (Fast Track)

Rockville, MD

nalmefene HCl Purdue Pharma opioid use disorder (Fast Track) Phase I

Stamford, CT www.purduepharma.com


http://www.achievelifesciences.com/

http://www.emberaneuro.com/

http://www.labct.it/en/

http://www.intervexion.com/

http://www.nasobain.com/

http://www.medicinova.com/

http://www.purduepharma.com/



naloxone nasal spray Hikma Pharmaceuticals opioid use disorder (overdose) application submitted

London, United Kingdom www.insysrx.com

nicotine transmucosal Bionex Pharmaceuticals tobacco use disorder in clinical trials

North Brunswick, NJ www.bionexpharma.com

NS2359 Saniona cocaine use disorder Phase II

(triple monoamine Ballerup, Denmark www.saniona.com

reuptake inhibitor) University of Pennsylvania

Philadelphia, PA

OMS405 Omeros opioid use disorder, Phase II

(PPAR gamma agonist) Seattle, WA tobacco use disorder www.omeros.com

OMS527 Omeros drug use disorder Phase I

(PDE7 inhibitor) Seattle, WA www.omeros.com

OPNT002 Opiant Pharmaceuticals alcohol use disorder Phase I

(opioid antagonist nasal spray) Santa Monica, CA www.opiant.com

OPNT003 Opiant Pharmaceuticals opioid use disorder Phase I

(nalmefene nasal spray) Santa Monica, CA www.opiant.com

PT-150 Pop Test Cortisol alcohol use disorder Phase I

(glucocorticoid receptor antagonist) Cliffside Park, NJ


http://www.insysrx.com/

http://www.bionexpharma.com/

http://www.saniona.com/

http://www.omeros.com/

http://www.omeros.com/

http://www.opiant.com/

http://www.opiant.com/



REL-1028 (BuTab) Relmada Therapeutics opioid use disorder Phase I completed

(oral buprenorphine) New York, NY www.relmada.com

TNX-1300 Tonix Pharmaceuticals cocaine use disorder Phase II

(double mutant cocaine esterase) New York, NY (Breakthrough Therapy) www.tonixpharma.com

X-22 22nd Century tobacco use disorder Phase II

(nicotinic receptor agonist) Williamsville, NY www.xxiicentury.com

Other Disorders


AR20 Arbor Pharmaceuticals mental disorders (pediatric) Phase I

Atlanta, GA www.arborpharma.com

AR33 Arbor Pharmaceuticals mental disorders (pediatric) Phase II

Atlanta, GA www.arborpharma.com

AVP-786 Avanir Pharmaceuticals disinhibition syndrome in neuro- Phase II

(deudextromethorphan analogue/ Aliso Viejo, CA degenerative disorders, www.avanir.com

quinidine) Concert Pharmaceuticals intermittent explosive disorder www.concertpharma.com

Lexington, MA


http://www.relmada.com/


http://www.xxiicentury.com/





Other Disorders


dasotraline (SEP-225289) Sunovion Pharmaceuticals binge eating disorder (adult) Phase III

(serotonin, norepinephrine and Marlborough, MA www.sunovion.com


FKW00GA Fabre-Kramer Pharmaceuticals sexual dysfunction Phase II

(serotonin 1A receptor agonist, Houston, TX www.fabrekramer.com

serotonin 2A receptor antagonist)

Rexulti® Lundbeck borderline personality disorder Phase II

brexpiprazole (oral) Deerfield, IL www.lundbeck.com

Otsuka Pharmaceutical www.otsuka.com

Rockville, MD

SRX246 Azevan Pharmaceuticals intermittent explosive disorder Phase II completed

(vasopressin 1a receptor antagonist) Bethlehem, PA www.azevan.com

SXC-2023 Promentis Pharmaceuticals moderate to severe trichotillomania Phase II

(SLC7A11 protein stimulant) Milwaukee, WI (recurrent hair pulling) in adults www.promentispharma.com

(impulse control disorder)

Travivo™ Fabre-Kramer Pharmaceuticals hypoactive sexual desire disorder Phase II








http://www.promentispharma.com/


The content of this report has been obtained through public, government and industry sources, and the Springer "Adis Insight” database based on the latest

information. Report current as of August 26, 2019. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials

in the United States abroad, PhRMA-member companies conducting trials in the United States and abroad, and foreign companies conducting clinical trials in

the United States. Some products may not be in active clinical trials. The information may not be comprehensive. For more, specific information about a particular

product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's

website: www.phrma.org.

Definitions

Application Submitted—An application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).

Breakthrough Therapy—Upon request by a sponsor, the FDA can grant this designation to expedite the development and review of a drug or biologic intended, alone

or in combination with one or more other drugs, to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that it may

demonstrate substantial improvement over existing therapies on one or more clinically-significant endpoints, such as substantial treatment effects observed early in

clinical development. If a drug or biologic is designated as a Breakthrough Therapy, the FDA will expedite the development and review. With this designation, all Fast

Track features convey to the medicine.

Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a

serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational

drug or biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will

progress from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation,

early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review

process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.

Orphan Designation—Upon request by a sponsor, the FDA can grant special status (“orphan status”) to a drug or biologic to treat a rare disease or condition.

In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or

condition that affects usually fewer than 200,000 people in the United States.

Phase I—Researchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate

its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.

Phase II—The investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an

optimal dose, and to further evaluate its short-term safety.

Phase III—The investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients

(but sometimes many more), to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies

and usually take place in multiple sites around the world.


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