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 Anxiety Disorders Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 2 Anxiety Disorders Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 3 Attention-Deficit/Hyperactivity Disorder Product Name Sponsor Indication Development Phase
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)
Medicines in Development: Mental Illnesses ǀ 2019 4 Attention-Deficit/Hyperactivity Disorder Product Name Sponsor Indication Development Phase
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 dopamine reuptake inhibitor)
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
Medicines in Development: Mental Illnesses ǀ 2019 5 Attention-Deficit/Hyperactivity Disorder Product Name Sponsor Indication Development Phase
Vyvanse® Takeda ADHD (4-5 years) Phase II completed lisdexamfetamine Deerfield, IL www.takeda.com
Bipolar Disorders Product Name Sponsor Indication Development Phase
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)
Medicines in Development: Mental Illnesses ǀ 2019 6 Bipolar Disorders Product Name Sponsor Indication Development Phase
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 Marlborough, MA www.sunovion.com
SEP-378608 Sunovion Pharmaceuticals bipolar disorder Phase I Marlborough, MA www.sunovion.com
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 Product Name Sponsor Indication Development Phase
AGN-241751 Allergan major depressive disorder Phase II (NMDA receptor modulator) Madison, NJ (Fast Track) www.allergan.com
Medicines in Development: Mental Illnesses ǀ 2019 7 Depression Product Name Sponsor Indication Development Phase
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 fixed-dose combination)
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)
Medicines in Development: Mental Illnesses ǀ 2019 8 Depression Product Name Sponsor Indication Development Phase 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 (serotonin receptor antagonist, New York, NY www.intracellulartherapies.com serotonin reuptake inhibitor, DPP modulator, glutamate 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
Medicines in Development: Mental Illnesses ǀ 2019 9 Depression Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 10 Depression Product Name Sponsor Indication Development Phase
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 Marlborough, MA www.sunovion.com
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
Medicines in Development: Mental Illnesses ǀ 2019 11 Depression Product Name Sponsor Indication Development Phase
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 gepirone ER Houston, TX www.fabrekramer.com
Trintellix™ Lundbeck major depressive disorder (pediatric) Phase III vortioxetine Deerfield, IL www.lundbeck.com Takeda www.takeda.com Deerfield, IL
Medicines in Development: Mental Illnesses ǀ 2019 12 Depression Product Name Sponsor Indication Development Phase
TS-121 Taisho Pharmaceutical major depressive disorder Phase II Tokyo, Japan www.taisho.co.jp
TS-161 Taisho Pharmaceutical depression Phase I Tokyo, Japan www.taisho.co.jp
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 Product Name Sponsor Indication Development Phase
Abilify Maintena® Lundbeck schizophrenia (2 month treatment) Phase I aripiprazole once-monthly Deerfield, IL www.lundbeck.com Otsuka www.otsuka.com Rockville, MD
Medicines in Development: Mental Illnesses ǀ 2019 13 Schizophrenia Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 14 Schizophrenia Product Name Sponsor Indication Development Phase
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)
Medicines in Development: Mental Illnesses ǀ 2019 15 Schizophrenia Product Name Sponsor Indication Development Phase
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 (serotonin receptor antagonist, New York, NY www.intracellulartherapies.com serotonin reuptake inhibitor, DPP modulator, glutamate receptor modulator)
LY03010 Luye Pharma schizophrenia, Phase I (paliperidone palmitate) Princeton, NJ schizoaffective disorder www.luye.cn
Medicines in Development: Mental Illnesses ǀ 2019 16 Schizophrenia Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 17 Schizophrenia Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 18 Schizophrenia Product Name Sponsor Indication Development Phase
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 Tokyo, Japan www.taisho.co.jp
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 Product Name Sponsor Indication Development Phase
AD04 ADial Pharmaceuticals alcohol use disorder Phase II (ondansetron) Charlottesville, VA www.adialpharma.com
Medicines in Development: Mental Illnesses ǀ 2019 19 Substance Use Disorders Product Name Sponsor Indication Development Phase
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 fixed-dose combination) 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
Medicines in Development: Mental Illnesses ǀ 2019 20 Substance Use Disorders Product Name Sponsor Indication Development Phase 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
Medicines in Development: Mental Illnesses ǀ 2019 21 Substance Use Disorders Product Name Sponsor Indication Development Phase 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
Medicines in Development: Mental Illnesses ǀ 2019 22 Substance Use Disorders Product Name Sponsor Indication Development Phase
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 Product Name Sponsor Indication Development Phase
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
Medicines in Development: Mental Illnesses ǀ 2019 23 Other Disorders Product Name Sponsor Indication Development Phase dasotraline (SEP-225289) Sunovion Pharmaceuticals binge eating disorder (adult) Phase III (serotonin, norepinephrine and Marlborough, MA www.sunovion.com dopamine reuptake inhibitor)
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 gepirone ER Houston, TX www.fabrekramer.com
Medicines in Development: Mental Illnesses ǀ 2019 24 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.
Medicines in Development: Mental Illnesses ǀ 2019 25