Generalized Anxiety Disorder

Neurology
15
Pipeline Programs
11
Companies
18
Clinical Trials
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
1
6
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 12 programs with unclassified modality

On Market (4)

Approved therapies currently available

U
ALPRAZOLAMApproved
alprazolam
Unknown Company
oral2007
U
DULOXETINE HYDROCHLORIDEApproved
duloxetine
Unknown Company
oral2013
U
QUETIAPINE FUMARATEApproved
quetiapine fumarate
Unknown Company
oral2012
U
SEROQUEL XRApproved
quetiapine fumarate
Unknown Company
oral2007

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
AlprazolamPhase 41 trial
Active Trials
NCT00662259Completed32Est. Sep 2009
UP
UCB PharmaBelgium - Brussels
1 program
1
NiravamPhase 41 trial
Active Trials
NCT00266409Completed418Est. Jun 2006
Teva
TevaIsrael - Petach Tikva
2 programs
2
GabitrilPhase 31 trial
GabitrilPhase 31 trial
Active Trials
NCT00236054Completed440Est. Dec 2005
NCT00236067Completed440Est. Mar 2006
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
DuloxetinePhase 31 trial
Active Trials
NCT00803361Completed210Est. Jan 2010
Pfizer
PfizerNEW YORK, NY
1 program
1
PD 0332334Phase 33 trials
Active Trials
NCT00820794Withdrawn0Est. Jun 2009
NCT00800280Terminated12Est. Feb 2009
NCT00658762Terminated286Est. Apr 2009
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
Quetiapine fumaratePhase 31 trial
Active Trials
NCT00329264Completed876Est. Aug 2007
Biohaven
BiohavenNEW HAVEN, CT
1 program
1
TroriluzolePhase 3Small Molecule1 trial
Active Trials
NCT03829241CompletedEst. May 2020
Bristol Myers Squibb
1 program
1
pexacerfontPhase 2/32 trials
Active Trials
NCT00481325Completed260Est. Mar 2008
NCT00135421Completed271Est. Oct 2007
Engrail Therapeutics
Engrail TherapeuticsCA - San Diego
1 program
1
ENX-102Phase 21 trial
Active Trials
NCT05749055Completed252Est. Sep 2025
M&
Merck & Co.RAHWAY, NJ
1 program
1
MK0777Phase 23 trials
Active Trials
NCT00546624Completed38Est. Feb 2003
NCT00539578Completed270Est. Feb 2003
NCT00543920Completed60Est. Feb 2003
Neuronetics
NeuroneticsMALVERN, PA
2 programs
TMSN/A1 trial
rTMS TreatmentN/A1 trial
Active Trials
NCT01659736Completed26Est. Dec 2014
NCT01815099Terminated4Est. Aug 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
RocheAlprazolam
UCB PharmaNiravam
BiohavenTroriluzole
Boehringer IngelheimDuloxetine
PfizerPD 0332334
AstraZenecaQuetiapine fumarate
TevaGabitril
TevaGabitril
Bristol Myers Squibbpexacerfont
Engrail TherapeuticsENX-102
Merck & Co.MK0777
Merck & Co.MK0777
Merck & Co.MK0777
Bristol Myers Squibbpexacerfont
PfizerPD 0332334

Showing 15 of 18 trials with date data

Clinical Trials (18)

Total enrollment: 3,895 patients across 18 trials

NCT00662259RocheAlprazolam

Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder

Start: Apr 2008Est. completion: Sep 200932 patients
Phase 4Completed
NCT00266409UCB PharmaNiravam

Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

Start: Oct 2005Est. completion: Jun 2006418 patients
Phase 4Completed
NCT03829241BiohavenTroriluzole

Randomized Trial of Adult Participants With Generalized Anxiety Disorder

Start: Feb 2019Est. completion: May 2020
Phase 3Completed
NCT00803361Boehringer IngelheimDuloxetine

Duloxetine for the Treatment of Generalized Anxiety Disorder

Start: Dec 2008Est. completion: Jan 2010210 patients
Phase 3Completed
NCT00658762PfizerPD 0332334

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

Start: May 2008Est. completion: Apr 2009286 patients
Phase 3Terminated
NCT00329264AstraZenecaQuetiapine fumarate

Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder

Start: Apr 2006Est. completion: Aug 2007876 patients
Phase 3Completed
NCT00236054TevaGabitril

A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

Start: Oct 2004Est. completion: Dec 2005440 patients
Phase 3Completed
NCT00236067TevaGabitril

A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

Start: Oct 2004Est. completion: Mar 2006440 patients
Phase 3Completed
NCT00481325Bristol Myers Squibbpexacerfont

Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder

Start: Jul 2007Est. completion: Mar 2008260 patients
Phase 2/3Completed
NCT05749055Engrail TherapeuticsENX-102

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder

Start: Jul 2023Est. completion: Sep 2025252 patients
Phase 2Completed
NCT00546624Merck & Co.MK0777

GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)

Start: Nov 2002Est. completion: Feb 200338 patients
Phase 2Completed
NCT00539578Merck & Co.MK0777

Treatment of Patients With Anxiety Disorder (0777-022)

Start: Sep 2002Est. completion: Feb 2003270 patients
Phase 2Completed
NCT00543920Merck & Co.MK0777

A Study of MK0777 in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-020)

Start: Aug 2002Est. completion: Feb 200360 patients
Phase 2Completed
NCT00135421Bristol Myers Squibbpexacerfont

Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Start: Nov 2005Est. completion: Oct 2007271 patients
Phase 1/2Completed
NCT00820794PfizerPD 0332334

A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

Start: May 2009Est. completion: Jun 20090
Phase 1Withdrawn
NCT00800280PfizerPD 0332334

Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

Start: Jan 2009Est. completion: Feb 200912 patients
Phase 1Terminated
NCT01815099NeuroneticsrTMS Treatment

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Start: May 2014Est. completion: Aug 20154 patients
N/ATerminated
NCT01659736NeuroneticsTMS

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Start: May 2012Est. completion: Dec 201426 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
11 companies competing in this space

Related Indications

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