Paxil
(paroxetine)ApprovedSmall molecule
Paroxetine is used to treat depression, anxiety disorders, panic disorder, and obsessive-compulsive disorder by helping balance chemicals in the brain that affect mood and emotions.[2] Paxil is currently approved and in use across 37 indications[4].[1]
Paxil is one of 879 small molecule programs targeting Response to Stress. It is currently in Approved.
37
Indications
139
Total Trials
9
Active Trials
878
Competitors
6
FDA Applications
NDA/BLA/ANDA regulatory filings
3
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 37 indications
Competition
Competitive Landscape
791 competitors in Rheumatoid Arthritis
#DrugCompanyPhaseTrials
1Paxil
SSebela Pharmaceuticals Development LLC
Approved
Cimzia
UCBPreclinical
Simponi
Johnson & JohnsonPreclinical
Arcoxia
NovartisPreclinical
Kevzara
AAzienda U.S.L. 1 di Massa e Carrara
Preclinical
Actos
TakedaPreclinical
Kineret
SSwedish Orphan Biovitrum
Preclinical
Cataflam
NovartisPreclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Velcade
SShilpa Grover, MD, MPH
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Generalized Anxiety Disorder9 trials
Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder
Terminated·—·Phase 3·NCT00836069·5 enrolled
Show 6 more trials
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders
Completed·—·Phase 4·NCT03277339·52 enrolled
Major Depressive Disorder7 trials
Show 4 more trials
Post-Traumatic Stress Disorder, PTSD6 trials
Neural Correlates of Early Intervention for Posttraumatic Stress Disorder (PTSD)
Terminated·FFoundation for Atlanta Veterans Education and Research, Inc.·Phase 4·NCT00665678·160 enrolled
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Completed·—·Phase 4·NCT00560612·12 enrolled
Interaction6 trials
Social Anxiety Disorder6 trials
66 more indications
Panic Disorder6 trials
Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
Unknown status·—·N/A·NCT00736346·204 enrolled
Show 3 more trials
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00677352·321 enrolled
Major Depression5 trials
Show 2 more trials
Amitriptyline and Paroxetine Treatment of Major Depression
Completed·—·Phase 3·NCT01049347·127 enrolled
Drug4 trials
Tics4 trials
Depression4 trials
Lamotrigine Augmentation in Resistant Depression
Completed·LLouisiana State University Health Sciences Center in New Orleans·N/A·NCT00901407·138 enrolled
Show 1 more trial
Post-Traumatic Stress Disorder4 trials
Bipolar Disorder3 trials
MDD2 trials
Menopause2 trials
Efficacy and Safety2 trials
Premature Ejaculation2 trials
Hot flashes2 trials
Treatment2 trials
A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks
Completed·—·N/A·NCT00457106·90 enrolled
Sexual Function2 trials
Drug Interactions2 trials
Parkinson's Disease2 trials
Rheumatoid Arthritis2 trials
Double-blind1 trial
Elective1 trial
Adult1 trial
Prevention1 trial
Anxiety1 trial
Infants1 trial
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Recruiting·—··NCT03511118·1,600 enrolled
Cohort Study1 trial
Cardiovascular Function1 trial
Effects of Paroxetine on Cardiovascular Function in Septic Patients
Recruiting·UUniversidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude·Phase 2·NCT05725837·92 enrolled
Type 2 Diabetes Mellitus1 trial
Combination Therapy1 trial
Burning Mouth Syndrome1 trial
Single Dose1 trial
Genetic Polymorphism1 trial
Severe Depression1 trial
Depressive Disorder1 trial
The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial
Completed·—·Phase 4·NCT02191124·164 enrolled
Medication1 trial
Advanced Malignant Tumors1 trial
Acute Kidney Injury1 trial
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02320240·3,255,526 enrolled
Cognitive Disorder1 trial
Chronic Hepatitis1 trial
Metabolism1 trial
Mental Disorders1 trial
Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders
Completed·—·N/A·NCT04218981·200 enrolled
Neuropathic Pain1 trial
Acute Myocardial Infarction1 trial
Prophylaxis1 trial
Unspecified7 trials
Show 4 more trials
Risperidone vs. Paroxetine for Panic Attacks
Terminated·—·Phase 2·NCT00206765·90 enrolled
Regulatory
FDA Approval Timeline[5]
Dec 29, 1992
PAXIL
NDA NDA020031
Jun 25, 1997
PAXIL
NDA NDA020710
Oct 9, 1998
PAXIL
NDA NDA020885
Feb 16, 1999
PAXIL CR
NDA NDA020936
Jul 3, 2003
PEXEVA
NDA NDA021299
Jun 28, 2013
BRISDELLE
NDA NDA204516
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Paxil drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for paroxetine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Paxil. U.S. Food & Drug Administration.
- [7]