PAROXETINE (paroxetine hydrochloride)
PAROXETINE is indicated for the treatment of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder; Posttraumatic Stress Disorder.
How PAROXETINE Works
The exact mechanism of action for paroxetine in treating its indicated conditions is unknown. Its therapeutic effects are presumed to be linked to the potentiation of serotonergic activity within the central nervous system. This process occurs through the inhibition of the neuronal reuptake of serotonin, also known as 5-hydroxytryptamine (5-HT).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-10-31
- Routes
- ORAL
- Dosage Forms
- TABLET
PAROXETINE Approval History
What PAROXETINE Treats
6 indicationsPAROXETINE is approved for 6 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Obsessive Compulsive Disorder
- Panic Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder
- Posttraumatic Stress Disorder
PAROXETINE Boxed Warning
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )]. Paroxetine is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See ...
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )]. Paroxetine is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Paroxetine is not approved for use in pediatric patients. ( 5.1 , 8.4 )
PAROXETINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PAROXETINE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
43 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06231745 | 314879 | Ph 3 | completed | Paroxetine Safety and Efficacy in Rheumatoid Arthritis |
| NCT07070232 | BNT326-01 2024-517261-16-00, 1011236 | Ph 1, Ph 2 | recruiting | A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors |
| NCT06799169 | 4863 | Ph 4 | active not recruiting | Management of Acute Tinnitus With Migraine Medications |
| NCT06763484 MENOXTINA | PGO-UNAH-48-2-2025 | Ph 2 | completed | Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause |
| NCT04757571 | RS10/2021 | Ph 1, Ph 2 | withdrawn | The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients |
| NCT05725837 | Paroxetine | Ph 2 | recruiting | Effects of Paroxetine on Cardiovascular Function in Septic Patients |
| NCT06232109 | ASN51-104 | Ph 1 | completed | Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects |
| NCT06065735 results posted | 219882 | Ph 1 | completed | Concentration-QT Study of Paroxetine in Healthy Adults |
| NCT01416220 | MoodDig-001 | Ph 4 | withdrawn | Lithium Versus Paroxetine in Major Depression |
| NCT05175430 SERT-LSD | BASEC 2021-02223 | Ph 1 | completed | Effects of SERT Inhibition on the Subjective Response to LSD in Healthy Subjects |
| NCT03779789 VESPA | 2016-0234923 2018-001444-66 | Ph 4 | completed | Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment |
| NCT03277339 Insula-TOP | InsulaTOP | Ph 4 | completed | Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders |
| NCT02022709 | 124119a8601 YG2013MS65 | Ph 4 | completed | Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients |
| NCT04650542 | HBI-3000-401 | Ph 1 | completed | Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects |
| NCT03274752 CARE-AMI | 2016-00349 | Ph 2 | completed | Paroxetine-mediated GRK2 Inhibition to Reduce Cardiac Remodeling After Acute Myocardial Infarction |
| NCT02174822 | 14-AVP-786-101 | Ph 1 | completed | A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects |
| NCT04311463 results posted | 212969 | Ph 1 | completed | Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants |
| NCT04981704 | SPI-POZ-103 | Ph 1 | completed | A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants |
| NCT04888728 | DW_DWN12088104 | Ph 1 | completed | To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers |
| NCT00677352 results posted | A0501088 | Ph 4 | completed | A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder |
| NCT01841502 ROLEX | AKF UMCN 12.02 | Ph 2 | terminated | Interaction Between Paroxetine and Telaprevir |
| NCT00557622 results posted | PIR109164 | Ph 2 | terminated | Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD) |
| NCT00836069 | 15002 | Ph 3 | terminated | Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder |
| NCT02932904 results posted | Vortioxetine-4001 U1111-1174-1779 | Ph 4 | completed | Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers |
| NCT03149419 | CAAE 6717515.1.0000.5259 | Ph 4 | completed | Hot Flash as a Marker of Cardiovascular Risk in Recent Postmenopause: Effects of Non-hormonal Treatments |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02681198 | USWM-LX1-1010 U01DA033276 | Ph 1 | completed | Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers |
| NCT01681849 results posted | IRB00000857 R01MH056120 | Ph 4 | completed | Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder |
| NCT01354314 ParaFlu results posted | NA_00037283 P30MH075673-05 | Ph 1, Ph 2 | completed | Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder |
| NCT00629551 COMPASS | EFC10438 EudraCT 2007-003863-31 | Ph 3 | completed | An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder |
| NCT00926835 | MIHWAF-CRCD-K-01 | Ph 4 | terminated | Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients |
| NCT02451475 | MUH-ANES-2013-10 | Ph 1, Ph 2 | completed | Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome |
| NCT02264184 | 527.79 | Ph 1 | completed | Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers |
| NCT02191124 | 2009-1051 | Ph 4 | completed | The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial |
| NCT00700999 results posted | MHBA-002-08S | Ph 4 | completed | Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD) |
| NCT00658372 | A5361018 | Ph 3 | terminated | A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2) |
| NCT00658008 | A5361019 | Ph 3 | terminated | A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1) |
| NCT00658762 | A5361020 | Ph 3 | terminated | A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3) |
| NCT00665678 | CDMRP PT074585 | Ph 4 | terminated | Neural Correlates of Early Intervention for Posttraumatic Stress Disorder (PTSD) |
| NCT00594269 DESEP | F06001 | Ph 4 | completed | Dementia Antipsychotics And Antidepressants Discontinuation Study |
| NCT00666757 TRY FIRST results posted | 11715 F1J-US-HMFT | Ph 4 | completed | A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression |
| NCT00879099 | 73654 Eudra CT 2008-007324-26 | Ph 1 | completed | Interaction Study of Timolol Eye Drops and Paroxetine Capsules |
| NCT01024491 | MPEP-01 | Ph 3 | completed | Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PAROXETINE FDA Label Details
Indications & Usage
PAROXETINE is indicated for the treatment of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder; Posttraumatic Stress Disorder.
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment