PAXIL CR (paroxetine hydrochloride)
PAXIL CR is indicated for the treatment of Major Depressive Disorder; Panic Disorder; Social Anxiety Disorder; Premenstrual Dysphoric Disorder.
How PAXIL CR Works
The exact mechanism of paroxetine in treating its indicated conditions is not fully known, but it is believed to work by enhancing serotonergic activity within the central nervous system. The drug functions by inhibiting the neuronal reuptake of serotonin (5-HT). By blocking this reuptake process, the medication increases the availability of serotonin, which is presumed to produce its therapeutic effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-02-16
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
PAXIL CR Approval History
What PAXIL CR Treats
4 indicationsPAXIL CR is approved for 4 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Panic Disorder
- Social Anxiety Disorder
- Premenstrual Dysphoric Disorder
PAXIL CR Boxed 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 )] PAXIL CR is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing informati...
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 )] PAXIL CR 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. PAXIL CR is not approved for use in pediatric patients. ( 5.1 , 8.4 )
PAXIL CR 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.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04311463 results posted | 212969 | Ph 1 | completed | Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants |
| NCT00749359 | PCR111656 | Ph 1 | completed | PAXIL CR Bioequivalence Study |
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.
PAXIL CR FDA Label Details
Indications & Usage
FDA Label (PDF)PAXIL CR is indicated for the treatment of Major Depressive Disorder; Panic Disorder; Social Anxiety Disorder; Premenstrual Dysphoric Disorder.
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...
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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