PRISTIQ (desvenlafaxine succinate)
PRISTIQ is indicated for the treatment of Major Depressive Disorder.
How PRISTIQ Works
While the exact mechanism of antidepressant action is unknown, desvenlafaxine is thought to work by potentiating serotonin and norepinephrine in the central nervous system through the inhibition of their reuptake. Non-clinical studies characterize desvenlafaxine as a potent and selective SNRI.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-02-29
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
PRISTIQ Approval History
What PRISTIQ Treats
1 indicationsPRISTIQ is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
PRISTIQ Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor ...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . PRISTIQ 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 the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ( 5.1 ). • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). • PRISTIQ is not approved for use in pediatric patients ( 8.4 ).
PRISTIQ 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 PRISTIQ
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03733574 | LY03005/CT-USA-106 | Ph 1 | completed | A Study of LY03005 vs Pristiq |
| NCT03357796 | LY03005/CT-USA-104 | Ph 1 | completed | Relative Bioavailability (RBA) Study of LY03005 vs Pristiq® |
| NCT02988024 | LY03005/CT-USA-103 | Ph 1 | completed | Pilot BA Study of New LY03005 vs Pristiq |
| NCT01316302 results posted | PF2010SAD WS1228302 | Ph 4 | completed | 12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder |
| NCT02055300 LY03005SAD | LY03005 | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics Study of LY03005 |
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.
PRISTIQ FDA Label Details
Indications & Usage
FDA Label (PDF)PRISTIQ is indicated for the treatment of Major Depressive Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients ove...
PRISTIQ Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for PRISTIQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 9 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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