KHEDEZLA (desvenlafaxine)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2013-07-10
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
KHEDEZLA Approval History
What KHEDEZLA Treats
1 FDA approvalsOriginally approved for its first indication in 2013 .
- Other (1)
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04476030 results posted | 217-MDD-305 | Ph 3 | completed | A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder |
| NCT04448431 VIVRE | 18498A | Ph 4 | completed | Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression |
| NCT02859103 | DVS-01 | Ph 4 | completed | Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment |
| NCT01975480 | WS2382578 | Ph 4 | completed | Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities |
| NCT02200406 | WI187002 Pfizer Reference Award Number | Ph 4 | completed | Desvenlafaxine in Opioid-Dependent Patients |
| NCT01803711 results posted | OmegaDVS | Ph 2, Ph 3 | terminated | Omega 3 FA Supplements as Augmentation in the Treatment of Depression |
| NCT01537068 results posted | #6457 Pfizer-WS1895577 | Ph 4 | completed | Desvenlafaxine vs. Placebo Treatment of Chronic Depression |
| NCT01527786 | PRISTIQ IOP # 3151A1-44 | Ph 3 | completed | Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine |
| NCT01443208 | B2061137 | Ph 1 | completed | Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet |
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.
KHEDEZLA FDA Label Details
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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