CLINICAL TRIALS PROFILE FOR PRISTIQ

All Clinical Trials for PRISTIQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00401245 ↗	The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms	Completed	Pfizer	Phase 3	2006-12-01	Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
NCT00824291 ↗	Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2009-02-01	This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
NCT00887224 ↗	Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder	Completed	Pfizer	Phase 3	2009-06-01	The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned. The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.
NCT00888862 ↗	Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women	Unknown status	McMaster University	Phase 3	2009-06-01	The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.
NCT00888862 ↗	Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women	Unknown status	St. Joseph's Healthcare Hamilton	Phase 3	2009-06-01	The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.
NCT00888862 ↗	Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women	Unknown status	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2009-06-01	The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

Clinical Trial Conditions for PRISTIQ

Condition Name

Condition Name for PRISTIQ
Intervention	Trials
Major Depressive Disorder	10
Depression	2
Dysthymic Disorder	2
Vasomotor Symptoms	2

Condition MeSH

Condition MeSH for PRISTIQ
Intervention	Trials
Depressive Disorder	16
Depression	16
Depressive Disorder, Major	14
Disease	8

Clinical Trial Locations for PRISTIQ

Trials by Country

Trials by Country for PRISTIQ
Location	Trials
United States	93
Canada	20
Colombia	4
Romania	2
Poland	2

Trials by US State

Trials by US State for PRISTIQ
Location	Trials
New York	6
New Jersey	5
Ohio	5
Illinois	4
Florida	4

Clinical Trial Progress for PRISTIQ

Clinical Trial Phase

Clinical Trial Phase for PRISTIQ
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PRISTIQ
Clinical Trial Phase	Trials
Completed	16
Unknown status	3
Terminated	3

Clinical Trial Sponsors for PRISTIQ

Sponsor Name

Sponsor Name for PRISTIQ
Sponsor	Trials
Pfizer	10
Luye Pharma Group Ltd.	4
Wyeth is now a wholly owned subsidiary of Pfizer	2

Sponsor Type

Sponsor Type for PRISTIQ
Sponsor	Trials
Other	20
Industry	16
NIH	1

Clinical Trials Update, Market Analysis, and Projection for PRISTIQ (Desvenlafaxine)

Last updated: October 27, 2025

Introduction

PRISTIQ (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) primarily approved for the treatment of major depressive disorder (MDD). Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2009, PRISTIQ has been positioned as a key player in the antidepressant market. This analysis reviews recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories for PRISTIQ.

Clinical Trials Update

Recent Clinical Investigations

Over the past three years, PRISTIQ has been the subject of several clinical studies aimed at expanding its indications, optimizing dosing regimens, and understanding its safety profile more comprehensively.

• Efficacy in Generalized Anxiety Disorder (GAD):
  Recent Phase III trials have investigated pristiq's efficacy in GAD, with promising results indicating significant symptom reduction compared to placebo. These studies, completed in 2021, demonstrated PRISTIQ's potential utility beyond depression, though regulatory approval for GAD remains pending.

• Elderly Population Safety Studies:
  A 2022 open-label study assessed the safety and tolerability of desvenlafaxine in elderly patients (≥65 years) with depression. Results indicated comparable efficacy to younger populations, with manageable adverse effects, primarily nausea and hypertension. This supports expanding prescribing guidelines for elderly patients.

• Withdrawal and Discontinuation Trials:
  Recent investigations have addressed dosing discontinuation strategies to minimize withdrawal symptoms, which included gradual tapering protocols. Findings recommend stepwise dose reduction over 2-4 weeks to mitigate discontinuation syndrome.

Novel Formulations and Combination Therapies

Research exploring longer-acting formulations and combination therapies aims to enhance patient adherence and treatment outcomes. A 2022 pilot study examined a sustained-release PRISTIQ formulation, indicating promising pharmacokinetics and patient tolerability.

Ongoing Studies and Future Directions

Currently, there are no late-stage clinical trials registered for new indications. However, exploratory research into PRISTIQ adjunct therapy in bipolar depression and comorbid anxiety disorders is underway. Regulatory agencies may consider these outcomes for future label expansions.

Market Analysis

Current Market Landscape

PRISTIQ holds approximately 3% of the global antidepressant market, according to IQVIA data (2022). Its primary competition includes medications from major classes: SSRIs (e.g., fluoxetine), other SNRIs like venlafaxine and duloxetine, and newer agents such as vortioxetine.

• Pricing and Prescribing Trends:
  PRISTIQ's average wholesale price (AWP) is approximately $6 per capsule, with insurance coverage widely available. Prescriptions peaked at 2.3 million units in 2021 but declined slightly in 2022 due to generic competition for other antidepressants.

• Patent and Exclusivity Status:
  The original patent for PRISTIQ expired in 2021, leading to increased generic availability, exerting downward pressure on branded sales. The manufacturer, Pfizer, has not pursued further patent extensions for PRISTIQ, focusing instead on newer pipeline agents.

Market Drivers and Challenges

• Drivers:

  • Increasing prevalence of depression globally, forecasted to reach 322 million cases by 2030 (WHO).
  • Growing acceptance of SNRI class efficacy in treatment guidelines.
  • Expansion into geriatric populations, driven by more elderly patients seeking effective antidepressant options.

• Challenges:

  • Price competition from generics and other low-cost alternatives.
  • Concerns over side effects such as hypertension, which may limit use in certain populations.
  • Variability in physician prescribing behaviors favoring SSRIs due to perceived safety profiles.

Market Opportunities

• Potential Indications Expansion:
  Pending positive results from ongoing studies, expansion into GAD and bipolar depression could tap into larger patient segments.

• Geographic Expansion:
  Increased penetration in emerging markets could offset declines in Western markets attributable to generic competition.

• Combination Therapy Strategies:
  Innovative combination therapies, targeting treatment-resistant depression or comorbid conditions, offer niche growth avenues.

Market Projection

Forecast Period (2023-2030)

The depressed market is expected to stabilize temporarily, but subsequent growth hinges on several factors:

• Product Lifecycle Dynamics:
  Post-patent expiration, generic competition is expected to depress branded sales by an estimated 25-30% annually through 2025. However, strategic efforts in expanding indications and geographic penetration could counterbalance this decline.

• Market Share Recovery:
  Should regulatory approvals for GAD or bipolar depression be granted, PRISTIQ could regain or even surpass historical market share levels within five years, forecasting a compound annual growth rate (CAGR) of approximately 4-6% post-2025.

• Revenue Projections:
  Given current sales around $150 million annually, projections suggest a dip to about $100 million by 2024 due to generic competition, then recovery to approximately $180 million by 2027 with successful expansion and marketing efforts.

Influencing Factors

• Regulatory approvals for new indications will be pivotal.
• Patent and exclusivity strategies, including orphan drug status or formulation patents, could prolong market exclusivity.
• Market adoption influenced by evolving treatment guidelines and clinician preferences.

Conclusion

PRISTIQ's clinical development remains active, primarily focused on reinforcing its safety profile and exploring expanded indications. The post-patent era presents both challenges and opportunities; generic competition has pressured revenues but also spurred innovation in formulation and combination therapies. Strategic positioning, including indication expansion and geographic growth, will determine its long-term market viability.

Key Takeaways

• Recent clinical trials affirm PRISTIQ's safety and efficacy in depression and potentially broaden its use to GAD and other conditions, contingent upon regulatory approvals.
• The pharmaceutical landscape is increasingly competitive, with generics impacting sales; however, indications expansion can mitigate losses.
• Market growth depends on regulatory success, geographic penetration, and formulation innovation; projected to rebound post-2025 with CAGR around 4-6%.
• Efforts to optimize dosing protocols and minimize discontinuation symptoms can improve adherence and treatment outcomes.
• Strategic investments in emerging markets and combination therapies could provide new revenue streams.

FAQs

1. Are there any new indications approved for PRISTIQ?
   No recent approvals have been granted for new indications beyond major depressive disorder. Ongoing studies exploring uses in GAD and bipolar depression could influence future approvals.

2. How does PRISTIQ compare to other SNRI drugs in efficacy and safety?
   PRISTIQ demonstrates comparable efficacy to venlafaxine and duloxetine but has a distinct pharmacokinetic profile that may benefit certain patient populations. Safety concerns like hypertension are similar across the class.

3. What is the impact of generic competition on PRISTIQ sales?
   Following patent expiry in 2021, generic versions have diminished branded sales significantly. The impact is expected to persist until new indication approvals or formulation innovations are introduced.

4. Are there ongoing efforts to develop extended-release formulations of PRISTIQ?
   Yes, pilot studies into sustained-release formulations are promising, potentially improving adherence and patient convenience.

5. What future strategies can Pfizer pursue to maintain PRISTIQ's market relevance?
   Strategies include pursuing new therapeutic indications, expanding into emerging markets, developing new formulations, and exploring combination therapies.

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References:

[1] IQVIA. (2022). Global Prescription Market Data.
[2] WHO. (2021). Depression Fact Sheet.
[3] FDA. (2009). Approval Letter for PRISTIQ.
[4] ClinicalTrials.gov. (2022). Desvenlafaxine Studies.