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predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial.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.
NCT00888862 ↗	Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women	Unknown status	Hamilton Health Sciences Corporation	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
Vasomotor Symptoms	2
Major Depression	2
Depression	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
Ohio	5
New Jersey	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
Terminated	3
Unknown status	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

Last updated: April 27, 2026

Pristiq (desvenlafaxine): Clinical Trials Update, Market Analysis, and 5-Year Projection

Pristiq (desvenlafaxine, ER) is an established branded SNRI for major depressive disorder (MDD) with broad label coverage across geographies. Trial activity in recent years has shifted toward post-approval commitments (pharmacokinetics, formulations, renal/hepatic considerations), life-cycle programs (drug-drug interaction and exposure-effect refinement), and competitor benchmarking studies rather than new pivotal registrations in large phase 3 programs. Market outcomes continue to be shaped by generic erosion, payer step therapy, and mix shift toward higher-acuity depression populations and maintenance treatment.

What is the current Pristiq clinical-trial footprint (registration-relevant)?

Across major regulators, Pristiq’s core label (MDD) originates from earlier pivotal programs. Contemporary “active” trial listings commonly reflect post-authorization work: bioequivalence, PK bridging, safety in specific subpopulations, and interaction studies. In the absence of new, clearly registrational phase 3 programs filed for Pristiq as a distinct chemical entity, the operational readthrough is that the clinical pipeline is focused on maintaining label defensibility and managing risk in real-world prescribing rather than expanding into new indications through fresh Phase 3 efficacy endpoints.

Trial activity patterns that still move the commercial needle

• Renal/hepatic and exposure studies: influence dosing guidance and can shift payer comfort where safety guardrails improve.
• Drug-drug interaction (DDI) trials: reduce prescribing friction in polypharmacy, supporting continuity for chronically treated patients.
• Formulation and bioavailability work: supports manufacturing continuity and substitution switching behavior under generic competition.

What endpoints dominate recent studies?

Where studies are registrational-adjacent, the endpoint set tends to be:

• PK exposure measures (Cmax, Tmax, AUC) and tolerability
• Safety and tolerability in populations defined by comorbidities (renal impairment, hepatic impairment)
• Interaction effects with common co-medications used in depression care

Which trial categories are most likely to impact near-term uptake?

1. Real-world compatible safety data in subpopulations
   Label comfort matters for continued prescribing in patients with renal impairment and polypharmacy, where SNRI switching risk can drive adherence drop.

2. DDIs that map to primary-care prescribing patterns
   DDI clarity affects clinician willingness to keep patients on desvenlafaxine rather than switching between antidepressants during medication reconciliation.

3. Maintenance durability proxies
   Where maintenance or relapse endpoints exist, they typically support continuity of therapy and can slow churn to cheaper alternatives when payers require justification for ongoing treatment.

What is the market base today (demand drivers and constraints)?

Pristiq’s demand has two opposing forces:

• Sustaining demand

  • Long-standing SNRI positioning in MDD
  • Clinician familiarity and established switching protocols
  • Maintenance treatment need in chronic depression cohorts

• Erosion pressure

  • Generic penetration for desvenlafaxine ER
  • Payer-driven formulary actions (preferred SNRI/SSRI switches)
  • PBM incentives for lower-cost equivalents

Demand drivers (commercially relevant)

• High chronicity in depression increases “lifetime value” per treated patient when continuity is maintained.
• SNRI preference for patients who failed SSRIs or who require norepinephrine pathway engagement.
• Tolerability and adherence: Pristiq’s once-daily ER regimen supports adherence relative to multi-dose alternatives.

Constraints (commercially relevant)

• Generic price compression reduces revenue regardless of clinical positioning.
• Formulary substitution: when payers convert members to generic desvenlafaxine or cheaper antidepressants, branded volume shifts to a residual cohort.
• Step therapy: can block new starts, forcing clinicians into prior authorization workflows.

How does Pristiq compare with key competitive classes (pricing and access)?

The relevant competitive set is not only direct desvenlafaxine generics but also other SNRI and SSRI options used in MDD.

Competitive pressure map (high-level):

• Direct generic desvenlafaxine ER: strongest price pressure in the MDD SNRI segment.
• SSRI and SNRI incumbents (formulary-aligned): can be preferred under PBM tiering.
• Other SNRIs: compete where payers standardize on a cheaper SNRI or where clinician preference follows side-effect profiles.

What is the near-term commercial outlook (what will likely happen next 12 to 24 months)?

Near-term outcomes are driven more by payer policy than by clinical readouts:

• Branded revenue: typically declines with generic share and formulary tier changes.
• Prescription volume: can stabilize if branded remains the “default SNRI” for a subset of patients after failed SSRIs.
• Net revenue: compresses faster than volume if list price is cut or rebates rise.

In a branded-to-generic erosion environment, the key commercial question becomes: how much patient retention exists after payer substitution? For SNRI-treated chronic depression, retention depends on tolerability and the clinician’s willingness to keep patients on the same mechanism rather than cycling antidepressants.

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Market Projection: 5-Year Revenue Path for Pristiq (Branded Brand Value)

Projection logic (model structure)

• Start from a baseline branded demand that degrades with:
  • Generic penetration growth
  • Formulary tightening
  • PBM substitutions
• Offset by:
  • Patient retention after failure of initial antidepressant class
  • Maintenance therapy persistence
  • Residual prescriber preference and continuity

Because Pristiq’s clinical pipeline does not appear dominated by new registrational phase 3 efficacy programs for new indications, the revenue trajectory is governed primarily by competitive access and branded discounting.

5-Year projection table (directional, indexed)

The following table presents a directional branded revenue index (Year 1 baseline = 100). It assumes no major label expansion and continued generic share growth.

Year	Indexed Branded Revenue (Y1=100)	Primary driver
1	100	Residual branded access and payer grandfathering
2	86	Generic substitution accelerates; rebate pressure increases
3	74	Higher persistence loss from formulary tiering
4	63	Continued volume shift to generics and preferred antidepressants
5	54	Branded becomes a minority share cohort

Interpretation for business planning

• Expect mid-single-digit to low-teens annual branded revenue decline after Year 1 in a mature generic environment.
• The clinical-trial landscape is unlikely to reverse the trajectory unless it delivers a clearly distinct label expansion, new dosing carve-outs that expand access, or compelling comparative outcomes that change payer behavior.

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Investment and R&D Implications

Where should stakeholders focus given Pristiq’s current dynamics?

1. Real-world retention
   • Measure persistence after payer switch to generic desvenlafaxine and persistence after switching between antidepressant classes.
2. Payer evidence packages
   • Use safety and DDI data as payer-facing proof points to justify continuation for maintenance cohorts.
3. Lifecycle risk controls
   • Continue PK and safety studies in comorbid populations to reduce switching and prior authorization friction.
4. Market-access strategy
   • Optimize contracting and formulary engagement based on plan-level switch rates, not clinical endpoints alone.

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Key Takeaways

• Pristiq’s current clinical trial activity is primarily post-approval and risk-management oriented (PK, DDI, subpopulation safety), with limited indication expansion signals.
• The market outlook is dominated by generic erosion and payer formulary management, not by new registrational phase 3 efficacy programs.
• A conservative 5-year branded revenue path is consistent with continued decline under generic pressure, modeled as an indexed drop from 100 to ~54 by Year 5.

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FAQs

1) Does Pristiq currently have a registrational phase 3 program for new indications?

No clear, registration-leading phase 3 expansion signal is indicated from current trial patterns; activity is largely post-approval oriented.

2) What trial types are most relevant to payer access for Pristiq today?

Renal/hepatic exposure studies, DDI trials, and safety/tolerability work that supports prescribing continuation in polypharmacy and comorbidity settings.

3) Why can branded Pristiq prescriptions persist despite generic availability?

Patient retention after antidepressant switching, maintenance therapy continuity, and clinician preference for consistent SNRI treatment in chronic MDD cohorts.

4) What is the biggest commercial risk over the next 2 years?

Formulary tightening and continued generic substitution that reduces branded share and increases rebate pressure.

5) What is the most actionable near-term business lever?

Build payer-ready dossiers around persistence, tolerability continuity, and DDI safety to reduce churn to alternatives.

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References (APA)

[1] ClinicalTrials.gov. (n.d.). Pristiq (desvenlafaxine) studies. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Pristiq (desvenlafaxine) prescribing information. https://www.accessdata.fda.gov/
[3] European Medicines Agency. (n.d.). Pristiq (desvenlafaxine) EPAR and product information. https://www.ema.europa.eu/