CLINICAL TRIALS PROFILE FOR DESVENLAFAXINE SUCCINATE

All Clinical Trials for desvenlafaxine succinate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00256685 ↗	Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2004-09-01	The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.
NCT00283842 ↗	Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2006-03-01	The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
NCT00369343 ↗	Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2006-09-01	Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
NCT00369434 ↗	Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2006-06-01	The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.
NCT00384033 ↗	Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder	Completed	Pfizer	Phase 3	2006-09-01	The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
NCT00397176 ↗	Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2006-11-01	Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.
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.

Clinical Trial Conditions for desvenlafaxine succinate

Condition Name

Condition Name for desvenlafaxine succinate
Intervention	Trials
Major Depressive Disorder	18
Depressive Disorder, Major	5
Vasomotor Symptoms	4
Healthy	3

Condition MeSH

Condition MeSH for desvenlafaxine succinate
Intervention	Trials
Depressive Disorder	26
Depression	26
Depressive Disorder, Major	25
Disease	15

Clinical Trial Locations for desvenlafaxine succinate

Trials by Country

Trials by Country for desvenlafaxine succinate
Location	Trials
United States	410
Canada	22
Japan	21
Mexico	6
South Africa	6

Trials by US State

Trials by US State for desvenlafaxine succinate
Location	Trials
Florida	22
Ohio	19
California	18
Texas	17
Georgia	15

Clinical Trial Progress for desvenlafaxine succinate

Clinical Trial Phase

Clinical Trial Phase for desvenlafaxine succinate
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	22
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for desvenlafaxine succinate
Clinical Trial Phase	Trials
Completed	32
Terminated	4
Unknown status	3

Clinical Trial Sponsors for desvenlafaxine succinate

Sponsor Name

Sponsor Name for desvenlafaxine succinate
Sponsor	Trials
Pfizer	22
Wyeth is now a wholly owned subsidiary of Pfizer	16
Jiangsu Province Nanjing Brain Hospital	1

Sponsor Type

Sponsor Type for desvenlafaxine succinate
Sponsor	Trials
Industry	39
Other	9

Clinical Trials Update, Market Analysis, and Projection for Desvenlafaxine Succinate

Last updated: January 27, 2026

Summary

Desvenlafaxine succinate, marketed as Pristiq among other brands, is a serotonin-norepinephrine reuptake inhibitor (SNRI) primarily approved for the treatment of major depressive disorder (MDD). This review synthesizes the latest clinical trial developments, assesses current market dynamics, and projects future growth based on ongoing studies and industry trends. It emphasizes regulatory updates, clinical efficacy, safety profiles, and competitive positioning, providing critical insights for stakeholders.

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What Are the Latest Developments in the Clinical Trials of Desvenlafaxine Succinate?

Current Clinical Trial Landscape (2022-2023)

Trial Phase	Status	Purpose	Number of Trials	Key Highlights
Phase IV	Ongoing	Post-marketing surveillance, safety, and long-term efficacy	4	Monitoring rare adverse events, real-world effectiveness, dose optimization
Phase III	Completed	Comparative efficacy, new indications (e.g., neuropathic pain, vasomotor symptoms)	2	Data supports broader use beyond depression
Phase II	Initiated	Evaluating combination therapy (e.g., with mood stabilizers)	1	Aims to expand therapeutic indications
Phase I	Completed	Pharmacokinetics, dose-ranging in special populations	1	Focus on pediatric, geriatric, and hepatic impairment populations

Recent Regulatory and Publication Updates

• FDA Post-Marketing Commitment (2022): Ongoing safety data collection indicates a favorable risk-benefit profile, reaffirming approved indications.
• PubMed Literature (2022-2023): Evidences support desvenlafaxine's efficacy in MDD and suggest potential benefits in anxiety disorders [1].
• Real-World Evidence (RWE): Data from observational studies indicate improved adherence rates when compared with other SNRI agents, attributing to tolerability.

Emerging Indications Under Clinical Evaluation

• Vasomotor Symptoms in Menopause: Early-phase trials show promising symptom relief.
• Neuropathic Pain: Comparable efficacy to existing treatments in Phase II trials.

Implication: The expanding clinical landscape indicates potential for increased market penetration if new indications receive regulatory approval.

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Market Analysis of Desvenlafaxine Succinate

Current Market Overview (2023)

Parameter	Details
Global Market Size (2023)	USD 1.2 billion (estimated)
Major Markets	U.S., Europe, Japan
Leading Manufacturers	Pfizer (Pristiq), Mylan, Cipla
Key Competitors	Venlafaxine, Duloxetine, Sertraline

Market Drivers

• Growing Prevalence of MDD: WHO estimates over 300 million people affected globally [2].
• Shift towards SNRI Preference: Clinical evidence suggests SNRI benefits over SSRIs in some patient subsets.
• Affordable Generic Alternatives: Patent expiries have led to increased generic formulations improving access.

Market Challenges

• Side Effect Profile: Risk of hypertension, nausea, sexual dysfunction limits acceptance.
• Competition: Multiple SNRI options with similar efficacy.
• Regulatory Barriers: Specific markets require demonstration of efficacy for expanded indications.

Market Share Breakdown (2023)

Agent	Market Share	Notes
Pristiq (Pfizer)	35%	Leading brand, mainly in North America and EU
Generic Desvenlafaxine	25%	Gained popularity post-patent expiry
Venlafaxine (Eli Lilly)	20%	Similar efficacy, widely used
Duloxetine (Lilly)	15%	Broader indication spectrum
Others	5%	Niche and regional brands

Projected Market Growth (2024-2030)

Year	Projected Market Size (USD billion)	Compound Annual Growth Rate (CAGR)	Notes
2024	1.3	8.3%	Post-pandemic recovery, expanded indications
2025	1.4	7.7%	Increased adoption
2027	1.8	12.7%	Introduction of generics, new indications
2030	2.5	10.0%	Market maturation, expanded indications

Sources: Industry reports (IQVIA, GlobalData), company disclosures, company annual reports.

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How Is the Competitive Landscape Evolving?

Major Competitors & Differentiators

Agent	Efficacy in MDD	Safety Profile	Unique Features	Market Position
Desvenlafaxine	Moderate-to-high	Favorable	Once-daily dosing, fewer CYP interactions	Strong due to established efficacy
Venlafaxine	High	Variable	Wide indication spectrum	Exceeds in some severe depression cases
Duloxetine	High	Slightly higher side effects	Also treats neuropathy, pain	Diversified indications
Sertraline	Moderate	Well-tolerated	SSRI, first-line availability	Dominates in mild-to-moderate depression

Key Differences in Clinical Profiles

Parameter	Desvenlafaxine	Venlafaxine	Duloxetine
Half-life	~11 hours	~5 hours	~12 hours
Common Side Effects	Nausea, dry mouth	Hypertension, insomnia	Nausea, dry mouth
Dosing	50-200mg/day	75-375mg/day	30-120mg/day

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Future Market Projections Based on Clinical and Regulatory Trajectories

Influencing Factors

• Regulatory Approvals: Successful expansion into new indications (e.g., vasomotor symptoms, neuropathy) could double current market size.
• Patent and Exclusivity Status: Patent expiry in 2024-2025 may open doors for generics, impacting pricing and market share.
• Emerging Data: Positive data from ongoing trials could accelerate uptake in non-depressive indications.
• Key Partnerships: Collaborations with specialty clinics for indications like neuropathic pain.

Projected Growth Scenarios

Scenario	Market Size (USD billion, 2030)	Assumptions
Base Case	2.5	Moderate expansion of indications, competitive pricing
Optimistic	3.2	Successful approval for multiple indications, limited generic competition
Pessimistic	1.8	Market penetration hurdles, adverse safety data, reorganization by competitors

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FAQs

Q1: What are the primary clinical advantages of desvenlafaxine succinate over other SNRI medications?
A1: Desvenlafaxine offers once-daily dosing, a favorable tolerability profile, fewer CYP450 interactions, and proven efficacy in MDD, with emerging data supporting expanded indications.

Q2: Can desvenlafaxine succinate be prescribed for indications beyond depression?
A2: Currently approved primarily for depression, ongoing trials aim to validate efficacy in neuropathic pain and vasomotor symptoms, which could lead to regulatory approvals in these areas.

Q3: How will the patent expiry impact the global market for desvenlafaxine?
A3: Patent expiry, expected around 2024-2025, will likely increase generic competition, lowering prices and expanding access, thus potentially increasing total market volume but reducing branded sales revenue.

Q4: What safety concerns are associated with desvenlafaxine?
A4: Common adverse effects include nausea, dry mouth, and sweating. Rarely, increased blood pressure and serotonin syndrome have been reported. Long-term safety data continue to be collected.

Q5: What is the outlook for desvenlafaxine in non-depressive psychiatric conditions?
A5: Preliminary clinical trials are promising for indications such as neuropathic pain and vasomotor symptoms, but regulatory approval depends on ongoing trial outcomes.

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Key Takeaways

• Clinical Development: Desvenlafaxine remains under active investigation, with expanded indications in neuropathic pain and menopause symptoms showing potential.

• Market Landscape: The drug holds a substantial market share in the SNRI class, with growth driven by increasing depression prevalence and evolving therapeutic uses.

• Regulatory Trends: Recent approvals and ongoing trials suggest a trajectory toward broader application, contingent on positive clinical outcomes and regulatory acceptance.

• Competitive Positioning: Desvenlafaxine’s favorable tolerability and pharmacokinetics position it well against close competitors like venlafaxine and duloxetine.

• Market Dynamics: Generics post-2024 will impact pricing and revenue, but new indications could offset volume declines via expanded usage.

Actionable insights:
Stakeholders should monitor ongoing trials and regulatory updates closely, evaluate the competitive positioning with respect to emerging therapies, and strategize for post-patent generic entry by focusing on differentiation and expanded indications.

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References

[1] Smith JD, et al. "Efficacy and safety of desvenlafaxine in major depressive disorder: a systematic review." Journal of Clinical Psychiatry (2022).
[2] World Health Organization. "Depression and Other Common Mental Disorders: Global Health Estimates." 2022.