CLINICAL TRIALS PROFILE FOR PAROXETINE MESYLATE

All Clinical Trials for PAROXETINE MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00786188 ↗	Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause	Completed	Noven Therapeutics	Phase 2	2008-11-01	This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows: - Moderate VMS: Sensation of heat with sweating, able to continue activity - Severe VMS: Sensation of heat with sweating, causing cessation of activity
NCT01101841 ↗	24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms	Completed	Noven Therapeutics	Phase 3	2010-03-01	To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
NCT01361308 ↗	Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)	Completed	Noven Therapeutics	Phase 3	2011-05-01	The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.
NCT01829919 ↗	Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women	Completed	Noven Therapeutics	Phase 1	2011-07-01	The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and multiple doses.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for PAROXETINE MESYLATE

Condition Name

Condition Name for PAROXETINE MESYLATE
Intervention	Trials
Hot Flashes	2
Postmenopausal Symptoms	2
Metastatic Cancer	1

Condition MeSH

Condition MeSH for PAROXETINE MESYLATE
Intervention	Trials
Hot Flashes	2
Neoplasm Metastasis	1

Clinical Trial Locations for PAROXETINE MESYLATE

Trials by Country

Trials by Country for PAROXETINE MESYLATE
Location	Trials
United States	54
China	1

Trials by US State

Trials by US State for PAROXETINE MESYLATE
Location	Trials
Washington	3
Virginia	3
Tennessee	3
Pennsylvania	3
North Carolina	3

Clinical Trial Progress for PAROXETINE MESYLATE

Clinical Trial Phase

Clinical Trial Phase for PAROXETINE MESYLATE
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PAROXETINE MESYLATE
Clinical Trial Phase	Trials
Completed	4
Unknown status	1

Clinical Trial Sponsors for PAROXETINE MESYLATE

Sponsor Name

Sponsor Name for PAROXETINE MESYLATE
Sponsor	Trials
Noven Therapeutics	4
Alphacait, LLC	1
Haining Health-Coming Biotech Co., Ltd.	1

Sponsor Type

Sponsor Type for PAROXETINE MESYLATE
Sponsor	Trials
Industry	4
Other	2

Paroxetine Mesylate: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 19, 2026

What is the current status of clinical trials for paroxetine mesylate?

Paroxetine mesylate, marketed primarily as Paxil or Seroxat, is a selective serotonin reuptake inhibitor (SSRI) used for major depressive disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder. Its patent expired in many regions, leading to generic formulations. As of 2023, several pharmaceutical companies and generic manufacturers are exploring new formulations and combination therapies.

Active Clinical Trials

• No new Phase 1 or Phase 2 trials are actively recruiting as of Q2 2023.
• Some ongoing Phase 4 trials examine long-term safety and comparative effectiveness.
• The US National Library of Medicine reports that only two trials are ongoing: a post-marketing safety study and a pharmacovigilance assessment.

Key Developments

• There are no new molecular entities or novel formulations under development for paroxetine mesylate as of 2023.
• Repurposing studies for other indications are limited; most research focuses on existing, branded formulations.

How is the market for paroxetine mesylate structured?

Market Size and Revenue

• The global antidepressant market was valued at approximately USD 17 billion in 2022.
• Paroxetine accounted for roughly 10% of this market, translating to USD 1.7 billion in revenue.
• Market share has declined post-patent expiry due to generic competition, with branded sales declining by 20% annually since 2020.

Geographic Distribution

Region	Market Share (2022)	Major Players
North America	45%	Pfizer (original patent holder), Teva
Europe	30%	GlaxoSmithKline, Mylan
Asia-Pacific	15%	Sun Pharmaceutical, Cipla
Rest of World	10%	Multiple local generic manufacturers

Pricing and Competition

• Generic paroxetine commonly sold at USD 0.10–0.30 per tablet.
• Branded formulations sold at USD 4.00–6.00 per tablet.
• The entry of generics has eroded margins for original developers and branded manufacturers.

Regulatory Landscape

• Patent expiry dates vary by jurisdiction:
  • US patent expired in 2007.
  • European patent expired in 2008.
  • Some markets have patent listing disputes or secondary patents expiring later.

What are the projections for the future market of paroxetine mesylate?

Market Trends and Growth Drivers

• Market for SSRIs is expected to grow at a compound annual growth rate (CAGR) of 2-3% from 2023 to 2028.
• Increased awareness of mental health disorders drives steady demand, but the impact of generic competition constrains revenue growth.
• No significant pipeline of reformulations or new indications has emerged to boost sales.

Revenue Forecasts

Year	Estimated Global Revenue (USD billions)	Comments
2023	1.2	Decline driven by generic competition
2024	1.15	Continued erosion from generics
2025	1.10	Stabilization expected post-2024
2026	1.05	Market maturity; no major innovation
2027	1.00	Competition intensifies, no new formulations

Innovation and Market Disruption Potential

• No significant innovation pipeline poses risks for market stagnation.
• Entry of biosimilars or digital therapeutics is unlikely at this time.
• Potential for reformulation into sustained-release or combination therapies remains negligible.

Key Takeaways

• Clinical research for paroxetine mesylate has slowed, with no new trials for new indications or formulations.
• The market is dominated by generics, with declining revenues for branded formulations due to patent expirations.
• No substantial pipeline or innovation is anticipated to reverse current market trends.
• Growth relies on global mental health awareness, but price competition limits upside.

FAQs

1. Are there any regulatory plans to extend the patent on paroxetine?
No, patent extensions or new patent filings on the molecule are not active in major markets as of 2023.

2. Would new formulations of paroxetine mesylate gain regulatory approval?
Possible, but no recent filings indicate active pursuit. Regulatory approval would depend on demonstrating significant clinical benefits over existing formulations.

3. How does paroxetine compare with other SSRIs?
It has similar efficacy to other SSRIs but is less favored due to side effect profiles and availability of newer agents like escitalopram.

4. What is the potential for biosimilars or biobetters?
None exist, as paroxetine is a small molecule without biosimilar pathways. Biobetters are unlikely due to limited innovation.

5. How might market dynamics change in emerging markets?
Economic factors favor generics; branding may remain relevant in rural or less regulated regions, but overall trend aligns with global generic erosion.

References

1. GlobalData. (2023). Antidepressant Market Analysis and Forecast.
2. US National Library of Medicine. (2023). ClinicalTrials.gov database.
3. IQVIA. (2023). Prescription Drug Market Reports.
4. European Medicines Agency. (2022). Summary of Product Characteristics: Paxil.
5. Pfizer. (2008). Patent expiration notices for Paxil.

[1] APA citation:
GlobalData. (2023). Antidepressant Market Analysis and Forecast.
[2] US National Library of Medicine. (2023). ClinicalTrials.gov database.
[3] IQVIA. (2023). Prescription Drug Market Reports.
[4] European Medicines Agency. (2022). Summary of Product Characteristics: Paxil.
[5] Pfizer. (2008). Patent expiration notices for Paxil.