CLINICAL TRIALS PROFILE FOR SAPHRIS

All Clinical Trials for SAPHRIS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00281320 ↗	Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-02-01	This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.
NCT00833976 ↗	Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia	Completed	GlaxoSmithKline	Phase 4	2009-07-01	This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
NCT00833976 ↗	Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia	Completed	Massachusetts General Hospital	Phase 4	2009-07-01	This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
NCT00878462 ↗	An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2005-06-29	This trial was a randomized trial to determine a patient's acceptability of unflavored antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients received 6 total doses of study drug (2 doses of each asenapine formulation) over 3 consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening. The formulations were: white unflavored, white raspberry flavored, and red raspberry flavored. Patients were given a questionnaire following each dose of study medication (one questionnaire twice per day for 3 days) to measure how acceptable each formulation was.
NCT01400113 ↗	Treating Acutely Agitated Patients With Asenapine Sublingual Tablets	Completed	Schering-Plough	Phase 4	2012-04-01	Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.
NCT01400113 ↗	Treating Acutely Agitated Patients With Asenapine Sublingual Tablets	Completed	St. Joseph Hospital Health Center	Phase 4	2012-04-01	Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.
NCT01400113 ↗	Treating Acutely Agitated Patients With Asenapine Sublingual Tablets	Completed	Unity Health Toronto	Phase 4	2012-04-01	Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.

Clinical Trial Conditions for SAPHRIS

Condition Name

Condition Name for SAPHRIS
Intervention	Trials
Schizophrenia	4
Bipolar Disorder	3
Psychosis	2
High Triglycerides	1

Condition MeSH

Condition MeSH for SAPHRIS
Intervention	Trials
Bipolar Disorder	4
Schizophrenia	4
Disease	3
Psychotic Disorders	3

Clinical Trial Locations for SAPHRIS

Trials by Country

Trials by Country for SAPHRIS
Location	Trials
United States	14
India	1

Trials by US State

Trials by US State for SAPHRIS
Location	Trials
North Carolina	3
California	2
Georgia	2
Ohio	2
Florida	1

Clinical Trial Progress for SAPHRIS

Clinical Trial Phase

Clinical Trial Phase for SAPHRIS
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for SAPHRIS
Clinical Trial Phase	Trials
Completed	10
Terminated	1
Suspended	1

Clinical Trial Sponsors for SAPHRIS

Sponsor Name

Sponsor Name for SAPHRIS
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
bioRASI, LLC	2
Sun Pharmaceutical Industries Limited	2

Sponsor Type

Sponsor Type for SAPHRIS
Sponsor	Trials
Industry	16
Other	11

Clinical Trials Update, Market Analysis, and Projection for Saphris (Asenapine)

Last updated: October 30, 2025

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Introduction

Saphris (brand name in the U.S.) is the trade name for asenapine, an atypical antipsychotic medication primarily approved for the treatment of schizophrenia and bipolar disorder. Developed by Allergan (now part of AbbVie), Saphris has carved a niche in the psychotropic drug market. With ongoing clinical trials and an evolving competitive landscape, understanding its current status, market potential, and future outlook is crucial for stakeholders.

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Clinical Trials Update

Recent Clinical Developments

While Saphris received FDA approval in 2009, recent clinical activity has been limited but focused on expanding its therapeutic applications and optimizing its safety profile.

• Expanded Indications and Efficacy Studies:
  Current trials explore Saphris’s efficacy in adjunctive therapy for treatment-resistant depression, a common frontier for atypical antipsychotics. However, as of 2022, no major pivotal trials specifically target this indication for Saphris, unlike other antipsychotics such as quetiapine or aripiprazole.

• Safety and Tolerability:
  Phase IV post-marketing surveillance continues to monitor adverse effects, emphasizing metabolic syndrome, weight gain, and extrapyramidal symptoms, which are typical concerns with second-generation antipsychotics. These ongoing studies aim to refine dose optimization and patient selection to mitigate risks.

• Formulation and Delivery Optimization:
  Recent research emphasizes improving drug adherence by evaluating alternative formulations, including transdermal patches or longer-acting injectables. Although exploratory, these initiatives aim to expand Saphris’s market reach, especially for non-adherent patients.

Key Clinical Trial Platforms and Registries

Clinical trials registered on ClinicalTrials.gov reflect limited active studies specific to Saphris. Most are observational or post-marketing surveillance, with few phase II or III studies planned or ongoing. This signals a potential prioritization of other newer agents in the pipeline or reevaluation of Saphris’s positioning.

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Market Analysis

Current Market Landscape

• Global Market Value:
  The global antipsychotic market was valued at approximately USD 12 billion in 2021 and is projected to grow at a CAGR of around 3.5% through 2030, driven by rising schizophrenia and bipolar disorder prevalence and expanding mental health awareness.

• Competitive Position:
  Saphris’s main competitors include Risperdal (risperidone), Abilify (aripiprazole), and newer agents like Vraylar (cariprazine). While Saphris retains niche usage owing to its unique sublingual formulation, its market share has declined slightly, primarily due to the emergence of drugs with better side effect profiles and convenience.

• Market Penetration:
  Its use remains primarily in the U.S. and select European markets. Factors such as the necessity for sublingual administration, dose frequency, and side effect concerns have limited broader adoption. Nevertheless, its efficacy in acute psychotic episodes and bipolar mania sustains its place in the therapeutic arsenal.

Patient Demographics and Prescribing Trends

• Target Demographics:
  Typically prescribed to adult patients with schizophrenia and bipolar disorder. The drug's quick onset makes it suitable for acute episodes.

• Prescribing Trends:
  Recent data indicate a trend toward prescribing newer atypical antipsychotics with more favorable side effect profiles, impacting Saphris's market share. However, in cases where rapid symptom control is prioritized, clinicians still prescribe Saphris due to its sublingual route's quick absorption.

Regulatory and Reimbursement Environment

• FDA and EMA:
  Both agencies maintain approval status. No significant label updates have taken place recently, but pharmacovigilance continues.
  • Reimbursement: Reimbursement remains generally favorable in the U.S., with coverage through major payers, though cost considerations influence prescribing behaviors.

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Market Projection

Growth Drivers

• Expanding Mental Health Burden:
  Rising prevalence of schizophrenia (~20 million globally) and bipolar disorder (~45 million globally) fuels drug demand. Trends toward early intervention and rapid symptom control support continued use of fast-onset agents like Saphris.

• Innovations in Formulation:
  Advancements such as long-acting injectables could revive interest, especially among non-adherent populations, thus potentially stabilizing or increasing market share.

Challenges and Barriers

• Safety Profile Concerns:
  Metabolic and neurological adverse effects remain significant barriers limiting broader adoption.

• Competitive Landscape:
  Introduction of newer agents with superior tolerability or oral formulations diminishes Saphris's attractiveness.

• Market Penetration:
  Limited geographic presence constrains growth. Strategies to expand into emerging markets could be beneficial, contingent on regulatory approvals.

Future Outlook (2023-2030)

Considering current clinical trial activity, safety concerns, and competitive pressures, Saphris’s market is expected to decline modestly in the next five years unless new formulations or indications gain regulatory approval.

• Projection:
  The global market for asenapine is projected to decrease at a CAGR of around 1-2%, primarily due to saturation and high competition. However, niche applications and formulations could offset some decline.

• Potential Upsides:

  • Expansion into adjunctive treatments for depression after additional trials.
  • Development of non-oral formulations to enhance compliance.
  • Entry into regional markets with unmet psychiatric needs.

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Conclusion

Saphris (asenapine) remains a relevant but niche player within the atypical antipsychotic landscape. Its clinical utility in rapid symptom control and bipolar mania sustains demand, but challenges such as safety, convenience, and competition dampen its growth prospects. Ongoing safety surveillance and formulation innovation are critical for maintaining its market presence.

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Key Takeaways

• Clinical Landscape:
  Limited new clinical trials suggest a plateau in Saphris’s development pipeline, with focus primarily on safety and administration enhancements rather than expanding indications.

• Market Position:
  The drug maintains a niche status driven by rapid onset and efficacy but faces declining market share amid newer agents with better safety profiles and user-friendly formulations.

• Market Outlook:
  Despite a growing global mental health burden, Saphris’s market is expected to contract slightly unless innovative formulations or new indications are successfully developed and commercialized.

• Strategic Opportunities:
  Aligning clinical research with unmet needs—such as long-acting formulations or adjunctive depression therapy—could revitalize its market potential.

• Regulatory Environment:
  Steady approval status underpins exposure but remains contingent on ongoing safety monitoring and potential new indication approvals.

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FAQs

1. What are the primary approved indications for Saphris (asenapine)?
Saphris is approved in the U.S. for treating schizophrenia and bipolar I disorder (manic or mixed episodes).

2. Are there any ongoing pivotal clinical trials for new indications of Saphris?
As of 2022, no active pivotal trials focus on expanding Saphris's indications. Most research centers on safety, tolerability, and formulation improvements.

3. How does Saphris compare to other atypical antipsychotics in terms of safety?
Saphris’s safety profile aligns with other second-generation antipsychotics, with notable concerns regarding weight gain, metabolic syndrome, and extrapyramidal symptoms, similar to drugs like risperidone.

4. What are the main challenges limiting Saphris’s market growth?
Key barriers include safety concerns, inconvenient sublingual administration, competition from newer agents, and limited geographic penetration.

5. Can Saphris’s market potential be increased through formulation innovations?
Yes. Developing long-acting injectable or transdermal formulations may enhance adherence and expand its use, particularly in populations with compliance challenges.

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References

1. FDA Drug Approval Package for Saphris [1].
2. Global Neuropsychiatric Drugs Market Report 2022 [2].
3. ClinicalTrials.gov Database [3].
4. Allergan and AbbVie press releases [4].
5. Market Analysis Reports (IQVIA, EvaluatePharma) [5].

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Note: Data is current as of 2022-2023; ongoing clinical and market developments may influence future insights.