CLINICAL TRIALS PROFILE FOR ASENAPINE

All Clinical Trials for Asenapine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00143182 ↗	9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)	Completed	Pfizer	Phase 3	2005-01-07	Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.
NCT00143182 ↗	9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-01-07	Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.
NCT00145470 ↗	12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-06-02	This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
NCT00145496 ↗	Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-12-01	Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
NCT00145509 ↗	40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-08-01	The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
NCT00150176 ↗	To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-04-01	Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Clinical Trial Conditions for Asenapine

Condition Name

Condition Name for Asenapine
Intervention	Trials
Schizophrenia	26
Bipolar Disorder	14
Schizoaffective Disorder	5
Bipolar I Disorder	3

Condition MeSH

Condition MeSH for Asenapine
Intervention	Trials
Schizophrenia	29
Bipolar Disorder	17
Disease	16
Psychotic Disorders	9

Clinical Trial Locations for Asenapine

Trials by Country

Trials by Country for Asenapine
Location	Trials
United States	60
Spain	9
India	7
Canada	4
Romania	3

Trials by US State

Trials by US State for Asenapine
Location	Trials
Ohio	6
New York	5
Texas	5
Georgia	4
California	4

Clinical Trial Progress for Asenapine

Clinical Trial Phase

Clinical Trial Phase for Asenapine
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	35
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Asenapine
Clinical Trial Phase	Trials
Completed	47
Recruiting	3
Unknown status	2

Clinical Trial Sponsors for Asenapine

Sponsor Name

Sponsor Name for Asenapine
Sponsor	Trials
Merck Sharp & Dohme Corp.	37
Forest Laboratories	4
Pfizer	4

Sponsor Type

Sponsor Type for Asenapine
Sponsor	Trials
Industry	59
Other	29

Asenapine: Clinical Trials, Market Analysis, and Projections

Introduction

Asenapine, marketed under the brand name Saphris or SECUADO, is an atypical antipsychotic medication used primarily for the treatment of schizophrenia and bipolar disorder. This article provides an update on the clinical trials, market analysis, and projections for asenapine.

Clinical Trials Update

Efficacy and Safety

Clinical trials have consistently demonstrated the efficacy and safety of asenapine. A 6-week, fixed-dose, randomized, double-blind, placebo-controlled trial (Study 1; NCT 02876900) showed that asenapine significantly improved symptoms in adult patients with schizophrenia compared to the placebo group[1].

In a long-term study, patients who received asenapine for 52 weeks following a 6-week double-blind trial showed sustained efficacy with no significant adverse effects on body weight, body mass index, or glycated hemoglobin levels. The study, conducted in Japan, Korea, and Taiwan, indicated that asenapine at doses of 10-20 mg/day was safe and effective for long-term treatment of schizophrenia[4].

Maintenance of Efficacy

A randomized withdrawal design study further demonstrated the maintenance of efficacy of sublingual asenapine. Patients who were stable on asenapine for 22 weeks were randomized to either continue asenapine or switch to placebo. The results showed that asenapine was statistically superior to placebo in preventing relapse or impending relapse, as measured by the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity (CGI-S) score[1].

Market Analysis

Market Segmentation

The asenapine market is segmented based on product type, application, and geographical region. The product types include 5 mg and 10 mg formulations, with the 5 mg dose having a significant impact due to its lower side effect profile and ease of administration[5].

The primary applications are in the treatment of schizophrenia and bipolar disorder, with schizophrenia being the largest segment due to the higher prevalence and severity of the condition[2].

Geographically, the market is divided into North America, Latin America, Western Europe, Eastern Europe, Asia Pacific, and the Middle East and Africa. North America and Europe are leading segments due to advanced healthcare infrastructure and significant investments in mental health research[3].

Market Drivers

Several factors drive the growth of the asenapine market:

• Increasing Prevalence of Mental Health Disorders: The rising prevalence of schizophrenia and bipolar disorder worldwide is a significant driver for the demand for asenapine[3].
• Aging Population: An aging population is more susceptible to mental health disorders, contributing to increased demand for treatments like asenapine[3].
• Growing Awareness and Diagnosis: Improved awareness and diagnostic tools have led to more patients being diagnosed and treated, boosting the demand for asenapine[3].
• Generic Drug Market Expansion: The expiration of patents for branded drugs has led to a growing market for generic versions of asenapine, driven by cost-effectiveness[3].

Market Competition

The asenapine market is highly competitive, with key players such as Allergan (now part of AbbVie), Merck & Co., and Actavis Generics (Teva) competing based on factors like price, user-friendly interface, value-added benefits, and service benefits. To gain a competitive edge, vendors are focusing on developing new technologies and integrating them into their product portfolios[2].

Market Projections

Growth Rate

The asenapine market is expected to grow significantly over the forecast period from 2025 to 2031. The market size is projected to increase at a moderate pace, driven by the increasing prevalence of mental health disorders and the expanding generic drug market[3][5].

Regional Dominance

North America is expected to dominate the global asenapine market due to its advanced healthcare infrastructure and significant investments in mental health research. The Asia-Pacific region is also emerging rapidly, driven by increasing awareness of mental health disorders and a burgeoning pharmaceutical industry[3].

Technological and Regulatory Trends

Pharmaceutical companies are investing in research and development to improve the efficacy and safety profile of asenapine. Innovations in formulations and regulatory approvals for new indications are expected to expand the market. Streamlined approval processes by regulatory bodies will also support market growth[3].

Key Takeaways

• Clinical Efficacy: Asenapine has demonstrated significant efficacy in treating schizophrenia and bipolar disorder in various clinical trials.
• Market Growth: The asenapine market is expected to grow driven by increasing prevalence of mental health disorders, an aging population, and the expansion of the generic drug market.
• Regional Focus: North America and the Asia-Pacific region are key markets due to their healthcare infrastructure and growing awareness of mental health issues.
• Competitive Landscape: The market is highly competitive, with vendors focusing on new technologies and cost-effective solutions.

FAQs

What are the primary uses of asenapine?

Asenapine is primarily used to treat schizophrenia and bipolar disorder, helping patients to think more clearly, feel less nervous, and participate in everyday life. It also helps reduce hallucinations and prevent severe mood swings[2].

What are the common dosages of asenapine?

The common dosages of asenapine are 5 mg and 10 mg, administered sublingually twice daily based on tolerability[1][2].

What are the key drivers of the asenapine market?

Key drivers include the increasing prevalence of mental health disorders, an aging population, growing awareness and diagnosis, and the expansion of the generic drug market[3].

Which regions are expected to dominate the asenapine market?

North America and the Asia-Pacific region are expected to dominate the global asenapine market due to their advanced healthcare infrastructure and growing awareness of mental health issues[3].

What are the potential side effects of long-term asenapine treatment?

Long-term studies have shown that asenapine is generally safe with no significant adverse effects on body weight, body mass index, or glycated hemoglobin levels. However, adverse events such as increased prolactin levels and other common antipsychotic side effects can occur[4].

Sources

1. SECUADO ® for the treatment of SCHIZOPHRENIA: IT'S ON - Secuado.
2. Saphris (Asenapine) Market Progresses for Huge Profits by 2025 - OpenPR.
3. Asenapine Maleate API Market Size, Share, Trends & Forecast - Verified Market Research.
4. Long‐term safety and efficacy of sublingual asenapine for the ... - Wiley Online Library.
5. Saphris Asenapine Market Report 2024 (Global Edition) - Cognitive Market Research.

Last updated: 2025-01-01