CLINICAL TRIALS PROFILE FOR BIPERIDEN HYDROCHLORIDE

All Clinical Trials for Biperiden Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00148590 ↗	Memantine for the Prevention of Cognitive Dysfunction and Negative Symptoms in Patients With Acute Schizophrenia	Terminated	Stanley Medical Research Institute	Phase 3	2005-11-01	The purpose of this study is to evaluate the efficacy and safety of a 6 weeks memantine add-on to risperidon treatment for the prevention of cognitive dysfunction and negative symptomatology in patients with acute schizophrenia. Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function were measured at baseline and week 6, and 24 by the California Verbal Learning Test, Benton Learning Test, Digit Span Forward and Backward Test, Continuous Performance Test, Stroop Test, Trail-Making Test, Verbal Fluency Test, and Wisconsin Card Sorting Test.
NCT00148590 ↗	Memantine for the Prevention of Cognitive Dysfunction and Negative Symptoms in Patients With Acute Schizophrenia	Terminated	M. Schaefer, MD	Phase 3	2005-11-01	The purpose of this study is to evaluate the efficacy and safety of a 6 weeks memantine add-on to risperidon treatment for the prevention of cognitive dysfunction and negative symptomatology in patients with acute schizophrenia. Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function were measured at baseline and week 6, and 24 by the California Verbal Learning Test, Benton Learning Test, Digit Span Forward and Backward Test, Continuous Performance Test, Stroop Test, Trail-Making Test, Verbal Fluency Test, and Wisconsin Card Sorting Test.
NCT00148616 ↗	Memantine for the Treatment of Cognitive Dysfunction and Negative Symptoms in Patients With Chronic Schizophrenia	Terminated	Stanley Medical Research Institute	Phase 3	2004-04-01	The purpose of this study is to evaluate the efficacy and safety of 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.
NCT00148616 ↗	Memantine for the Treatment of Cognitive Dysfunction and Negative Symptoms in Patients With Chronic Schizophrenia	Terminated	M. Schaefer, MD	Phase 3	2004-04-01	The purpose of this study is to evaluate the efficacy and safety of 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.
NCT00495092 ↗	Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients	Completed	Hospital Universitari Vall d'Hebron Research Institute	Phase 2/Phase 3	2005-01-01	The aim of this study is to assess the efficacy of caffeine compared to placebo in detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also studied. 108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 6 months. Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology, craving for cocaine and mental status during detoxifying period, 2) study retention and 3) cocaine use. Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.

Clinical Trial Conditions for Biperiden Hydrochloride

Condition Name

Condition Name for Biperiden Hydrochloride
Intervention	Trials
Schizophrenia	4
Cocaine Dependence	2
Depression	1
Acute Brain Injury	1

Condition MeSH

Condition MeSH for Biperiden Hydrochloride
Intervention	Trials
Schizophrenia	5
Cocaine-Related Disorders	3
Cognitive Dysfunction	2
Wounds and Injuries	2

Clinical Trial Locations for Biperiden Hydrochloride

Trials by Country

Trials by Country for Biperiden Hydrochloride
Location	Trials
Germany	3
Brazil	3
Spain	2
Taiwan	2

Clinical Trial Progress for Biperiden Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Biperiden Hydrochloride
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Biperiden Hydrochloride
Clinical Trial Phase	Trials
Completed	3
Terminated	3
Unknown status	2

Clinical Trial Sponsors for Biperiden Hydrochloride

Sponsor Name

Sponsor Name for Biperiden Hydrochloride
Sponsor	Trials
Stanley Medical Research Institute	2
M. Schaefer, MD	2
Hospital Universitari Vall d'Hebron Research Institute	2

Sponsor Type

Sponsor Type for Biperiden Hydrochloride
Sponsor	Trials
Other	17
Industry	1

Biperiden Hydrochloride: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update

Post-Traumatic Epilepsy (PTE) Prevention Trial

A significant clinical trial focusing on the use of biperiden hydrochloride as an antiepileptogenic agent in preventing post-traumatic epilepsy (PTE) after traumatic brain injury (TBI) has provided valuable insights. This randomized, double-blinded clinical trial, conducted between 2018 and 2022, involved adults with acute TBI who were randomly assigned to receive either biperiden or a placebo for 10 days.

• Primary Outcome: The trial aimed to evaluate the incidence of PTE. However, the results indicated a lack of evidence that biperiden reduces the incidence of PTE compared to the placebo group (2.6, 95% CI, 0.65–10.57; p = 0.170)[1].
• Secondary Outcomes: The study also assessed the frequency of seizures, adverse events, and mortality. Notably, the frequency of late post-traumatic seizures was higher in the biperiden group (2.03, 95% CI = 0.912–3.1597; p <0.001)[1].
• Challenges: The trial was halted and later terminated due to the COVID-19 pandemic, resulting in an adjusted sample size of 123 patients instead of the planned 132[1].

This trial suggests that larger studies are necessary to fully understand the potential of biperiden in preventing PTE.

Market Analysis

Global Market Size and Forecast

The global market for biperiden hydrochloride is experiencing steady growth driven by several factors.

• Current Market Size: The market was estimated to be worth USD 364.27 million in 2023 and is expected to reach USD 384.70 million in 2024[3].
• Forecast: By 2030, the market is projected to grow to USD 536.76 million at a Compound Annual Growth Rate (CAGR) of 5.69%[3].
• Regional Analysis: The market is segmented by region, with North America, Europe, and the Asia-Pacific region being key contributors. Each region is expected to grow at varying CAGRs, reflecting local healthcare infrastructure and demand for neurological treatments[2][5].

Market Segmentation

The biperiden hydrochloride market is segmented based on several criteria:

• Purity: The market is segmented into purity levels of below 98%, 98-99%, and higher than 99%. Each segment has its own market size and development potential[2][5].
• Application: The primary applications are in hospitals and laboratories, with other segments also contributing to the market growth[2][5].
• Formulation: Biperiden is available in various formulations, including injections, oral tablets, and research formulations, catering to different patient needs and clinical settings[3].

Key Players and Competitive Landscape

The market is dominated by several key players, including CF Pharma, Lifecare Labs, AbbVie, Synnat Pharma, and others. These companies hold a significant share of the market revenue and are actively involved in research and development to enhance the therapeutic efficacy and safety of biperiden hydrochloride.

• Competitive Analysis: The competitive landscape is highly regulated and competitive, with companies focusing on strategic partnerships, innovative research, and optimizing drug delivery systems to maintain market position[2][5].

Market Drivers and Opportunities

Growing Demand for Neurological Treatments

The increasing incidence of neurological disorders, such as Parkinson's disease, and the aging global population are significant drivers of the biperiden hydrochloride market.

• Neurological Disorders: The rising prevalence of Parkinson’s disease and other motor function disorders has increased the demand for anticholinergic agents like biperiden[3].
• Aging Population: An aging population contributes to a higher incidence of neurological conditions, thereby boosting the market for biperiden hydrochloride[3].

Expanding Healthcare Infrastructure

Emerging markets, particularly in Asia and Africa, offer opportunities for growth as their healthcare infrastructure related to neurological treatments expands.

• Emerging Markets: Enhancing awareness and accessibility of biperiden in these regions can tap into untapped markets and drive market expansion[3].

Technological Innovations

Advancements in pharmaceutical technologies and drug delivery systems are crucial for the market's growth.

• Innovative Drug Delivery: Collaborations with technology firms to develop effective drug delivery mechanisms can improve patient compliance and therapeutic efficacy[3].

Market Challenges

Alternative Therapies and Side Effects

Despite the growth potential, the market faces several challenges.

• Alternative Therapies: The availability of alternative therapies reduces the market dominance of biperiden hydrochloride. Continuous research and innovation are necessary to stay competitive[3].
• Side Effects: Long-term use of biperiden is associated with side effects, which can hinder market growth. Optimizing the therapeutic formulation to reduce side effects is a key challenge[3].

Regulatory and Generic Competition

Strict regulatory guidelines and generic competition also pose significant challenges.

• Regulatory Guidelines: Adhering to strict regulatory requirements can be challenging for manufacturers. Ensuring compliance is essential for market sustainability[3].
• Generic Competition: Generic competition diminishes profit margins, making it crucial for market leaders to innovate and differentiate their products[3].

Key Takeaways

• Clinical Trials: The recent clinical trial on biperiden hydrochloride for preventing PTE after TBI showed insufficient evidence of its efficacy, highlighting the need for larger studies.
• Market Growth: The global market for biperiden hydrochloride is projected to grow at a CAGR of 5.69% to reach USD 536.76 million by 2030.
• Market Segmentation: The market is segmented by purity, application, and formulation, with key players dominating the competitive landscape.
• Market Drivers: Growing demand for neurological treatments, expanding healthcare infrastructure, and technological innovations drive the market.
• Market Challenges: Alternative therapies, side effects, regulatory guidelines, and generic competition are significant challenges.

FAQs

What is the primary use of biperiden hydrochloride?

Biperiden hydrochloride is primarily used to treat Parkinson's disease and medication-induced extrapyramidal symptoms due to its anticholinergic properties[3].

What were the findings of the clinical trial on biperiden hydrochloride for preventing PTE?

The clinical trial found insufficient evidence that biperiden hydrochloride reduces the incidence of post-traumatic epilepsy (PTE) after traumatic brain injury (TBI), and it also noted a higher frequency of late post-traumatic seizures in the biperiden group[1].

What is the forecasted market size of biperiden hydrochloride by 2030?

The market is projected to grow to USD 536.76 million by 2030 at a CAGR of 5.69%[3].

Who are the key players in the biperiden hydrochloride market?

Key players include CF Pharma, Lifecare Labs, AbbVie, Synnat Pharma, and others[2][5].

What are the main challenges facing the biperiden hydrochloride market?

The main challenges include the availability of alternative therapies, side effects associated with long-term use, strict regulatory guidelines, and generic competition[3].

Sources

1. Frontiers in Neurology: "Initial clinical evidence on biperiden as antiepileptogenic after traumatic brain injury: a randomized, double-blinded clinical trial"[1]
2. QYResearch: "Biperiden Hydrochloride- Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030"[2]
3. 360iResearch: "Biperiden Market Size & Share 2025-2030"[3]
4. Patsnap: "Biperiden Hydrochloride - Drug Targets, Indications, Patents"[4]
5. OpenPR: "Biperiden Hydrochloride Market Growth will Accelerate at CAGR value, SWOT Analysis and EBITA Analysis 2030"[5]