Bipolar Disorder (Manic Depression)- Pipeline Insight, 2024

DelveInsight's, "Bipolar Disorder (Manic Depression)- Pipeline Insight, 2024" report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Bipolar Disorder (Manic Depression) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Bipolar Disorder (Manic Depression): Understanding

Bipolar Disorder (Manic Depression): Overview

Bipolar disorder, formerly known as manic depression, is a mental health condition characterized by extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). These mood swings can affect sleep, energy levels, behavior, and the ability to carry out day-to-day tasks. Bipolar disorder is a chronic condition that requires lifelong management. It is classified into several types: Bipolar I, marked by manic episodes lasting at least seven days or by manic symptoms severe enough to require immediate hospital care; Bipolar II, defined by a pattern of depressive episodes and hypomanic episodes, which are less severe than full-blown manic episodes; and Cyclothymic Disorder, characterized by periods of hypomanic and depressive symptoms lasting for at least two years.

The signs and symptoms of bipolar disorder vary depending on whether the person is experiencing mania, hypomania, or depression. During manic episodes, individuals might feel excessively happy, energetic, or irritable, and they may engage in risky behaviors, have racing thoughts, and experience a decreased need for sleep. Hypomania is similar but less intense. Depressive episodes are marked by feelings of sadness, hopelessness, or emptiness, along with fatigue, difficulty concentrating, changes in sleep and appetite, and thoughts of death or suicide. The frequency and intensity of these episodes can vary, with some individuals experiencing rapid cycling between moods. The exact causes of bipolar disorder are not fully understood, but it is believed to result from a combination of genetic, biological, and environmental factors. There is a strong hereditary component; individuals with a family history of bipolar disorder are at higher risk. Biological differences in brain structure and function, as well as imbalances in neurotransmitters, also play a role. Stressful life events and trauma can trigger or worsen episodes of bipolar disorder in susceptible individuals.

Pathophysiologically, bipolar disorder is associated with dysregulation in brain circuits involving the prefrontal cortex and limbic system, which are responsible for mood regulation, decision-making, and impulse control. Neuroimaging studies have shown abnormalities in these brain regions in individuals with bipolar disorder. Additionally, neurotransmitter imbalances, particularly involving serotonin, dopamine, and norepinephrine, are implicated in the mood swings observed in bipolar disorder. These imbalances affect neural connectivity and communication, leading to the symptomatic extremes of mania and depression.

Diagnosis of bipolar disorder involves a thorough clinical evaluation, including a detailed medical and psychiatric history, assessment of symptoms, and, often, input from family members. Standardized questionnaires and rating scales can aid in the diagnostic process. It's crucial to distinguish bipolar disorder from other conditions that can cause mood swings, such as major depressive disorder, borderline personality disorder, and schizophrenia.

Treatment for bipolar disorder typically involves a combination of medication and psychotherapy. Mood stabilizers like lithium and anticonvulsants, as well as atypical antipsychotics, are commonly prescribed to manage mania and hypomania. Antidepressants may be used cautiously due to the risk of triggering manic episodes. Psychotherapy, particularly cognitive-behavioral therapy (CBT) and psychoeducation, helps individuals understand their condition, develop coping strategies, and adhere to treatment plans. Lifestyle modifications, such as regular sleep schedules and stress management techniques, are also important. In severe cases, electroconvulsive therapy (ECT) may be considered. Long-term, consistent treatment is essential for managing symptoms and improving quality of life.

"Bipolar Disorder (Manic Depression)- Pipeline Insight, 2024" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Bipolar Disorder (Manic Depression) pipeline landscape is provided which includes the disease overview and Bipolar Disorder (Manic Depression) treatment guidelines. The assessment part of the report embraces, in depth Bipolar Disorder (Manic Depression) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Bipolar Disorder (Manic Depression) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Bipolar Disorder (Manic Depression) R&D. The therapies under development are focused on novel approaches to treat/improve Bipolar Disorder (Manic Depression).

Bipolar Disorder (Manic Depression) Emerging Drugs Chapters

This segment of the Bipolar Disorder (Manic Depression) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Bipolar Disorder (Manic Depression) Emerging Drugs

• LYN-005: Lyndra Therapeutics

LYN-005 Risperidone is one of the most prescribed treatments for patients with schizophrenia and bipolar disorders LYN-005 is the Lyndra's lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. Lyndra Therapeutics announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder. The study also met its secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score, a score used for measuring symptom severity in schizophrenia. Oral weekly risperidone (LYN-005) was generally safe and well tolerated. Currently the drug is in Phase III stage of development for the treatment of bipolar disorder.

• AL001: Alzamend Neuro, Inc.

AL001, is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate, for the treatment of AD, bipolar disorder, MDD, and PTSD. AL001 recently completed the clinical portion of Phase IIA trials and announced topline data in June 2023. Based on our preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer's, bipolar disorder, MDD and PTSD in humans. Currently the drug is in Phase II stage of development for the treatment of bipolar disorder.

• SKL-PSY: SK Bio-Pharmaceuticals

SKL-PSY is a novel candidate being developed by SK Bio-Pharmaceuticals. In October 2011, SK biopharmaceuticals announced that they have entered into a research and development agreement with Medicilon, of Shanghai, China, for their novel new small molecule SKL-PSY that is being developed for the treatment of depression and bipolar disorder. SK Biopharmaceuticals and Shanghai Medicilon have been conducting various preclinical experiments for SKL-PSY since 2011. Unlike currently-marketed antidepressants that can require 2-4 weeks to become effective, SKL-PSY has a relatively quick onset of therapeutic effects in animal models of depressive and manic states. Currently, the drug is in Phase I stage of its development for the treatment of bipolar disorder.

Further product details are provided in the report........

Bipolar Disorder (Manic Depression): Therapeutic Assessment

This segment of the report provides insights about the different Bipolar Disorder (Manic Depression) drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Bipolar Disorder (Manic Depression)
• There are approx. 20+ key companies which are developing the therapies for Bipolar Disorder (Manic Depression). The companies which have their Bipolar Disorder (Manic Depression) drug candidates in the most advanced stage, i.e. phase III include, Lyndra Therapeutics.
• Phases

DelveInsight's report covers around 20+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Bipolar Disorder (Manic Depression) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Bipolar Disorder (Manic Depression): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Bipolar Disorder (Manic Depression) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Bipolar Disorder (Manic Depression) drugs.

Bipolar Disorder (Manic Depression) Report Insights

• Bipolar Disorder (Manic Depression) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Bipolar Disorder (Manic Depression) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Bipolar Disorder (Manic Depression) drugs?
• How many Bipolar Disorder (Manic Depression) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Bipolar Disorder (Manic Depression)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bipolar Disorder (Manic Depression) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Bipolar Disorder (Manic Depression) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Lyndra Therapeutics
• Alzamend Neuro, Inc.
• SK Bio-Pharmaceuticals
• Reviva Pharmaceuticals
• COMPASS Pathways
• NRx Pharmaceuticals
• Sage therapeutics
• Alzamend Neuro, Inc.
• Neumora Therapeutics
• Vanda Pharmaceuticals

Key Products

• LYN-005
• AL001
• SKL-PSY
• RP5063
• COMP360
• NRX-101(TM)
• SAGE-217
• AL001
• Navacaprant
• VHX 896