Bipolar Depression - Pipeline Insight, 2024

This “Bipolar depression- Pipeline Insight, 2024” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Bipolar 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 depression: Understanding

Bipolar depression: Overview

Bipolar disorder affects approximately 12.6 million individuals in the United States and an estimated 29 million people worldwide. A person is usually diagnosed with bipolar disorder after experiencing at least one manic episode, with symptoms that are not better explained by another mental health condition, such as schizophrenia.3 Bipolar disorder is characterized by debilitating mood swings, interspersed with periods of stable mood and behavior. When individuals with bipolar disorder are experiencing symptoms, most tend to be depressed, rather than manic.

Depressive episodes tend to be longer in duration and are less responsive to existing treatments than manic episodes. Suicidal behavior can occur in all phases of the illness, with depressive episodes carrying the highest risk. Bipolar disorder is associated with significant impairment in personal and professional relationships, quality of life and ability to function.

Around 64% of clinical encounters for depression occur in primary care, with misdiagnosis of bipolar depression common in both primary care and psychiatry. Although bipolar disorder is characterized by manic, hypomanic, and depressive episodes, the most common and debilitating symptomatic presentation is depression. Misdiagnosis as unipolar depression is common, often resulting in mistreatment with an unopposed monoamine antidepressant.

Antidepressants are often ineffective for treating bipolar depression and may cause detrimental consequences such as treatment-emergent hypomania/mania, rapid cycling, or increased suicidality. A past depressive episode plus at least one episode of mania or hypomania are signs that one has Bipolar Depression. Cariprazine, fluoxetine/olanzapine, lurasidone, and quetiapine are approved to treat bipolar depression; only cariprazine and quetiapine are approved to treat both bipolar mania and depression.

Bipolar depression- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Bipolar depression pipeline landscape is provided which includes the disease overview and Bipolar depression treatment guidelines. The assessment part of the report embraces, in depth Bipolar 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 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 depression R&D. The therapies under development are focused on novel approaches to treat/improve Bipolar depression.

Bipolar depression Emerging Drugs Chapters

This segment of the Bipolar 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 depression Emerging Drugs

SEP-4199: Sunovion Pharmaceuticals Inc.

SEP-4199 is a non-racemic ratio of amisulpride enantiomers with the potential to be the first benzamide treatment available in the U.S. for mood disorders. Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific, and that increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors.

SEP-4199 was designed to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of bipolar depression. The pharmacological effect of SEP-4199 is distinct from racemic amisulpride, which is approved in several countries outside the U.S. for the treatment for schizophrenia and other psychiatric conditions. The drug currently investigated in Phase III trial which is expected to be completed by May 2025.

NRX-100/NRX-101: NRx Pharmaceuticals, Inc.

NRX-101 is a fixed-dose combination of D-Cycloserine and Lurasidone. NRX-101 is part of NRx Pharma’s investigational medicine regimen of NRX-100 (ketamine) and NRX-101. If approved by the U.S. Food and Drug Administration (FDA) and other health-regulatory agencies, would be the first medicine regimen to treat Severe Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior (ASIB).

NRX-101 is a patented, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator at certain dosage ranges; and Lurasidone, a 5-HT2a receptor antagonist. The FDA has granted the combination therapy a Breakthrough Therapy Designation (BTD) for the treatment of severe bipolar depression in patients with acute suicidal ideation and behavior (ASIB), after initial stabilization with ketamine or other effective therapy. The combination is currently under Phase III trial for Bipolar Depression.

Bipolar depression: Therapeutic Assessment

This segment of the report provides insights about the different Bipolar depression drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Bipolar depression

There are approx. 5+ key companies which are developing the therapies for Bipolar depression. The companies which have their Bipolar depression drug candidates in the most advanced stage.

Phases

This report covers around 5+ 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 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Bipolar depression: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Bipolar 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 depression drugs.

Bipolar depression Report Insights

• Bipolar depression Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Bipolar 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 depression drugs?
• How many Bipolar 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 depression?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bipolar 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 depression and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Sunovion Pharmaceuticals Inc
• NRx Pharmaceuticals, Inc.
• Elevar Therapeutics
• Celon Pharma

Key Products

• SEP-4199
• NRX-100/NRX-101
• ILT101
• ING-41
• Esketamine

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