Schizophrenia - Pipeline Insight, 2024

This “Schizophrenia- Pipeline Insight, 2024” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in Schizophrenia 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

Schizophrenia: Understanding

Schizophrenia: Overview

Schizophrenia causes psychosis and is associated with considerable disability and may affect all areas of life including personal, family, social, educational, and occupational functioning. It is thought that an interaction between genes and a range of environmental factors may cause schizophrenia. Psychosocial factors may also affect the onset and course of schizophrenia. Heavy use of cannabis is associated with an elevated risk of the disorder. Schizophrenia may result in some combination of hallucinations, delusions, and extremely disordered thinking and behavior that impairs daily functioning, and can be disabling. People with schizophrenia require lifelong treatment. Early treatment may help get symptoms under control before serious complications develop and may help improve the long-term outlook.

Schizophrenia is characterized by significant impairments in the way reality is perceived and changes in behavior related to: Persistent delusions, persistent hallucinations, experiences of influence, control or passivity, disorganized thinking, highly disorganized behavior, “negative symptoms” such as very limited speech, extreme agitation or slowing of movements etc. diagnosis of schizophrenia is reached through an assessment of patient-specific signs and symptoms like delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, and negative symptoms. Symptoms can vary in type and severity over time, with periods of worsening and remission of symptoms. Some symptoms may always be present.

It's not known what causes schizophrenia, but researchers believe that a combination of genetics, brain chemistry and environment contributes to development of the disorder. Problems with certain naturally occurring brain chemicals, including neurotransmitters called dopamine and glutamate, may contribute to schizophrenia. Diagnosis of schizophrenia involves ruling out other mental health disorders and determining that symptoms are not due to substance abuse, medication or a medical condition. Determining a diagnosis of schizophrenia may include: Physical exam, Tests and screenings, Psychiatric evaluation, Diagnostic criteria for schizophrenia.

Treatment is usually lifelong and often involves a combination of medications, psychotherapy and coordinated specialty care services. Schizophrenia requires lifelong treatment, even when symptoms have subsided. Treatment with medications and psychosocial therapy can help manage the condition. In some cases, hospitalization may be needed. Medications are the cornerstone of schizophrenia treatment, and antipsychotic medications are the most commonly prescribed drugs. They're thought to control symptoms by affecting the brain neurotransmitter dopamine.

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

Schizophrenia Emerging Drugs Chapters

This segment of the Schizophrenia 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.

Schizophrenia Emerging Drugs

Ulotaront: Otsuka Pharmaceutical Ulotaront (SEP-363856), one of the first of a new class of CNS-active compounds, is an agonist at trace amine-associated receptor 1 (TAAR1) as well as serotonin 5-HT1A receptors. TAAR1 is a G-protein-coupled receptor expressed in cortical, limbic, and midbrain monoaminergic regions that modulate dopaminergic, serotonergic, and glutamatergic activity. In contrast to first- and second-generation antipsychotics, the efficacy of ulotaront is not mediated by blockade of D2 or 5-HT2A receptors. Ulotaront has demonstrated positive effects in rodent models assessing endophenotypes of schizophrenia, including phencyclidine (PCP)-induced hyperactivity, prepulse inhibition, and PCP-induced deficits in social interaction and cognition. An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects with Schizophrenia. Currently, the drug is in Phase III stage of its development for the treatment of dry eyesdisease.

AVP 786: Avanir Pharmaceuticals Deudextromethorphan (AVP 786) is a combination product of a deuterium-containing analogue of dextromethorphan and an ultra-low dose of quinidine, that is being developed by Avanir Pharmaceuticals (a subsidiary of Otsuka Pharmaceuticals), under a license from Concert Pharmaceuticals, for the treatment of psychiatric and Neurological Indications. Currently it is being evaluated in phase II/III stage of development for the treatment of schizophrenia.

Luvadaxistat: Takeda Luvadaxistat is a potential first-in-class, investigational, oral, selective inhibitor with a high binding affinity to d-amino acid oxidase (DAAO). It targets glutamate, an abundant neurotransmitter in the brain. In schizophrenia, N-methyl D-aspartate (NMDA) receptor hypofunction on PV+ gamma-aminobutyric acid (GABA) interneurons results in disinhibition of cortical or hippocampal glutamate neurons projecting to the pyramidal neurons. The cortical disturbances account for the negative/cognitive symptoms of schizophrenia, while the downstream subcortical dopamine release manifests as the positive symptoms of the disorder. A Phase II Randomized, Double-Blind, Placebo-Controlled, cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia isongoing.

CY6463: Cyclerion Therapeutics CY6463 is the first CNS-penetrant s GC stimulator to be developed as a symptomatic and potentially disease-modifying therapy for serious CNS diseases. The nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (c GMP) signaling pathway is a fundamental mechanism that precisely controls key aspects of physiology throughout the body. Cyclerion Therapeutics has initiated a double-blinded, randomized, placebo-controlled, multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants withStableSchizophrenia.

M4 PAMs: Addex Therapeutics M4 PAM, as a novel orally available treatment for schizophrenia & other psychosis. M4 PAM represents a novel therapeutic approach for the treatment of schizophrenia based on indirect modulation of the dopaminergic neurotransmission. Therapeutic utility of targeting muscarinic acetylcholine receptors in schizophrenia has been demonstrated in the clinic with the non-selective M1/M4 agonist, xanomeline, which reduced positive and negative symptoms and alleviated cognitive abnormalities in patients with schizophrenia. Currently the drug is in preclinical stage for the treatment of Schizophrenia.

Schizophrenia: Therapeutic Assessment

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

Major Players in Schizophrenia

• There are approx. 70+ key companies which are developing the therapies for Schizophrenia. The companies which have their Schizophrenia drug candidates in the most advanced stage, i.e. phase III include, Otsuka Pharmaceutical.

Phases

This report covers around 70+ 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

Schizophrenia 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.

Schizophrenia: Pipeline Development Activities

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

Schizophrenia Report Insights

• Schizophrenia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Schizophrenia 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 Schizophrenia drugs?
• How many Schizophrenia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Schizophrenia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Schizophrenia 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 Schizophrenia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Otsuka Pharmaceutical
• Avanir Pharmaceuticals
• Takeda
• Cyclerion Therapeutics
• Addex Therapeutics
• Vigonvita Life Sciences
• Valentech
• Minerva Neurosciences
• Recognify Life Sciences
• Neurocrine Biosciences
• ACADIA Pharmaceuticals
• Medin CellS.A.
• Heptares Therapeutics
• SyneuRx International (Taiwan) corp
• Merck Sharp & Dohme

Key Products

• Ulotaront
• AVP 786
• Luvadaxistat
• CY6463
• M4 PAMs
• VV 119
• VLT-015
• Roluperidone
• RL-007
• Valbenazine
• Pimavanserin
• Olanzapine
• HTL 0016878
• NaBen
• MK-8189

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