Schizophrenia- Pipeline Insight, 2025

DelveInsight's, "Schizophrenia- Pipeline Insight, 2025" report provides comprehensive insights about 55+ companies and 60+ 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 is a chronic, severe mental disorder that affects how a person thinks, feels, and behaves. It is characterized by episodes of psychosis, which involve disturbances in thought processes, perceptions, emotional responsiveness, and social interactions. Schizophrenia affects about 1% of the population worldwide and typically manifests in late adolescence or early adulthood. The exact cause of schizophrenia is not fully understood, but it is believed to result from a complex interplay of genetic, environmental, and neurobiological factors.

The symptoms of schizophrenia are generally categorized into positive, negative, and cognitive symptoms. Positive symptoms include hallucinations (often auditory), delusions (false beliefs), and disorganized thinking and speech. Negative symptoms refer to diminished emotional expression, lack of motivation, and social withdrawal. Cognitive symptoms affect memory, attention, and executive functioning, leading to difficulty in performing daily activities. These symptoms can vary in severity and may fluctuate over time, with periods of exacerbation and remission. The etiology of schizophrenia is multifactorial, involving genetic predisposition, prenatal and perinatal factors, and psychosocial stressors. Genetic studies indicate a high heritability, with several susceptibility genes identified. Environmental factors such as prenatal exposure to infections, malnutrition, and psychosocial stressors during early development may also contribute. The pathophysiology of schizophrenia involves dysregulation of neurotransmitters, particularly dopamine, glutamate, and serotonin, leading to abnormalities in brain structure and function. Neuroimaging studies have shown changes in brain regions such as the prefrontal cortex and hippocampus, as well as alterations in brain connectivity.

Diagnosing schizophrenia is based on clinical assessment, including a thorough psychiatric evaluation and medical history. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria are commonly used, which require the presence of two or more core symptoms (delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, and negative symptoms) for a significant portion of time during a one-month period. Other conditions, such as substance use disorders and mood disorders with psychotic features, must be ruled out. Additionally, the duration of symptoms should persist for at least six months. Treatment for schizophrenia involves a combination of pharmacotherapy, psychotherapy, and social support. Antipsychotic medications are the cornerstone of treatment, with second-generation antipsychotics (such as risperidone, olanzapine, and aripiprazole) being commonly prescribed due to their efficacy and lower risk of extrapyramidal side effects compared to first-generation antipsychotics. Psychosocial interventions, including cognitive-behavioral therapy (CBT), family therapy, and social skills training, are crucial in addressing the cognitive and social deficits associated with the disorder. Additionally, community support services, vocational rehabilitation, and educational programs play a vital role in improving the quality of life and functional outcomes for individuals with schizophrenia. Early intervention and a comprehensive, multidisciplinary approach are essential for optimizing treatment outcomes.

"Schizophrenia- Pipeline Insight, 2025" report by DelveInsight 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 III, II, II/III 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: Sunovion Pharmaceuticals

SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Research has shown that ulotaront results in a greater reduction from baseline in the PANSS total score than placebo. Treatment with ulotaront, as compared with placebo, was also associated with an improvement in sleep quality. Currently, the drug is in the Phase III stage of its development for the treatment of Schizophrenia

• Emraclidine: Abbvie

Emraclidine is a selective M4 receptor PAM, meaning it selectively targets the M4 receptor to harness the anti-psychotic effect believed to be associated with this receptor while minimizing the side effects associated with other pan-muscarinic agonists. The company believes emraclidine has the potential to provide a significant medical advancement as the muscarinic acetylcholine pathway has long been associated with mediation of neurotransmitter imbalance and psychosis. Emraclidine is the only selective M4 receptor PAM currently in clinical development. Currently, the drug is in the Phase II stage of its development for the treatment of Schizophrenia.

• CY 6463: Cyclerion Therapeutics

CY6463 is the first CNS-penetrant sGC 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 (cGMP) signaling pathway is a fundamental mechanism that precisely controls key aspects of physiology throughout the body. As an sGC stimulator, CY6463 acts as a positive allosteric modulator to sensitize the sGC enzyme to NO, increase the production of cGMP, and thereby amplify endogenous NO signaling. By compensating for deficient NO-sGC-cGMP signaling, CY6463 and other sGC stimulators may have broad therapeutic potential as a treatment to improve cognition and function in people with serious CNS diseases. Currently, the drug is in the Phase I stage of its development 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. 55+ 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, Sunovion Pharmaceutical.

• Phases

DelveInsight's report covers around 60+ 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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• 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

• Sunovion Pharmaceuticals
• Denovo BioPharma
• Cyclerion Therapeutics
• Karuna Therapeutics
• Boehringer Ingelheim
• Merck Sharp & Dohme
• MapLight Therapeutics
• Valentech LLC
• Addex Therapeutics
• Biodexa Pharmaceuticals
• Autifony Therapeutics
• Vanda Pharmaceuticals
• Luye Pharma
• Reviva Pharmaceuticals
• SyneuRx
• Avanir Pharmaceuticals
• Newron Pharmaceuticals
• Celon Pharma
• Delpor
• Zhejiang Jingxin Pharmaceutical
• Sirtsei Pharmaceuticals

Key Products

• Ulotaront
• Enzastaurin
• CY 6463
• KarXT
• Iclepertin
• MK-8189
• ML-007
• VLT-015
• M4 PAM
• MTD211
• Back up modulators
• VHX 896
• Paliperidone palmitate
• Brilaroxazine
• Sodium benzoate
• Deudextromethorphan
• Evenamide
• CPL 500036
• Risperidone controlled-release
• JX 11502MA
• SP 624