Schizophrenia Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, And Companies

DelveInsight's, “Schizophrenia Pipeline Insights 2025” report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in Schizophrenia pipeline landscape. It covers the Schizophrenia pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Schizophrenia therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Schizophrenia Pipeline Report

• On 28 August 2025, AbbVie announced a study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia.
• On 22 August 2025, Merck Sharp & Dohme LLC organized a study was to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses were the following: (1) that MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, and (2) that MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score.
• On 22 August 2025, ACADIA Pharmaceuticals Inc. conducted a Phase 3 study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia.
• On 20 August 2025, Bristol-Myers Squibb conducted a phase 3 study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia.
• DelveInsight's Schizophrenia pipeline report depicts a robust space with 55+ active players working to develop 60+ pipeline therapies for Schizophrenia treatment.
• The leading Schizophrenia Companies such as Sunovion Pharmaceuticals, Denovo BioPharma, 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 and others.
• Promising Schizophrenia Therapies such as x Brexpiprazole, ICLEPERTIN (BI-425809), KarXT (Xanomeline-Trospium), NUPLAZID (pimavanserin), MK-5720, NaBen, Brilaroxazine (RP-5063), ULOTARONT (SEP-363856), LUVADAXISTAT (NBI 1165844/TAK 831), Roluperidone (MIN-101), BXCL501 80, TV-44749, Evenamide (NW-3509/NW-3509A), LYN-005 (risperidone, weekly), OKEDI (risperidone ISM), Emraclidine (CVL-231), and others.

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Schizophrenia Emerging Drugs Profile

• 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.

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Schizophrenia Companies

Sunovion Pharmaceuticals, Denovo BioPharma, 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 and others.

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

Schizophrenia Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

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Scope of the Schizophrenia Pipeline Report

• Coverage- Global
• Schizophrenia Companies- Sunovion Pharmaceuticals, Denovo BioPharma, 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 and others.
• Schizophrenia Therapies- Brexpiprazole, ICLEPERTIN (BI-425809), KarXT (Xanomeline-Trospium), NUPLAZID (pimavanserin), MK-5720, NaBen, Brilaroxazine (RP-5063), ULOTARONT (SEP-363856), LUVADAXISTAT (NBI 1165844/TAK 831), Roluperidone (MIN-101), BXCL501 80, TV-44749, Evenamide (NW-3509/NW-3509A), LYN-005 (risperidone, weekly), OKEDI (risperidone ISM), Emraclidine (CVL-231), and others
• Schizophrenia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Schizophrenia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Schizophrenia Pipeline on our website @ Schizophrenia Emerging Drugs and Companies

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