Schizophrenia Pipeline: Analysis of 90+ key pipeline therapies, 90+ key pharma competitors, unmet needs, and opportunities

Doria and ALKS 3831 expected to grab the attention. Several pharmaceutical companies are in the Schizophrenia market, including Alkermes, Avanir Pharmaceuticals, Boehringer Ingelheim, Acadia Pharmaceuticals, Rovi Pharmaceuticals Laboratories, Minerva Neurosciences, BioXcel Therapeutics, Acadia Pharmaceuticals, and others.


Los Angeles, USA, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Schizophrenia Pipeline: Analysis of 90+ key pipeline therapies, 90+ key pharma competitors, unmet needs, and opportunities  

Doria and ALKS 3831 expected to grab the attention. Several pharmaceutical companies are in the Schizophrenia market, including Alkermes, Avanir Pharmaceuticals, Boehringer Ingelheim, Acadia Pharmaceuticals, Rovi Pharmaceuticals Laboratories, Minerva Neurosciences, BioXcel Therapeutics, Acadia Pharmaceuticals, and others. 

DelveInsight’s Schizophrenia Pipeline Insights report provides a comprehensive outlook of the pipeline therapies that are in different clinical and pre-clinical stages of development, their launch, and how the market is expected to transform in the aftermath across the Schizophrenia domain.

The Schizophrenia Pipeline Analysis report offers a 360° view of the therapeutics landscape by development stage, product type, route of administration, molecule type, and MOA for Schizophrenia emerging therapies.

The pipeline report lays down the business opportunities, threats, prospective collaborations, strong competitors, and growth strategies. 

Some of the key highlights from the Schizophrenia Pipeline report:

  • 90+ key pharma players are proactively working to propel the Schizophrenia market landscape by 2026-27.
  • Over 90+ Schizophrenia pipeline therapies are under different stages of development and their expected approval in the Schizophrenia market shall uplift the market revenue significantly. 
  • Out of emerging therapies, SEP-363856 is in Phase III of clinical development, whereas, AVP-786 is in Phase II/III stage of trials. Similarly, MK-8189 is undergoing Phase II developmental phase for Schizophrenia. 
  • Schizophrenia pipeline therapies in the early stages of development include CAD-9303, and CVL 231 in Phase I of clinical trials.
  • In December 2020, FDA assigns PDUFA action date of (01/06/2021) for ALKS 3831 for Schizophrenia and Bipolar disorders.
  • In June 2020, Neurocrine Biosciences and Takeda entered into a strategic collaboration agreement to develop and commercialize compounds in Takeda’s early-to-mid-stage psychiatry pipeline. Takeda granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including three clinical-stage assets for schizophrenia, treatment-resistant depression, and anhedonia.

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Schizophrenia is a chronic and severe mental disorder affecting 20 million people worldwide. It is characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior. If left untreated, the symptoms of schizophrenia can be persistent and disabling. However, effective treatments are available such as antipsychotic medications, psychotherapy, and self-management strategies.

Schizophrenia Pipeline Analysis: Drug Profile 

  • SEP-363856: Sunovion Pharmaceuticals

SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity. The therapy is under trial for the treatment of schizophrenia and other psychiatric conditions. Sunovion is running a global Phase III development program for schizophrenia (DIAMOND) with additional indications under consideration. 

NCT04109950: Study SEP361-301 or Study SEP361-302,  “an open-label extension study to assess the safety and tolerability of SEP-363856 in subjects with Schizophrenia”, is currently in the recruiting stage with an estimated enrollment of 555 participants and expected to be completed in November 2022.

NCT04072354: Sunovion initiated a phase III trial titled “A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of SEP-363856 in Acutely Psychotic Subjects with Schizophrenia”, which is expected to be completed in September 2021.

  • Doria (Risperidone extended-release): Rovi Pharmaceuticals Laboratories

Doria is a monthly intramuscular injection that does not require loading doses or concurrent oral risperidone. It is a new long-acting injectable (LAI) intramuscular formulation of risperidone, for monthly administration without oral supplementation. As researchers suggest that the intramuscular route of administration is more effective compared to oral, hence Doria is expected to generate the highest market share compared to other therapies. It is in the preregistration stage for Schizophrenia in the USA.

  • Roluperidone (MIN-101): Minerva Neurosciences

Roluperidone is meant to block a specific subtype of serotonin receptor called 5-HT2A. When 5-HT2A is blocked, certain symptoms of schizophrenia, such as hallucinations, delusions, agitation, and thought and movement disorders, as well as the side effects associated with antipsychotic treatments, can be minimized. Additionally, blocking 5-HT2A promotes slow-wave sleep, a sleep stage often disrupted in patients with schizophrenia. It is currently in phase 3 of clinical trials and in December 2020 Minerva Neurosciences announces its intention to request a pre-NDA meeting with the US FDA for planned NDA submission of Roluperidone for Schizophrenia.

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Key Pipeline Therapies along with Companies 

  • TV-44749: Teva Pharmaceutical 
  • AVP-786: Avanir Pharmaceuticals
  • CAD-9303: Cadent Therapeutics
  • CVL 231: Cerevel Therapeutics
  • SEP-363856: Sunovion Pharmaceuticals
  • Doria: Rovi Pharmaceuticals Laboratories
  • Roluperidone: Minerva Neurosciences
  • Lu AF11167: H. Lundbeck A/S
  • KarXT: Karuna Pharmaceuticals
  • MK-8189: Merck
  • NaBen: SyneuRx International
  • TAK-831: Takeda
  • RL 007: Recognify Life Sciences
  • Dexmedetomidine (BXCL501): BioXcel Therapeutics
  • RO-6889450: Roche
  • Evenamide: Newron Pharmaceuticals
  • BI 409306: Boehringer Ingelheim
  • PF 6412562: Pfizer
  • ALKS 3831: Alkermes plc 
  • Pimavanserin:  ACADIA Pharmaceuticals

Schizophrenia Pipeline Therapeutics Assessment

  • By Product Type
    • Monotherapy
    • Combination Therapy
  • By Stage
    • Discovery 
    • Pre-clinical
    • Phase I
    • Phase II
    • Phase III
    • Pre-registration 
  • By Route of Administration
    • Oral
    • Intravenous
    • Inhalation
    • Sub-cutaneous
  • By Molecule Type
    • Small Molecule 
    • Gene Therapy
    • Stem Cell Therapy 
  • Targets:
    • Protease
    • Immunomodulatory
    • Multiple Kinase Inhibitor
  • By Mechanism of Action
    • NMDA receptor modulators
    • NMDA receptor agonists
    • CYP2D6 inhibitor
    • Serotonin 1A receptor agonists
    • Trace amine-associated receptor 1 agonists
    • Muscarinic  M4 receptor modulators
    • Monotherapy
    • Combination Therapy 

Got queries? Reach out for more information @ Schizophrenia Drug Pipeline Assessment 

Scope of the Report

  • Coverage: Global
  • Key Market Players: Teva Pharmaceutical, Avanir Pharmaceuticals, Cadent Therapeutics, Cerevel Therapeutics, Sunovion Pharmaceuticals, Rovi Pharmaceuticals Laboratories, Acadia Pharmaceuticals, Pfizer, Merck Sharp & Dohme, Karuna Pharmaceuticals, Takeda, GW Pharmaceuticals, Alkermes, Lundbeck A/S, Roche, Boehringer Ingelheim, Celon Pharma, SyneuRx International, Avineuro Pharmaceuticals, Recognify Life Sciences, among others.
  • Key Pipeline Therapies: TV-48438, AVP-786, CAD-9303, CVL 231, Lu AF11167, KarXT, PF 6412562,MK-8189, GWP42003, RO6889450, CPL500036, NaBen, AVN 211, RL 007, among others.
  • Novel Therapies: Doria, Roluperidone, Dexmedetomidine, SEP363856, Pimavanserin, ALKS 3831, BI 409306, KarXT, and Evenamide.

Table of Content 

1Report Introduction
2Schizophrenia 
3Schizophrenia Current Treatment Patterns
4Schizophrenia - DelveInsight's Analytical Perspective
5Therapeutic Assessment
6Schizophrenia Late-Stage Products (Phase-III)
7Schizophrenia Mid Stage Products (Phase-II)
8Early-Stage Schizophrenia Products (Phase-I)
9Schizophrenia Pre-clinical Products and Discovery Stage Products
10Inactive Products
11Dormant Products
12Schizophrenia Discontinued Products
13Schizophrenia Product Profiles
14Schizophrenia Key Companies
15Schizophrenia Key Products
16Dormant and Discontinued Products
17Schizophrenia Unmet Needs
18Schizophrenia Future Perspectives
19Schizophrenia Analyst Review
20Appendix
21 Report Methodology

Know more of what’s covered in the Schizophrenia Pipeline Assessment report

Key Questions Answered in the Schizophrenia Report

  • What are the current options for Schizophrenia treatment?
  • How many companies are developing therapies for the treatment of Schizophrenia? 
  • What are the principal therapies developed by these companies in the industry?
  • How many therapies are developed by each company for the treatment of Schizophrenia?
  • How many Schizophrenia emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of Schizophrenia?
  • Out of total pipeline products, how many therapies are given as a monotherapy and in combination with other therapies? 
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and major licensing activities that will impact the Schizophrenia market? 

Request for a Webex demo @ Schizophrenia Drug Pipeline and get a walk-through of our report 

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