This Schizophrenia - Pipeline Insight, 2021 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.
Schizophrenia Emerging Drugs
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.
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.
BI 425809: Boehringer Ingelheim
BI 425809 is a glycine transporter inhibitor that is being developed for the treatment of schizophrenia in Phase III stage of development. The rationale behind this approach is that abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in both these diseases, hence boosting NMDA receptor function might benefit synaptic plasticity and cognition.
BI 425809 is proposed to increase glycine levels and its ability to modulate NMDA receptor function. On 25 May, 2021 Boehringer Ingelheim announced that its BI 425809 product had been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for cognitive impairment associated with schizophrenia (CIAS).
TV-46000: Teva Pharmaceuticals
TV-46000 is an extended-release subcutaneous risperidone injection, an investigational once-monthly or once-every-two-months injectable formulation of the well-characterized and widely used atypical antipsychotic risperidone for the treatment of schizophrenia.
The investigational subcutaneous risperidone injection utilizes a novel polymer delivery platform that allows the product to be delivered subcutaneously. The polymer delivery platform, in combination with risperidone, allows for control of the rate and duration of drug release and a range of dosing options. The investigational subcutaneous risperidone injection has been studied extensively in non-clinical and clinical studies, including a global Phase 3 clinical development program with two pivotal studies evaluating investigational subcutaneous risperidone injection in schizophrenia. Teva Pharmaceutical intends to submit NDA application for Schizophrenia.
KarXT: Karuna Therapeutics
Karuna therapeutics product candidate, KarXT, selectively activates muscarinic acetylcholine receptors in the brain to unlock the therapeutic potential of xanomeline, which previously demonstrated significant benefits in Phase 2 studies in schizophrenia and Alzheimer's.
M1 and M4 muscarinic receptors are the receptor subtypes believed to mediate the antipsychotic, procognitive and analgesic effects of xanomeline and other muscarinic agonists. Results from preclinical studies and clinical trials conducted by third parties support the hypothesis that xanomeline can reduce psychosis and improve cognition. The drug is currently being evaluated in Phase III clinical to treat Schizoprenia.
AVP-786: Avanir Pharmaceuticals
This investigational therapeutic is a deuterated, second-generation version of AVP-923/Nuedexta, a fixed-dose combination of two approved drugs. AVP-786 is a combination of deudextromethorphan hydrobromide (d6-DM) and quinidine sulfate (Q), a CYP2D6 inhibitor. Deuteration was observed to significantly reduce susceptibility to cytochrome P450 (CYP2D6) enzyme metabolism thereby increasing the bioavailability of d6-DM. It is being investigated in Phase II/III clinical trial to treat Schizophrenia.
MK-8189: Merck sharp & Dohme
MK 8189 is an orally administered, phosphodiesterase 10A (PDE10A) inhibitor, being developed and investigated in Phase III stage of developemntby Merck Sharp & Dohme, 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, Sunovion Pharmaceuticals.
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
Products have been categorized under various Molecule types such as
The 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
Impact of Drugs
Schizophrenia Report Assessment
Pipeline Product Profiles
Inactive drugs assessment
GW Research Ltd
Janssen Research & Development
Jiangsu Nhwa Pharmaceutical
Luye Pharma Group Ltd.
Merck Sharp & Dohme
Sirtsei Pharmaceuticals, Inc.
For more information about this clinical trials report visit https://www.researchandmarkets.com/r/w8rn42
View source version on businesswire.com: https://www.businesswire.com/news/home/20210804006241/en/
Laura Wood, Senior Press Manager
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