Delving into the Latest Updates on Cariprazine hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

cariprazine, Cariprazine hydrochloride (JAN/USAN), SYMVENU

+ [10]

Target

5-HT1A receptor x 5-HT2A receptor x D2 receptor

Mechanism

5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor agonists(Dopamine D2 receptor agonists)

Therapeutic Areas

Other DiseasesCardiovascular DiseasesCongenital Disorders

Active Indication

Depressive Disorder, MajorBipolar and Related DisordersBipolar Disorder+ [7]

Inactive Indication

Chronic schizophreniaGeneralized anxiety disorderMajor depressive disorder, moderate (MDD)+ [2]

Originator Organization

Chemical Works of Gedeon Richter Plc

Active Organization

Gedeon Richter (UK) Ltd.

AbbVie, Inc.

Zhejiang Jingxin Pharmaceutical Co., Ltd.

+ [4]

Inactive Organization

Forest Laboratories, Inc.Gedeon Richter Pharma GmbH

Whan In Pharmaceutical Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

US (17 Sep 2015),

Bipolar I disorderSchizophrenia

Regulation-

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Structure

Molecular FormulaC21H33Cl3N4O

InChIKeyGPPJWWMREQHLQT-BHQIMSFRSA-N

CAS Registry1083076-69-0

This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.

Start Date01 Oct 2024

Sponsor / Collaborator

Chengdu Kanghong Pharmaceutical Group Co., Ltd.

NCT05060549 / Not yet recruitingPhase 4IIT

Dopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant Benefit

Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Here, we will use a recently approved medication, cariprazine (Vraylar), to treat participants with bipolar depression. They will have brain imaging with PET scans before and during treatment to understand how the medication may be working. Particularly, we will look at the role of the D3 dopamine receptor.

Start Date01 Oct 2024

Sponsor / Collaborator

The New York State Psychiatric Institute

100 Clinical Results associated with Cariprazine hydrochloride

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100 Translational Medicine associated with Cariprazine hydrochloride

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100 Patents (Medical) associated with Cariprazine hydrochloride

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521

Literatures (Medical) associated with Cariprazine hydrochloride

01 Dec 2024·JOURNAL OF AFFECTIVE DISORDERS

Full-spectrum efficacy of cariprazine across manic and depressive symptoms of bipolar I disorder in patients experiencing mood episodes: Post hoc analysis of pooled randomized controlled trial data

Article

Author: McIntyre, Roger S ; Nguyen, Huy-Binh ; Vieta, Eduard ; Kramer, Ken ; Aronin, Lauren C ; Yu, Jun

INTRODUCTION:

Patients with bipolar I disorder may experience mood destabilization or treatment-emergent affective switch (TEAS) from one symptom pole to the other spontaneously or following treatment. Optimal treatment should address symptoms from both poles without precipitating destabilization.

METHODS:

These were pooled post hoc analyses of data from randomized, double-blind, placebo-controlled studies of cariprazine 3-12 mg/d for bipolar I mania (NCT00488618, NCT01058096, NCT01058668) and cariprazine 1.5 mg/d or 3 mg/d for bipolar I depression (NCT01396447, NCT02670538, NCT02670551). Changes from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 6 and Young Mania Rating Scale (YMRS) total score at week 3 were analyzed in each indication using a mixed-effects model for repeated measures. Percentages of patients with increasing levels of endpoint response and TEAS (bipolar mania = MADRS total score ≥ 19; bipolar depression = YMRS score ≥ 16) were determined.

RESULTS:

Cariprazine significantly reduced manic and depressive symptoms in patients with bipolar I disorder mood episodes. In patients with a manic episode and up to mild baseline depressive symptoms, cariprazine also significantly reduced depressive symptoms. In patients with a depressive episode and manic symptoms in remission at baseline, numerical reduction (without statistical significance) in YMRS indicated no worsening of mania. In both indications, cariprazine-treated patients had numerically greater response rates (presenting symptom pole) than placebo-treated patients; lower percentages of cariprazine- than placebo-treated patients had TEAS at visits where data were collected.

LIMITATIONS:

Post hoc analysis.

CONCLUSION:

Results suggested that cariprazine had full-spectrum efficacy across symptoms from both poles in patients with bipolar I disorder mood episodes; TEAS risk was low. Patient-level response suggested that improvement was clinically relevant.

01 Dec 2024·EUROPEAN NEUROPSYCHOPHARMACOLOGY

The polarity index of cariprazine

Article

Author: Vieta, Eduard ; Popovic, Dina

03 Oct 2024·CURRENT DRUG METABOLISM

Quality by Design Approach for the Development of Cariprazine Hydrochloride Loaded Lipid-Based Formulation for Brain Delivery via Intranasal Route

Article

Author: Mastiholimath, Vinayak ; Biradar, Prakash ; Chiprikar, Pallavi ; Shirkoli, Nisha

Background::

Cariprazine (CPZ) is a third-generation antipsychotic medication that has been approved for treating schizophrenia. This study aimed to develop a cariprazine-loaded nanostructured lipid carrier (CPZ-NLCs) to prevent first-pass metabolism and improve bioavailability and site-specific delivery from the nose to the brain.

Method::

The CPZ-NLCs were prepared using melt emulsification. The formulation was optimized using the Box–Behnken design (BBD); where the influence of independent variables on critical quality attributes, such as particle size and entrapment efficiency, was studied.

Result::

The optimized batch (F6) had a particle size of 173.3 ± 0.6 nm and an entrapment efficiency of 96.1 ± 0.57%, respectively. The in vitro release showed >96% release of CPZ from NLC within 30 min. The optimized formulation's ex vivo studies revealed significantly increased CPZ permeability (>75%) in sheep nasal mucosa compared to the CPZ suspension (~26%). The ciliotoxicity study of the nasal mucosa revealed that the CPZ-NLC formulation did not affect the nasal epithelium. The intranasal administration of the formulation achieved 76.14±6.23 μg/ml concentration in the brain which was significantly higher than the oral CPZ suspension administration (30.46±7.24 μg/ml). The developed formulation was stable for 3 months.

Conclusion::

The study concluded that the developed CPZ-NLC could significantly improve the bioavailability with quick delivery to the brain.

50

News (Medical) associated with Cariprazine hydrochloride

01 Nov 2024

·www.prnewswire.com

NeuroBlu: New Data Partner and Enterprise SSO Integration

Major expansion of behavioral health data with 940K+ new patient records, enterprise SSO integration, and enhanced analytics tools for deeper research insights. NEW YORK, Nov. 1, 2024 /PRNewswire/ -- Holmusk, a global leader in behavioral health real-world evidence, today announced the release of NeuroBlu Analytics v4.6, a major platform upgrade that combines expanded data coverage, enhanced analytics capabilities, and improved enterprise security through single sign-on (SSO) integration. This latest version of NeuroBlu reflects Holmusk's commitment to advancing behavioral health research and clinical insights by broadening access to quality, structured real-world data and strengthening analytical precision. A new partnership with a leading health provider network has added over 940,000 patient records from the New York City Metro area, increasing NeuroBlu's U.S. coverage to nearly 5 million patient encounters annually. This expanded dataset, integrated with Datavant tokenization, now enables pharmaceutical researchers to link granular psychiatric assessment data with claims outcomes, providing unprecedented insights into real-world treatment patterns and outcomes. "The most recent updates to NeuroBlu mark a transformative step forward in our ability to link clinical data with claims, unlocking insights that will drive better research and patient outcomes," said Holmusk CEO Nawal Roy. "With this powerful update to our new dataset, our platform enables researchers to make evidence-driven decisions in trial design, patient care, and health economics." Major Dataset Expansion The latest partnership expands NeuroBlu's reach into the Northeastern United States, adding comprehensive data for over 436,000 patients with anxiety disorders and 158,000 with major depressive disorder. Coverage includes key psychiatric medications, with insights into treatment sequences and real-world usage patterns. This unique dataset provides: Extensive Medication Data: 94% of patients have detailed medication history, covering commonly prescribed psychiatric medications like Vraylar (3,600+ patients) and Rexulti (2,200+ patients). Robust Geographic Representation: Coverage across NY, NJ, PA, CT, and FL enhances regional insights and relevance. Longitudinal Data and Vitals Tracking: Patients' treatment patterns and outcomes are tracked over time, offering a detailed view of treatment pathways and patient journeys. Claims Data Integration Through the integration of Datavant tokenization, NeuroBlu 4.6 enables the linkage of detailed psychiatric assessments with claims data, creating new possibilities for pharmaceutical research and health outcomes research. Key benefits include: Clinical Trial Optimization: Linking scales like PSS-3, PHQ-9, and GAD-7 with claims data enables researchers to optimize clinical trial design, track real-world treatment patterns across 940,000+ patients, and develop synthetic control arms. Evidence Generation: Linked datasets allow researchers to validate clinical endpoints, analyze medication adherence, and assess treatment discontinuation in real-world settings. These insights support augmentation strategies, examine concomitant medication use, and analyze healthcare utilization across diverse patient subgroups. Value Demonstration and HEOR Support: NeuroBlu's data-linking capabilities enable health economics and outcomes research (HEOR) by connecting clinical outcomes with cost data, examining treatment sequences, and enabling comparative effectiveness research. Long-term safety and effectiveness can now be tracked through linked datasets, strengthening insights into the value of mental health interventions. Enterprise-Grade Security with SSO Integration With the release of NeuroBlu Analytics v4.6, Holmusk introduces enterprise-grade single sign-on (SSO) integration, significantly enhancing security and access management for users. This new SSO functionality allows enterprise clients to securely and seamlessly access the NeuroBlu platform, meeting high-security standards and making user management more efficient for larger teams and organizations. Additionally, NeuroBlu 4.6 offers new SQL templates, allowing researchers to accelerate their data workflows, along with updated R and Python libraries featuring improved documentation for streamlined data integration. Together, these upgrades support researchers in extracting deeper insights with ease and efficiency, advancing NeuroBlu's mission to set new standards for security, usability, and innovation in behavioral health research. About Holmusk Holmusk is on a mission to harness real-world data to transform research and behavioral health care. Combining leading behavioral health data with AI-powered analytics and digital solutions designed to address the most pressing challenges in behavioral health, Holmusk is advancing the frontier of evidence generation and fueling innovation. Holmusk is headquartered in New York, with four additional offices worldwide. For more information, please visit . SOURCE Holmusk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

29 Oct 2024

·www.echemi.com

AbbVie Spends $1.4 Billion to Acquire Aliada, Betting on Uncertain Alzheimer’s Treatment Prospects, Stock Price Only Slightly Rises by 1%

AbbVie announced on Monday that it would buy Aliada Therapeutics for $1.4 billion in cash, a bet on an experimental Alzheimer's treatment that is in early development. The acquisition pitted AbbVie, which has a market capitalization of as much as $330 billion, against at least three other pharmaceutical companies interested in Aliada, according to insiders. Shares of AbbVie were up 1% at Monday's close. Competition for Aliada's privately held Alzheimer's drug candidate has driven up the deal price, according to people familiar with the matter, showing that despite the historical regulatory risks associated with drugs for the mentally wasting disease, there are still many pharmaceutical companies willing to invest early in such treatments. Two similar therapies that reduce toxic amyloid plaques in the brain were recently approved in the U.S. after decades of failure. AbbVie is aggressively expanding its portfolio of neuroscience products as sales of its top-selling arthritis drug Humira fell 33%. Humira was once the world's best-selling drug, but now faces competition from several cheaper biosimilars. To further strengthen its pipeline, AbbVie has already acquired neuroscience drug developer Cerevel Therapeutics and cancer drug developer ImmunoGen earlier this year in deals totaling about $19 billion. At least 11 monkeys have died at Hong Kong Zoo in the past week. Abbvie said Aliada's antibody therapy, ALIA-1758, could be the best of its kind. ALIA-1758 uses a protein in the blood called transferrin to carry iron to transport an antibody that degrades and eliminates amyloid plaques - sticky protein deposits in the brain that are a sign of Alzheimer's disease. "Many promising CNS targeted therapies fail to enter late-stage trials because they cannot cross the blood-brain barrier," said Michael Ryan, Aliada's medical director. "Our [drug delivery] platform directly addresses this challenge, effectively delivering targeted drugs and potentially transforming the way we treat neurological diseases," he added. With the approval of Biogen (BIIB.O) and Eisai (4523.T) (Leqembi) and Lilly (Lill.N) (Kisunla), amyloid plaques are confirmed as a therapeutic target, BMO analyst Evan Seigerman said. But Alzheimer's disease remains a high-risk indication. The number of people with Alzheimer's disease is expected to double from 6.9 million in 2020 to nearly 14 million by 2060, according to the CDC. Abbvie expects to close the deal by the end of this year. Abbvie's neuroscience therapies, which include botox and bipolar disorder drug Vraylar, brought in $4.13 billion in sales in the first half of 2024, up 15.3% year over year.

AcquisitionDrug Approval

25 Oct 2024

·endpts.com

EnGene’s $60M PIPE; AbbVie to develop neuropsychiatric drugs with Gedeon Richter

Plus, news about Tectonic Therapeutic, Molecular Partners and Arcus Biosciences: EnGene snags $60M: The Boston and Montreal gene therapy biotech raised the private placement from new and current investors a month after giving an early look at bladder cancer data . It’s the second big private placement for the biotech since it went public via a SPAC last fall. — Kyle LaHucik AbbVie partners again with Gedeon Richter: The companies have worked together for nearly two decades, developing CNS medicines like the antipsychotic Vraylar, and now plan to collaborate on more neuropsychiatric drugs. The Budapest-based pharma company gets $25 million upfront in the new pact. — Kyle LaHucik Tim Springer buys more shares of Tectonic Therapeutic: A repeat biotech builder and co-founder of Tectonic, Springer bought $10 million worth of shares from Atlas Ventures this week, according to an SEC filing . He owns about 31% of the company, which went public via a reverse merger this summer. — Kyle LaHucik Molecular Partners prices $20M offering: The Swiss biotech said the raise from HBM Healthcare Investments and other investors will close next week, and the process will support its radiopharma pipeline. — Kyle LaHucik Arcus Biosciences touts data from HIF-2a inhibitor in kidney cancer: The company shared Phase 1/1b data for casdatifan showing 81% of patients experienced disease control with either a partial response or stable disease. Other data demonstrated that 34% of patients experienced an objective response. It’s planning to start a Phase 3 trial of casdatifan in the first half of next year. The study is also enrolling another arm of patients to try out a combination of Arcus’ drug and Exelixis’ Cabometyx. — Katherine Lewin

Gene TherapyPhase 3

100 Deals associated with Cariprazine hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D09876	Cariprazine hydrochloride	N05AX15	DB06016

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder, Major	US	AbbVie, Inc.	16 Dec 2022
Bipolar and Related Disorders	CA	Gedeon Richter (UK) Ltd.	27 Apr 2022
Bipolar Disorder	CA	Allergan, Inc.	22 Apr 2022
Bipolar I disorder	US	AbbVie, Inc.	17 Sep 2015
Schizophrenia	US	AbbVie, Inc.	17 Sep 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute schizophrenia	Phase 3	-	Chengdu Kanghong Pharmaceutical Group Co., Ltd.	01 Oct 2024
Heart Septal Defects, Atrial	Phase 3	US	AbbVie, Inc.	07 Jul 2022
Heart Septal Defects, Atrial	Phase 3	PR	AbbVie, Inc.	07 Jul 2022
Irritable Mood	Phase 3	US	AbbVie, Inc.	07 Jul 2022
Irritable Mood	Phase 3	PR	AbbVie, Inc.	07 Jul 2022
Autism Spectrum Disorder	Phase 3	US	AbbVie, Inc.	01 Feb 2021
Autism Spectrum Disorder	Phase 3	PR	AbbVie, Inc.	01 Feb 2021
Depressive Disorder	Phase 3	EE	Forest Laboratories, Inc.	17 Mar 2016
Depressive Disorder	Phase 3	LT	Forest Laboratories, Inc.	17 Mar 2016
Major depressive disorder, moderate (MDD)	Phase 3	US	Gedeon Richter (UK) Ltd.	15 Nov 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Schizophrenia	116	cariprazine (women outpatients)	mjcxgtuovj(zrcisljfwa) = There was a significant change from baseline in women to week 16 in the SAND scores: negative symptoms decreased by 6.2, positive symptoms decreased with 1.0, which is a remarkable, combined 7.2 drop. mrtfdnvmxq (ivcwnajnvp )	-	18 Oct 2023
NCT03573297 (CTgov)	Phase 3	Mania \| Depressive Disorder \| Bipolar I disorder	901	placebo (Double-Blind Placebo QD)	bnajujefwf(esomfcxxue) = tcwficnrmn zsxjrmztwm (jdfdpsxghu, njgqlxwizp - qucozoxhuk) View more	-	28 Sep 2023
				Cariprazine (Double-Blind Cariprazine 1.5 mg QD)	bnajujefwf(esomfcxxue) = utwogtmqgv zsxjrmztwm (jdfdpsxghu, uodulqpuvt - mdorqiaorx) View more
Pubmed	Phase 3	Depressive Disorder, Major	751	Placebo	(bxnsqrttba) = llknemhulu gwkcydfkch (enfmhbmnxx )	Positive	15 Feb 2023
				Cariprazine 1.5 mg/day	(bxnsqrttba) = wvyyrxrnix gwkcydfkch (enfmhbmnxx )
NCT03738215 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	759	Placebo (Placebo + ADT)	sqtfawcqzo(suqyipgzln) = nhefuexeay gikpjofmdr (pofpnbgzjq, ngsrhpxxui - gvjovtdara) View more	-	25 Oct 2022
				Cariprazine (Cariprazine 1.5 mg/Day + ADT)	sqtfawcqzo(suqyipgzln) = vxcnqncfeu gikpjofmdr (pofpnbgzjq, fjlbxcqpxz - hftoalfiux) View more
NCT03739203 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	752	Placebo+Antidepressant Therapy (ADT) (Placebo + ADT)	nhexidzxkb(idmeazlhcv) = kmppgtqfje wcehevrwyg (acjswsitfd, jhwtnyjfql - wumpqzqkef) View more	-	21 Sep 2022
				Antidepressant Therapy (ADT)+Cariprazine (Cariprazine 1.5 mg/Day + ADT)	nhexidzxkb(idmeazlhcv) = zbtkeqlvri wcehevrwyg (acjswsitfd, qchcalpjqh - unxlmntgph) View more
NCT03593213 (CTgov)	Phase 3	Schizophrenia	587	Placebo (Placebo (Double-blind Treatment Period))	eseyusixgg(nnomtxiupn) = jnolnxvmqk tickzmdcmz (dxexruucsl, merrsbwvqd - yhwyuwzvqn) View more	-	08 Mar 2022
				Cariprazine (Cariprazine 3.0 mg/Day (Double-blind Treatment Period))	eseyusixgg(nnomtxiupn) = rqsljfnetb tickzmdcmz (dxexruucsl, mgjqazdttj - kbedobmhyu) View more
NCT01626885 (CTgov)	Phase 2/3	Schizophrenia	42	MP-214	hzooaqzzuj(ipjkvwwcow) = nvcfpjvhcw geajbodovx (ttmfyfkxrf, vibdsvoioy - ceyvrmgvzs) View more	-	13 Apr 2021
NCT01625897 (CTgov)	Phase 2/3	Schizophrenia	125	MP-214 (MP-214 1.5-9mg)	eyzkgfzbsa(yexllmllig) = wlidervtwh rwicpfmjnl (jwqrgxjhdy, xpwzwyheem - gksbdsevgc) View more	-	13 Apr 2021
				Risperidone (Risperidone 2-12mg)	eyzkgfzbsa(yexllmllig) = sgcmfanbwp rwicpfmjnl (jwqrgxjhdy, clwiqrorlu - xojrjbyffr) View more
NCT01626859 (CTgov)	Phase 2/3	Schizophrenia	38	MP-214 3mg (MP-214 3mg)	wdbhhiybdo(nhljeuwckb) = mfsxyarexn cmpxvfbadl (dofofisnhv, ayitiecxvi - crymexxvqt) View more	-	12 Apr 2021
				MP-214 6mg (MP-214 6mg)	wdbhhiybdo(nhljeuwckb) = seszlbuqti cmpxvfbadl (dofofisnhv, ukmchzzrje - tevewflfui) View more
NCT01626872 (CTgov)	Phase 2/3	Schizophrenia	254	MP-214 3mg (MP-214 3mg)	kmhivkksuf(khoqivrrut) = ijtqwbmgdb suofhmlwdm (urbqbccbfy, fyijrpddoy - pqefrrvfpk) View more	-	12 Apr 2021
				MP-214 6mg (MP-214 6mg)	kmhivkksuf(khoqivrrut) = jadsjutmsp suofhmlwdm (urbqbccbfy, kiogrolmsw - rimfnsvucd) View more