Last update 04 Nov 2024

Aripiprazole

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAripiprazole, also known by its trade name Abilify Discmelt®, is an atypical antipsychotic medication that is utilized in the treatment of a diverse range of mood and psychotic disorders, including but not limited to schizophrenia, bipolar I disorder, major depressive disorder, irritability linked with autism, and Tourette's syndrome. This medication functions through its mechanism of action as both a 5-HT2A agonist and a D2 receptor agonist. Aripiprazole was first approved by the US FDA in 2002, with Otsuka Holdings as the pharmaceutical company responsible for its development. Its primary indication is for the treatment of schizophrenia.

Drug Type

Small molecule drug

Synonyms

ABILIFY MAINTENA, Abilify MyCite, Abilify Prolonged Release Aqueous Suspension

+ [30]

Target

5-HT1A receptor x 5-HT2A receptor x D2 receptor x D3 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

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Autism Spectrum DisorderTourette SyndromeDepressive Disorder+ [9]

Inactive Indication

Acute schizophreniaAffective Disorders, PsychoticAlzheimer Disease+ [14]

Originator Organization

Otsuka Holdings Co., Ltd.

Active Organization

Accord Healthcare SLUOtsuka Holdings Co., Ltd.

Otsuka Pharmaceutical Co., Ltd.

+ [9]

Inactive Organization

Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka America Pharmaceutical, Inc.

H. Lundbeck A/S

+ [4]

Drug Highest PhaseApproved

First Approval Date

US (15 Nov 2002),

Schizophrenia

RegulationOrphan Drug (US), Priority Review (CN)

Structure

Molecular FormulaC23H27Cl2N3O2

InChIKeyCEUORZQYGODEFX-UHFFFAOYSA-N

CAS Registry129722-12-9

530

Clinical Trials associated with Aripiprazole

CTRI/2024/08/072829 / Not yet recruitingNot Applicable

An Open-Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Multiple-Dose, Steady-State, Fully Replicate, Crossover Bioequivalence Study of Aripiprazole 400 mg Powder and Solvent for Prolonged-Release Suspension for Injection and Abilify Maintena® 400 mg Powder and Solvent for Prolonged-Release Suspension for Injection in Adult Patients withSchizophrenia under Fasting Condition. - NIL

Start Date02 Dec 2024

Sponsor / Collaborator

Laboratorios Liconsa SA

[+1]

TCTR20240524006 / Not yet recruitingPhase 1IIT

A randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence bioequivalence study of Aripiprazole Tablets 10 mg relative to Abilify (Aripiprazole Tablets 10 mg) in healthy Thai volunteers under fasting condition.

Start Date13 Nov 2024

Sponsor / Collaborator

Bio-innova Co., Ltd

NCT05545891 / Not yet recruitingPhase 2IIT

A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors

This study is 6 weeks long and involves subjects taking aripiprazole or placebo. If they are randomly assigned to the aripiprazole arm and are eligible to participate in the study, they will begin by taking 5mg once daily of aripiprazole for two weeks, then 10mg once daily for the remaining three weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either aripiprazole or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

Start Date01 Nov 2024

Sponsor / Collaborator

The University of Chicago

100 Clinical Results associated with Aripiprazole

100 Translational Medicine associated with Aripiprazole

100 Patents (Medical) associated with Aripiprazole

5,621

Literatures (Medical) associated with Aripiprazole

31 Dec 2024·Future Science OA

Haloperidol-induced painless legs and moving toe syndrome in a schizophrenia patient: a case report

Author: Begum, M Yasmin ; Sankar, Karthik ; Jeyabalan, Srikanth ; Maheshwari, Mugundan U ; Shanmugasundaram, Natarajan ; Sabarathinam, Sarvesh ; Sekar, Mahendran ; Wong, Ling S

Painless legs and moving toe syndrome (PoLMT) is a rare syndrome characterized by involuntary movements of the toe without pain. The exact etiology of the patient's PoLMT is unknown. We present a case of PoLMT in 45-year-old woman with a history of haloperidol intake for 10 months. Haloperidol was discontinued, and aripiprazole (15 mg) was initiated. After this switch, a reduction in movement was observed in the third and fourth toes; however, the second toe showed no discernible change.

01 Dec 2024·INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED

Early surgical care of the anticoagulated hip fracture patient within 24 hours

Article

Author: Hofmann, Matti ; Gebhard, Florian ; Pankratz, Carlos ; Dehner, Christoph ; Cintean, Raffael ; Schuetze, Konrad ; Boitin, Dominik

INTRODUCTION:

Hip fractures are still associated with high morbidity and mortality. Despite international guidelines advocating for urgent surgical treatment, delays often occur, particularly for patients on long-term antithrombotic therapy. We hypothesised that urgent surgical care for the anticoagulated hip fracture patient is not associated with severe bleeding complications.

MATERIAL AND METHODS:

For the period from 2015 to 2021, we retrospectively reviewed clinical records of 1142 patients with proximal femur fractures treated within 24 h of admission to our trauma centre (mean age 80.4 ± 12.4 years; 761 females, 381 males). The cohort comprised 409 femoral neck and 733 trochanteric fractures, managed with either arthroplasty (n = 297), hip-preserving techniques (n = 147), or intramedullary nailing (n = 698). Of these, 583 patients (51.1 %) were on long-term antithrombotic therapy. The primary endpoints included transfusion rate and the difference in haemoglobin (Hb) levels from pre- to postoperative. Secondary endpoints were in-patient mortality and occurrence of postoperative haematomas requiring surgical revision. A regression analysis was performed.

RESULTS:

The mean time to surgery was 10.3 h, with delays observed in patients on direct oral anticoagulants (DOACs). Overall, 25.9 % (n = 296) of the patients required blood transfusions. The transfusion rate was dependent on duration of the surgery, preoperative Hb level, and anticoagulation with DOACs. Similarly, the Hb difference was found to be dependent on the duration of surgery, preoperative Hb level, and anticoagulation with DOACs. In-patient mortality was 5.3 % (n = 60). Regression analysis indicated that mortality was dependent on a high ASA classification of 4 and the time to surgery, but not on the type of antithrombotic therapy. 3.1 % of the patients needed surgical revision due to postoperative haematoma with prolonged duration of surgery and antithrombotic therapy (PAI [OR = 3.7, 95 % CI: 1.1-12.7], DOACs [OR = 3.4, 95 % CI: 1.3-8.8], and VKA [OR = 5.5, 95 % CI: 1.8-17.1], p < 0.05) as independent risk factors.

CONCLUSION:

As postoperative haematoma and the need for transfusion are manageable situations, we conclude that immediate surgical treatment of hip fracture patients on long-term antithrombotic therapy within 24 h is feasible and patients may benefit.

01 Dec 2024·PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY

Role of CYP2D6 and CYP3A4 polymorphisms on aripiprazole and dehydroaripiprazole concentrations in patients undergoing long-acting treatment

Article

Author: Cajade-Pascual, Francisco ; Zarra-Ferro, Irene ; Vidal-Villares, María ; Fernández-Ferreiro, Anxo ; Rial-Pérez, Alicia ; Durán-Maseda, María José ; Toja-Camba, Francisco José ; Vidal, Gonzalo Hermelo ; Maroñas, Olalla ; Mondelo-García, Cristina ; Vidal-Millares, María ; Gestal, Ana Estany ; Carracedo, Angel

Aripiprazole once-monthly (AOM) exhibits an important interindividual pharmacokinetic variability with significant implications for its clinical use. CYP2D6 and CYP3A4 highly contributes to this variability, as they metabolize aripiprazole (ARI) into its active metabolite, dehydroaripiprazole (DHA) and the latter into inactive metabolites. This study aims to evaluate the effect of CYP2D6 and CYP3A4 polymorphisms in combination and the presence of concomitant inducers and inhibitors of this cytochromes on ARI and DHA plasma concentrations in a real clinical setting. An observational study of a cohort of 74 Caucasian patients under AOM treatment was conducted. Regarding CYP2D6, higher concentrations were found for active moiety (ARI plus DHA) (AM) (67 %), ARI (67 %) and ARI/DHA ratio (77 %) for poor metabolizers (PMs) compared to normal metabolizers (NMs). No differences were found for DHA. PMs for both CYP2D6 and CYP3A4 showed a 58 % higher AM and 66 % higher plasma concentration for ARI compared with PMs for CYP2D6 and NMs for CYP3A4. In addition, PMs for both CYP2D6 and CYP3A4 have 45 % higher DHA concentrations than NMs for both cytochromes and 41 % more DHA than PMs for CYP2D6 and NMs for CYP3A4, suggesting a significant role of CYP3A4 in the elimination of DHA. Evaluating the effect of CYPD26 and CYP3A4 metabolizing state in combination on plasma concentrations of ARI, DHA and parent-to-metabolite ratio, considering concomitant treatments with inducers and inhibitor, could optimize therapy for patients under AOM treatment.

News (Medical) associated with Aripiprazole

26 Aug 2024

·www.prnewswire.com

Schizophrenia Market: RISVAN's Approval Has Sparked a Competitive Race Among Pharmaceutical Companies | DelveInsight

The recent approval of Rovi Pharmaceuticals Laboratories' OKEDI/RISVAN (risperidone ISM) has spiked the competition among the other pharmaceutical companies that are developing novel therapies to improve the treatment landscape. RISVAN has the potential to become a blockbuster drug. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- Schizophrenia is a severe mental illness affecting about 1% of Americans, cognitive functions, emotional responses, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women. Currently, as per the WHO, the vast majority of schizophrenia patients around the world are not receiving mental health care. Approximately 50% of people in mental hospitals have a schizophrenia diagnosis, and only 31.3% of people with psychosis receive specialist mental health care. As per DelveInsight analysis, in 2023 the total diagnosed prevalent cases of schizophrenia in the 7MM were found to be approximately 4 million cases out of which the US accounted for nearly 1.5 million cases. It is anticipated that these numbers will rise by 2034 due to several factors, including population growth, improved diagnostic techniques, increased awareness, and reduced stigma around mental health issues prompting more individuals to seek diagnosis, and potentially, environmental stressors contributing to a higher occurrence of the disorder. Schizophrenia treatment involves a blend of medication, psychological counseling, and social support. However, nearly one-third of patients do not respond sufficiently to standard treatments. Relapses, characterized by psychotic symptoms and functional impairments, are significant. Schizophrenia treatment mainly consists of antipsychotic medications that target dopamine neurotransmitters. Second-generation medications are favored because they lower the risk of severe side effects. Long-acting injectable antipsychotics can enhance adherence and improve treatment outcomes. High-dose regimens of specific medications may be advantageous for patients with severe, treatment-resistant schizophrenia. Additionally, hospitalization and electroconvulsive therapy might be necessary for patients who do not respond to medication therapy or during severe episodes. First-generation antipsychotics like chlorpromazine, fluphenazine, haloperidol, and perphenazine are effective in treating positive symptoms such as hallucinations and delusions but do not alleviate negative symptoms or cognitive impairments. Second-generation antipsychotics, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), and LYBALVI (olanzapine and samidorphan), were developed to address both positive and negative symptoms, as well as cognitive symptoms. Although these medications typically have fewer extrapyramidal side effects, they can cause weight gain, sexual dysfunction, and other metabolic disorders. Additionally, elderly patients using FGAs and SGAs are at an increased risk of developing pneumonia. Learn more about the FDA-approved schizophrenia drugs @ Drugs for Schizophrenia Treatment REXULTI (brexpiprazole) is an oral tablet available in strengths from 0.25 mg to 4 mg, containing various inactive ingredients. While its exact mechanism of action is not fully understood, it work as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors and as an antagonist at serotonin 5-HT2A receptors. REXULTI was first approved in the US in July 2015 for use in adults with MDD and schizophrenia. In January 2022, it received FDA approval for pediatric patients aged 13–17. The EMA approved it in July 2018, and Japan approved it in tablet form in January 2018 and as an oral-disintegrating dose in August 2021. Generic versions of REXULTI have now been approved, which may affect its market presence. Janssen Pharmaceutical's INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA (paliperidone palmitate) is an SGA agent that seems to act as a D2 partial agonist and a 5-HT-2A receptor antagonist. INVEGA SUSTENNA is administered monthly, INVEGA TRINZA every three months, and INVEGA HAFYERA twice yearly. Paliperidone is a benzisoxazole derivative. In the EU and Japan, INVEGA SUSTENNA is marketed as XEPLION. In the EU, INVEGA TRINZA is sold as TREVICTA, and in Japan as XEPLION TRI. INVEGA HAFYERA is a long-acting injectable treatment administered in the upper buttocks every six months, providing continuous treatment and symptom control over this period. Additionally, the recent approval of RISVAN (Risperidone ISM) has intensified the competition in the schizophrenia treatment space. Risperidone ISM is a long-acting injectable antipsychotic created and patented by ROVI for treating schizophrenia in adults. From the first injection, it delivers immediate and sustained plasma drug levels without the need for loading doses or additional oral risperidone. This approval is based on the positive outcomes of the pivotal PRISMA-3 study, which assessed the efficacy and safety of Risperidone ISM in patients with schizophrenia. The study's findings demonstrate that the two doses tested (75 mg and 100 mg administered once monthly) successfully met the predetermined primary and secondary efficacy endpoints for treating patients with moderate to severe schizophrenia symptoms. Furthermore, OKEDI (risperidone ISM) was launched in Germany, the UK, and Spain in 2022. The approval was based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of risperidone ISM in schizophrenia patients. As per the estimates by Delveinsight analysts, this drug has blockbuster potential in the schizophrenia market with medium-fast uptake. To know more about schizophrenia treatment options, visit @ New Treatment for Schizophrenia The schizophrenia market is crowded with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Boehringer Ingelheim's Iclepertin (BI-425809), Sumitomo Pharma/Otsuka's Ulotaront (SEP-363856), Reviva Pharmaceuticals' Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma's Roluperidone (MIN-101/MT-210), Karuna Therapeutics (Bristol Myers Squibb)/Royalty Pharma's KarXT (xanomeline-trospium), ACADIA Pharmaceuticals' NUPLAZID (pimavanserin), Teva Pharmaceutical/MedinCell/Royalty Pharma's Olanzapine LAI (mdc-TJK/TV-44749), Neurocrine Biosciences/Mitsubishi Tanabe Pharma's Valbenazine (NBI-98854), Lyndra Therapeutics' LYN-005 (long-acting oral risperidone), Newron Pharmaceuticals' Evenamide (NW-3509), Luye Pharma's LY03010 (ER paliperidone palmitate), and others. Discover which therapies are expected to grab major schizophrenia market share @ Schizophrenia Market Report Iclepertin (BI 425809) is an investigational drug and a glycine transporter 1 (GlyT1) inhibitor aimed at addressing the brain biology related to cognitive symptoms in schizophrenia (CIAS). Abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in this condition. Enhancing NMDA receptor function could potentially improve synaptic plasticity and cognition. Glycine, an essential NMDA receptor co-agonist, is modulated by glycine transporters GlyT-1 and GlyT-2, which are located in presynaptic and astrocyte membranes. These transporters regulate glycine levels by taking it up into nerve terminals and adjacent glial cells, affecting synaptic cleft glycine concentration. By inhibiting these transporters, BI 425809 aims to increase glycine levels, thereby modulating NMDA receptor function. Administered orally, this potent and selective GlyT1 inhibitor is also under investigation for Alzheimer's disease. However, early 2020 Phase II trial results did not support its continued development for this indication, and the focus has now shifted to schizophrenia, with multiple Phase III trials currently underway. Since schizophrenia, patients frequently ignore certain symptoms, such as cognitive impairment. Therefore, if approved, BI-425809 will be the first approved pharmacotherapy for the treatment of CIAS. Ulotaront (SEP-363856), developed by Sumitomo Pharma and Otsuka Pharmaceuticals, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Ulotaront is currently in late-stage development for schizophrenia and generalized anxiety disorder (GAD) in Japan and as an adjunctive treatment for major depressive disorder, schizophrenia, and GAD in the US. Top-line results from Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia have been released, but the Phase III DIAMOND 3 trial in the US has been halted. Sumitomo Pharma has also stopped a Phase III trial for schizophrenia in Japan and another Phase II/III trial in China, Japan, Taiwan, and the Philippines, citing business strategy reasons. Despite this, two Phase III trials are still ongoing. Recently, Otsuka and Sumitomo revised their licensing agreement, excluding SEP-4199 and SEP-378614. Under this revision, Otsuka gained exclusive rights from SMPA to develop, manufacture, and commercialize ulotaront worldwide. If Otsuka successfully develops and commercializes ulotaront, they will pay up to 30 million USD (approximately 4.5 billion yen) in milestones, along with royalties based on sales, without any upfront payment. Starting January 2024, Otsuka will cover the full cost of studies conducted by both Sumitomo Pharma Group and Otsuka, except for certain studies. KarXT (xanomeline–trospium) is an oral modulator targeting muscarinic receptors found in both the central nervous system (CNS) and various peripheral tissues. This proprietary product combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS. As a dual M1/M4 muscarinic acetylcholine receptor agonist, KarXT aims to improve the positive, negative, and cognitive symptoms of schizophrenia. The US FDA has accepted Karuna Therapeutics' NDA for KarXT for adult schizophrenia treatment, with a PDUFA date of September 26, 2024. Additionally, KarXT is undergoing multiple Phase III trials as an adjunctive treatment with standard-of-care agents for schizophrenia and is being evaluated for psychosis treatment in Alzheimer's disease patients. Following Bristol Myers Squibb's acquisition of Karuna Therapeutics, Karuna is now a wholly-owned subsidiary of BMS. At the Annual Congress of the Schizophrenia International Research Society (SIRS) in April 2024 in Italy, BMS presented promising results from the latest interim analysis of the Phase III EMERGENT-4 open-label extension trial, showing KarXT's efficacy in reducing symptoms in adults with schizophrenia. BMS plans to continue discussions with the US FDA and will release more data from the EMERGENT program later this year. Discover more about drugs for schizophrenia in development @ Schizophrenia Clinical Trials The anticipated launch of these emerging therapies for schizophrenia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the schizophrenia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for schizophrenia is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Schizophrenia market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Schizophrenia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Schizophrenia Total Diagnosed Prevalent Cases of Schizophrenia Gender-specific Diagnosed Prevalent Cases of Schizophrenia Severity-specific Diagnosed Prevalent Cases of Schizophrenia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this schizophrenia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space. Related Reports Schizophrenia Pipeline Schizophrenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others. Schizophrenia Epidemiology Forecast Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Bipolar Depression Market Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2Clinical ResultDrug ApprovalLicense out/in

23 Jul 2024

·www.fiercepharma.com

Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data near

Lyndra is advancing a pipeline of long-acting pills spanning several therapeutic areas. Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company's recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of "all future products," a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. "With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients," the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson said. Lyndra's core business is a drug delivery platform spun out of MIT that aims to significantly reduce the dosing frequency required for oral pills. LYN-005 is a longer-acting version of schizophrenia medicine Risperdal, originally developed by Johnson & Johnson. A phase 3 trial for the pill started in March and is looking to enroll 90 patients. A long-acting injectable version of the approved drug, Uzedy, was at the center of a marketing scandal ten years ago after J&J pled guilty to a criminal misdemeanor charge of improperly marketing the product to older adults for unapproved uses. Federal prosecutors also alleged that the company falsely marketed the product to younger children and people with developmental disabilities. Lyndra hopes to boost the drug's duration and reclaim its reputation in the process. The biotech’s clinical progress comes as Karuna Therapeutics gears up for approval of its own, novel schizophrenia drug called KarXT. Recent phase 3 results showed that patients on the treatment experienced an 8.4% reduction on the Positive and Negative Syndrome Scale, a measure of schizophrenia symptoms. The drug seemingly performed better at reducing “positive” symptoms, such as hallucinations, versus “negative” symptoms, like feeling withdrawn from the world. Karuna’s application is expected any day after the company estimated it would formally submit a package to the FDA in the third quarter of the year. As for Lyndra, the company in July replaced CEO Patricia Hurter with chief operations officer Jessica Ballinger. The company also announced that chief medical officer Richard Scranton, M.D., would gain the additional title of president of global product development. Ballinger said at the time that Lyndra had a “clear line of sight to NDA filing” for LYN-005. Lyndra is also working on a long-acting version of another antipsychotic, Abilify, though that candidate remains in the preclinical stage. Elsewhere, the company has two phase 1-stage candidates for diabetes med Farxiga and Crestor. The company's platform has drawn interest from the Bill and Melinda Gates Foundation, which is helping fund trials of a long-acting version of malaria pill ivermectin in addition to a long-acting, once-a-month, oral contraceptive, LYN-064. Lyndra is also working on long-acting alternatives for opioid use disorder treatments in partnership with the National Institutes of Health. The company’s last round of fundraising came in June 2021 when it bagged nearly $61 million. The fundraising round was supported by Gilead Sciences, Polaris and AIG Investments, among others. Editor's note: This story was updated to clarify that Uzedy was a long-acting, injectable version of Risperdal. Both were developed by J&J.

Phase 3Executive ChangePhase 1NDAClinical Result

23 Jul 2024

·www.biospace.com

Lyndra Therapeutics Raises $101 Million in Series E Funding

WATERTOWN, Mass.--(BUSINESS WIRE)-- Lyndra Therapeutics®, a clinical-stage biopharmaceutical company, today announced the closing of a $101 million Series E financing round. The proceeds of the round, led by Sarissa Capital and including Sun Pharmaceutical Industries Limited [Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715], ("Sun Pharma" and includes its subsidiaries and/or associate companies) and Polaris Partners, will support the development of Lyndra’s pipeline, including oral weekly risperidone (LYN-005), which is near completion of a pivotal phase 3 study. Lyndra’s investigational therapies are enabled by the company’s LYNX® drug delivery platform, which creates long-acting oral medicines that can be taken once weekly. “We appreciate the support our investors are providing as we complete our risperidone phase 3 trials and continue the development of our pipeline of oral weekly therapies through this round of financing,” said Jessica Ballinger, Lyndra Therapeutics’ President and CEO. “This investment validates the LYNX platform and moves us forward in our plans to bring our lead product candidate, oral weekly risperidone, through the regulatory pathway and to patients.” As part of the financing, Sun Pharma will receive an exclusive license to manufacture and market oral weekly risperidone (LYN-005), oral weekly dapagliflozin (LYN-045) and oral weekly aripiprazole (LYN-006) in six countries, including Brazil and India, pending further clinical development of these investigational candidates. “This investment will provide Lyndra with the resources and leadership to achieve what we know is possible with the LYNX platform: a transformation of the relationship between people and their medicines,” said Amy Schulman, Lyndra Therapeutics co-founder, former CEO and Executive Chair of the Board. “This is an important step toward helping people adhere to their medication regimens and enabling them to better achieve their treatment goals.” Prior to the development of the LYNX technology, oral pills have been limited to ‘extended release’ formulations, which do not last for more than a day. Lyndra’s LYNX drug delivery platform is enabled by more than 50 patented innovations in design, engineering and materials science to achieve dramatically reduced dosing frequency. The platform originated from the Bob Langer and Gio Traverso Laboratories at MIT, with which Lyndra has an exclusive technology license. The round follows a $20.3 million Series D financing led by Polaris Partners that was completed in June 2023. About Lyndra Therapeutics Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra’s LYNX® drug delivery platform is one of the most significant advances in oral drug delivery in decades, creating medicines that last for a week or longer in an oral dosage form. Based on technology invented in the Bob Langer and Gio Traverso Laboratories at MIT, the LYNX platform has progressed rapidly since 2015 through preclinical and early human studies and achieved proof of concept of the platform and lead asset in a Phase 2 study. Lyndra’s initial focus is on developing therapies in psychiatry, cardiometabolic diseases and other conditions where current approaches to treatment fail to meet patients’ needs and expectations. Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. Since the founding of Lyndra, the company has received product funding from the Bill & Melinda Gates Foundation, the NIH, AbbVie, and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, MA, and has a state-of-the-art GMP manufacturing facility in Lexington, MA. About Sun Pharmaceutical Industries Limited Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology and onco-dermatology and accounts for over 16% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow Sun Pharma on “X” @SunPharma_Live. About Sarissa Capital Management LP Sarissa Capital Management was founded by Alex Denner, Ph.D., in 2013 to capitalize on compelling opportunities for constructive shareholder activism within the healthcare sector. Sarissa's team of subject matter experts and philosophy of thoughtful engagement aims to create positive outcomes for investors, shareholders and patients by taking an owner-oriented approach to their investments. Sarissa seeks to optimize healthcare companies so they can efficiently provide important medicines to society and increase the impact of medical innovation, while also generating value to shareholders.

Phase 2Phase 3License out/in

100 Deals associated with Aripiprazole

External Link

KEGG	Wiki	ATC	Drug Bank
D01164	Aripiprazole	N05AX12	DB01238

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Autism Spectrum Disorder	JP	Otsuka Holdings Co., Ltd.	28 Sep 2016
Tourette Syndrome	US	Otsuka Pharmaceutical Co., Ltd.	12 Dec 2014
Tourette Syndrome	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	12 Dec 2014
Depressive Disorder	JP	Otsuka Holdings Co., Ltd.	14 Jun 2013
Autistic Disorder	US	Otsuka Pharmaceutical Co., Ltd.	19 Nov 2009
Irritable Mood	US	Otsuka Pharmaceutical Co., Ltd.	19 Nov 2009
Depressive Disorder, Major	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	16 Nov 2007
Depressive Disorder, Major	US	Otsuka Pharmaceutical Co., Ltd.	16 Nov 2007
Agitation	US	Otsuka Pharmaceutical Co., Ltd.	29 Oct 2007
Bipolar Disorder	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	10 Dec 2004
Bipolar I disorder	EU	Otsuka Pharmaceutical Netherlands B.V.	04 Jun 2004
Bipolar I disorder	IS	Otsuka Pharmaceutical Netherlands B.V.	04 Jun 2004
Bipolar I disorder	LI	Otsuka Pharmaceutical Netherlands B.V.	04 Jun 2004
Bipolar I disorder	NO	Otsuka Pharmaceutical Netherlands B.V.	04 Jun 2004
Schizophrenia	US	Otsuka Pharmaceutical Co., Ltd.	15 Nov 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bipolar II disorder	Phase 3	KR	Korea Otsuka Pharmaceutical Co., Ltd.	22 Feb 2018
Dementia due to Alzheimer's disease (disorder)	Phase 3	JP	Otsuka Pharmaceutical Co., Ltd.	11 Jun 2014
Depression, Postpartum	Phase 3	CA	Bristol Myers Squibb Co.	01 Jun 2011
Major depressive disorder, moderate (MDD)	Phase 3	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010
Major depressive disorder, moderate (MDD)	Phase 3	AU	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010
Major depressive disorder, moderate (MDD)	Phase 3	BG	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010
Major depressive disorder, moderate (MDD)	Phase 3	IN	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010
Major depressive disorder, moderate (MDD)	Phase 3	PH	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010
Major depressive disorder, moderate (MDD)	Phase 3	RO	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010
Major depressive disorder, moderate (MDD)	Phase 3	SK	Otsuka Pharmaceutical Development & Commercialization, Inc.	29 Jul 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02918370 (CTgov)	Phase 3	Alcoholism \| Bipolar Disorder	75	Aripiprazole (Aripiprazole)	ynzhjkcppg(autojlpkub) = vewjcyqczr pivzftgszu (exxsekmiub, rcaheusnvv - saccvrjlcz) View more	-	19 Sep 2024
				Placebo (Placebo)	ynzhjkcppg(autojlpkub) = ysmkzunxad pivzftgszu (exxsekmiub, swcexaxyye - uuoslqwrxk) View more
NCT06372210 (CTgov)	Not Applicable	Bipolar I disorder \| Depressive Disorder, Major \| Behavioural disorders ... View more	54	Placebo (Cohort 1: D-Tect Patch + Placebo-embedded IEM)	evoicsghvd(eindimbshg) = npaklfoiww lexapotwuv (rzghazyipf, bzhxkjvrok - keucouaoor) View more	-	31 Jul 2024
				Aripiprazole (Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM))	mxrknxtnfp(veksbbwkiu) = dphphxdlao eljcemgzmz (cyptjebhfd, anpbzimmow - ykdhawgvqa) View more
FDA_CDER Manual	Not Applicable	Schizophrenia	-	Aripiprazole 15 mg/day (Study 1)	essngsatrf(wgxkhgmdep) = ifjlxlpefj vssrtymnbk (dbbhmqafbb, 2.40) View more	Positive	22 Jul 2024
				Aripiprazole (30 mg/day) (Study 1)	essngsatrf(wgxkhgmdep) = ellarvezwl vssrtymnbk (dbbhmqafbb, 2.39)
NCT03487783 (Pubmed) Manual	Phase 3	Tourette Syndrome	121	Aripiprazole oral solution	suibkpcdzj(ocufadmrtw): Difference (LS Mean) = -5.5 (95% CI, - 8.4 - - 2.6) View more	Positive	18 Jul 2024
				Placebo
NCT02977299 (ASCERTAIN-TRD, Pubmed) Manual	Phase 4	Depressive Disorder, Treatment-Resistant	260	Aripiprazole	gvybbzvogu(ykfosluovg) = afmxilmntw szyizialme (geyskpirso, 1.1) View more	Negative	07 Mar 2024
				Repetitive transcranial magnetic stimulation	gvybbzvogu(ykfosluovg) = dwyfhpyygi szyizialme (geyskpirso, 1.3) View more
NCT04030143 (CTgov)	Phase 1/2	Bipolar I disorder \| Schizophrenia	266	Aripiprazole (Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder)	utofsxtdcx(owcpvahvqz) = nhgstbriww rnnpytpivs (mkmajwkfss, nspkxzxhsl - tsqgoxdrov) View more	-	18 Nov 2023
				Aripiprazole (Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder)	utofsxtdcx(owcpvahvqz) = qwlbrritxa rnnpytpivs (mkmajwkfss, xlrsxbquyy - tnahqdxeqt) View more
NCT02357849 (FACT, CTgov)	Phase 4	Psychotic Disorders	9	Aripiprazole (Aripiprazole)	vryciapjup(fghktmtean) = iprtaujjvh hhfanvzgyp (lgulwemkha, euklwkfovv - udlqbwjwvu) View more	-	15 Nov 2023
				Fluoxetine (Fluoxetine)	vryciapjup(fghktmtean) = bjubmosrvo hhfanvzgyp (lgulwemkha, fndnluxyui - hvdkfxitrb) View more
NCT04030143 (Pubmed \| J Clin Psychiatry)	Phase 3	Schizophrenia	-	Aripiprazole 2-month ready-to-use 960 mg	iaisasyphq(fqxghhaafe) = Ari 2MRTU 960: 21.7%; AOM 400: 18.3% pgstrilwby (ovjayyeoiz )	Positive	04 Sep 2023
				Aripiprazole once-monthly 400 mg
NCT04030143 (Pubmed)	Phase 1/2	Bipolar I disorder	266	Aripiprazole 2-month ready-to-use 960 mg	gltkfmfasf(cthuxezwxx) = bvgyaexdrz aamlbdmjsp (cwbnoaoedu ) View more	-	09 Jun 2023
				Aripiprazole once-monthly 400 mg	gltkfmfasf(cthuxezwxx) = qzhqvtusea aamlbdmjsp (cwbnoaoedu ) View more
FDA Manual	Not Applicable	Schizophrenia	339	Abilify Maintena 400 to 300 mg	vcaxzlbwup(zzdwdkqoei) = coaqpyyvpt hyjgdaxngw (ghuuritofx, 1.6)	Positive	27 Apr 2023
				Placebo	vcaxzlbwup(zzdwdkqoei) = fxhpjqcdak hyjgdaxngw (ghuuritofx, 1.6)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis