A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder

This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.

Start Date02 Aug 2022

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT03912350

/ WithdrawnPhase 1

The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan: A Phase I, Multiple-Center, Open-Label Study Following Multiple Daily Oral Doses of Balovaptan in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function

This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared to healthy subjects with normal hepatic function matched by age (±10 years), sex, and body mass index (BMI; ±20%).

Start Date26 Jun 2022

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT05399550

/ WithdrawnPhase 2

A Phase II, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate The Safety and Efficacy of Balovaptan in Patients With Acute Ischemic Stroke at High Risk of Developing Malignant Cerebral Edema

This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cerebral Edema (MCE)

Start Date22 Jun 2022

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Balovaptan

100 Translational Medicine associated with Balovaptan

100 Patents (Medical) associated with Balovaptan

Literatures (Medical) associated with Balovaptan

01 May 2025·JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY

Predictors of Placebo Response in the Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

Article

Author: Bhattachan, Suvekcha ; Jutla, Amandeep ; Kolevzon, Alexander ; Sanders, Kevin B. ; Palumbo, Michelle ; Spanos, Marina ; Sikich, Linmarie ; Kim, Soo-Jeong ; Verdes, Alyssa ; Siecinski, Stephen ; Marler, Sarah ; Chandrasekhar, Tara ; Veenstra-VanderWeele, Jeremy ; Minjarez, Mendy ; Rockhill, Carol ; King, Bryan H. ; Gregory, Simon G. ; Giamberardino, Stephanie ; McDougle, Christopher J. ; Nowinski, Lisa

Background: Although randomized clinical trials (RCTs) have investigated several treatments for social communication difficulties and repetitive behavior in autism, none has yet shown consistent superiority over placebo. Placebo response in autism RCTs may impede the ability to detect meaningful treatment effects. Objective: We sought to identify individual-level predictors of placebo response in Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B), a 24-week RCT of intranasal oxytocin for social impairment in autistic youth. In our primary analysis, we examined predictors of change in the Aberrant Behavior Checklist-modified Social Withdrawal (ABC-mSW) score at 24 weeks in SOARS-B participants taking placebo. Secondary analyses examined predictors of ABC-mSW change at 12 weeks and of Clinical Global Impressions-Improvement at 24 and 12 weeks. We also examined predictors of response among SOARS-B participants taking oxytocin. Methods: For each analysis, we first used lasso (least absolute shrinkage and selection operator) regression to identify potentially influential predictors from a large group that included demographic factors, rating scale data, and prescribed medications. We then estimated an unpenalized linear regression model for the outcome of interest that included only variables retained by the optimal lasso. We considered variables with statistically significant coefficients to be influential predictors. Results: Higher baseline ABC-mSW score was the only significant predictor of greater ABC-mSW change in the placebo group at 24 and 12 weeks. Conclusions: In SOARS-B, higher baseline severity on a measure of reciprocal social communication predicted greater placebo response. This is consistent with the finding that lower social communication adaptive functioning was associated with greater placebo response in recent RCTs of balovaptan for social impairment in autism. However, it contrasts with findings from a trial of citalopram for repetitive behavior in autism, in which lower baseline severity of a composite of autistic and mood symptoms predicted greater placebo response. This may indicate that different factors contribute to placebo response in different symptom domains.

01 Jan 2025·PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY

The pediatric psychopharmacology of autism spectrum disorder: A systematic review - Part II: The future

Review

Author: Arango, Celso ; Cortese, Samuele ; Asta, Lisa ; Persico, Antonio M. ; Persico, Antonio M ; Vitiello, Benedetto ; Chehbani, Fethia ; Parlatini, Valeria ; Mirabelli, Silvestro

Part I of this systematic review summarized the state-of-the-art of pediatric psychopharmacology for Autism Spectrum Disorder (ASD), a severe and lifelong neurodevelopmental disorder. The purpose of this Part II follow-up article is to provide a systematic overview of the experimental psychopharmacology of ASD. To this aim, we have first identified in the Clinicaltrials.gov website all the 157 pharmacological and nutraceutical compounds which have been experimentally tested in children and adolescents with ASD using the randomized placebo-controlled trial (RCT) design. After excluding 24 drugs already presented in Part I, a systematic review spanning each of the remaining 133 compounds was registered on Prospero (ID: CRD42023476555), performed on PubMed (August 8, 2024), and completed with EBSCO, PsycINFO (psychology and psychiatry literature) and the Cochrane Database of Systematic reviews, yielding a total of 115 published RCTs, including 57 trials for 23 pharmacological compounds and 48 trials for 17 nutraceuticals/supplements. Melatonin and oxytocin were not included, because recent systematic reviews have been already published for both these compounds. RCTs of drugs with the strongest foundation in preclinical research, namely arbaclofen, balovaptan and bumetanide have all failed to reach their primary end-points, although efforts to target specific patient subgroups do warrant further investigation. For the vast majority of compounds, including cannabidiol, vasopressin, and probiotics, insufficient evidence of efficacy and safety is available. However, a small subset of compounds, including N-acetylcysteine, folinic acid, l-carnitine, coenzyme Q10, sulforaphane, and metformin may already be considered, with due caution, for clinical use, because there is promising evidence of efficacy and a high safety profile. For several other compounds, such as secretin, efficacy can be confidently excluded, and/or the data discourage undertaking new RCTs. Part I and Part II summarize "drug-based" information, which will be ultimately merged to provide clinicians with a "symptom-based" consensus statement in a conclusive Part III, with the overarching aim to foster evidence-based clinical practices and to organize new strategies for future clinical trials.

01 Jun 2024·JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations

Article

Author: Derks, Michael ; Schaedeli Stark, Franziska ; Chavanne, Clarisse ; Lagraauw, Hendrik Maxime ; Prins, Klaas ; Silber Baumann, Hanna E ; Lindbom, Lars ; Jolling, Koen

Abstract:

Balovaptan is a brain-penetrating vasopressin receptor 1a antagonist previously investigated for the core symptoms of autism spectrum disorder (ASD). A population pharmacokinetic (PK) model of balovaptan was developed, initially to assist clinical dosing for adult and pediatric ASD studies and subsequently for new clinical indications including malignant cerebral edema (MCE) and post-traumatic stress disorder. The final model incorporates one-compartment disposition and describes time- and dose-dependent non-linear PK through empirical drug binding and a gut extraction component with turnover. An age effect on clearance observed in children was modeled by an asymptotic function that predicts adult-equivalent exposures at 40% of the adult dose for children aged 2–4 years, 70% for 5–9 years, and at the full adult dose for ≥ 10 years. The model was adapted for intravenous (IV) balovaptan dosing and combined with in vitro and ex vivo pharmacodynamic data to simulate brain receptor occupancy as a guide for dosing in a phase II trial of MCE prophylaxis after acute ischemic stroke. A sequence of three stepped-dose daily infusions of 50, 25 and 15 mg over 30 or 60 min was predicted to achieve a target occupancy of ≥ 80% in ≥ 95% of patients over a 3-day period. This model predicts both oral and IV balovaptan exposure across a wide age range and will be a valuable tool to analyze and predict its PK in new indications and target populations, including pediatric patients.

News (Medical) associated with Balovaptan

01 Feb 2024

·www.fiercebiotech.com

Roche, pipeline bulging from deal spree, axes 8 oncology and neurology programs to speed up R&D

Roche’s clear-out was accompanied by an influx of other assets. Roche has removed eight phase 1 and 2 oncology and neurology candidates from its pipeline as part of a set of “trade-offs” intended to “increase the overall portfolio value and speed up development.” In the fourth quarter (PDF), Roche removed eight drug candidates and replaced them with eight different prospects, shifting the balance of its pipeline away from neurology and, to a lesser extent, oncology and toward immunology, cardiovascular and metabolism in the process. The number of neurology prospects fell from 18 to 12, although one of those was moved to another part of the pipeline. CEO Thomas Schinecker said the the resources will be shifted "to projects we want to accelerate." He also foreshadowed similar pipeline cuts to come in the first quarter during a fourth quarter earnings call Thursday. Basmisanil is one of the candidates Roche is kicking to the curb. The drugmaker trialed the GABAA α5 receptor negative allosteric modulator in ischemic stroke and schizophrenia patients from 2016 to 2019. The discovery of an EEG biomarker of dup15q, a developmental disorder, spurred interest in treating the syndrome by reducing GABA activity in the brain and led Roche to start enrolling patients in a phase 2 trial in 2022. ClinicalTrials.gov lists the study as recruiting, but Roche removed the asset from its pipeline. Roche also axed balovaptan, a small-molecule vasopressin V1A receptor antagonist that previously made it to phase 3 in autism spectrum disorder only to fail to move the needle. The drugmaker tried again in the aftermath of the failure, kicking off a phase 2 study in post-traumatic stress disorder. Roche finished that trial last year and promptly removed balovaptan from its pipeline. News of the other neurology changes preceded the fourth-quarter update. AC Immune said Roche had returned the Alzheimer’s disease prospects crenezumab and semorinemab last month, and details of the decision to drop Angelman syndrome candidate rugonersen emerged via the patient community last year. On the oncology side, Roche removed three phase 1 candidates from the pipeline. The drugmaker dealt a second blow to the hopes of treating solid tumors by targeting FAP. Having already stopped studying a FAP-IL-2v candidate, Roche removed the solid tumor FAP-CD40 prospect RG6189 from its pipeline in the fourth quarter. A phase 1b trial of a FAP-4-1BBL candidate, RG7827, is continuing. The other two axed oncology assets are the EGFRvIIIxCD3 bispecific antibody RG6156, which Roche was studying in brain cancer, and another bispecific designed to bind to HLA-G on tumor cells and CD3 on T cells. Roche’s clear-out was accompanied by an influx of other assets, including candidates acquired through the takeovers of Carmot Therapeutics and Telavant. A longer-term bet delivered a clinical candidate, too, with Roche moving a covalent inhibitor of WRN, the synthetic lethal target at the heart of a $135 million deal with Vividion Therapeutics, into phase 1.

Phase 2Phase 1PROTACsClinical Trial Failure

05 Mar 2021

·www.globenewswire.com

Autism Spectrum Disorder Therapeutics Market Projected to Hit USD 4,612.1 Million and Surge at 4.3% CAGR by 2026; Awareness Campaigns Conducted to Spread Awareness Regarding the Condition to Propel Growth, Says Fortune Business Insights™

Pune, India, March 04, 2021 (GLOBE NEWSWIRE) -- According to a report published by Fortune Business Insights, titled, “ Autism Spectrum Disorder Therapeutics Market ”: Global Market Analysis, Insights and Forecast, 2018-2026,” the global market is likely to reach US$ 4,612.1 Mn by 2026 owing to the rising incidence of autism spectrum disorder worldwide. The report provides valuable insights into the global market trends and factors that are directly affecting the growth of the market. As per the report, the global autism spectrum disorder therapeutics market was worth US$ 3,293.0 Mn in 2018. Considering the increasing awareness programs regarding this particular disorder and less availability of treatment options, the global market is expected to rise at a moderate CAGR of 4.3% during the forecast period (2019-2026). The report further states that the number of children diagnosed with autism is increasing day by day across the globe. This, combined with favorable reimbursement scenario, will increase the demand for applied behavioral analysis therapies. Such therapies aid in improving learning and physical disabilities in autistic children. Furthermore, FDA approvals of numerous medicines that are used to manage autism spectrum disorder are expected to propel the global autism spectrum disorder therapeutics market during the forecast period. Request a Sample Copy of the Research Report: Autistic Disorder Segment to Witness Growth Owing to the Rising Prevalence of the Disease The global autism spectrum disorder therapeutics market is grouped into drug therapy and communication and behavioral therapy in terms of treatment type. Amongst these, the communication and behavioral therapy segment was in the leading position in the global market. Fortune Business Insights predicts that it will retain its position throughout the forecast period. In terms of type, the autism spectrum disorder therapeutics market is classified into Asperger syndrome, autistic disorder, pervasive development disorder, and others. Out of these, the autistic disorder segment procured the highest autism spectrum disorder therapeutics market share in the year 2018. It is anticipated to witness significant growth in the coming years. This growth is attributed to the increasing prevalence of this disorder. For more information in the analysis of this report, visit: Fusion Autism Center Opens its New Therapy Center to Provide Pediatric Services Several renowned market players have begun investing huge sums in the research and development of advanced and effective drugs for the treatment of autism spectrum disorder. This will contribute to the global autism spectrum disorder therapeutics market growth in the coming years. Below are three latest initiatives that have been recently taken by the prominent market players to drive global market sales. Fusion Autism Center (FAC), a mental health service provider, based in the U.S.A., announced in February 2019 that it has successfully expanded its center-based services of Applied Behavioral Analysis therapy for kids on the autism spectrum. The new center is built in Augusta so that it would provide much-needed services to the communities with special needs residing in the area. Apart from that, FAC has its centers in Roswell, Woodstock, Cumming, Peachtree, and Duluth. Quick Buy Autism Spectrum Disorder Therapeutics Market Research Report: Q BioMed Inc., a prominent developer of biomedical assets, based in New York, announced in June 2018 that it has applied for Orphan Drug status with European and the U.S. regulators for QBM-001, the company’s pediatric autism drug. F. Hoffmann-La Roche Ltd., a multinational healthcare company, headquartered in Switzerland, announced that the FDA has approved Breakthrough Therapy Designation for its oral medication balovaptan in January 2018. The investigational oral medicine has the potential to improve communication and interaction abilities of those affected with autism spectrum disorder. Have Any Query? Ask Our Experts: List of the Companies Profiled in the Global Market: Applied Behavior Consultants, Allergan, Pfizer Inc., Q BioMed Inc, Fusion Autism Center, AstraZeneca, Hopebridge, LLC., Johnson & Johnson Services, Inc., Behavior Innovations, Eli Lilly and Company, Otsuka Holdings Co. Ltd., other prominent market players. Get your Customized Research Report: Detailed Table of Content: Introduction Research Scope Market Segmentation Research Methodology Definitions and Assumptions Executive Summary Market Dynamics Market Drivers Market Restraints Market Opportunities Key Insights Prevalence of Autism Spectrum Disorder for Key Countries/Region Recent Industry Developments Such As Partnerships, Mergers, & Acquisitions Regulatory Framework by Key Countries Global Reimbursement Scenario and Economic Cost Burden for the Treatment of Autism Spectrum Disorder by Key Countries/Region Global Autism Spectrum Disorder Therapeutics Market Analysis, Insights and Forecast, 2015-2026 Key Findings / Summary Market Analysis, Insights and Forecast – By Type Autistic Disorder Asperger Syndrome Pervasive Developmental Disorder Others Market Analysis, Insights and Forecast – By Treatment Type Communication & Behavioral Therapies Applied behavior analysis (ABA) Speech & Language Therapy Occupational Therapy Others Drug Therapies Antipsychotic Drugs SSRIS Stimulants Sleep Medications Others Market Analysis, Insights and Forecast – By Region North America Europe Asia pacific Latin America Middle East & Africa TOC Continued…!! Have a Look at Related Reports: MicroRNA Market Size , Share & Covid-19 Impact Analysis, By Product (Instruments and Kits & Reagents) By Application (Isolation & Purification, Detection & Quantification, Disease Diagnostics, and Others) and By End User (Pharma & Biotech Companies, Academic & Research Institutes, Healthcare Facilities, and Others), Regional Forecast, 2020-2027 Nurse Call Systems Company Size, Share & Industry Analysis, By Technology (Wired, Wireless), By Product (Basic Button Based Systems, Mobile Integrated Systems, IP Based Systems, Others), By End-user (Hospitals and Clinics, Assisted Living and Nursing Centres, Home Care Setting, Others), and Regional Forecast, 2019 – 2026 Telerehabilitation Market Size, Share and Covid-19 Impact Analysis, By Type (Products, Services), By Application (Occupational Therapy, Physical Therapy, Chronic Diseases, and Others), By End-User (Healthcare Facilities and Homecare); and Regional Forecast, 2020-2027 Active Wound Care Market Share and Industry Analysis by Product Type (Biological Skin Equivalents, Growth Factors, Biological Dressings, Others), By Indication (Diabetic Foot Ulcers, Pressure Ulcers, Lower Limb Ulcers), By End User (Hospitals, Clinics, Home Care Settings), and Regional Forecast 2018-2025 About Us: Fortune Business Insights™ offers expert corporate analysis and accurate data, helping organizations of all sizes make timely decisions. We tailor innovative solutions for our clients, assisting them to address challenges distinct to their businesses. Our goal is to empower our clients with holistic market intelligence, giving a granular overview of the market they are operating in. Our reports contain a unique mix of tangible insights and qualitative analysis to help companies achieve sustainable growth. Our team of experienced analysts and consultants use industry-leading research tools and techniques to compile comprehensive market studies, interspersed with relevant data. At Fortune Business Insights™ we aim at highlighting the most lucrative growth opportunities for our clients. We, therefore, offer recommendations, making it easier for them to navigate through technological and market-related changes. Our consulting services are designed to help organizations identify hidden opportunities and understand prevailing competitive challenges. Contact Us: Fortune Business Insights™ Pvt. Ltd. 308, Supreme Headquarters, Survey No. 36, Baner, Pune-Bangalore Highway, Pune - 411045, Maharashtra, India. Phone: US :+1 424 253 0390 UK : +44 2071 939123 APAC : +91 744 740 1245 Email: sales@fortunebusinessinsights.com Fortune Business Insights™ LinkedIn | Twitter | Blogs

Orphan DrugBreakthrough TherapyAcquisition

04 Feb 2021

·www.biospace.com

Roche Washes Hands of Mid and Late-Stage Trial Failures

Jonathan Weiss/Shutterstock Roche is closing out its fourth-quarter with some house cleaning. The Swiss pharma giant announced in its earnings report that it was terminating studies of several mid- and late-stage assets, including two late-stage breast cancer programs. Jonathan Weiss / Shutterstock Roche is closing out its fourth-quarter with some house cleaning. The Swiss pharma giant announced in its earnings report that it was terminating studies of several mid- and late-stage assets, including two late-stage breast cancer programs. In its fourth-quarter presentation, Roche noted several programs that have been terminated after earlier clinical trial failures in 2020. Roche included a checklist for ongoing programs and the ones that have been terminated included a large, red X. One of the studies terminated is the Phase III IMagyn050 trial assessing a combination of two previously approved cancer drugs. The study was seeking to determine if adding Tecentriq (atezolizumab) to a combination of Avastin (bevacizumab), paclitaxel and carboplatin would make a difference in the treatment of women with newly diagnosed advanced-stage ovarian cancer. It did not. The addition of Tecentriq did not improve progression-free survival to the first-line combination therapy. Another program terminated is the Phase III IPATunity130 study. That trial was assessing ipatasertib, an Akt inhibitor, and chemotherapy for the treatment of patients with PIK3CA/AKT1/PTEN-altered hormone receptor-positive, HER2-negative advanced breast cancer. The trial failed to meet its endpoints of both progression-free survival and objective response rate. AKT1/2/3, which ipatasertib inhibits, is the central node of the PI3K/AKT pathway, which plays a critical role in HR-positive, HER2-negative breast cancer. Although ipatasertib missed the mark in the breast cancer study, Roche is still investigating its use in other cancers. Last year, the asset hit the mark in the Phase III IPATential150 study in patients with metastatic castration-resistant prostate cancer whose tumors had PTEN loss. Ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, the company said at the time. The other Phase III program culled by Roche is a combination of idasanutlin, an MDM2 antagonist, and chemotherapy for the treatment of acute myeloid leukemia. The combination failed to reach endpoints of improving survival in the late-stage MIRROS program. Roche had hoped to determine if the addition of idasanutlin to chemotherapy would prove superior to chemotherapy alone. The addition of the MDM2 antagonist did not prolong life in those patients. Although idasanutlin failed in the MIRROS trial, Roche and Genentech are investigating it along with Venclexta in patients with relapsed or refractory AML who are not eligible for chemotherapy. It wasn’t just late-stage programs that saw the proverbial axe. Roche also terminated two mid-stage programs in ulcerative colitis and autism spectrum disorder. Roche subsidiary Genentech reported etrolizumab demonstrated a mixed bag in a Phase III ulcerative colitis test. While the drug hit its endpoint of inducing remission versus placebo, it failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis. The autism study that Roche terminated involved an asset that received Breakthrough Therapy designation in 2018. Last year, Roche announced it was terminating the trial assessing balovaptan, a vasopressin 1a (V1a) receptor antagonist. Roche stopped the Phase II study of balovaptan early last year following a futility assessment. In its fourth-quarter report , Roche said sales in its Pharmaceuticals Division decreased 2% to CHF 44.5 billion, mainly due to stronger than expected biosimilars competition and the COVID-19 pandemic. Sales in the U.S. slipped 6%. Roche said biosimilars for blue-chip assets MabThera/Rituxan, Herceptin and Avastin were particularly impacted by biosimilars. Tecentriq sales increased mainly due to growth in the new indications, including certain forms of lung, breast and liver cancer, the company said.

Breakthrough TherapyPhase 3Phase 2Clinical Trial Failure

100 Deals associated with Balovaptan

External Link

KEGG	Wiki	ATC	Drug Bank
D11476	Balovaptan	-	DB14823

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autism Spectrum Disorder	Phase 3	United States	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	Canada	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	France	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	Italy	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	Spain	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	08 Aug 2018
Stress Disorders, Post-Traumatic	Phase 2	United States	Hoffmann-La Roche, Inc.	02 Aug 2022
Acute Ischemic Stroke	Phase 2	United States	Hoffmann-La Roche, Inc.	22 Jun 2022
Brain Edema	Phase 2	United States	Hoffmann-La Roche, Inc.	22 Jun 2022
Gas Gangrene	Phase 2	United States	Hoffmann-La Roche, Inc.	22 Jun 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05401565 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	29	Placebo (Placebo)	djlgibidey(dkljqggjtx) = rcppsfhojr zashwbprxk (uteeflrtvu, 9.3) View more	-	18 Apr 2024
				Balovaptan (Balovaptan)	djlgibidey(dkljqggjtx) = umzhcaeefv zashwbprxk (uteeflrtvu, 7.8) View more
NCT02901431 (aV1ation, Pubmed) Manual	Phase 2	Autism Spectrum Disorder	167	Balovaptan 10mg	uvhionibgx(jekknjtery): difference = -0.16 (90% CI, -2.56 to 2.23), P-Value = 0.91	Negative	06 Jul 2022
				Placebo
NCT03504917 (Pubmed \| Lancet Psychiatry) Manual	Phase 3	Autistic Disorder \| Communication Disorders	322	balovaptan	txkidxaxuz(vfwjesahhg) = uzbmzyxeyh ojnlfihwjb (kdmxrwamwz, 10.85) View more	Negative	01 Mar 2022
				Placebo	txkidxaxuz(vfwjesahhg) = ezefrsuixj ojnlfihwjb (kdmxrwamwz, 12.18) View more
NCT01418963 \| NCT03764449 (Pubmed \| Expert Opin Investig Drugs)	Phase 1	-	93	Balovaptan	tbavynvdod(zaahxpdmro) = unhrezocoy vltsqsflsl (lecxfhjkvq )	-	03 Aug 2021
NCT03504917 (CTgov)	Phase 3	Autism Spectrum Disorder	322	Balovaptan (Balovaptan)	ttuaxibxge(umlsuokuih) = dhtqucmxnc hikzslwogi (vokrsagatz, 10.85) View more	-	07 May 2021
				Placebo (Placebo)	ttuaxibxge(umlsuokuih) = ejbzidxzrr hikzslwogi (vokrsagatz, 12.18) View more
NCT04049578 (CTgov)	Phase 1	Autism Spectrum Disorder	2	Balovaptan	yjuolhbazt = bofzlhhpit ergvpjcplp (vecwmhbvwh, evwqqbrtia - ugzzvdglox) View more	-	14 Oct 2020
NCT03586726 (CTgov)	Phase 1	-	16	Rifampicin+Balovaptan	bjgcaqxvkj(kwdzunbwtw) = gyoldkmoez ylnskjmukg (ufqtmmfikc, 33.4) View more	-	07 Nov 2019
NCT03579719 (CTgov)	Phase 1	-	15	Itraconazole+Balovaptan	eygxaoeaiq(iflfvunyxg) = lhrlmthdar qxzswnpwec (slkmlozlas, 25.3) View more	-	04 Nov 2019

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