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 Aug 2022·JAMA psychiatry

Balovaptan vs Placebo for Social Communication in Childhood Autism Spectrum Disorder

Article

Author: Hollander, Eric ; Murtagh, Lorraine ; Sanders, Kevin ; Wandel, Christoph ; Veenstra-VanderWeele, Jeremy ; Smith, Janice ; Gleissl, Teresa ; Jou, Roger ; McNamara, Nora ; Sikich, Linmarie ; Jacob, Suma ; Squassante, Lisa ; Tobe, Russell

Importance:

There are no approved medications for the core symptoms of autism spectrum disorder (ASD), socialization and communication difficulties.

Objective:

To evaluate the efficacy and safety of balovaptan, an oral selective vasopressin 1a receptor antagonist, compared with placebo in children and adolescents with ASD.

Design, Setting, and Participants:

The aV1ation study was a randomized, double-blind, 24-week, parallel-group, placebo-controlled phase 2 trial. Between November 22, 2016, and September 3, 2019, individuals were screened and randomly assigned to treatment groups. The primary efficacy analysis population comprised participants taking age-adjusted balovaptan equivalent to a 10-mg adult dose and participants from the concurrently randomized placebo group. This multicenter trial took place across 41 sites in the US. Participants were aged 5 to 17 years with diagnosed ASD and an IQ of 70 or greater. Data were analyzed from April 8 to November 16, 2020.

Interventions:

Participants were randomly assigned to daily 4-mg or 10-mg adult-equivalent balovaptan or placebo, until the 4-mg group was discontinued.

Main Outcomes and Measures:

The primary end point was change from baseline on the Vineland-II two-domain composite (2DC; socialization and communication domains) score at week 24.

Results:

Between November 2016 and September 2019, a total of 599 individuals were screened and 339 participants were randomly assigned to receive 4-mg balovaptan adult-equivalent dose (91 [26.8%]), 10-mg balovaptan adult-equivalent dose (126 [37.2%]), or placebo (122 [36.0%]). Primary analysis included 86 participants assigned to receive 10-mg balovaptan adult-equivalent dose and 81 assigned to receive placebo (mean [SD] age, 12.1 [3.4] years; 139 male participants [83.2%]). No statistically significant differences were observed between the balovaptan and placebo groups in change from baseline on the Vineland-II 2DC score at week 24 (difference in adjusted least-squares mean, -0.16; 90% CI, -2.56 to 2.23; P = .91). No improvements for balovaptan vs placebo were observed at week 24 for any secondary end points. Balovaptan was well tolerated with no emerging safety concerns. Similar proportions of participants reported adverse events (balovaptan, 66 of 86 [76.7%] vs placebo, 61 of 81 [75.3%]) and serious adverse events (balovaptan, 1 of 86 [1.2%] vs placebo, 4 of 81 [4.9%]).

Conclusions and Relevance:

In this randomized clinical trial, balovaptan did not demonstrate efficacy in improvement of socialization and communication in this population with pediatric ASD. Balovaptan was well tolerated in children 5 years or older. Further development of robust, sensitive, and objective outcome measures may help to improve future studies in the assessment of therapies targeting communication and socialization in pediatric ASD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02901431.

03 Aug 2021·Expert opinion on investigational drugsQ2 · MEDICINE

Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers

Q2 · MEDICINE

Article

Author: Squassante, Lisa ; Wandel, Christoph ; Kletzl, Heidemarie ; Guenther, Andreas ; Lennon-Chrimes, Sian ; Szczesny, Piotr ; Derks, Michael ; Paehler, Axel

BACKGROUND:

Balovaptan is a potent, selective vasopressin 1a receptor antagonist. The early-phase pharmacokinetics (PK) of balovaptan are reported.

RESEARCH DESIGN AND METHODS:

Two Phase 1 studies (overall N = 93) assessed single- and multiple-dose balovaptan PK in healthy adults. One (N = 16) assessed absolute oral bioavailability (10 mg or 50 mg) vs a [¹³C]-balovaptan microdose. The other (N = 77) explored single- (0.5-76 mg) and multiple-dose (14 days; 12-52 mg/day) - randomized 6:2 balovaptan:placebo per dose - PK, dose proportionality, and the effect of food on single-dose (32 mg) C_max and AUC_inf.

RESULTS:

Absolute balovaptan bioavailability was high (103-116%). Steady-state (Day 14) balovaptan PK was approximately dose proportional with a half-life of 45-47 hours, but single-dose C_max increased more than dose proportionally and half-life was inversely dose-proportional - a discordance partially attributable to a dose-and-time-dependent volume of distribution. Accumulation (Day 1-Day 14) was inversely dose-proportional (~3.5 [12 mg] to ~1.8 [52 mg]). There was no relevant effect of a high-fat meal on single-dose balovaptan exposure. There were no safety signals: 2/93 subjects discontinued for adverse events.

CONCLUSIONS:

Balovaptan was well tolerated at single (≤76 mg) and multiple (≤52 mg/day) doses, with a PK profile supportive of once-daily administration without food restrictions.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03764449; NCT01418963.

01 Nov 2020·Advances in therapyQ3 · MEDICINE

Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers

Q3 · MEDICINE

Article

Author: Bolt, Stuart K ; Derks, Michael G M ; Wandel, Christoph ; Young, Annie ; Meyenberg, Christoph

INTRODUCTION:

Balovaptan, an investigational vasopressin 1a receptor antagonist that has been evaluated for improvement of social communication and interaction, is primarily metabolized by cytochrome P450 3A4 (CYP3A4).

METHODS:

Two single-center, non-randomized, two-period, phase 1 studies assessed the effect of the strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan in healthy volunteers. Participants received balovaptan (5 or 10 mg/day) alone for 10 days, or in combination with itraconazole (200 mg/day) for 15 days, or rifampicin (600 mg/day) for 10 days, following balovaptan washout and itraconazole/rifampicin pre-dosing. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for the area under the concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C_max) of balovaptan dosed with vs. without itraconazole/rifampicin were estimated from a mixed effects model.

RESULTS:

Both studies comprised 15-16 healthy male and female volunteers. Itraconazole 200 mg/day elevated steady-state exposure to 5 mg/day balovaptan approximately 4.5-5.5-fold (Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C_max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ 5 days to ~ 13-14 days. Rifampicin 600 mg/day resulted in ~ 90% reductions in both the C_max (Day 10 GMR [90% CI], 0.14 [0.12-0.15]) and AUC (0.07 [0.06-0.07]) of balovaptan 10 mg/day. Time to balovaptan steady state could not be determined with rifampicin. There were no clinically significant safety findings in either study.

CONCLUSIONS:

Strong modulators of CYP3A4 activity will significantly alter the PK of balovaptan, with the effect of CYP3A4 induction greater than that of inhibition. Caution should be taken when concomitantly dosing balovaptan with moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors.

TRIAL REGISTRATION NUMBER:

NCT03579719; NCT03586726.

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. 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. Most Read Today

Breakthrough TherapyBiosimilar

100 Deals associated with Balovaptan

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KEGG	Wiki	ATC	Drug Bank
D11476	-	-	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	US	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	CA	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	FR	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	IT	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	ES	Hoffmann-La Roche, Inc.	08 Aug 2018
Autism Spectrum Disorder	Phase 3	GB	Hoffmann-La Roche, Inc.	08 Aug 2018
Stress Disorders, Post-Traumatic	Phase 2	US	Hoffmann-La Roche, Inc.	02 Aug 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)	vacirjqfxi(mtjuycphby) = ewxhizoawf yztzixbrez (olyoxcxpvl, tamwbckuni - zfqshcbtar) View more	-	18 Apr 2024
				Balovaptan (Balovaptan)	vacirjqfxi(mtjuycphby) = jcnjuchiqx yztzixbrez (olyoxcxpvl, jfvafuwxkr - aysthbgjxh) View more
NCT02901431 (aV1ation, Pubmed) Manual	Phase 2	Autism Spectrum Disorder	167	Balovaptan 10mg	xrvapfvmlo(xxecztoacl): difference = -0.16 (90% CI, -2.56 to 2.23), P-Value = 0.91	Negative	06 Jul 2022
				Placebo
NCT03504917 (Pubmed) Manual	Phase 3	Autistic Disorder \| Communication Disorders	322	balovaptan	cwzsdosilb(gexkrhtvrb) = qgectlnasm uhhwijtuat (nvotfxewus, 10.85) View more	Negative	01 Mar 2022
				Placebo	cwzsdosilb(gexkrhtvrb) = uolvojyevu uhhwijtuat (nvotfxewus, 12.18) View more
NCT03504917 (CTgov)	Phase 3	Autism Spectrum Disorder	322	Balovaptan (Balovaptan)	ssvthluigk(ndxhhxzusd) = izagdfgrfl gvksmderqd (ssrzqjxlnl, wagjevrhce - jdmpkrnqxq) View more	-	07 May 2021
				placebo (Placebo)	ssvthluigk(ndxhhxzusd) = yrkldgsttd gvksmderqd (ssrzqjxlnl, pmhrofadtn - ysapsuiuot) View more
NCT04049578 (CTgov)	Phase 1	Autism Spectrum Disorder	2	Balovaptan	iuooubtdjl(uzjswzfwwq) = xxayzzzvjf lqoijahans (dpydmhsikr, racxftspti - kooxdtblcf) View more	-	14 Oct 2020
NCT03586726 (CTgov)	Phase 1	-	16	Rifampicin+Balovaptan	qsmimphsns(mrkcwiwuka) = oapiilgpqr kvoaywdmle (rwacpzivhv, xvfxmjkdpd - bwugiceaek) View more	-	07 Nov 2019
NCT03579719 (CTgov)	Phase 1	-	15	itraconazole+Balovaptan	ekiffboggo(ytiksrrzgw) = bvbucrjmjk mxamprvsfl (cuuzfhzxmd, uwwylvxqbm - ieqbcdaznx) View more	-	04 Nov 2019

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