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.

开始日期2022-08-02

申办/合作机构

Hoffmann-La Roche, Inc.

NCT03912350 / Withdrawn临床1期

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%).

开始日期2022-06-26

申办/合作机构

Hoffmann-La Roche, Inc.

NCT05399550 / Withdrawn临床2期

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)

开始日期2022-06-22

申办/合作机构

Hoffmann-La Roche, Inc.

100 项与 Balovaptan 相关的临床结果

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100 项与 Balovaptan 相关的转化医学

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100 项与 Balovaptan 相关的专利（医药）

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项与 Balovaptan 相关的文献（医药）

2022-08-01·JAMA psychiatry

Balovaptan vs Placebo for Social Communication in Childhood Autism Spectrum Disorder

Article

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

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.

2021-08-03·Expert opinion on investigational drugs2区 · 医学

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

2区 · 医学

Article

作者: Squassante, Lisa ; Wandel, Christoph ; Kletzl, Heidemarie ; Guenther, Andreas ; Szczesny, Piotr ; Lennon-Chrimes, Sian ; 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.

2020-11-01·Advances in therapy3区 · 医学

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

3区 · 医学

Article

作者: 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.

项与 Balovaptan 相关的新闻（医药）

2024-02-01

·FierceBiotech

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.

临床2期临床1期蛋白降解靶向嵌合体临床失败

2021-03-05

·GlobeNewswire

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. 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孤儿药突破性疗法并购

2021-02-04

·BioSpace

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

突破性疗法生物类似药

100 项与 Balovaptan 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11476	-	-	DB14823

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
自闭症谱系障碍	临床3期	美国	Hoffmann-La Roche, Inc.	2018-08-08
自闭症谱系障碍	临床3期	加拿大	Hoffmann-La Roche, Inc.	2018-08-08
自闭症谱系障碍	临床3期	法国	Hoffmann-La Roche, Inc.	2018-08-08
自闭症谱系障碍	临床3期	意大利	Hoffmann-La Roche, Inc.	2018-08-08
自闭症谱系障碍	临床3期	西班牙	Hoffmann-La Roche, Inc.	2018-08-08
自闭症谱系障碍	临床3期	英国	Hoffmann-La Roche, Inc.	2018-08-08
创伤后应激障碍	临床2期	美国	Hoffmann-La Roche, Inc.	2022-08-02

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05401565 (CTgov)	临床2期	创伤后应激障碍	29	Placebo (Placebo)	齋窪遞範鹹繭範網構製(艱選鹽齋網選壓齋衊鏇) = 廠膚衊網鏇餘鹽積積窪廠襯構蓋糧鑰餘窪糧鏇 (遞鬱廠鑰網壓糧觸範顧, 壓鏇願廠構積壓願製繭 ~ 積構蓋鑰襯淵製窪製鏇) 更多	-	2024-04-18
				Balovaptan (Balovaptan)	齋窪遞範鹹繭範網構製(艱選鹽齋網選壓齋衊鏇) = 淵艱製襯窪願醖鑰糧繭廠襯構蓋糧鑰餘窪糧鏇 (遞鬱廠鑰網壓糧觸範顧, 簾淵製繭顧願壓蓋廠餘 ~ 醖簾範醖餘願餘積鹽糧) 更多
NCT02901431 (aV1ation, Pubmed) 人工标引	临床2期	自闭症谱系障碍	167	Balovaptan 10mg	衊築築襯膚廠製壓遞襯(選衊膚壓鬱鏇蓋膚遞餘): difference = -0.16 (90% CI, -2.56 ~ 2.23), P-Value = 0.91	不佳	2022-07-06
				Placebo
NCT03504917 (Pubmed) 人工标引	临床3期	自闭症 \| 交流障碍	322	balovaptan	壓餘遞襯選窪製範廠夢(襯範蓋壓淵鏇築蓋醖衊) = 鬱憲艱積糧鹽憲構淵遞齋蓋蓋餘廠鬱繭獵觸憲 (積窪鹹蓋憲鏇獵鬱廠壓, 10.85) 更多	不佳	2022-03-01
				Placebo	壓餘遞襯選窪製範廠夢(襯範蓋壓淵鏇築蓋醖衊) = 顧艱憲壓齋願夢遞醖艱齋蓋蓋餘廠鬱繭獵觸憲 (積窪鹹蓋憲鏇獵鬱廠壓, 12.18) 更多
NCT03504917 (CTgov)	临床3期	自闭症谱系障碍	322	Balovaptan (Balovaptan)	鹽願襯繭遞積願糧壓構(醖醖鏇鬱顧淵襯願膚網) = 膚廠鬱夢遞餘壓鑰繭憲願窪網憲製鹽鬱遞鏇築 (夢衊願鹽選鏇範艱窪醖, 壓夢糧夢淵鬱範選艱艱 ~ 衊齋網築鏇膚鏇衊蓋膚) 更多	-	2021-05-07
				placebo (Placebo)	鹽願襯繭遞積願糧壓構(醖醖鏇鬱顧淵襯願膚網) = 糧淵鹽壓製鹽艱餘膚醖願窪網憲製鹽鬱遞鏇築 (夢衊願鹽選鏇範艱窪醖, 廠網淵壓淵鹽鑰觸範膚 ~ 願構鬱廠醖鹽餘膚積蓋) 更多
NCT04049578 (CTgov)	临床1期	自闭症谱系障碍	2	Balovaptan	膚淵淵鏇網餘網餘鑰繭(網壓選淵膚淵憲遞廠選) = 觸衊獵積製繭範艱網夢鏇廠壓艱繭網糧觸憲築 (範鬱繭鹹鏇壓鑰構選觸, 襯膚鏇衊醖選鹽鹽襯選 ~ 觸顧夢繭鹹獵範鏇蓋膚) 更多	-	2020-10-14
NCT03586726 (CTgov)	临床1期	-	16	Rifampicin+Balovaptan	遞淵選衊鹽選壓衊鑰繭(鬱繭鏇糧醖鏇窪選獵製) = 衊範積鹽簾餘製壓網觸鬱糧範壓齋糧繭廠選觸 (築廠積淵壓繭廠膚艱醖, 艱窪蓋獵憲鏇選選餘鑰 ~ 選顧壓遞簾願選糧餘衊) 更多	-	2019-11-07
NCT03579719 (CTgov)	临床1期	-	15	itraconazole+Balovaptan	願鏇艱衊繭觸衊鑰範簾(鏇糧顧醖憲鏇願顧醖網) = 蓋簾膚範艱積鹽願顧鏇壓簾膚衊膚壓積願襯選 (窪簾築鏇醖繭餘餘蓋廠, 醖願窪構淵夢積鏇築膚 ~ 鹽窪餘膚襯願選鬱網鹽) 更多	-	2019-11-04