balovaptan: Clinical Trials

5 completed, 2 terminated, 2 withdrawn. 6 Phase 1, 2 Phase 2, 1 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	6	Completed 4, Terminated 1, Withdrawn 1
Phase 2	2	Completed 1, Withdrawn 1
Phase 3	1	Terminated 1

Follow balovaptan: new trials by email Literature Review of balovaptan trials Research Report on balovaptan

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD) Balovaptan, Placebo - Stress Disorders, Post-Traumatic	Phase 2	Completed	Hoffmann-La Roche	29	2022-08-02	2024-04-18
The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan Balovaptan - Autism Spectrum Disorder	Phase 1	Withdrawn	Hoffmann-La Roche		2022-06-26	2022-02-08
Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema Balovaptan, Placebo - Acute Ischemic Stroke	Phase 2	Withdrawn	Hoffmann-La Roche		2022-06-22	2023-08-07
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder Balovaptan - Autism Spectrum Disorder	Phase 1	Terminated	Hoffmann-La Roche	2	2019-12-19	2020-10-14
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers Balovaptan, Esomeprazole - Autism Spectrum Disorder	Phase 1	Completed	Hoffmann-La Roche	16	2019-11-19	2021-03-16
A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers Oral Balovaptan, IV Balovaptan - Healthy Volunteers	Phase 1	Completed	Hoffmann-La Roche	16	2019-01-10	2020-02-24
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension Balovaptan, Placebo - Autism Spectrum Disorder	Phase 3	Terminated	Hoffmann-La Roche	322	2018-08-08	2021-10-27
A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers Balovaptan, Rifampicin - Healthy Volunteers	Phase 1	Completed	Hoffmann-La Roche	16	2018-07-24	2019-11-07
A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers Balovaptan, Itraconazole - Healthy Volunteers	Phase 1	Completed	Hoffmann-La Roche	15	2018-07-10	2019-11-04

Conditions studied

Autism Spectrum Disorder (4)  ·  Ischemic Stroke (1)  ·  Stress Disorders, Post-Traumatic (1)

Sponsors

Hoffmann-La Roche (9)

Countries

United States (5)  ·  Netherlands (3)  ·  Canada (1)  ·  France (1)  ·  Italy (1)  ·  Spain (1)  ·  United Kingdom (1)

Results publications

PMID 32935287, PMID 34176392, PMID 35151410, PMID 41198718

NIH funding

2018 (2)