Japan’s MHLW approves Viatris’ Effexor SR (venlafaxine) as the first treatment specifically indicated for generalized anxiety disorder (GAD) in adults, supported by positive Phase 3 trial results.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
Viatris has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Effexor® SR (venlafaxine hydrochloride) capsules 37.5 mg and 75 mg for the treatment of adults with generalized anxiety disorder (GAD), marking the first therapy specifically indicated for the condition in Japan.
Effexor SR is a serotonin–noradrenaline reuptake inhibitor (SNRI) that works by increasing the levels of serotonin and norepinephrine in the brain, neurotransmitters involved in mood regulation and anxiety control. The drug is already approved in Japan for the treatment of major depressive disorder (MDD), and the new indication expands its use to adults living with GAD.
Generalized anxiety disorder is one of the most common and disabling mental health conditions worldwide, characterized by persistent and excessive worry about everyday situations. Symptoms can include restlessness, sleep disturbances, muscle tension, irritability, and difficulty concentrating, often impairing daily functioning and quality of life. A recent study estimated the prevalence of probable GAD in Japan at around 7.6% of the general population, suggesting the condition may be significantly underdiagnosed.
The approval was supported by results from a Phase 3, randomized, double‑blind, placebo‑controlled, multicenter study (Study B2411367, jRCT2031220156) conducted in Japanese patients with GAD. The trial met its primary endpoint, demonstrating superior anxiolytic effects of venlafaxine compared with placebo at eight weeks, as measured by changes in the Hamilton Anxiety Rating Scale (HAM‑A) total score from baseline (two‑sided p = 0.012). All seven predefined secondary efficacy endpoints were also achieved.
Effexor SR showed a safety profile consistent with previous studies. Discontinuation due to treatment‑emergent adverse events (TEAEs) was low at 7.3% in the venlafaxine group compared with 1.7% in the placebo group, with treatment‑related discontinuations reported in 3.9% versus 0.6%, respectively. No serious TEAEs or severe‑intensity adverse events were observed in the venlafaxine group. Data from a long‑term extension study in Japanese outpatients with GAD were also included in the regulatory submission.
According to Philippe Martin, Chief R&D Officer at Viatris, the approval reflects the company’s strategy to advance differentiated therapies in Japan and optimize the lifecycle of established brands while addressing significant unmet medical needs.
Corinne Le Goff, Chief Commercial Officer at Viatris, added that the company plans to leverage its central nervous system (CNS) expertise and infrastructure in Japan to expand access to the treatment.
Effexor is already approved for the treatment of GAD in more than 80 countries outside Japan.
Viatris’ innovative portfolio in Japan also includes Spydia® nasal spray (diazepam) for the treatment of status epilepticus, while several investigational programs are progressing in the country. These include pitolisant for excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy, as well as late‑stage programs such as selatogrel in acute myocardial infarction, Nefecon in IgA nephropathy, and cenerimod in systemic lupus erythematosus.
Reference
Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD), 23 March 2026, Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD) – Mar 23, 2026
Otsubo T et al, A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release in Japanese patients with generalized anxiety disorder. Psychiatry Clin Neurosci. 2025 Dec;79(12):849-858. Epub 2025 Oct 22. PMID: 41123332; PMCID: PMC12683617, https://doi.org/10.1111/pcn.13907
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.