Japan approves Wegovy for MASH

Japan's Ministry of Health, Labour and Welfare approved Wegovy Subcutaneous Injection (semaglutide) as a treatment for metabolic dysfunction-associated steatohepatitis, or MASH, in patients without cirrhosis who have moderate to advanced liver scarring, according to Sumitomo Pharma, which co-promotes the drug with Novo Nordisk Pharma in Japan ^[1]. The approval makes Wegovy the first treatment for MASH cleared in Japan ^[1]. Separately, Novo Nordisk filed an application with the US Food and Drug Administration for oral semaglutide 25 mg to treat MASH during the second quarter of 2026, though no decision timeline had been announced as of September 2026 ^[2].

The Japanese approval rests on Part 1 of the Phase 3 ESSENCE trial, which enrolled adults with MASH and stage F2 or F3 fibrosis, meaning moderate to advanced scarring ^[1]. At week 72, 36.8% of patients on semaglutide 2.4 mg had liver fibrosis improve without their MASH getting worse, compared with 22.4% on placebo ^[1]. MASH resolved without fibrosis worsening in 62.9% of the semaglutide group versus 34.3% on placebo ^[1]. Sumitomo Pharma said the safety profile matched earlier data and no new safety signals turned up ^[1].

MASH is a liver disease tied to obesity and type 2 diabetes that often causes no symptoms early on but can progress to cirrhosis, liver failure, or liver cancer ^[1]. Japan's estimated MASH prevalence is about 3.0%, and patients who progress to liver cancer have a five-year relative survival rate of just 35.8% ^[1]. The disease has also been linked to higher rates of cardiovascular disease and cancers beyond the liver, including colorectal and breast cancer ^[1].

The ESSENCE study is a two-part trial designed to randomize 1,200 patients 2:1 to semaglutide or placebo on top of standard care for 240 weeks ^[1]. Japan's approval used interim results from the first 800 randomized patients in Part 1 ^[1]. Part 2, still ongoing, is testing whether the drug lowers the risk of serious liver-related events like cirrhosis or liver failure over the full 240 weeks, with study completion expected in 2029 ^[1].

Why it matters for patients

Wegovy is not yet approved in the United States for MASH. The Japanese approval covers the injectable form of semaglutide at 2.4 mg, the same dose already used for weight management here, but for a different indication and patient group — those with confirmed liver fibrosis, not obesity alone ^[1]. US patients currently taking Wegovy for weight loss or Ozempic for diabetes should not assume this Japanese approval changes what their prescription covers.

The oral formulation under FDA review, semaglutide 25 mg, is a pill rather than an injection, and it is being evaluated specifically for MASH, not for weight loss ^[2]. If approved, it could give patients and doctors in the US another option for a liver disease that has had few treatments. But because no FDA decision date has been set, it is not yet known when — or whether — this pill will reach the US market, or what its approved dose, label, or price might look like ^[2].

What happens next

Part 2 of the ESSENCE trial is continuing, with results expected around 2029, and those findings will show whether semaglutide actually reduces serious liver complications over time, not just fibrosis and inflammation markers ^[1]. In the US, Novo Nordisk's application for oral semaglutide 25 mg for MASH remains under FDA review after being filed in the second quarter of 2026, but as of September 2026 the company had not announced a target decision date ^[2].