Kayshild(Semaglutide)
Metabolic· 927 cited findings· 1 source document
Company: Novo Nordisk A S →
What the regulatory reviews say
Kayshild (Semaglutide) is a solution for injection administered subcutaneously, developed by Novo Nordisk A/S. The application for this product was submitted on 4 March 2025. It is identified by EMA product number EMEA/H/C/006426 and ATC code A10BJ06, available in strengths of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg.
In a 72-week phase III trial involving 67 subjects, Kayshild demonstrated efficacy in the resolution of steatohepatitis and no worsening in liver fibrosis in 62.9% of subjects, compared to 34.3% in the placebo group. Improvement in liver fibrosis with no worsening of steatohepatitis was observed in 36.8% of subjects, versus 22.4% for placebo. The drug also led to an estimated mean change from baseline in body weight of -10.51 kg, compared to -2.04 kg in the placebo group.
Regarding safety, 86.3% of subjects receiving Kayshild experienced adverse events (AEs), with an event rate of 407.1 events per 100 PYE, compared to 78.7% and 303.0 events per 100 PYE for placebo, respectively. Gastrointestinal AEs were reported in 69.5% of subjects, with common incidences including nausea (36.1%), diarrhoea (26.8%), and constipation (22.1%). A post-authorisation efficacy study is due by 31 December 2029.
Key figures — cited to the source page
| Resolution of steatohepatitis and no worsening in liver fibrosis (Kayshild) | 62.9 % | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.88 |
| Resolution of steatohepatitis and no worsening in liver fibrosis (Placebo) | 34.3 % | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.88 |
| Estimated mean change from baseline in body weight (Kayshild) | -10.51 kg | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.89 |
| Estimated mean change from baseline in body weight (Placebo) | -2.04 kg | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.89 |
| Proportion of subjects with AEs (Kayshild) | 86.3 % | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.109 |
| Proportion of subjects with AEs (Placebo) | 78.7 % | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.109 |
| Nausea incidence (Kayshild) | 36.1 % | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.116 |
| Application submission date | 4 March 2025 | Novo Nordisk A S — Kayshild EMA EPAR public assessment repor, p.12 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.