NOVO NORDISK A S · Data as of 2026-09-08
this year
Also for this year, we look forward to regulatory decisions for next-generation treatments, such as Mim8 within haemophilia and CagriSema within obesity, as well as a number of exciting R&D read-outs, including phase 3 read-outs for etavopivat and ziltivekimab,Source filing
this year
Also for this year, we look forward to regulatory decisions for next-generation treatments, such as Mim8 within haemophilia and CagriSema within obesity, as well as a number of exciting R&D read-outs, including phase 3 read-outs for etavopivat and ziltivekimab,Source filing
H2 2026
Novo Nordisk plans to submit for the first regulatory approval of etavopivat in the second half of 2026.Source filing
H2 2026
The trial is a single-ascending-dose study in around 48 people living with overweight or obesity and is expected to read out in the second half of 2026.Source filing
H2 2026
Novo Nordisk expects regulatory decisions in the EU and the UK on semaglutide 7.2 mg in a single-dose pen in the second half of 2026.Source filing
late 2026
CagriSema for weight management was submitted to the US FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials, and an FDA decision is anticipated by late 2026.Source filing
Q4 2026
The 25 mg dose for Ozempic ® pill was submitted for US FDA approval earlier in the year with an expected FDA decision during Q4 2026.Source filing
Q1 2027
Regulatory decision is expected in the first quarter of 2027.Source filing
H1 2027
The REDEFINE 11 phase 3 trial exploring CagriSema 2.4/2.4 mg full weight-loss potential in obesity is expected to report data during the first half of 2027, while initiation of the phase 3 CagriSema higher-dose trial is planned for the second half of 2026.Source filing
H1 2027
The trial will investigate single and multiple ascending doses of oral ACSL5i for up to 2 weeks in around 96 people living with overweight or obesity and is expected to read out during the first half of 2027.Source filing
H1 2027
A regulatory decision is expected during the first half of 2027.Source filing
H1 2027
The phase 2 trial will investigate the safety, tolerability and efficacy of once-weekly Triple for up to 40 weeks in around 270 people and is expected to read out in the first half of 2027.Source filing
during 2027
Novo Nordisk expects their global phase 1b/2a trial to read out during 2027.Source filing
Q1 2027
T he US FDA has accepted the filing for inclusion of MASH data for Wegovy ® pill (oral semaglutide 25 mg), with expected decision in Q1 2027.Source filing
H1 2027
The two additional ongoing cardiovascular outcomes trials investigating ziltivekimab in people with heart failure (HERMES) and in people following an acute heart attack (ARTEMIS) are planned to continue and are anticipated to read out in the first half of 2027.Source filing
H1 2028
The trial is expected to read out in the first half of 2028.Source filing
2029
Part 2 of the ESSENCE trial is expected to read out in 2029.Source filing
2026
The detailed results from REIMAGINE 2 will be presented at a scientific conference in 2026.Source filing
2026
The detailed results from the HIBISCUS phase 3 trial will be presented at a scientific conference in 2026.Source filing
Nov 16–Nov 19
Topline results from the evoke/evoke+ trials will be presented at the Clinical Trials in Alzheimer's Disease (CTAD) conference on 3 December 2025, and full results at the 2026 Alzheimer's and Parkinson's Diseases Conferences (AD/PD) in March 2026.Source filing