相关临床试验
12
7 进行中
药物批准
96
批准总数
监管机构
3
监管机构数
成立时间
N/A
进行中（未招募）
6
50.0%
已完成
3
25.0%
尚未招募
1
8.3%
招募中
2
16.7%
- Novo Nordisk reported that CagriSema produced an estimated average weight loss of 12.4% in a late-stage trial in patients with diabetes. - A 1 mg dose of CagriSema was superior to 5 mg tirzepatide for weight loss, which achieved 9.1% in the same head-to-head study. - CagriSema also demonstrated non-inferior blood sugar reduction versus tirzepatide in patients with diabetes, and a separate late-stage obesity study showed 21% weight loss versus placebo. - Novo Nordisk is targeting an early 2026 launch for the CagriSema combination, with an FDA decision on its weight management application expected in the fourth quarter.
- Novo Nordisk told its Capital Markets Day in London it aims to launch more than five blockbuster drugs by 2030 and generate over 150 billion Danish kroner in pipeline sales by 2035. - The company detailed a staged obesity injectable rollout: CagriSema launch targeted for early next year, standalone cagrilintide and high-dose CagriSema in 2028, then zenagamtide. - Novo aims to reach more than 60 million patients globally by 2030 and scale manufacturing tenfold to supply 15 million patients with oral obesity therapies by decade's end. - Semaglutide, the active ingredient in Ozempic and Wegovy, has lost patent exclusivity in Canada, India, Brazil and Turkey this year, with Europe and the U.S. running into the early 2030s.
- More than 90 lawsuits have been filed in New Jersey state court against Novo Nordisk on behalf of patients who developed NAION after taking Ozempic or Wegovy. - The European Medicines Agency concluded in June 2025 that NAION is a very rare side effect of semaglutide, while the FDA continues investigating without requiring a US label warning. - Denmark has paid more than $1.5 million to 27 patients who developed vision loss after Ozempic or Wegovy, with 38 additional cases still under review. - Evidence on causality remains mixed, with studies reporting risk increases from roughly two-fold to nearly eight-fold while a Novo Nordisk-supported study found no increased risk.
- The EMA's CHMP issued a positive opinion recommending once-weekly Sogroya (somapacitan) for children with idiopathic short stature and persistent growth disturbance. - If approved, Sogroya would become the first and only growth hormone treatment authorised for idiopathic short stature in the European Union. - The recommendation rests on the REAL8 trial, in which once-weekly Sogroya was non-inferior to once-daily growth hormone for mean annualised height velocity at Week 52. - The European Commission is expected to decide later in 2026 on a marketing authorisation covering idiopathic short stature, children born small for gestational age, and Noonan Syndrome.
- Health Canada has granted marketing authorisation to Sandoz Semaglutide, a generic GLP-1 receptor agonist injection referencing Novo Nordisk's Ozempic, for adults with type 2 diabetes. - The approval covers once-weekly subcutaneous dosing in three strengths across two pen presentations, including 0.25 mg and 0.5 mg pens and a 1 mg pen. - Sandoz frames the move as an access milestone in a Canadian GLP-1 market worth an estimated USD 2.6 billion, with nearly 12 million semaglutide injection pens used annually. - The Canadian authorisation follows FDA acceptance of Sandoz's generic tirzepatide applications and Brazilian approval of Owozy (semaglutide), and Sandoz expects no material 2026 contribution from generic semaglutide launches.
- Novo Nordisk has halted two additional heart-failure trials of its experimental cardiovascular drug ziltivekimab, ending them ahead of schedule. - An independent data monitoring committee found a low likelihood the two studies would differ from a prior late-stage trial in which ziltivekimab failed to reduce major adverse cardiovascular events. - One ziltivekimab study continues in patients recovering from a heart attack, with results expected in the first half of 2027. - The decision narrows Novo Nordisk's cardiovascular pipeline and increases its reliance on the obesity and diabetes franchise, where it competes with Eli Lilly.
- The EMA's CHMP recommended marketing authorization for FREHEMGO (denecimig), a factor VIIIa mimetic bispecific antibody for routine prophylaxis in hemophilia A. - The positive opinion covers adults and children with hemophilia A, with or without factor VIII inhibitors, using a prefilled pen dosed weekly, biweekly or monthly. - CHMP's decision rested on the phase 3 FRONTIER program, where mean annualized bleeding rates stayed below one and many patients had zero treated bleeds. - Novo Nordisk expects first European launches in Q4 2026 with broader EU rollout in early 2027, while a US Biologics License Application filed in September 2025 remains under review.
- Phase 3b FRONTIER5 results published in the Journal of Thrombosis and Haemostasis show denecimig was well tolerated after a direct switch from emicizumab without washout or loading dose. - Among 61 adolescents and adults with hemophilia A, 107 treatment-emergent adverse events occurred in 43 patients (70.5%), with 98.1% classified as mild to moderate. - Exploratory data showed mean thrombin peak height rose 78.8% from baseline into the normal range and was sustained over 26 weeks with no clinical evidence of excessive clotting. - Most patients rated the denecimig pen injector easy to use, and a Biologics License Application for routine prophylaxis is under FDA review across three dosing frequencies.
- Orbis Medicines and Novo Nordisk signed a strategic collaboration and license agreement to discover oral macrocycle therapeutics for cardiometabolic diseases. - Orbis is eligible for up to USD 1.4 billion in upfront and potential development and commercial milestones, plus tiered royalties on future sales. - The partnership leverages Orbis' AI-enabled nGen platform, which designs orally bioavailable nCycles intended to replace injectable biologic medicines. - Novo Nordisk will also make a strategic investment in Orbis Medicines, whose pipeline targets proteins validated by blockbuster injectable biologics.
- Novo Nordisk has filed Wegovy Pill (semaglutide) and Eli Lilly has filed Foundayo (orforglipron) for South Korean marketing authorization with the Ministry of Food and Drug Safety. - Both oral candidates launched in the US at $149 per month at the starting dose, roughly 85% below the $1,000 US starting price of injectable Wegovy and Mounjaro. - Hanmi Pharmaceutical targets October approval for its injectable EPPE, which cut weight 9.75% at 40 weeks in a 448-patient South Korean Phase 3 trial.
