Innovation and therapeutic focus
Focused science,
faster progress
Susanne Svendsen is a laboratory technician in Gentofte, Denmark.
Obesity and diabetes are profoundly impacting global health, with prevalence rising across regions, onset occurring earlier in life and the burden falling disproportionately on vulnerable communities. The consequences extend beyond day-to-day symptoms into cardiometabolic risks that affect almost every part of the body, placing growing pressure on health services.
Building on Novo Nordisk’s long-standing expertise in obesity and diabetes, our Research & Development (R&D) organisation is developing multi‑target medicines addressing weight, blood glucose, cardiovascular risk and other related comorbidities together.
Our innovation engine builds on decades of leadership in incretin biology, exemplified by semaglutide, and is now advancing dual and triple agonists to deliver stronger, more comprehensive outcomes tailored to different patient needs.
Key assets include CagriSema, a once-weekly combination therapy in phase 3 trials, and zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist in phase 3 development for obesity and diabetes. These assets target clinically meaningful weight reduction and improved glycaemic control, alongside favourable effects on blood pressure and other comorbidities. Aligned with our updated corporate strategy, we prioritise programmes with the greatest potential to improve outcomes in obesity and diabetes.
Our pipeline continues to deliver breakthrough results, with recent approvals for higher‑dose Wegovy® (semaglutide 7.2 mg) and the Wegovy® pill, reinforcing our focused approach to incretin biology. Semaglutide 7.2 mg achieved 20.7% mean weight loss if all trial participants adhered to treatment, among the highest observed in clinical studies to date. Meanwhile, oral semaglutide 25 mg became the first and only once-daily oral GLP‑1 medicine approved for chronic weight management, delivering 16.6% weight loss if all study participants adhered to treatment – on par with injectable Wegovy® (semaglutide 2.4 mg).
“Our pipeline continues to deliver breakthrough results, with recent approvals for higher‑dose Wegovy® (semaglutide 7.2 mg) and the Wegovy® pill”
In parallel, recent phase 2 results in type 2 diabetes with zenagamtide further underscore the clinical impact of our R&D, with HbA1c reductions enabling up to 89% of participants to achieve target levels below 7% and with significant weight loss of up to 14.5% after just 36 weeks. The goal is clear: translate breakthrough science into therapies that work in real‑world care.
To sustain momentum from discovery to delivery, we have created a more seamless, end-to-end engine with the 2025 reconfiguration of our R&D organisation. This integrated approach, enhanced by AI and digital technologies, accelerates our pipeline and decision-making, while bringing manufacturability and supply considerations into drug development earlier to enhance speed and efficiency.
Across R&D, we remain focused on meeting the rising unmet need in obesity and diabetes with therapies that deliver durable, meaningful improvements in health and quality of life – as quickly and responsibly as possible.
OBESITY& RELATED COMORBIDITIES
Next-generation obesity treatments move closer to market
Almost 1 billion people worldwide live with obesity, often alongside type 2 diabetes and other cardiometabolic conditions. Addressing this complex disease requires a range of treatment options that can achieve sustained weight loss, are tolerable for long‑term use and can be tailored to diverse individual needs and preferences. Unlike traditional clinical pathways, obesity care demands approaches that recognise people’s need for discretion and personalised support – insights that have fundamentally reshaped our treatment philosophy.
Because appetite, satiety and glucose regulation are governed by peptide hormones – including GLP‑1, GIP, amylin and glucagon – and their protein receptors, our approach harnesses protein and peptide science alongside complementary mechanisms, rigorous clinical development and targeted partnerships to create multiple pathways for personalised care.
CagriSema, a unique fixed‑dose combination of the amylin analogue cagrilintide and semaglutide, brings together two peptide‑based mechanisms that act on complementary protein receptors, offering patients a dual‑action approach. CagriSema has now completed two pivotal phase 3a trials with clinically meaningful results. In REDEFINE 1, CagriSema delivered weight loss of 22.7% vs 2.3% with placebo at 68 weeks if all trial participants adhered to treatment – with more than 40% of patients achieving weight loss of 25% or more. The REDEFINE 2 trial in adults with obesity or overweight and type 2 diabetes, showed average weight loss of 15.7% vs 3.1% with placebo when all participants adhered to treatment. We filed for the first regulatory approval for CagriSema in the US in December 2025.
“CagriSema delivered weight loss of 22.7% vs 2.3% with placebo at 68 weeks if all trial participants adhered to treatment – with more than 40% of patients achieving weight loss of 25% or more”
For patients who may benefit from a different therapeutic approach, cagrilintide is being advanced as a monotherapy. A sub‑analysis of the phase 3 REDEFINE 1 trial showed that once‑weekly cagrilintide 2.4 mg produced an average 11.8% body‑weight reduction vs 2.3% with placebo after 68 weeks, if all adhered to treatment. More than 30% of participants achieved at least 15% weight loss compared with less than 5% on placebo. Based on these results, cagrilintide has entered the RENEW phase 3 programme.
We are also initiating phase 3 development of zenagamtide (formerly known as amycretin) –
Robert Williams lives with obesity in Brazil.
OBESITY& RELATED COMORBIDITIES
Expanding opportunities through strategic partnerships
Strategic partnerships and alliances are enhancing the breadth of our biology and modality portfolio in obesity, expanding our toolkit of potential treatment options. This approach allows us to explore novel biological pathways, exemplified by our exclusive licence for UBT251, a GLP-1/GIP/glucagon triple receptor agonist that targets yet another mechanism for tackling obesity’s complex biology.
Beyond injectables, we are also advancing oral treatment options through targeted collaborations. Our exclusive Septerna partnership targets GLP-1, GIP and glucagon receptors across four programmes, whilst we have licensed LX9851 from Lexicon Pharmaceuticals, a first-in-class oral ACSL5 inhibitor. Preclinical data demonstrate that when combined with semaglutide, LX9851 enhanced weight reduction, limited weight regain and showed positive steatosis effects after discontinuation – addressing the critical challenge of weight maintenance.
Our partnership strategy extends to related metabolic conditions, particularly metabolic dysfunction-associated steatohepatitis (MASH). Following FDA approval of Wegovy® for noncirrhotic MASH with moderate to advanced fibrosis, we acquired Akero Therapeutics and efruxifermin (EFX), a once-weekly FGF21 analogue now in phase 3 development and the only investigational drug ever to have demonstrated reversal of fibrosis in patients with cirrhosis due to MASH. This acquisition supports people across the disease spectrum, with potential for EFX as a standalone therapy or combined with Wegovy® to tackle this rapidly growing metabolic burden.
Juan Pablo Villaseñor lives with obesity and cardiovascular disease in Mexico.
DIABETES& RELATED COMORBIDITIES
Improving lives through safer and smarter diabetes solutions
For the nearly 600 million people living with diabetes, progress is measured in everyday moments: more time‑in‑range, fewer hypoglycaemic episodes and weight that stays off. Our pipeline aspires to deliver those outcomes.
CagriSema leads this approach – a once‑weekly fixed‑dose combination of amylin analogue, cagrilintide and semaglutide in phase 3 development for type 2 diabetes. The landmark REIMAGINE 2 trial demonstrated 1.91%‑point HbA1c reduction and 14.2% weight loss after 68 weeks, with 43% of participants achieving ≥15% weight loss. These outcomes demonstrate superiority over semaglutide alone – validating our innovative dual‑target approach. Zenagamtide reinforces this strategy, delivering compelling phase 2 results by targeting both GLP-1 and amylin receptors. Subcutaneous zenagamtide achieved HbA1c reductions of up to 1.8%, with 89% of participants reaching target levels below 7%. The oral formulation demonstrated improvements of up to 1.5%, with 78% reaching target. With phase 3 initiation planned for 2026, we are closer to offering treatment options that align with patient preferences and everyday routines.
Beyond type 2 diabetes, our commitment to type 1 diabetes remains unwavering. Following the closure of our in-house cell therapy unit, an expanded partnership with Aspect Biosystems seeks to advance cellular medicines that could restore natural blood sugar control – pursuing the ultimate ambition of a cure. Separately, we continue exploring GLP‑1‑based medicines in people at risk of developing type 1 diabetes to delay disease onset.
Gulshan Lal Suchdev lives with type 2 diabetes in Spain. Pictured here with his granddaughter Luna.
DIABETES& RELATED COMORBIDITIES
Tackling diabetes comorbidities with targeted therapies
People living with diabetes face interconnected health challenges that extend far beyond blood glucose management. Comorbidities such as cardiovascular disease and chronic kidney disease frequently accompany type 2 diabetes, sharing the same biological roots of metabolic dysfunction and chronic inflammation. Our approach recognises these connections, developing treatments that address the broader cardiometabolic spectrum affecting people living with diabetes.
Ziltivekimab, our monoclonal antibody targeting interleukin-6, represents this integrated strategy in cardiovascular medicine. By addressing cardiovascular inflammation – a key driver of complications in people with diabetes – phase 3 trials are testing whether targeted anti-inflammatory therapy can transform care from symptom management to disease modification. With readouts expected between 2026 and 2027 across three clinical settings, ziltivekimab could offer people with diabetes crucial protection against cardiovascular complications.
Meanwhile, the evoke programme explored whether semaglutide’s benefits could extend to neurodegeneration, specifically early Alzheimer’s disease. Building on growing evidence linking diabetes and cognitive decline, we evaluated semaglutide in two of the largest early-stage Alzheimer’s trials ever conducted. While results showed no meaningful reduction in disease progression vs placebo, this research advanced scientific understanding within the field of neurodegeneration.
Lazaro Montantes lives with type 2 diabetes and cardiovascular disease in Mexico.
RARE DISEASE
Building on rare disease leadership with next-generation therapies
For people living with rare diseases, each innovation can be life-changing. Our focus is to reduce the care burden with therapies that are effective, tolerable and easier to use.
Denecimig (Mim8), a Factor VIIIa mimetic bispecific antibody now under FDA and EMA review, significantly reduced treated bleeds with once‑monthly, fortnightly or once-weekly subcutaneous injections in clinical studies, offering the potential for both strong efficacy and less frequent dosing. Etavopivat, an investigational oral therapy for sickle cell disease, reduced pain crises and improved haemoglobin in phase 2, pointing to a treatment that could help support daily management and patient outcomes.
We have also strengthened our portfolio with an asset purchase and global licence agreement for zaltenibart from Omeros Corporation. This antibody blocks MASP‑3, a key switch in the alternative complement pathway – part of the immune system that can become overactive and damage healthy cells. By calming that response without compromising core defences, zaltenibart has best‑in‑class potential across multiple rare blood and kidney disorders.
Together, these programmes reflect our patient‑centred approach: advancing life-changing options to change the course of disease while lowering treatment burden and improving overall quality of life.
Emil Grullón lives with haemophilia A in the Dominican Republic.
Pipeline overview
We remain committed to bringing innovative therapies to patients. In 2025, two assets entered phase 1, one was acquired in late-stage phase 2 and one advanced in phase 2, two progressed to phase 3 and two assets initiated submissions for regulatory approval in key markets.
Phase 1
- Obesity&
- Diabetes&
- Rare disease
|
|
Project |
|
Indication |
|
Description |
|
|
|---|---|---|---|---|---|---|---|---|
|
|
Amylin 355 |
|
Obesity |
|
Amylin receptor agonist |
|
|
|
|
Amylin 1213 |
|
Obesity |
|
Amylin receptor agonist |
|
New |
|
|
SLC25A5 |
|
MASH1 |
|
siRNA2 |
|
|
|
|
GSI3 Albumin |
|
T1D4 |
|
Insulin |
|
|
|
|
GYS2 GalXC |
|
T2D5 |
|
siRNA |
|
New |
|
|
Ventus NLRP3i6 |
|
CVD7 |
|
NLRP3 inhibitor |
|
|
|
|
CNP HF8 |
|
Heart failure |
|
C-type natriuretic peptide |
|
|
|
|
Inno8 |
|
Haemophilia A |
|
FVIIIa9 mimetic bispecific antibody fragment |
|
|
Phase 2
- Obesity&
- Diabetes&
- Rare disease
|
|
Project |
|
Indication |
|
Description |
|
|
|---|---|---|---|---|---|---|---|---|
|
|
Monlunabant |
|
Obesity |
|
CB-110 receptor inverse agonist |
|
|
|
|
Zenagamtide |
|
Obesity |
|
Unimolecular GLP-111 and amylin receptor agonist |
|
|
|
|
Triple |
|
Obesity |
|
|
1 → 2 |
|
|
|
UBT 251 |
|
Obesity and T2D |
|
A triple agonist |
|
New |
|
|
CDR132L |
|
Heart failure |
|
Oligonucleotide inhibitor |
|
|
|
|
Zenagamtide |
|
T2D |
|
Unimolecular GLP-1 and amylin receptor agonist |
|
|
|
|
Etavopivat |
|
Thalassemia |
|
PKR13-activator |
|
|
|
|
NDec |
|
Sickle cell |
|
Combination of decitabine and tetrahydrouridine in collaboration with EpiDestiny |
|
|
|
|
Zaltenibart |
|
PNH14 |
|
Antibody |
|
New |
Phase 3
- Obesity&
- Diabetes&
- Rare disease
|
|
Project |
|
Indication |
|
Description |
|
|
|---|---|---|---|---|---|---|---|---|
|
|
CagriSema |
|
Obesity |
|
Long-acting amylin receptor agonist in combination with a long-acting GLP-1 analogue |
|
|
|
|
Cagrilintide |
|
Obesity |
|
Amylin receptor agonist |
|
2 → 3 |
|
|
Efruxifermin |
|
MASH |
|
FGF21 agonist |
|
|
|
|
CagriSema |
|
T2D |
|
Long-acting amylin receptor agonist in combination with a long-acting GLP-1 analogue |
|
|
|
|
Ziltivekimab |
|
CKD15 |
|
Monoclonal antibody |
|
|
|
|
Coramitug |
|
CVD |
|
Monoclonal antibody |
|
2 → 3 |
|
|
Etavopivat |
|
Sickle cell disease |
|
PKR-activator |
|
|
Submission and/or approval
- Obesity&
- Diabetes&
- Rare disease
|
|
Project |
|
Indication |
|
Description |
|
||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
Oral Semaglutide |
|
Obesity |
|
GLP-1 receptor agonist |
|
3 → Subm/Appr. |
|||||||||||||||||||||||||||||||||||||
|
|
Semaglutide 7.2 mg |
|
Obesity |
|
GLP-1 receptor agonist |
|
3 → Subm/Appr. |
|||||||||||||||||||||||||||||||||||||
|
|
CagriSema |
|
Obesity |
|
Long-acting amylin receptor agonist in combination with a long-acting GLP-1 receptor agonist |
|
3 → Subm/Appr. |
|||||||||||||||||||||||||||||||||||||
|
|
Semaglutide |
|
MASH |
|
GLP-1 receptor agonist |
|
3 → Subm/Appr. |
|||||||||||||||||||||||||||||||||||||
|
|
IcoSema |
|
T2D |
|
Semaglutide and basal insulin |
|
|
|||||||||||||||||||||||||||||||||||||
|
|
Icodec |
|
T1D and T2D |
|
Basal insulin analogue |
|
|
|||||||||||||||||||||||||||||||||||||
|
|
Denecimig |
|
Haemophilia A |
|
FVIIIa mimetic bispecific antibody |
|
3 → Subm/Appr. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
Research and development progress
obesity
Regulatory events
- Wegovy® received accelerated approval by the Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and data were submitted to European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) and Centre for Drug Evaluation (CDE).
- CagriSema new drug application was submitted to the FDA for initial marketing authorisation for weight management.
- Wegovy® pill, oral semaglutide (25 mg), was approved by the FDA for weight management and reduction of major adverse cardiovascular events and data were submitted to the EMA.
- Wegovy® label update was approved by the FDA to reflect reduction in hospitalisations for heart failure or urgent heart failure visits in people with overweight or obesity and atherosclerotic cardiovascular disease based on SELECT data.
- Wegovy®, subcutaneous (sc.) semaglutide 7.2 mg, received a positive opinion by EMA for weight management and was submitted to the FDA for marketing authorisation.
Clinical progress
- Phase 3a trial REDEFINE 2, investigating CagriSema (cagrilintide 2.4 mg in combination with semaglutide 2.4 mg) to evaluate efficacy and safety in people with overweight/obesity and type 2 diabetes (T2D), was completed.
- Phase 3a trials RENEW 1 and RENEW 2, investigating cagrilintide in people with obesity, with and without T2D, were initiated.
- Acquisition of Akero Therapeutics, Inc., with lead compound efruxifermin (EFX) in Phase 3 for the treatment of MASH, was completed.
- Phase 3b trials REDEFINE 8 and REDEFINE 11, investigating CagriSema for long-term weight loss and its full weight-loss potential, were initiated.
- In-licensing of lead asset UBT-251 and an early-stage glucagon for the treatment of obesity, T2D, and other diseases from The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology) was completed.
- Phase 2 trial investigating once-weekly GIP–GLP-1 was completed.
- Phase 1b/2 trial investigating Triple in people with obesity was initiated.
- Phase 1 trial investigating SLC25A5 in MASH was initiated.
- Phase 1 trial investigating oral zenagamtide (amycretin) was completed.
diabetes
Regulatory events
- Kyinsu® (IcoSema) was approved by the EMA for the treatment of T2D in adults insufficiently controlled by basal insulin or GLP-1 receptor agonists.
- Kyinsu® was submitted to the PMDA and the CDE for initial marketing authorisation for the treatment of T2D.
- Awiqli® Biologics License Application (BLA) was resubmitted to the FDA for the treatment of people with T2D.
- Ozempic® label expansion was approved by the FDA to reflect the reduction in kidney disease related events in people with T2D based on FLOW results.
- Rybelsus® label expansion was approved by the FDA and EMA to reflect the risk reduction of major cardiovascular events in people with T2D based on SOUL results.
- Ozempic® label expansion was approved by the EMA to reflect the improvements of functional outcomes in people with T2D and peripheral artery disease (PAD) based on STRIDE results.
Clinical progress
- Phase 3a trials REIMAGINE 2 and 3, investigating CagriSema in people with T2D, were completed.
- Phase 3a trial CLEOPATRA, investigating Coramitug in people living with transthyretin amyloidosis (ATTR) cardiomyopathy, was initiated.
- Phase 3a trials evoke and evoke+, investigating semaglutide in Alzheimer’s disease, completed interim readouts and the programme was terminated.
- Phase 3b trial REMODEL, a mechanistic study investigating semaglutide in patients with T2D and chronic kidney disease, was completed.
- Phase 2 trial investigating sc. and oral zenagamtide in people with T2D was completed.
- Phase 2 trial investigating once-weekly GIP–GLP-1 in people with T2D was completed.
- Phase 2 trial investigating Coramitug in people living with ATTR cardiomyopathy was completed.
- Phase 1 trial investigating GalXC GYS2 was initiated.
- Early-stage projects STAT3 (oncology/acromegaly), PD‑L1 (oncology) and XDH GalXC‑lipid (gout) were terminated.
- Phase 1 trial investigating Ventus NLRP3i was completed.
- Alternative routes were pursued for early-stage projects within stem cell therapy.
rare disease
Regulatory events
- Denecimig (Mim8) BLA was submitted to the FDA and Marketing authorization application (MAA) to the EMA for initial marketing authorization for treatment of haemophilia A in people with and without inhibitors.
- Sogroya® label label extension for the treatment of non-replacement indications was submitted to FDA, EMA, CDE and PMDA.
- Alhemo® (concizumab) was approved by FDA and EMA for the expanded treatment of haemophilia A or B in people without inhibitors.
Clinical progress
- Phase 3a trial HIBISCUS 2, investigating etavopivat in people with sickle cell disease (SCD), was initiated.
- Phase 3a FRONTIER 2 and FRONTIER 3 trials, investigating denecimig in adults/ adolescents and children with haemophilia A, were completed.
- Phase 2 part, of the HIBISCUS phase 2/3 trial, investigating etavopivat in people with SCD, was completed.
- Phase 2 trial ASCENT1, investigating NDec in people with SCD, was completed.
- Acquisition of MASP‑3 inhibitor zaltenibart from Omeros Corporation for the treatment of rare blood and kidney disease, of which the phase 2 trial was completed.