A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan

The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.

Start Date01 Feb 2025

Sponsor / Collaborator

Novo Nordisk A/S

CTRI/2024/05/067886

/ RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes

Start Date20 Jun 2024

Sponsor / Collaborator

Novo Nordisk India Pvt Ltd.

NCT06340854

/ Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Start Date19 Apr 2024

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Icodec Insulin

100 Translational Medicine associated with Icodec Insulin

100 Patents (Medical) associated with Icodec Insulin

Literatures (Medical) associated with Icodec Insulin

01 Apr 2025·DIABETES OBESITY & METABOLISM

Efficacy and hypoglycaemia outcomes with once‐weekly insulin icodec versus once‐daily basal insulin in individuals with type 2 diabetes by kidney function: A post hoc participant‐level analysis of the ONWARDS 1–5 trials

Article

Author: Benamar, Malik ; Cheng, Alice Y. Y. ; Rossing, Peter ; Kumar, Bharath ; Laugesen, Christian ; Bajaj, Harpreet S.

Abstract:

Aim:

This post hoc analysis of ONWARDS 1–5 assessed the efficacy and hypoglycaemia outcomes with once‐weekly insulin icodec (icodec) versus once‐daily basal insulin comparators (degludec, glargine U100 or glargine U300) in insulin‐naive (ONWARDS 1, 3 and 5) and insulin‐experienced (ONWARDS 2 and 4) adults (aged ≥18 years) with type 2 diabetes (T2D) by kidney function subgroup.

Materials and Methods:

Treatment outcomes were analysed by trial according to kidney function subgroup (estimated glomerular filtration rate [eGFR] ≥90; eGFR 60–<90; eGFR 30–<60; eGFR <30; all mL/min/1.73m2). Severe kidney function impairment (eGFR <30) at screening was an exclusion criterion for ONWARDS 1–4, but not ONWARDS 5.

Results:

ONWARDS 1–5 included 3765 participants; 3763 were included in this analysis. In ONWARDS 1, 3 and 5, there were no statistically significant treatment interactions by kidney function subgroup for change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT); there were statistically significant subgroup interactions in ONWARDS 2 and 4 (both p‐interaction <0.05). Change in body weight (baseline to EOT) across kidney function subgroups was comparable between treatment arms. Across trials, there was no consistent trend by kidney function subgroup for mean weekly insulin dose during the last 2 weeks of treatment or rates of combined clinically significant or severe hypoglycaemia. There were no statistically significant treatment interactions by kidney function subgroup for the achievement of HbA1c <7% without clinically significant or severe hypoglycaemia; all p‐interaction >0.05.

Conclusions:

Efficacy and hypoglycaemia outcomes of icodec versus once‐daily comparators were generally consistent among adults with T2D, regardless of kidney function.

01 Mar 2025·Journal of Diabetes Investigation

Pharmacological characteristics of once‐weekly insulin icodec in Japanese individuals with type 1 diabetes

Article

Author: Navarria, Andrea ; Nishida, Tomoyuki ; Halberg, Inge Birk ; Søgaard, Stinne Byrholdt ; Eto, Takashi ; Kristensen, Niels Rode ; Ribel‐Madsen, Rasmus ; Haranaka, Miwa

ABSTRACT:

Introduction:

Insulin icodec is a basal insulin designed for once‐weekly administration. This study assessed the pharmacological properties of icodec in Japanese individuals with type 1 diabetes (T1D).

Materials and Methods:

In a randomized, open‐label, crossover study, 24 Japanese individuals with T1D (20–64 years; glycated hemoglobin ≤9.0%) received once‐weekly icodec for 8 weeks and once‐daily insulin glargine U100 for 14 days at individual constant equimolar doses per week together with bolus insulin aspart. Individual doses were determined during run‐in with glargine U100 titrated to prebreakfast self‐measured plasma glucose (SMPG) of 4.4–7.2 mmol/L. Blood samples for icodec pharmacokinetics were taken from the first icodec dose until 35 days after last dose. The steady‐state glucose‐lowering effect was measured in glucose clamps (target 6.7 mmol/L) during 24–48 h and 150–168 h after last icodec dose and 0–24 h after last glargine U100 dose. One‐week glucose‐lowering effect of icodec was simulated using a pharmacokinetic/pharmacodynamic model. Hypoglycemia was identified from SMPG during the treatment periods.

Results:

Icodec pharmacokinetic steady state was achieved on average after 2–3 weeks of treatment. Model‐derived daily glucose‐lowering effect during the weekly dosing interval averaged 14.6%, 18.0%, 16.6%, 14.9%, 13.3%, 11.9%, and 10.7%, respectively. Rates of level 2 hypoglycemia (PG <3.0 mmol/L) were 37.3 vs 30.6 episodes per patient‐year of exposure for icodec vs glargine U100.

Discussion:

Icodec pharmacological properties in Japanese individuals with T1D in this study support the potential of icodec to provide basal insulin coverage with once‐weekly dosing in Japanese individuals with diabetes.

01 Feb 2025·Endocrine Practice

Pharmacokinetic/Pharmacodynamic Modeling of Efficacy and Hypoglycemia Rate When Switching From Once-Daily Basal Insulin to Once-Weekly Insulin Icodec Without or With a One-Time Additional Dose in Insulin-Experienced Individuals With Type 2 Diabetes

Article

Author: Ásbjörnsdóttir, Björg ; Knop, Filip K ; Kristensen, Niels R ; Lingvay, Ildiko ; Vianna, André ; Laugesen, Christian

OBJECTIVE:

Insulin icodec (icodec), a once-weekly basal insulin analog, has been investigated in the phase 3a ONWARDS clinical trial program. This pharmacokinetic (PK)/pharmacodynamic (PD) modeling analysis of data from the ONWARDS 2 and 4 trials investigated efficacy outcomes and hypoglycemia rate in insulin-experienced individuals with type 2 diabetes when switching from daily basal insulin to icodec without or with a 50% one-time additional dose for the first injection only.

METHODS:

Data from 2 randomized, 26-week, phase 3a trials of insulin-experienced individuals with type 2 diabetes on a basal (ONWARDS 2) or basal-bolus (ONWARDS 4) insulin regimen were used for PK/PD model development and validation. The effect of switching to icodec without versus with a 50% one-time additional dose on prebreakfast self-measured blood glucose, glycated hemoglobin, weekly insulin dose, and clinically significant hypoglycemia was assessed.

RESULTS:

Model predictions suggested that switching to icodec without versus with a 50% one-time additional dose would result in a mild, transient (1-2 weeks) increase in prebreakfast self-measured blood glucose after treatment initiation that would decrease to matching levels between groups by week 4 and remain similar between groups until end of treatment (week 26). There were no model-predicted differences between groups in glycated hemoglobin reduction or clinically significant hypoglycemia over the 26-week study period or in weekly icodec dose at week 26.

CONCLUSIONS:

This PK/PD model analysis suggests that omitting administration of a 50% one-time additional dose when switching to icodec from daily basal insulin would not be predicted to result in any sustained effects.

News (Medical) associated with Icodec Insulin

05 Mar 2025

·www.biospace.com

Novo, Sanofi Hit With Anti-Competitive Probe in South Africa:

iStock, valiantsin suprunovich The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices. The South African government is investigating alleged anti-competitive practices by Novo Nordisk and Sanofi in connection with human insulin pens, Bloomberg reported on Monday evening. The Competition Commission of South Africa, the government’s anti-trust agency, is scrutinizing the companies’ device patents and proprietary designs to determine if these are being exploited to limit competition and block the entry of other developers and suppliers, as per Bloomberg. The watchdog is currently in the process of coordinating with Novo Nordisk’s and Sanofi’s local entities. BioSpace has reached out to Sanofi and Novo Nordisk for their statements and will update this article accordingly. The insulin market has seen some heavy upheaval over the last few years, driven by key policy changes around the world. Chief among these is the Inflation Reduction Act, signed into law in August 2022, and the Affordable Insulin Now Act, both of which seek to dramatically minimize Americans’ out-of-pocket spending for insulins. Pressure from lawmakers have also helped lower insulin prices in the U.S. The Competition Commission’s investigation comes shortly after it fined Google about $30 million per year for the next five years, while also investigating Meta and the social media network X (formerly Twitter), all for business practices that harmed South African media. Eli Lilly in March 2023 announced that it would lower insulin prices by 70% and cap out-of-pocket costs at $35 per month. Novo and Sanofi followed suit soon after, enacting their respective price cuts in the subsequent weeks. Months later, however, Novo announced that it would discontinue its long-acting insulin product Levemir, removing both the vials and pen from the market by the end of 2024. Lilly in Mach 2024 announced that due to marketing constraints, availability of two of its inulin products—Humalog an Lispro— would be limited . Sanofi also discontinued its pre-mixed insulin product Insuman, though this move mostly affected the U.K. and came in February 2023, a month before it announced the insulin price cuts. In a May 2024 interview with BioSpace , BMO Capital Markets analyst Evan Seigerman said that Novo “can’t make a product they’re losing money on, which may be the case with some insulins, and at some point they need to be smart with capital.” Still, the drugmakers continue to innovate on insulins. Lilly, for instance, is advancing a once-weekly insulin injection, Phase III readouts for which showed it could lower A1C by 1.34% , as compared with the 1.26% reduction for once-daily insulin degludec. Novo is also working on its own once-weekly product, dubbed insulin icodec. In July 2024, however, the program hit a regulatory road bump when the FDA rejected its drug application, flagging issues with the use of the product in type 1 diabetes.

Phase 3

08 Jan 2025

·www.prnewswire.com

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePhase 3Immunotherapy

31 Oct 2024

·www.fiercepharma.com

Novo Nordisk hit with FDA write-up over production issues at critical semaglutide plant

Novo Nordisk was hit with an FDA Form 483 following a March inspection of its production site in Kalundborg, Denmark, which is used to make the GLP-1 diabetes and obesity meds Ozempic and Wegovy. Novo Nordisk landed in hot water with the FDA following an inspection at one of the drugmaker’s key semaglutide and insulin manufacturing plants this past spring.Earlier this year, the FDA issued a Form 483 (PDF) rebuke to Novo Nordisk following an inspection of the company’s production site in Kalundborg, Denmark. Novo uses the site to make its hit GLP-1 drugs for diabetes and obesity, Ozempic and Wegovy, plus the once-weekly insulin icodec product Awiqli. The regulatory reprimand, dated March 25, was posted on the FDA website on Tuesday. The inspection itself took place during several days in March. The facility walkthrough resulted in 8 observations from the FDA. Inspectors found the facility lacked records that indicated the water used in drug production was adequately controlled for certain microorganisms. Additionally, the agency found the facility didn’t have written procedures in place for the production, processing or packing in order to assure identity, strength, quality and purity of a drug substance which had its name redacted in the filing.Besides the key GLP-1 products, the site is responsible for making Novo's once-weekly insulin icodec, which the FDA declined to approve in July over manufacturing issues, a company spokesperson said in an email to Fierce. Novo's spokesperson said the issues around the insulin product—approved in places like Canada, Europe and Japan as Awiqli—are unlikely to be resolved this year. The ability of of Novo's GLP-1s to help patients lose weight has been a boon for Ozempic and Wegovy, however, immense mainstream popularity has also resulted in repeated supply shortages in the past few years. To keep up with demand, the company has announced new manufacturing projects in places like Ireland, France and China.In addition, Novo is pumping about $8.7 billion into the Kalundborg campus through 2029 in a move to boost capacity. The investment is expected to create about 1,200 new jobs on top of the site's current workforce of roughly 4,400.

100 Deals associated with Icodec Insulin

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	European Union	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	Iceland	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	Liechtenstein	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	Norway	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus, Type 1	Canada	Novo Nordisk Canada, Inc.	12 Mar 2024
Diabetes Mellitus, Type 2	Canada	Novo Nordisk Canada, Inc.	12 Mar 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04770532 (ONWARDS 2, CTgov)	Phase 3	Diabetes Mellitus, Type 2	526	Insulin Icodec (Insulin Icodec)	gbmlyzmysv(lkkdgkdsze) = okwvxczvjl zxjtkqnoff (yziwiqhvqa, 0.05) View more	-	20 Feb 2025
				Insulin degludec (Insulin Degludec)	gbmlyzmysv(lkkdgkdsze) = bxqcvduncw zxjtkqnoff (yziwiqhvqa, 0.06) View more
NCT04795531 (ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	etbxscllvq(askvlpzpmi) = syeuhpcvch hxxiptpywh (pmhsbceuxk, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	etbxscllvq(askvlpzpmi) = gaaiqjhhou hxxiptpywh (pmhsbceuxk, 0.05) View more
NCT04880850 \| NCT04770532 (ONWARDS 4 \| ONWARDS 2, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	-	Once-weekly icodec	tahhedgcrj(vxqdklnefr) = illfzshica qgelzguyvv (nmbfmuigyj )	Positive	04 Oct 2023
				Once-daily degludec	tahhedgcrj(vxqdklnefr) = qvwoofwdor qgelzguyvv (nmbfmuigyj )
NCT04460885 (ONWARDS 1, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 insulin-naïve	492	Once-weekly insulin icodec	yoejmlnvyp(taszbkhcgr) = TBR <54 mg/dL was not significantly different between arms qhsxgscqpv (pefwefqlde ) View more	Positive	03 Oct 2023
NCT04795531 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	588	Once-weekly insulin icodec	jjegsnbtnb(klftpywbub) = gxarlwiwjy mrujsrmudx (wonujklvoa ) View more	Positive	24 Jun 2023
				Once-daily insulin degludec	jjegsnbtnb(klftpywbub) = zlamofeolk mrujsrmudx (wonujklvoa ) View more
NCT04460885 (ONWARDS 1, ADA2023)	Phase 3	Diabetes Mellitus, Type 2	984	Once-weekly Insulin Icodec	gfapydzilw(dpzlurvuzu) = msvmmfbsid vopmkmfgmp (ryovfbrijn ) View more	Positive	24 Jun 2023
				Insulin Glargine U100	gfapydzilw(dpzlurvuzu) = vvvvvfspnb vopmkmfgmp (ryovfbrijn ) View more
NCT04760626 (ONWARDS 5, ADA2023)	Not Applicable	Diabetes Mellitus, Type 2	-	Once-Weekly Insulin Icodec with a Dosing Guide App	lneicdtqzw(fnpaccrjzy) = rlvyiisyhl mdamraklij (kjmmhvbsar )	Positive	20 Jun 2023
				Once-Daily Basal Insulin Analogs (degludec, glargine U100 or glargine U300)	lneicdtqzw(fnpaccrjzy) = ghpseknngt mdamraklij (kjmmhvbsar )
NCT04770532 (ONWARDS 2, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	526	Icodec Insulin	whydqvqbon(fyhmcjowkd) = wjcgvndimg jkjufvdfwi (naenxoxxpf ) View more	Non-inferior	22 Sep 2022
				Insulin degludec	whydqvqbon(fyhmcjowkd) = fqmzehbfqq jkjufvdfwi (naenxoxxpf ) View more
EASD2022	Phase 2	Diabetes Mellitus, Type 2	606	Insulin icodec	dgyphrwdcd(riioedzhbj) = Only 1 hypoglycemia level 3 event was noted (patient on icodec) fbhhulncjj (uqvqollmhs )	Positive	20 Sep 2022
NCT04795531 (ONWARDS 3, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2 First line	588	Icodec Insulin	bermmpancf(nbjbghixdb) = vpixpiqouh cnccurwngz (aisirbparw ) View more	Non-inferior	29 Jul 2022
				Insulin degludec	bermmpancf(nbjbghixdb) = zterpguzgr cnccurwngz (aisirbparw ) View more

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Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis