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

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

NCT06288412

/ Active, not recruitingPhase 1

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Start Date26 Feb 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

101

Literatures (Medical) associated with Icodec Insulin

01 Jun 2025·DIABETES OBESITY & METABOLISM

Efficacy and hypoglycaemia outcomes with once‐weekly insulin icodec versus once‐daily basal insulin in type 2 diabetes according to baseline glucagon‐like peptide‐1 receptor agonist and sodium‐glucose co‐transporter‐2 inhibitor use: A post hoc analysis of ONWARDS 1–5

Article

Author: Søgaard, Stinne Byrholdt ; Kellerer, Monika ; Vilsbøll, Tina ; Goldenberg, Ronald ; Kumar, Bharath ; Fu, Ariel

Abstract:

Aims:

To assess the treatment effects of once‐weekly insulin icodec (icodec) versus once‐daily basal insulin comparators in individuals with type 2 diabetes (T2D) according to baseline glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) and sodium‐glucose co‐transporter‐2 inhibitor (SGLT2i) use.

Materials and Methods:

This post hoc analysis of the randomized ONWARDS 1–5 trials of individuals with T2D assessed treatment outcomes by trial according to baseline GLP‐1RA and/or SGLT2i use.

Results:

At screening, 21.3% (801/3765) and 36.9% (1388/3765) of participants in ONWARDS 1–5 were treated with a GLP‐1RA or an SGLT2i, respectively. Baseline characteristics were broadly similar across treatment arms irrespective of GLP‐1RA/SGLT2i use; GLP‐1RA users had numerically higher body mass indices than non‐users. Across trials, there were no statistically significant treatment interactions by GLP‐1RA or SGLT2i subgroups with respect to: change in glycated haemoglobin (HbA1c) and body weight from baseline to end of treatment (except for body weight change by SGLT2i use in ONWARDS 5); weekly basal insulin dose during the last 2 weeks of treatment (except SGLT2i use in ONWARDS 5); and achievement of HbA1c less than 7% without clinically significant or severe hypoglycaemia. Irrespective of GLP‐1RA/SGLT2i use, the rates of clinically significant or severe hypoglycaemia were less than one episode per patient‐year of exposure across all trials except ONWARDS 4 (basal‐bolus trial).

Conclusions:

The efficacy and hypoglycaemia profile of icodec versus once‐daily comparators was generally consistent across ONWARDS trials irrespective of background GLP‐1RA and/or SGLT2i use.

01 Jun 2025·ANNALS OF PHARMACOTHERAPY

Icodec: A Novel Once-Weekly Basal Insulin for Diabetes Management

Review

Author: Isaacs, Diana ; Goldman, Jennifer ; Triplitt, Curtis

Objective::

To evaluate the efficacy, safety, and clinical implications of insulin icodec, a novel once-weekly basal insulin for the treatment of type 1 diabetes (T1D) and type 2 diabetes (T2D), with an emphasis on its advantages and challenges in comparison with existing daily basal insulins.

Data Sources::

A literature search was performed using PubMed, Google Scholar, Embase, and ClinicalTrials.gov up to August 26, 2024, using the search terms icodec and ONWARDS trial . Studies involving patients living with T1D or T2D on once-weekly insulin icodec compared with once-daily insulins glargine U100, glargine U300, and degludec were considered for this review.

Study Selection and Data Extraction::

Relevant English-language studies and those conducted in humans were considered.

Data Synthesis::

Insulin icodec offers reduced dosing frequency and potentially superior glycemic management with a safety profile comparable to existing basal insulins.

Relevance to Patient Care and Clinical Practice::

Insulin icodec once-weekly dosing could significantly improve convenience and efficacy over daily basal insulins, representing a significant innovation in insulin therapy.

Conclusions::

Insulin icodec emerges as a promising option for diabetes management, potentially improving treatment adherence and quality of life.

01 May 2025·DIABETES OBESITY & METABOLISM

No evidence of increased hypoglycaemia attributed to physical activity with once‐weekly insulin icodec versus once‐daily basal insulin degludec in type 1 diabetes: A post hoc analysis of ONWARDS 6

Letter

Author: Philis‐Tsimikas, Athena ; Bracken, Richard M. ; Pagliaro Rocha, Thaís M. ; Sourij, Harald ; Carstensen, Lisbeth ; Kehlet Watt, Sara

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

24 Jan 2025

·www.echemi.com

Breakthrough in Self-Developed Long-Acting Insulin Brings Hope to 900 Million Diabetics

On January 23, HengRui Pharma announced that the application for the marketing authorization of Shudi Insulin Injection (INS068) has been accepted by the National Medical Products Administration. This product marks the first self-developed long-acting insulin analogue in China. The marketing application is primarily based on positive results from two pivotal Phase III clinical trials (Studies 301 and 302). These trials assessed the efficacy and safety of Shudi insulin injection compared to glargine insulin in adults with type 2 diabetes mellitus (T2DM) who had poor glycemic control while on basal insulin or oral hypoglycemic agents. The 301 study enrolled 423 participants, while the 302 study included 513 participants. Both studies were successfully completed in December 2024. Results showed that after 26 weeks of treatment, Shudi insulin maintained a similar reduction in glycated hemoglobin (HbA1c) compared to glargine insulin, whether used alone or in conjunction with oral hypoglycemic agents. Moreover, the safety and tolerability profiles of Shudi insulin were favorable, with adverse events resembling those of glargine, and incidences of hypoglycemia, particularly nocturnal hypoglycemia, slightly lower than those observed with glargine. Both studies met their primary endpoints. Diabetes is a metabolic syndrome characterized by high blood sugar levels due to insulin secretion defects and/or inadequate insulin action. In 2021, the global population of diabetics reached 537 million, with approximately 140 million cases in China, making it the country with the highest number of diabetes patients. Projections indicate that by 2045, the global count may rise to 783 million, with China accounting for 170 million. T2DM constitutes over 90% of all cases, primarily resulting from insulin resistance and progressive decline in pancreatic β-cell function. If left uncontrolled or poorly managed, high blood sugar can lead to irreversible vascular complications, including retinopathy, renal failure, myocardial infarction, stroke, and amputation. The treatment of T2DM currently employs a comprehensive management model that includes dietary control, exercise, blood sugar monitoring, diabetes education, and pharmacotherapy. Lifestyle interventions serve as foundational treatment measures, and as T2DM progresses, it often necessitates a combination of different classes of hypoglycemic agents. Clinical guidelines recommend initiating insulin therapy when blood sugar levels remain uncontrolled after treatment with one or more oral agents. For newly diagnosed T2DM patients exhibiting significant hyperglycemic symptoms or ketosis, a short-term insulin intensification regimen is the preferred option. Shudi insulin injection is HengRui Pharma's self-developed long-acting insulin, characterized by its steady onset, prolonged duration of action, and lower risk of nighttime hypoglycemia. To date, approximately 34.88 million yuan has been allocated to the development of Shudi insulin-related projects. Globally, similar products have already received approval, including Novo Nordisk's Tresiba® and Sanofi's Toujeo®. According to the Nextpharma database, global sales of Tresiba® and Toujeo® combined reached $2.3 billion in 2023.

Phase 3Clinical ResultDrug Approval

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

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05823948 (ONWARDS 9, Pubmed \| Diabetes Technol Ther) Manual	Phase 3	Diabetes Mellitus, Type 2	51	Once-weekly Insulin Icodec	snvmmfdelg(pqlvhnfkuu) = sixncaphsb ikmlywvacv (tvjbzplpda, -1.36 to -0.99)	Positive	05 Mar 2025
NCT04770532 (ONWARDS 2, CTgov)	Phase 3	Diabetes Mellitus, Type 2	526	Insulin Icodec (Insulin Icodec)	tiyldvsjwy(uxfgqrjtjm) = dfblhgrwtc mlzjvbzacj (nsscsvqhtc, 0.05) View more	-	20 Feb 2025
				Insulin Degludec (Insulin Degludec)	tiyldvsjwy(uxfgqrjtjm) = gtpuzdzelz mlzjvbzacj (nsscsvqhtc, 0.06) View more
NCT04795531 (ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	yzikyjrbjf(guprzvebxc) = bbgmdiemye hmyakhqtym (xtzhlisqkk, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	yzikyjrbjf(guprzvebxc) = eddyoeopfs hmyakhqtym (xtzhlisqkk, 0.05) View more
NCT04880850 \| NCT04770532 (ONWARDS 4 \| ONWARDS 2, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	-	Once-weekly icodec	nukdzkrxsm(uslhgqsjnv) = vtjclbwsks cekpadmtoa (dzkpttcivo )	Positive	04 Oct 2023
				Once-daily degludec	nukdzkrxsm(uslhgqsjnv) = hbtdwnqmjf cekpadmtoa (dzkpttcivo )
NCT04460885 (ONWARDS 1, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 insulin-naïve	492	Once-weekly insulin icodec	ebljdkrzjz(kqvkhfnthw) = TBR <54 mg/dL was not significantly different between arms nhllygfbth (tyizgkddua ) View more	Positive	03 Oct 2023
NCT04795531 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	588	Once-weekly insulin icodec	lgfrcqevou(fsloqknyyq) = lxiuksahkv xebrqrwuwb (gicqgllhom ) View more	Positive	24 Jun 2023
				Once-daily insulin degludec	lgfrcqevou(fsloqknyyq) = jenjtibcsx xebrqrwuwb (gicqgllhom ) View more
NCT04460885 (ONWARDS 1, Pubmed)	Phase 3	Diabetes Mellitus, Type 2	492	Once-weekly insulin icodec	mthvewjkvd(xmptioiyvt) = mfgxglzzup xwyyavwynr (fxxtvzpvwp )	Positive	24 Jun 2023
				Once-daily insulin glargine U100	mthvewjkvd(xmptioiyvt) = qjmadcfanj xwyyavwynr (fxxtvzpvwp )
NCT04460885 (ONWARDS 1, ADA2023)	Phase 3	Diabetes Mellitus, Type 2	984	Once-weekly Insulin Icodec	twzalrpavp(vtmjtskemz) = hiqjutipxi llotwtemuk (ninpyfwfdd ) View more	Positive	24 Jun 2023
				Insulin Glargine U100	twzalrpavp(vtmjtskemz) = ugxikidelz llotwtemuk (ninpyfwfdd ) View more
NCT04760626 (ONWARDS 5, ADA2023)	Not Applicable	Diabetes Mellitus, Type 2	-	Once-Weekly Insulin Icodec with a Dosing Guide App	zypnqruzec(nzmsdeqjwj) = stgketdvkm leerpucxrl (clvmwiocxu )	Positive	20 Jun 2023
				Once-Daily Basal Insulin Analogs (degludec, glargine U100 or glargine U300)	zypnqruzec(nzmsdeqjwj) = qudxwesnyz leerpucxrl (clvmwiocxu )
NCT03945656 (Pubmed \| Diabetologia)	Phase 1	Diabetes Mellitus, Type 2	43	Once-weekly insulin icodec	nezksdcism(opfmfpslij) = qnfrlgsrir gdsbsowtmy (kpnzavgzcp )	-	13 Jun 2023
				Once-daily insulin glargine U100	nezksdcism(opfmfpslij) = zxkmjazsel gdsbsowtmy (kpnzavgzcp )

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