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.

CTIS2023-506084-34-00

/ Not yet 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 - NN1436-7724

Start Date19 Apr 2024

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

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 Dec 2024·Diabetes, Obesity and Metabolism

Cost–utility analysis and drug pricing of once‐weekly insulin icodec versus once‐daily insulin degludec for type 2 diabetes patients treated with basal insulin in China

Article

Author: Qi, Chendong ; Fan, Guorong ; Hu, Shanshan ; Wang, Shuowen ; Shi, Chenyang ; Gu, Shengying

AbstractAimInsulin icodec is a first once‐weekly administration basal insulin analogue for type 2 diabetes. This study aimed to investigate the price range of icodec for type 2 diabetes in the Chinese market, taking insulin degludec as reference.Materials and MethodsLong‐term health outcomes and costs for icodec and degludec were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model (version 2.1) over 40 years from the Chinese healthcare provider's perspective. The efficacy and safety data were obtained from the ONWARDS 2 trial (Switching to once‐weekly insulin icodec versus once‐daily insulin degludec in individuals with basal insulin‐treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat‐to‐target trial). Cost–utility analysis and a binary search were used to investigate the price range of icodec. Sensitivity analyses were performed to verify the robustness of the base‐case analysis results.ResultsAfter a 40‐year simulation, the quality‐adjusted life years (QALY) of icodec and degludec were 10.32 and 10.28 years, respectively. At the initial assumption of the same annual costs of icodec and degludec of $455.40, icodec was the dominant therapy compared with degludec, with higher QALYs and lower total cost. After the binary search, we observed that the annual cost range of icodec was $625.17–$855.25. This cost range was finally adjusted to be $597.66–$736.34 using one‐way sensitivity analysis and confirmed using probabilistic sensitivity analysis and scenario analysis. The scenario analysis revealed that the annual cost range of icodec could be $506.70–$736.34 if the price of degludec decreased by 20% in the future.ConclusionInsulin icodec appears to be more cost effective than degludec if the annual cost of icodec ranges from $597.66 to $736.34 for patients with type 2 diabetes in China.

01 Dec 2024·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: Knop, Filip K ; Ásbjörnsdóttir, Björg ; Kristensen, Niels R ; Lingvay, Ildiko ; Vianna, André ; Laugesen, Christian

OBJECTIVEInsulin 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.METHODSData from two 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 (SMBG), glycated hemoglobin (HbA1c), weekly insulin dose, and clinically significant hypoglycemia was assessed.RESULTSModel 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 SMBG 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 HbA1c reduction or clinically significant hypoglycemia over the 26-week study period or in weekly icodec dose at week 26.CONCLUSIONSThis 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.

01 Dec 2024·Diabetes, Obesity and Metabolism

Efficacy and safety of once‐weekly insulin icodec versus once‐daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials

Article

Author: Nishimura, Rimei ; Ásbjörnsdóttir, Björg ; Nishida, Tomoyuki ; Yamamoto, Yuiko ; Kadowaki, Takashi ; Yamauchi, Toshimasa ; Watada, Hirotaka

AbstractAimTo explore the efficacy and safety of once‐weekly insulin icodec (icodec) in Japanese adults (≥20 years old) with type 2 diabetes from the global ONWARDS 1, 2 and 4 trials.Materials and MethodsInsulin‐naive (ONWARDS 1) and insulin‐experienced (ONWARDS 2 and 4) individuals were randomized to icodec or a once‐daily insulin comparator: insulin glargine U100 [ONWARDS 1 (basal insulin only) and 4 (basal–bolus regimen)] or insulin degludec [ONWARDS 2 (basal insulin only)]. The primary outcome was change in glycated haemoglobin from baseline to end of treatment (EOT) (ONWARDS 1: Week 52; ONWARDS 2 and 4: Week 26). Here, we present the Japanese subgroup results.ResultsSimilar reductions in glycated haemoglobin from baseline to EOT were observed in each trial for icodec and comparators. The proportion of time in range (blood glucose 3.9–10.0 mmol/L) at EOT was also comparable across treatment groups (time in range: 58%–68%), as was time spent with blood glucose below 3.0 mmol/L (<1.0%). Combined clinically significant (blood glucose <3.0 mmol/L) or severe (requiring external assistance for recovery) hypoglycaemia rates were low, with no severe events (ONWARDS 1 and 2) or a single severe event (ONWARDS 4; icodec group) reported. These results generally aligned with findings from the respective global populations. No new safety issues were identified.ConclusionsIcodec improved glycaemic control to a similar degree as once‐daily basal insulin comparators while maintaining low levels of clinically significant or severe hypoglycaemia. The findings support icodec use in Japanese individuals with different levels of type 2 diabetes progression.

News (Medical) associated with Icodec Insulin

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

29 Oct 2024

·endpts.com

Following March inspection, Novo Nordisk's semaglutide manufacturing facility cited by FDA

The FDA on Tuesday released an inspection report sent to Novo Nordisk earlier this year citing quality-related issues at a site in Kalundborg, Denmark, that manufactures its blockbuster semaglutide drugs and its long-acting insulin. The heavily redacted Form 483 includes eight observations related to the site’s quality, following a seven-day FDA inspection in March. Among the observations are ones related to adequately describing critical process parameters and in-process controls for drug substance manufacturing and processing unit operations. “Master production and control records lack complete manufacturing and control instructions,” the 483 said. The agency also noted that the responsibilities and procedures applicable to the site’s quality control unit “are not fully followed,” and that lab controls at the facility “do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that production cultures conform to appropriate standards of identity, strength, quality, and purity.” “This is the manufacturing process we referred to when we received the CRL for Awiqli from the FDA in July,” a Novo spokesperson told Endpoints News in an email. “We continue to be in contact with the FDA and do not expect to resolve as related to Awiqli this year.” The FDA in July issued a complete response letter to Awiqli, which is approved in the EU, Canada and other markets. At that time, the regulator requested more information relating to the manufacturing process. The company said last November that it would invest more than DKK 42 billion (about $6 billion) to expand existing manufacturing facilities in Denmark, including the Kalundborg site, mainly to increase its capacity for active pharmaceutical ingredients. Back in August, nearly all versions of Novo’s GLP-1 drugs — Wegovy and Ozempic — were taken off the FDA shortage list, and the company reported that prescriptions had doubled in the US since the beginning of the year. “We’re scaling our supply and now we’re serving twice as many people with Wegovy today compared to just at the beginning of the year and we continue to scale,” CEO Lars Fruergaard Jørgensen said at the time.

Drug Approval

11 Sep 2024

·www.biospace.com

Lilly Continues Once-Weekly Insulin Rally With Two Phase III Diabetes Readouts

iStock, JHVEPhoto The late-stage clinical trial results showed that Eli Lilly’s once-weekly insulin efsitora matched daily injections for patients with type 1 and 2 diabetes, respectively. Eli Lilly on Tuesday unveiled data from two late-stage studies, further building the case for its once-weekly insulin efsitora in patients with diabetes. The pharma presented its findings at the 2024 Annual Meeting of European Association for the Study of Diabetes. In QWINT-2 , Lilly tested efsitora in insulin-naïve type 2 diabetes patients versus daily insulin degludec. Results showed that the once-weekly injection could lower A1C by 1.34%, compared with the 1.26% reduction in degludec patients—an effect that was non-inferior, according to the company. A1C level at 52 weeks was 6.87% after efsitora treatment and 6.95% in degludec comparators. Efsitora continued to match degludec in patients who were and were not taking GLP-1 receptor agonists, resulting in non-inferior reductions in A1C. QWINT-2 results also showed that patients treated with the weekly insulin spent 45 minutes more in time in range per day versus degludec, a key secondary endpoint. Efsitora’s safety pro similar to daily insulin, resulting in severe hypoglycemic episodes, versus six in the degludec arm. Time in hypoglycemia was not increased. “With these results, we believe we’re headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora,” Jeff Emmick, Lilly’s senior vice president of product development, said in a statement. The QWINT-2 readout adds to growing evidence supporting efsitora in type 2 diabetes. Last week, Lilly also posted data drops from QWINT-1 and QWINT-3, demonstrating that the once-weekly efsitora could match daily injections in patients who were insulin-naïve and in those who were switching to a weekly schedule from daily basal insulin. Lilly is also positioning efsitora as a potential once-weekly treatment for type 1 diabetes. At the EASD Annual Meeting, the pharma also revealed findings from the Phase III QWINT-5 study, which established the non-inferiority of efsitora versus daily degludec injections. At week 26, patients treated with efsitora saw a 0.53% drop in A1C, versus the 0.59% reduction in degludec comparators. A1C levels at this time point was 7.37% and 7.39% in the respective treatment arms. Efsitora also matched daily degluec in terms of the percent of time spent in range in the four-week period leading up to the 26-week follow-up. The rate of patients-reported clinically significant or severe hypoglycemic episodes was slightly higher in patients treated with efsitora, though the duration of hypoglycemia was comparable between treatments. Severe hypoglycemic events per patient-year of exposure were also slightly more frequent in the efsitora group. Findings from the QWINT program could help put Lilly ahead of Novo Nordisk, which failed to win the FDA’s approval for its once-weekly basal insulin icodec in July 2024. The regulator pointed to manufacturing issues and raised concerns about icodec’s benefit/risk pro type 1 diabetes.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Icodec Insulin

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus	LI	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	EU	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	IS	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	NO	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus, Type 1	CA	Novo Nordisk Canada, Inc.	12 Mar 2024
Diabetes Mellitus, Type 2	CA	Novo Nordisk Canada, Inc.	12 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	US	Novo Nordisk A/S	07 May 2023
Diabetes Mellitus, Type 1	Preclinical	US	Novo Nordisk A/S	-
Diabetes Mellitus	Discovery	CN	Novo Nordisk A/S	26 Nov 2021
Diabetes Mellitus, Type 1	Discovery	US	Novo Nordisk A/S	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04795531 (ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	fsisbnvrbi(gfwaazbfqk) = qpdklngzip zjzdxvpaty (owcbajuzsf, pmbcujwnat - ozpusptdvg) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	fsisbnvrbi(gfwaazbfqk) = xqiduccgit zjzdxvpaty (owcbajuzsf, brzdryjrwu - mpyyxxqqyk) View more
NCT04460885 (ONWARDS 1, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 insulin-naïve	492	Once-weekly insulin icodec	(xufgbyfjfr) = TBR <54 mg/dL was not significantly different between arms gsnxarwfkw (xesjbphwsj ) View more	Positive	03 Oct 2023
NCT04460885 (ONWARDS 1, ADA2023)	Phase 3	Diabetes Mellitus, Type 2	984	Once-weekly Insulin Icodec	(vcyvrxugmx) = ppivtwkrht zopfkvjuvq (tqamgyijeu ) View more	Positive	24 Jun 2023
				Insulin Glargine U100	(vcyvrxugmx) = uyoffoyzfj zopfkvjuvq (tqamgyijeu ) View more
NCT04795531 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	588	Once-weekly insulin icodec	(zkvsbxostj) = tlyecmmora somrpzzfzg (btfmsymwgx ) View more	Positive	24 Jun 2023
				Once-daily insulin degludec	(zkvsbxostj) = zoesfayfln somrpzzfzg (btfmsymwgx ) View more
NCT04770532 (ONWARDS 2, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	526	Icodec Insulin	(dtstvmouds) = tqdekjkpiu omjarhersg (ubaszwykpy ) View more	Non-inferior	22 Sep 2022
				Insulin degludec	(dtstvmouds) = ssobpwexrx omjarhersg (ubaszwykpy ) View more
EASD2022	Phase 2	Diabetes Mellitus, Type 2	606	Insulin icodec	ljcenbawoa(gefwmttknc) = Only 1 hypoglycemia level 3 event was noted (patient on icodec) hxqcmxsynm (wdbcjpqmpj )	Positive	20 Sep 2022
NCT04795531 (ONWARDS 3, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2 First line	588	Icodec Insulin	(mvaxgcavib) = mojbdormgj xwwbmddtet (enbujttcmu ) View more	Non-inferior	29 Jul 2022
				Insulin degludec	(mvaxgcavib) = hmliziudhv xwwbmddtet (enbujttcmu ) View more
NCT04880850 (ONWARDS 4, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2	582	Insulin aspart+Icodec Insulin	(zkbawprqjp) = lhygyqsrwn fuxrdqgwpd (hhcwgxdglx ) View more	Non-inferior	29 Jul 2022
				Insulin aspart+Insulin glargine	(zkbawprqjp) = cysatafjhk fuxrdqgwpd (hhcwgxdglx ) View more
ADA2022	Not Applicable	Diabetes Mellitus, Type 2	43	Once-Weekly Insulin Icodec	twqsbteyau(fkmzhelwvx) = lcbeeetrng rhuchutpvh (deayvutlhy ) View more	-	01 Jun 2022
				Once-Daily Insulin Glargine	twqsbteyau(fkmzhelwvx) = rbxiimudrg rhuchutpvh (deayvutlhy ) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin Icodec	odlueuzuhq(fhwghithka) = xeiapmvajw coxywtluvj (womuglhhwm, (20.0 - 70.0))	-	01 Jun 2021
				Insulin Glargine U100	odlueuzuhq(fhwghithka) = zncfkwshyr coxywtluvj (womuglhhwm, (20.0 - 60.0))

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

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

Icodec Insulin

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation