RegulationPriority Review (United States), Accelerated Approval (United States), Priority Review (China), Breakthrough Therapy (China), Commissioner's National Priority Voucher (United States), Conditional marketing approval (China), Conditional marketing approval (Canada)

Structure/Sequence

Sequence Code 50953

Source: *****

708

Clinical Trials associated with Semaglutide (Novo Nordisk)

NCT07586150

/ Not yet recruitingNot ApplicableIIT

Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies

This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.

Start Date01 Oct 2028

Sponsor / Collaborator

Ludwig-Maximilians-Universität München

NCT07430332

/ Not yet recruitingPhase 2IIT

Leveraging Semaglutide for Preservation of Beta Cell Function and Restoration of Alpha Cell Function

This study seeks to evaluate the hormone responses of insulin, c-peptide, glucagon, and incretins to semaglutide, a GLP-1 receptor agonist therapy, in individuals with stage 1 type 1 diabetes. The goal of this study is to see if semaglutide can protect beta cell function in this group of people and delay the progression to stage 2 type 1 diabetes.

Start Date01 Sep 2027

Sponsor / Collaborator

Children's Hospital & Medical Center

NCT07797036

/ Not yet recruitingPhase 2/3IIT

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial

This is an effectiveness-implementation Hybrid Type 1 study using a randomized clinical trial design to evaluate the effectiveness and potential real-world integration of immediate postpartum semaglutide following a pregnancy complicated by gestational diabetes mellitus (GDM). A total of 226 postpartum individuals with recent GDM will be randomized 1:1 to semaglutide or standard postpartum care for a 6-month active treatment phase. The primary effectiveness outcome, development of metabolic syndrome, will be assessed at 6 months postpartum. Participants will subsequently enter a 6-month maintenance phase, during which semaglutide continuation, discontinuation, or initiation will reflect patient preferences, clinical decision-making, medication access, and insurance coverage.

Start Date01 Sep 2027

Sponsor / Collaborator

UMass Chan Medical School

100 Clinical Results associated with Semaglutide (Novo Nordisk)

100 Translational Medicine associated with Semaglutide (Novo Nordisk)

100 Patents (Medical) associated with Semaglutide (Novo Nordisk)

430

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

01 Jan 2027·JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION

Quantifying Medicare prescription payment plan benefits under Medicare Part D

Article

Author: Zhang, Minlu ; Zhang, Yi Wolf

BACKGROUND:

The Medicare prescription payment plan (MPPP) enables beneficiaries to convert prescription out-of-pocket (OOP) costs into a capped monthly bill. Clinicians and patients lack practical, mechanism-based guidance on when MPPP meaningfully smooths costs versus when it provides limited or counterproductive value. Quantifying conditions under which MPPP improves monthly affordability and predictability, to derive simple, portable rules for clinical counseling, has not been systematically evaluated.

OBJECTIVE:

Using diabetes regimens as a clinically familiar price-tier model, quantify how MPPP changes monthly payments across plan designs, medication regimens, fill cadences, and enrollment dates, as well as identify mechanism-based patterns that may inform patient-specific counseling.

METHOD:

Medication regimens comprised a generic diabetes backbone and brand-name add-ons using Jardiance (a mid-priced proxy) and Ozempic (a high-priced proxy), administered alone or in combination, to simulate monthly OOP costs with and without enrolling in MPPP, under four canonical Part D plan designs. We modeled 30- vs. 90-day fills and MPPP enrollment in January, July, or October. Monthly payment trajectories were the foundational outcomes; six study-developed descriptive measures summarized first-bill relief, peak-payment reduction, variability, and late-year payment concentration.

RESULTS:

In a deductible/co-insurance plan with brand therapy, MPPP produced payment-smoothing benefits (PBR% ≈ 40-75%, FBR% ≈ 40-80%, VR% ≈ 40-60%, DSI ≈1.0-1.4), largest for Ozempic-like or two-brand regimens and with 90-day fills. July starts retained these gains, and October starts still yielded meaningful improvements under a 90-day supply. In flat-copayment plans, generic-only or single mid-priced brand regimens showed PBR ≈ 0 and VR% ≤0 with higher late-year concentration (YES% ≥ 45, DSI ≥ 2), with exceptions for high-cost two-brand regimens on 90-day fills.

CONCLUSIONS:

MPPP is most effective when paired with deductibles or co-insurance plans for mid- to high-priced brand-name medications; even mid- and late-year starts can be advantageous. In flat-copayment plans or generic-only regimens, benefits are minimal, and late-year concentration can worsen. Lower early payments may be followed by MPPP bills that exceed the corresponding standard Part D payments later in the year. These mechanism-anchored rules generalize beyond diabetes to other conditions with similar price tiers under Part D.

31 Dec 2026·Pulmonology

Effect of anti-tuberculosis drugs on the pharmacokinetics and pharmacodynamics of novel antidiabetic drugs: A scoping review

Article

Author: Lourenço, Joana ; Vieira, Mariana ; Moura, Maria J. ; Duarte, Raquel ; Ramos, João Pedro ; Gomes, David S. ; Pinheiro, Marina

BACKGROUND:

The co-occurrence of tuberculosis (TB) and diabetes mellitus (DM) presents a growing public global health concern. Managing DM during anti-TB therapy is challenging due to potential drug-drug interactions, especially with rifamycin (RIF).

RESEARCH QUESTION:

Assess the effects of anti-TB drugs on the pharmacokinetics and pharmacodynamics of novel antidiabetic agents, including DPP-4 inhibitors (DPP4i), SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1a).

STUDY DESIGN AND METHODS:

A PRISMA-ScR-based scoping review was conducted among four databases.

RESULTS:

Ten studies involving 307 participants were included. RIF significantly reduced the plasma exposure of DPP4i (saxagliptin, gemigliptin, evogliptin) and canagliflozin, while other SGLT2i (dapagliflozin, empagliflozin, ertugliflozin) were minimally affected. No direct data was available for GLP-1a. Adverse events were rare in healthy participants but more frequent in elderly patients with poorly controlled DM. Linezolid and dapagliflozin co-administration may lead to severe pancytopenia.

DISCUSSION:

RIF co-administration with gemigliptin, evogliptin and canagliflozin requires caution and potential requiring dose adjustments, while saxagliptin, dapagliflozin, ertugliflozin and empagliflozin appear safer alternatives. Haematologic monitoring is recommended when combining linezolid and dapagliflozin. However, current evidence remains limited by small sample sizes, single-dose designs, inclusion of mainly healthy participants, and lack of data on GLP-1a or other anti-TB agents. The limited inclusion of DM patients with TB, restricted to one study with latent TB infection, further reduces generalisability. We developed a clinical decision algorithm to support co-treatment in TB - DM cases, but further dedicated studies are warranted to guide optimal co-treatment.

01 Nov 2026·JOURNAL OF CONTROLLED RELEASE

Dual-transporter-targeted oral semaglutide nanomicelles enable enhanced intestinal absorption and metabolic reprogramming in obesity and diabetes

Article

Author: Phuyal, Susmita ; Kim, Eunbin ; Cho, Seung-Sik ; Bamjan, Arjun Dhwoj ; Subedi, Laxman ; Kim, Ki-Taek ; Park, Jin Woo ; Sapkota, Binaya ; Shim, Jung-Hyun ; Seo, Jong Bae

Obesity is a chronic, relapsing metabolic disorder associated with insulin resistance, dyslipidemia, and related complications. Although glucagon-like peptide-1 receptor agonists (GLP-1 RAs), particularly semaglutide (SEMA), exhibit robust therapeutic efficacy, their clinical application is limited by low oral bioavailability. Here, we report a dual-transporter-targeted oral nanomicellar platform (SGT-M) designed to overcome these limitations. SEMA was electrostatically complexed with glucosamine and taurolithocholate to enable transporter-mediated recognition, followed by incorporation into an n-dodecyl-β-D-maltoside-based nanomicelle. The optimized SGT-M had a particle size of 64.7 ± 1.27 nm and near-complete drug incorporation. In vitro, SGT-M enhanced apparent permeability by 28.8-fold in Caco-2/HT-29-MTX-E12 monolayers, while in situ intestinal perfusion demonstrated a 12.6-fold increase in effective permeability. Oral administration achieved a relative bioavailability of 4.62%. Mechanistic studies revealed a multivalent absorption pathway involving dual targeting of the apical sodium-dependent bile acid transporter (ASBT) and glucose transporter 2 (GLUT2), together with clathrin- and caveolae/lipid-mediated endocytosis. In a high-fat-diet-induced obese mouse model, daily oral administration of SGT-M produced dose-dependent therapeutic effects; at 5 mg/kg, it reduced body weight by 30.3% and fasting glucose by 65.6%, while improving HbA1c and HOMA-IR and decreasing adipose tissue mass. Notably, the highest oral dose of SGT-M produced therapeutically meaningful outcomes that approached those observed with subcutaneous SEMA (0.5 mg/kg) under the experimental conditions used. Collectively, SGT-M represents an engineered oral SEMA delivery system that enables effective systemic exposure and therapeutic efficacy, offering a promising strategy to transform injectable peptide therapies into clinically viable oral formulations.

3,484

News (Medical) associated with Semaglutide (Novo Nordisk)

6 hours ago

·www.fiercebiotech.com

Novo’s CEO still looking for deals to ‘close some of the gaps,’ as misfires hit profits

Novo’s CEO has told Fierce that the company remains on the hunt for deals that “close some of the gaps” in its pipeline, as the Big Pharma reports billions of dollars in impairment charges from a string of recent clinical misses. In its third-quarter earnings results , Novo disclosed 15 billion Danish kroner ($2.2 billion) in major impairment charges. Over two-thirds of this came from pipeline missteps, including 4.6 billion kroner ($690 million) from the failure of the cardiovascular drug ziltivekimab and 4 billion kroner ($600 million) from scrapping the obesity hopeful monlunabant . The charges meant that despite seeing adjusted operating profits grow 27% in the quarter—driven by a strong rollout of oral obesity drug Wegovy— the company still saw reported operating profits drop 9%. On a call with journalists this morning, Novo’s Chief Financial Officer Karsten Munk Knudsen said the charges—which also included 4.1 billion kroner ($620 million) for righting the pharma’s manufacturing network—were all one-offs. “If anything, I would say it leaves us with a much cleaner balance sheet and hence a better runway going forward,” added Knudsen, who Novo announced this morning would be leaving the company at the end of the year. The third quarter was a period of significant change at Novo, including a major rebrand and a Capital Markets Day in September where CEO Mike Doustdar set out an updated strategy for the company. When asked by Fierce this morning whether he agreed with reporting that investors had been underwhelmed by the company’s deal-making strategy, Doustdar said Novo was still on the hunt for acquisitions. “We continue, of course, to mention that we are looking and searching across all of our therapy areas for innovation that fits and closes, maybe, some of the gaps that we have, as well as, of course, synergizes with what we're doing ourselves,” the CEO responded. “We remain disciplined,” Doustdar continued. “I think, for us, it’s not about running and making sure we close a certain number of deals just to satisfy the headline news.” “For us, it really starts [by] mak[ing] sure that we deeply search into what is strategically fitting into our portfolio of products and our strategy, and we'll continue doing that.” Novo used its Capital Markets Day to set out an ambition to deliver mid-single-digit compounded annual sales growth in line with its industry peers from 2026 to 2030. This strategy involves growing and diversifying the pipeline, driving sustainable growth, and delivering attractive returns to shareholders, Doustdar reminded journalists on the call. “From this quarter onward, we will hold ourselves accountable and report progress against each of them,” he said. “On growing and diversifying our pipeline, we have initiated seven first [in] human dose trials so far this year, and we have 10 ongoing phase 3 programs.” In the near-term, Novo is aiming for “two exciting potential launches” next year, Doustdar pointed out. One of these, the next-generation factor VIIIa mimetic bispecific antibody Frehemgo, has already received the nod from European regulators to treat hemophilia A. An FDA decision is awaiting some manufacturing issues to be rectified. The other is CagriSema, a combination of the amylin analog cagrilintide with Novo’s well-known GLP-1 quantity semaglutide. The FDA is expected to make an approval decision before the end of this year, based on Novo’s earnings documents. “Together with our exciting key growth brands, this is where our focus and investment will be in 2027,” Doustdar said on the call. “With Frehemgo, our job now is to make switching from today's standard of care seamless, safe, and become the preferred choice for patients and doctors.” “For CagriSema, our job is simple: we need to get it to patients as fast as possible through multiple channels, the CEO added. “That means we are not waiting for approval to get ready.” Where Big Pharma is placing its bets is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:

Phase 3Drug ApprovalAcquisitionFinancial Statement

15 hours ago

·www.biospace.com

Novo, Lilly battle for oral GLP-1 dominance with data tit for tat

iStock, z_wei Novo CEO Mike Maziar Doustdar insists that his company is ahead of fierce rival Eli Lilly as oral Wegovy rises to 8 million total prescriptions since its January launch. It’s a battle of the numbers, with both Novo and Eli Lilly claiming superiority in the early oral GLP-1 race. But who is right? Novo CEO Mike Maziar Doustdar insists his rival doesn’t have all the data. Last week, Lilly reported that Foundayo has secured 40% of new patient starts since the oral GLP-1 entered the market in the second quarter. This would leave Novo with 60% of the market, which it entered with the Wegovy pill at the beginning of the year. But Doustdar said his rival is relying solely on reports from clinical research provider IQVIA, which does not provide a full portrait of his company’s early market dominance. The CEO, in reporting third quarter earnings on Wednesday, said that the Wegovy pill has actually secured 80% of the burgeoning market, while Lilly only has 20%. “They have actually themselves, led by their CFO, mentioned that they are looking at IQVIA, which covers 90 to 95% of their scripts and only 65% of our scripts,” Doustdar explained. Earnings Novo dips 6% on Wegovy pill stumble despite Q2 earnings beat Novo Nordisk’s shares fell 6% on Tuesday afternoon after its second quarter earnings report showed a slight miss for the Wegovy pill vs. consensus. August 4, 2026 · 1 min read · Annalee Armstrong Read more But Novo has prescriptions coming through other channels, like its collaboration with telehealth companies Hims & Hers, Ro and more. These are not captured in IQVIA’s data, leaving an incomplete picture of the oral weight loss space—a picture that Lilly has relied on to tout Foundayo’s prowess. “Those companies do not share their data with IQVIA,” Doustdar said of the telehealth providers. “If they did, then you actually would get to our numbers.” And those numbers would put Novo on top, he added. “This underpins the strong competitiveness of the Wegovy pill label, with highest proven weight loss for an oral obesity medication, the ease of use and familiarity with the semaglutide molecule being the one.” Obesity Novo takes first round of oral obesity duel. Can it stay ahead of Lilly? Despite coming away with an early victory over Eli Lilly in the oral obesity face-off, analysts don’t expect Novo Nordisk’s lead to last for very long. August 19, 2026 · 7 min read · Tristan Manalac Read more Novo reported on Wednesday’s call that it has reached 8 million cumulative prescriptions for the Wegovy pill since launch—what Doustdar called “the strongest pharma launch by volume in the U.S. in the last decade.” For the third quarter, Novo recorded sales of 5.39 million DKK ($811.6 million). “We see a long runway for the pill in the U.S. with current and incoming initiatives expected to drive more uptake into the year to come,” the CEO continued. The Wegovy franchise, which includes the pill and an injectable at multiple doses, has allowed Novo to offer patients a range of options with one familiar molecule. Lilly, on the other hand, has admitted that launching a completely new drug like Foundayo put them at a slight disadvantage . But as Doustdar said on Wednesday morning’s call, “this is still at early innings. Many people are still in need of treatments and have not received treatments.” C-suite Novo’s plan to hit $23B in revenue by 2035 leaves investors wanting Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions. September 21, 2026 · 5 min read · Annalee Armstrong Read more Lilly said the same last week, with CEO David Ricks touting a massive 39% revenue increase thanks to unprecedented demand in the weight loss markets. Doustdar said that 80% of people who are starting on the Wegovy pill are new to treatment, meaning the oral market is driving an expansion into new patients that the injectables had not tapped. “It is really the market expansion that drives the growth for us in mid- and longer term, as well as for our competitor,” Doustdar said. “This is why this GLP-1 market has become so interesting because there are just so many people in need.” Checking boxes While Novo’s third quarter revenue did not near the heights of its American rival Lilly—which reported $24.4 billion for the period—shares rallied for the Danish pharma on what was a strong consensus beat. The semaglutide maker reported 79.2 billion DKK ($11.9 billion) in net sales for the quarter, representing 6% growth compared to the same period a year earlier. Analysts had been expecting about $11.07 billion in net sales, according to Yahoo Finance . Adjusted operating profit was 31.72 billion DKK ($4.77 billion). This represented a 27% increase over the third quarter last year, when Novo embarked on a company-wide cost cutting initiative that resulted in thousands of job losses . Earnings Novo CEO sees innovation as a matter of survival amid pipeline setbacks Novo Nordisk CEO Maziar Mike Doustdar on a second quarter earnings call argued that failure is par for the course in the drug development business. The Danish pharma is focused on building out its pipeline to move past recent clinical roadblocks. August 5, 2026 · 3 min read · Tristan Manalac Read more Novo’s shares climbed more than 6% to $42.69 in pre-market trading on Wednesday. Year to date, the stock has declined 21%. But Novo is looking to grow, with executives predicting during a September investor day that the company will reach $23 billion in sales in 2035. This projection disappointed investors and analysts , who saw the plan as too familiar. Investors had also hoped for a more aggressive stance on business development. Doustdar vowed to remain disciplined but focused on filling gaps in Novo’s pipeline across existing therapeutic areas. “For us, it’s not about running and making sure we close a certain number of deals just to satisfy the headline news,” Doustdar said. “For us, [it’s] to make sure that we deeply search into what is strategically fitting into our portfolio of products and our strategy, and we’ll continue doing that.” Obesity Deep dive: The oral obesity wars BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk. May 18, 2026 · 3 min read · Heather McKenzie Read more

15 hours ago

·www.biospace.com

Novo raises full-year outlook on continued GLP-1 momentum, with third-quarter adjusted operating profit increasing 27% at CER to DKK 31,720 million

4 November - Financial report for the period 1 January 2026 to 30 September 2026 Financial performance Q3 2026 adjusted and reported sales increased by 4% at CER, driven by continued GLP-1 volume growth across the US and International operations, primarily in obesity. Q3 2026 adjusted operating profit increased by 27% at CER, driven by GLP-1 sales growth and a favourable comparison base following DKK 9 billion of company-wide transformation costs recognised in Q3 2025. Q3 2026 reported operating profit decreased by 9% at CER, reflecting DKK 8.7 billion of non-cash impairment charges in the quarter, related to ziltivekimab (DKK 4.6 billion) and right-sizing of manufacturing network (DKK 4.1 billion). Commercial highlights By the end of Q3, Wegovy® pill had been launched in the US, UAE, UK and Germany, with uptake driving Q3 2026 sales of DKK 5,394 million. More recently, launches in four additional countries increased the total number of launched markets to eight. The Wegovy® franchise maintains its US leadership in new patient starts, with more than 50% share in the branded obesity market. Ozempic® pill was launched in the US in May, with encouraging early momentum. Weekly new-to-brand prescriptions (NBRx) are currently up around 100% compared with pre-launch levels under the Rybelsus® brand. The global roll-out of Ozempic® 2.0 mg and the Wegovy® 7.2 mg single-dose pen across International Operations is progressing. Pipeline progress Within obesity, CagriSema (1.0/1.0 mg) delivered encouraging weight loss of 21% at week 68 in the REDEFINE 9 trial. Also in obesity, the AMAZE 9 phase 3 trial with oral zenagamtide has been initiated in September. Within diabetes, CagriSema (1.0/1.0 mg) achieved superior weight loss of 12.4% compared with 9.1% for tirzepatide 5 mg, while demonstrating non-inferior HbA 1c reduction at week 60 in adults with type 2 diabetes and obesity in the REIMAGINE 5 trial. Within blood & endocrine disorders, Frehemgo® (denecimig) received positive CHMP opinion on 17 September and pending full EU approval, the first launches are planned in Europe around the turn of the year. In the US, the regulatory review of denecimig is still ongoing, and pending regulatory decision, a US launch is expected in H1 2027. Outlook Adjusted sales growth for 2026 is now expected to be -2% to +2% at CER and adjusted operating profit growth is now expected to be -2% to +2% at CER. The improved outlook is driven by increased expectations for GLP-1 product sales. PROFIT AND LOSS DKK million Q3 2026 Growth in DKK Growth at CER 9M 2026 Growth in DKK Growth at CER Net sales 79,195 6% 4% 254,506 11% 13% Operating profit 23,011 (3%) (9%) 109,690 14% 18% Adjusted net sales 1 79,195 6% 4% 227,746 0% 2% Adjusted operating profit 1 31,720 34% 27% 97,967 5% 8% CER: Constant exchange rates; 1 Adjusted sales and adjusted operating profit exclude certain exceptional and non-recurring items not reflective of the Group’s normal course of operating activities, as defined in Appendix 7. “We delivered a stronger-than-expected third quarter and are raising our full-year outlook for adjusted sales and adjusted operating profit. We are particularly pleased to see both US Operations and International Operations deliver sales growth this quarter. Growth was led by our obesity portfolio, with continued uptake of Wegovy® pill in the US and encouraging early launches internationally. Our focus is on sustaining this progress through disciplined execution and broader access to our medicines. We are also advancing our pipeline and preparing for the US launch of CagriSema in early 2027, subject to regulatory approval,” said Mike Doustdar, president and CEO of Novo. On 4 November 2026 at 13.00 CET, corresponding to 07.00 am EST, an earnings call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under 'Investors' (the contents of the company's website do not form a part of this Form 6-K). Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 66,500 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. Novo's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 usmediarelations@novonordisk.com Investors: Michael Novod +45 3075 6050 nvno@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com Max Ung +45 3077 6414 mxun@novonordisk.com Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com Company announcement No 65 / 2026 Attachment CA261104-NOVO-Q3-2026

Phase 3Drug ApprovalFinancial StatementClinical Result

100 Deals associated with Semaglutide (Novo Nordisk)

External Link

KEGG	Wiki	ATC	Drug Bank
D10025	Semaglutide (Novo Nordisk)	A10BJ06	DB13928

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Diseases	United Kingdom	Novo Nordisk A/S	01 Apr 2026
Fibrosis, Liver	United States	Novo Nordisk, Inc.	22 Dec 2025
Pulmonary Fibrosis	Canada	Novo Nordisk Canada, Inc.	21 Dec 2025
Metabolic Dysfunction Associated Steatohepatitis	United States	Novo Nordisk, Inc.	15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis	United States	Novo Nordisk A/S	15 Aug 2025
Chronic Kidney Diseases	United States	Novo Nordisk A/S	28 Jan 2025
Chronic Kidney Diseases	United States	Novo Nordisk, Inc.	28 Jan 2025
Stroke	Australia	Novo Nordisk Pharmaceuticals Pty Ltd.	16 Dec 2024
Myocardial Infarction	Canada	Novo Nordisk Canada, Inc.	27 Nov 2024
Cardiovascular Diseases	United States	Novo Nordisk, Inc.	08 Mar 2024
Obesity	United States	Novo Nordisk, Inc.	04 Jun 2021
Overweight	United States	Novo Nordisk, Inc.	04 Jun 2021
Diabetes Mellitus, Type 2	United States	Novo Nordisk, Inc.	05 Dec 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 3	United States	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	China	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Japan	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Argentina	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Australia	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Belgium	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Brazil	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Bulgaria	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Canada	Novo Nordisk Pharma Ltd.	11 Nov 2026
Hypertension	Phase 3	Denmark	Novo Nordisk Pharma Ltd.	11 Nov 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2026	Not Applicable	Primary Biliary Cholangitis	964	Semaglutide users receiving UDCA	fzvhujopue(ffjyocawgo) = pgqawmceng ycamkebynr (giwajfypcc ) View more	Positive	05 Nov 2026
				UDCA-treated nonusers without GLP-1 receptor agonist exposure	fzvhujopue(ffjyocawgo) = jgbdovuvjf ycamkebynr (giwajfypcc ) View more
NCT04822181 (ESSENCE, AASLD2026)	Phase 3	Metabolic Dysfunction Associated Steatohepatitis	106	Semaglutide 2.4 mg	lcfvntgplx(bxfxpnunsf): ETR = 0.61 (95.0% CI, 0.48 - 0.77) View more	Positive	05 Nov 2026
				Placebo
AASLD2026	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	118	Semaglutide	gdgcuyxiwe(valnkqfqya) = decreased by a median of 0.4% rbciafdkbg (uznlzpgevq ) View more	Positive	05 Nov 2026
AASLD2026	Not Applicable	Metabolic Dysfunction Associated Steatohepatitis	22,160	Semaglutide	bxrdblhobr(qxvpaoltkk) = busfaigzas hmujgxvtnu (zyfrvcaenz ) View more	Positive	05 Nov 2026
				DPP-4 inhibitors	bxrdblhobr(qxvpaoltkk) = gydqnlrnbt hmujgxvtnu (zyfrvcaenz ) View more
AASLD2026	Not Applicable	Metabolic Dysfunction Associated Steatohepatitis	108	Resmetirom monotherapy	hdeyazbczm(odybikqony) = xhpqditcyj byvsqatdlr (mklgbccpnb ) View more	Positive	05 Nov 2026
				Semaglutide monotherapy	hdeyazbczm(odybikqony) = ycxtndecyu byvsqatdlr (mklgbccpnb ) View more
AASLD2026	Not Applicable	Diabetes Mellitus, Type 2 \| Metabolic dysfunction-associated steatotic liver disease HbA1c	3,406	Semaglutide	pdugujmagj(jrvfzyylrb) = zwlpxjpkbs opdvihhgkk (cmixwpfrte ) View more	Positive	05 Nov 2026
				SGLT2 inhibitors (SGLT2i)	pdugujmagj(jrvfzyylrb) = dwenrjcvfb opdvihhgkk (cmixwpfrte ) View more
AASLD2026	Not Applicable	Metabolic Dysfunction Associated Steatohepatitis	5,488	Semaglutide	lumpiusfye(uhmjijnzup) = udgqrbtvzd lfvlubardo (sahzqxplks ) View more	Positive	05 Nov 2026
				Resmetirom	lumpiusfye(uhmjijnzup) = jicemcrplv lfvlubardo (sahzqxplks ) View more
NCT04916470 (STEP-HFpEF and STEP-HFpEF DM \| STEP-HFpEF Program \| STEP-HFpEF-DM \| STEP HFpEF DM \| STEP-HFpEF DM \| STEP-HFpEF, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Heart failure with normal ejection fraction \| Obesity	617	Semaglutide (Semaglutide 2.4 mg)	mybmhywqvq(lctgjaqvnh) = cregdohcbx xpbmljvbzi (rmbgulanfu, 18.3) View more	-	02 Nov 2026
				placebo+semaglutide (Placebo)	mybmhywqvq(lctgjaqvnh) = kueaxqhnyr xpbmljvbzi (rmbgulanfu, 18.8) View more
NCT05073835 (BARI-STEP, CTgov)	Phase 3	Metabolic Syndrome \| Diabetes Mellitus \| Obesity	70	placebo (Placebo)	xyjdulyghy(mywdnkmykh) = tnsrjcnutj pemfjbpyno (wbxbyqorgk, 7.0) View more	-	26 Oct 2026
				Semaglutide (Semaglutide 2.4mg)	xyjdulyghy(mywdnkmykh) = cwhdnfomwi pemfjbpyno (wbxbyqorgk, 9.2) View more
NCT06041217 (STEP 12, Pubmed \| Lancet Diabetes Endocrinol)	Phase 3	Overweight \| Obesity	242	Semaglutide 2.4 mg	spynphupwa(hloehgvahy) = fgxskqohoq ukcywifspw (tsscvahown )	Positive	01 Oct 2026
				Placebo	spynphupwa(hloehgvahy) = etrqkimkdl ukcywifspw (tsscvahown )

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