Delving into the Latest Updates on Semaglutide (Novo Nordisk) with Synapse

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

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Structure/Sequence

Sequence Code 50953

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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

NCT07614412

/ Not yet recruitingPhase 2IIT

Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.

Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by progressive destruction of pancreatic beta cells mediated by autoreactive T lymphocytes, resulting in absolute insulin deficiency. Preservation of residual beta-cell function at the time of diagnosis is a critical therapeutic window, as even marginal endogenous insulin secretion - reflected by detectable C-peptide levels - is associated with improved glycemic control, reduced hypoglycemia burden, and decreased long-term vascular complication rates.
This study evaluates the hypothesis that combinatorial immunomodulation - using the AS01B adjuvant system within the Recombinant Zoster Vaccine (RZV; Shingrix, GSK) alongside metabolic and cytoprotective support via a GLP-1 receptor agonist (semaglutide) - can synergistically preserve residual beta-cell function in adults within 100 days of T1D diagnosis. The AS01B adjuvant system activates innate immune pathways that promote regulatory T-cell (Treg) expansion and shift the immunological milieu toward tolerance, while GLP-1 receptor agonism provides direct beta-cell cytoprotection, reduces glucotoxicity, and may suppress autoimmune cytokine signaling.
SHIELD-T1D is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial enrolling 240 adults (18-50 years) diagnosed with T1D within 100 days, with confirmed residual beta-cell function (stimulated C-peptide ≥0.2 nmol/L). Participants are randomized 1:1:1:1 to one of four arms: (1) Shingrix alone, (2) Semaglutide alone, (3) Shingrix + Semaglutide combination, or (4) dual placebo. The primary endpoint is change in 2-hour stimulated C-peptide AUC during a Mixed Meal Tolerance Test (MMTT) from baseline to 12 months.
This phase II randomized, double-blind, placebo-controlled multicenter trial will evaluate the efficacy and safety of the recombinant zoster vaccine (Shingrix) and a glucagon-like peptide-1 (GLP-1) receptor agonist, alone and in combination, for preservation of residual beta-cell function in adults with recent-onset type 1 diabetes. The working hypothesis is that combining AS01 adjuvant-mediated immunomodulation with the metabolic and cytoprotective actions of a GLP-1 receptor agonist will provide dual protection for pancreatic beta cells, slowing autoimmune destruction and improving functional insulin secretion compared with placebo.

Start Date01 Jan 2027

Sponsor / Collaborator-

100 Clinical Results associated with Semaglutide (Novo Nordisk)

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100 Translational Medicine associated with Semaglutide (Novo Nordisk)

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

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381

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

01 Jul 2026·FREE RADICAL BIOLOGY AND MEDICINE

Semaglutide ameliorates aortic endothelial cell dysfunction in sarcopenia through the SIRT1/cGAS-STING signaling axis

Article

Author: Zhang, Xin ; Wang, Xinglin ; Huang, Ziteng ; Ye, Xiangming ; Qiao, Gan ; Huang, Ting ; Sun, Weiyue ; Yang, Ping ; Wu, Haoran ; Liu, Yang ; Tang, Linyi ; Li, Liyun

Sarcopenia associated with aging is a significant health issue affecting the quality of life in the elderly, yet research on effective treatments remains insufficient. This study aims to investigate the therapeutic effects and mechanisms of Semaglutide (Sema) in D-gal-induced aging-related sarcopenia and endothelial cell senescence. By establishing D-gal-induced mouse models and human aortic endothelial cells (HAEC), and employing methods such as grip strength tests, ELISA, and immunohistochemistry, the therapeutic efficacy and underlying mechanisms of Sema were systematically evaluated. The results demonstrated that Sema significantly improved grip strength in D-gal-induced mice and reduced serum levels of IL-1β and TNF-α, indicating its protective role against sarcopenia. Furthermore, Sema effectively alleviated endothelial cell senescence and improved endothelial function, with the underlying mechanisms potentially involving the upregulation of SIRT1 expression and inhibition of the cGAS-STING signaling pathway activation. This study systematically reveals, for the first time, the therapeutic potential of Sema in aging-related sarcopenia, especially its protective effect against aortic endothelial senescence, providing new perspectives and evidence for its clinical application.

01 Jul 2026·International journal of social determinants of health and health services

Ozempic and Wegovy Meet Congress: Political Economy Without Critique and Sociology Without Society

Article

Author: Loeppky, Rodney

In the fall of 2024, a U.S. Senate Hearing on the high price of Novo Nordisk's prescription drugs Ozempic and Wegovy underlined some of the deepest challenges in the U.S. health care system. This article utilizes critical approaches to both political economy and sociological discussions of medicalization as a means to address these challenges. Market-led organization and medicalization underlie not only these products’ pricing, but also wider issues of cost control and health care organization. Congressional debate tends to either attribute blame on individual corporate actors, largely sidestepping larger structural issues, or defend industry and profit-oriented care, deflecting blame for high costs on the lifestyle choices of individual Americans. The article reestablishes an interrelation between critical political economy and medicalization, calling for a reorientation of health purchasing in the United States, along the lines of a single payer system that would, by necessity, interrogate the value of evolving drug (and other medical) provision for American society. This argument has strong practical political implications, potentially enabling policymakers to approach the emergence of ‘wonder’ drugs like Ozempic/Wegovy on terms that matter to both patients and U.S. society—price, medical necessity, access, and overall health care costs.

01 Jun 2026·BIOETHICS

Ethical Issues Related to the Use of GLP‐1 Receptor Agonists Such as Ozempic and Mounjaro: Impact on Individuals and Society at Large

Article

Author: Minerva, Francesca

ABSTRACT:

This paper explores the ethical implications of emerging weight‐loss medications such as Semaglutide (Ozempic) and Tirzepatide (Mounjaro), analysing their therapeutic applications for obesity and potential use as enhancement drugs. These medications promise significant benefits, including improved individual health outcomes, reduced healthcare costs and, potentially, reduced environmental harms. However, their widespread adoption raises various concerns, such as unknown long‐term side effects, the exacerbation of weight‐based discrimination, and the reinforcement of socioeconomic disparities. The paper argues that, with robust regulatory frameworks in place, the potential benefits of these medications are likely to outweigh the risks. Nonetheless, ongoing monitoring of their effect on individuals and society at large remains essential.

3,165

News (Medical) associated with Semaglutide (Novo Nordisk)

10 Jul 2026

·www.pharmaceutical-technology.com

Chinese biotech MindRank secures $52m to advance AI-designed oral GLP-1RA

China represents a major market opportunity for weight loss therapies, both for injectables and next-generation pills. Credit: Boxyray/Shutterstock.com. MindRank has raised $52m to advance its pipeline of candidates discovered and designed by artificial intelligence (AI), including a lead glucagon-like peptide-1 receptor agonist (GLP-1RA) currently in a Phase III trial in China. MindRank, which is based in China’s Zhejiang province capital Hangzhou, has built a Molecule Arts Platform (MAP) that utilises a mix of computation, experimental evidence, and clinical learning to advance biology and chemistry. This, the biotech adds, creates a “unified” R&D system to uncover new medicines. The Series B raise will help build out the platform, along with supporting lead drug candidate MDR-001. The oral GLP-1RA entered a Phase III trial (NCT07274137) for obesity treatment in 2025 and is also in clinical development for the treatment of type 2 diabetes. Obesity forms the lion’s share of indications MindRank is currently pursuing. The biotech has a glucose-dependent insulinotropic polypeptide (GIP) asset, a cannabinoid receptor 1 (CB1), and two further undisclosed programmes, all for obesity indications. Two oncology indications mark the sixth and seventh programmes in MindRank’s pipeline. “Our goal is to translate advances in computation and AI into better medicines for patients,” said Zhangming Niu, founder and CEO of MindRank. “By integrating biological, chemical, computational and clinical data into a continuously learning R&D engine, MAP is designed to make drug discovery and development more predictable, scalable and capital-efficient.” Obesity market’s global expansion The global obesity market is currently dominated by Eli Lilly and Novo Nordisk, companies that market Zepbound (tirzepatide) and Wegovy (semaglutide). Tirzepatide is branded as Mounjaro and semaglutide is marketed as Ozempic for type 2 diabetes in the US. Mounjaro is also the brand name for tirzepatide outside the US. According to GlobalData’s Obesity: Seven-Market Drug Forecast and Market Analysis – Update , the obesity market will grow at a compound annual growth rate of 32.3% until 2031 in the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US). China represents a major market opportunity, both for injectables and next-generation pills. Novo’s CEO Mike Doustdar confirmed last month that the company will seek regulatory approval for its Wegovy weight loss pill in China, while Lilly has already submitted a marketing application for Foundayo (orforglipron). Both companies’ injectables are approved in China, branded as Wegovy and Mounjaro. In addition to the two major drugmakers, there are numerous Chinese biotechs alongside MindRank developing obesity drugs, with key readouts having already come so far this year. In May 2026, Vincentage Pharma’s oral GLP-1RA met its endpoints in a Phase III obesity trial. Earlier this month, Hengrui Pharma’s GLP-1RA netted two Phase III wins in obesity and type 2 diabetes. Novo is also co-developing a triple agonist of the receptors for GLP-1, GIP, and glucagon with China-based United Laboratories. The therapy demonstrated 19.7% weight loss in a Phase II trial as per a readout in February 2026, which is more than injectable Wegovy achieves.

Phase 3Phase 2Clinical Result

09 Jul 2026

·www.fiercepharma.com

A $10B deal, China trial scrutiny and highlights from ADA 2026

This week on "The Top Line," we’re covering some of the biggest stories across biopharma before turning to one of the industry’s major scientific meetings of the summer. First, we discuss Vertex’s $10 billion acquisition of Crinetics Pharmaceuticals, the company’s largest deal to date, and what it says about Vertex’s push beyond its historic strength in cystic fibrosis. We also cover growing scrutiny from U.S. lawmakers over the industry’s use of clinical trials in China. Then, Fierce Pharma Senior Editor Fraiser Kansteiner recounts his recent trip to New Orleans for the American Diabetes Association’s 2026 Scientific Sessions with Fierce Pharma Marketing’s Zoey Becker. For years, ADA has focused heavily on its eponymous indication, but this year’s meeting made clear how much the conversation is evolving, with obesity data from drugmakers of all stripes taking up more of the spotlight. Topics include the biggest data sets from the meeting, what it was like to sit down with Novo Nordisk’s new CEO for the first time and the latest from Insulet’s Marvel collaboration on a line of comics about an Omnipod-wearing superheroine. Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO ADA: Lilly pulls back curtain on impressive triple-G efficacy in patients with obesity, diabetes ADA: Amgen highlights Repatha perks, GLP-1 pitfalls in push to boost cardiometabolic pedigree With ADA in the books, analyst says Lilly is ‘widening its lead’ in the obesity race ADA: Novo's Wegovy pill reaches new GLP-1 patients with impressive 3M prescription milestone ADA: Tolerability ‘not to be underappreciated’ in Roche, Zealand’s amylin obesity prospect ADA: Boehringer execs claim survodutide tolerability 'consistent' with class despite phase 3 update ADA: Lilly posts oral semaglutide-topping data as Foundayo speeds toward 2nd potential nod in diabetes

Phase 3Acquisition

09 Jul 2026

·www.fiercepharma.com

Dr. Reddy's presses pause on generic semaglutide supply after flagging API issue

When launching a drug as big as semaglutide, even as a generic, the market expectations are immense, and any fumble on the part of the drugmaker can take a toll. Case in point, Dr. Reddy’s share price sank Thursday—ultimately landing at a decline of around 3.5% by 8 a.m. ET—on news that the Indian pharma will delay commercial supplies of its generic version of Novo Nordisk’s GLP-1 receptor agonist for obesity and Type 2 diabetes after uncovering unspecified issues related to the product’s active pharmaceutical ingredient. Commercial supplies of Dr. Reddy’s semaglutide, which has now debuted in India and Canada, “will be delayed for a certain period of time,” the company said in a July 9 filing on India’s BSE stock exchange. The move comes after some of the firm’s semaglutide batches were “found to be out of specification due to an issue associated with the active pharmaceutical ingredient (API) used in the product,” per the filing. Dr. Reddy’s noted that it’s delaying supplies of the med as it investigates the source of the problem and takes actions to safeguard product quality. “There is no impact on patient safety or on the product's existing global regulatory filings,” Dr. Reddy’s clarified, adding that it remains focused on offering dependable supplies of its semaglutide product around the world. Alongside many other local drugmakers like Zydus and Sun Pharma, Dr. Reddy’s joined a wave of generic semaglutide launches in India earlier this year. More recently, Dr. Reddy’s was among the first clutch of companies to launch a generic semaglutide product in Canada, specifically in the drug’s Type 2 diabetes indication. Novo’s branded semaglutide products carry the Wegovy and Ozempic brand names across their respective obesity and Type 2 diabetes uses. Dr. Reddy’s did not specify in its filing when it expects the issue with its semaglutide supply to be resolved. In its home market in India, Dr. Reddy’s has sold roughly 31,000 units of its generic semaglutide across its oral formulation and specific injectable brands for the GLP-1 med’s diabetes and obesity indications since March, Bloomberg said this week, citing data from market research outfit Pharmarack. When Novo’s semaglutide patents expired in India back in March, nearly all of India’s generics heavyweights had launches on deck , including Dr. Reddy’s, Sun, Cipla, Biocon, Lupin, Natco, Zydus and Mankind. With so many players vying for a spot in India’s massive and growing market for GLP-1 medications—expected to boom now that generics are launching and bringing substantial price cuts with them—Dr. Reddy’s semaglutide supply stumble could put the company on the backfoot in its own territory. Supply constraints early in the launches of Novo's semaglutide and Eli Lilly's rival tirzepatide products Zepbound and Mounjaro led to major headaches for both companies. While the Big Pharmas have managed to sort out manufacturing capacity and restore stability to their metabolic medicine supply chains, protracted shortfalls in the U.S. earlier in the 2020s fueled a lucrative GLP-1 compounding market that has remained difficult to snuff out.

100 Deals associated with Semaglutide (Novo Nordisk)

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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
Cardiovascular Diseases	United States	Novo Nordisk, Inc.	15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis	United States	Novo Nordisk A/S	15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis	United States	Novo Nordisk, Inc.	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
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.

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Indication	Highest Phase	Country/Location	Organization	Date
Albuminuria	Phase 3	Canada	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Germany	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Netherlands	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Spain	Novo Nordisk A/S	14 Mar 2022
Osteoarthritis, Knee	Phase 3	United States	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Canada	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Colombia	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Denmark	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	France	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Norway	Novo Nordisk A/S	01 Oct 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2026	Not Applicable	Diabetes Mellitus, Type 2	66	Insulin Icodec + Semaglutide (Uncontrolled Type 2 Diabetes)	sfthjbsltn(bpzcfmvurb) = improved significantly from 54.8±23.3% at baseline to 78.1±18.9% (95% CI 9.5-25.5, P<0.001) ygxdddcvet (aqmzssiacc ) View more	Positive	20 Jun 2026
NCT05537233 (ADJUST-T1D, ADA2026)	Phase 3	Diabetes Mellitus, Type 1	72	Semaglutide	fhmedskzxk(jqwpvrtjrd) = uhhiwysxpe dskfvqfpwc (keqpjbwvuu )	Positive	20 Jun 2026
				Placebo	fhmedskzxk(jqwpvrtjrd) = vnnwanbfsy dskfvqfpwc (keqpjbwvuu )
ADA2026	Not Applicable	Diabetes Mellitus, Type 2 \| Peripheral Arterial Disease	24,374	Tirzepatide	inmrwyycde(ecublmqslj): RR = 0.65 (95.0% CI, 0.45 - 0.92), P-Value = 0.015	Positive	20 Jun 2026
				Injectable Semaglutide
SELECT (ADA2026)	Not Applicable	Cardiovascular Diseases \| Obesity	17,017	Semaglutide 2.4mg (Asian)	pwbarnrote(ysuucjekvc) = iwnjxetssr judpeugilp (khozvormdz )	Positive	20 Jun 2026
				Semaglutide 2.4mg (Hispanic)	pwbarnrote(ysuucjekvc) = hjvzwsiftx judpeugilp (khozvormdz )
GAROS (ADA2026)	Not Applicable	Obesity	1,091	Oral Semaglutide 42 mg/day	lwcxeoarzp(etrmtsncix) = nyulxiuemj bgvrooavzi (auzontlwbw ) View more	Positive	20 Jun 2026
SELECT (ADA2026)	Phase 3	Asthma blood high-sensitivity C-reactive protein [hsCRP]	1,190	Semaglutide 2.4 mg	tgbiczneky(rqzsbmgfni) = vyanjiyhfs elmqelzvxb (yafqehcmov ) View more	Positive	20 Jun 2026
				Placebo	tgbiczneky(rqzsbmgfni) = htdoryamlp elmqelzvxb (yafqehcmov ) View more
ADA2026	Not Applicable	Obesity	177	Oral Semaglutide (Rybelsus) (Diabetes)	lqxfuyseae(bxxamrnxzu) = rcrvqjavvk rrlrqvhpzy (rwaytdejbf ) View more	Positive	20 Jun 2026
ADA2026	Not Applicable	Diabetes Mellitus, Type 2	104	Semaglutide 0.5-1.0 mg weekly (Type 2 Diabetes)	ydwfxofggl(jkqnerjbvu) = eppwrfqvtj qgvolfcdng (azbaabwlxj ) View more	Positive	20 Jun 2026
NCT04707469 (PIONEER PLUS, ADA2026)	Phase 3	Diabetes Mellitus, Type 2	262	Oral Semaglutide 14 mg	vgcqkjgmlw(rpxmbdxuej) = skiwaypsmd djyganclmu (bdlmqngbpx ) View more	Positive	20 Jun 2026
				Oral Semaglutide 25 mg	vgcqkjgmlw(rpxmbdxuej) = kxrinmmaqd djyganclmu (bdlmqngbpx )
ADA2026	Not Applicable	Diabetes Mellitus, Type 2	45	Semaglutide (Kidney Transplant Recipients + Type 2 Diabetes)	mwbmfhwrfw(tmkbttvoyr) = ojblvhtzbr wuexemmkov (backrndvos )	Positive	20 Jun 2026

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