Metabolic disease/endicrinology

A flurry of recent FDA announcements and legal maneuvers has placed two popular weight-loss drugs — tirzepatide (marketed as Mounjaro and Zepbound by Eli Lilly) and semaglutide (marketed as Ozempic and Wegovy by Novo Nordisk) — at the center of a growing squabble. Patients are desperate for affordable access, compounding pharmacies see a market opportunity,…

A phase 3b open-label randomized clinical trial (SURMOUNT-5) has shown that tirzepatide leads to greater weight reduction compared to semaglutide in adults with obesity or overweight conditions. The study from Eli Lilly demonstrated a mean weight loss of 20.2% with tirzepatide (Zepbound) versus 13.7% with semaglutide (Wegovy) over a 72-week period. Last year, a pre-print…

Sanofi announced its largest-ever investment in China, committing €1 billion ($1.04 billion) to establish a new insulin production facility in the Beijing Economic and Technological Development Zone. This strategic manufacturing expansion represents a calculated response to China’s growing diabetes crisis, with recent data indicating 140 million adults living with diabetes as of 2021. The new…

Although Lilly has shared the topline results of the SURMOUNT-1 trial, now, the full data from the three-year study have been published in the New England Journal of Medicine. The company also recently presented the data at ObesityWeek in San Antonio.  The biggest conclusion was that 98.7% (752 of 762) of participants who received tirzepatide…

Protein Data Bank Eli Lilly is suing three medical spas and online vendors for selling products purportedly containing tirzepatide—the active ingredient in its weight-loss drug Zepbound. Similarly, Novo Nordisk has pursued legal action against a string of organizations to protect its semaglutide-based drugs from unauthorized competition and potentially unsafe copycat products. The company has filed…

GLP-1 therapies just got a whole lot less expensive for patients who pay out of pocket. Eli Lilly’s Zepbound (tirzepatide) single-dose vials are now available at rates similar to compounded versions of semaglutide. Patients can now access a four-week supply of Zepbound for as little as $399 for the 2.5 mg dose and $549 for…

Eli Lilly’s hit drug tirzepatide has demonstrated a 94% reduction in the risk of developing type 2 diabetes among overweight and obese prediabetic adults, according to new findings from a 176-week Phase 3 trial. The SURMOUNT-1 study, the longest completed trial of tirzepatide to date, also showed sustained weight loss through the treatment period, with…

Ozempic is still the GLP-1 king, but Lilly is rapidly gaining market share, with its Q2 2024 sales reaching $3.01 billion compared to Novo Nordisk’s $5.38 billion. In terms of Q2 quarterly sales, Lilly’s chronic weight management therapy Zepbound in particular is growing quickly with 140% growth between Q1 and Q2. Mounjaro, which, like Zepbound…

Heart disease remains the number one killer globally, but the megablockbuster tirzepatide is proving it can do more than just help people lose weight – it’s now showing promise in fighting heart failure, too. In topline results from the phase 3 SUMMIT study, Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide cut the risk of heart failure…

By now, almost everyone has heard about the meteoric rise of GLP-1 drugs, like Wegovy and Mounjaro. But a perhaps under-appreciated reality is that the GLP-1 obesity drugs are poised to drive record overall prescription drug sales growth and catapult Novo Nordisk and Eli Lilly into the upper echelon of Big Pharma companies by the…

An original investigation published in JAMA Ophthalmology indicated that the megablockbuster metabolic medication Wegovy (semaglutide) may increase the risk of a serious eye condition. The research, published on Wednesday, examined the occurrence of nonarteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide. The GLP-1 receptor agonists Wegovy, Ozempic, and Rybelsus, all containing the active…

Boehringer Ingelheim has partnered with Gubra, a specialized biotech company and preclinical CRO that specializes in peptide-based drug discovery for metabolic diseases, to launch phase 1 clinical trials for BI 3034701. This drug candidate is a long-acting peptide designed to target three different receptors associated with weight loss, offering a potential new avenue for tackling…

Generic giant Teva Pharmaceuticals will launch the first generic version of Victoza (liraglutide injection 1.8mg) in the U.S, making it the first generic GLP-1 drug to enter the U.S. market. The patent for Novo Nordisk–developed liraglutide is set to expire until November 18, 2024. Other popular GLP-1 drugs, such as semaglutide (marketed as Ozempic and…

Today, Lilly announced promising data for the SURMOUNT-OSA phase 3 clinical trials testing tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The company shared the data at the American Diabetes Association’s (ADA) 84th Scientific Sessions while publishing them in The New England Journal of Medicine (NEJM). The SURMOUNT-OSA phase 3 trial consists…

In 2023, the American Society of Anesthesiologists (ASA) issued guidelines advising patients to discontinue GLP-1 receptor agonists (GLP1-RAs) a week before surgery, citing concerns over potential operative complications, leading to delayed or rescheduled surgeries across the U.S. Dr. David Klonoff, a diabetes researcher and Endocrinologist at Mill Peninsula Medical Center, thought it was curious that…

Dandelion Health, the maker of a real-world data and clinical AI platform, has launched the first multimodal real-world clinical dataset focused on uncovering insights and opportunities related to GLP-1 receptor agonist drugs. The company describes the GLP-1 data library as “the first multimodal real-world clinical dataset” related to GLP-1 receptor agonists. The library is sourced…

GLP-1 agonists may have turned obesity treatment upside down, becoming a viral phenomenon thanks to social media acclaim and celebrity endorsements along with their ability to support tangible weight loss results for many patients. But the skyrocketing demand for these therapies has a shadow side, leading to supply shortages, access inequities and bureaucratic hurdles that…

Ozempic, Rybelsus and Wegovy have transformed the diabetes and weight loss treatment landscape, but when it comes to the impact of their active ingredient, semaglutide, on fetal development, “the answer is we do not know,” said Dr. Marijane Hynes, clinical professor of medicine at the George Washington University School of Medicine and Health Sciences. Hynes…

The latest crop of glucagon-like peptide-1 (GLP-1) agonists, such as semaglutide and tirzepatide (technically, a dual GIP/GLP-1 receptor agonist), have upended the way we treat metabolic disorders, including obesity. These drugs mimic gut hormones, improving blood sugar control and often leading to significant weight loss. But as Kyasha Sri Ranjan, Ph.D., engagement manager at Lifescience…

A recent review of more than 2,000 studies related at least indirectly to obesity on clinicaltrials.gov highlights the pronounced significant shift in research focus toward GLP-1 receptor agonists for a range of indications with at least some involvement of metabolic disorders. The site, which provides a robust but not-exhaustive snapshot of clinical trial activity, cites…

 The graphic above shows darker bubbles for companies with larger market caps as of March 25, 2024. Revenue and R&D spending figures are in USD. More data are available when hovering over a given company.  After a COVID-19 rebound in public perception and willingness to explore novel modalities, the pharma industry faces mounting pressures…

The recent FDA approval of a cardiovascular risk reduction indication for Wegovy (semaglutide) could point toward a significant opportunity for pharma companies seeking to reshape payer perceptions and expand coverage for next-gen metabolic therapies. This regulatory shift, allowing Wegovy to be prescribed for reducing the risk of major adverse cardiovascular events such as heart attack…

When reviewing R&D spending trends for 2023, Merck & Co. is a clear outlier given its decision to count its $10.3 billion Prometheus acquisition as an R&D charge. In all, the company committed more than half of its revenue to R&D. But Swiss giants Roche and Novartis remain frontrunners in terms of their pipeline of…

Semaglutide was already one of the best-selling drugs of recent memory. And Novo Nordisk the fastest-growing Big Pharma firm. Now, the FDA’s decision to expand the label of its weight-loss version of the drug to include cardiovascular benefits could help unlock more growth momentum for Novo Nordisk. This positions Wegovy as the first weight-loss medication…

No longer just a diabetes company, Novo Nordisk’s semaglutide-based therapies have fueled its rise to pharma powerhouse status. From 2021 to 2023, the company cemented its position as the fastest-growing Big Pharma player, reaching a 35% year-over-year growth rate in 2023 and 74% growth from 2020 to 2023 when measured in U.S. dollars. While Pfizer…