MedPath

Dulaglutide

Generic Name
Dulaglutide
Brand Names
Trulicity
Drug Type
Biotech
CAS Number
923950-08-7
Unique Ingredient Identifier
WTT295HSY5
Background

Dulaglutide, marketed by Eli Lilly as Trulicity, is a once-weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist designed using recombinant DNA technology; it has been approved as an adjunct therapy to diet and exercise in the management of 2 diabetes (T2DM). Dulaglutide was initially approved by the FDA in 2014, and in February 2020 was approved for use in patients with T2DM and multiple cardiovascular risk factors for the prevention of cardiovascular events. It is the first T2DM drug approved to reduce major adverse cardiovascular events (MACE) risk in primary and secondary prevention populations.

Indication

Dulaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years of age with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Associated Conditions
Major Adverse Cardiovascular Events, Type 2 Diabetes Mellitus

Weight Loss Injections Show Promising Anti-Cancer Effects Beyond Weight Reduction

• Research presented at the European Congress on Obesity suggests weight loss injections may reduce obesity-related cancer risk by nearly 50%, potentially through anti-inflammatory mechanisms beyond simple weight reduction. • Scientists from the University of Manchester are designing a large-scale clinical trial involving tens of thousands of patients to further investigate GLP-1 agonists as cancer prevention tools. • Experts believe these findings could herald a "new dawn" in preventative cancer medicine, potentially benefiting even non-obese individuals with high cancer risk factors.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

RedHill's Opaganib Shows Promise for Weight Loss and Diabetes, Potentially Disrupting $100B Market

• New research published in Diabetes, Metabolic Syndrome and Obesity demonstrates opaganib's effectiveness in promoting weight loss and improving glucose tolerance in preclinical models, comparable to semaglutide. • Opaganib, a first-in-class oral sphingosine kinase-2 inhibitor, offers a novel non-peptide approach that could avoid common GLP-1 inhibitor side effects while targeting multiple metabolic pathways. • With existing human safety data from over 470 subjects across several clinical programs, opaganib may have a de-risked regulatory pathway as RedHill Biopharma positions it to compete in the rapidly growing obesity-diabetes market.

2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars

• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition. • Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition. • The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.

Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors

• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes. • As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage. • Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.

GLP-1 Agonists Show Significant Benefits for Kidney Transplant Recipients with Type 2 Diabetes

• A landmark study by NYU Langone Health reveals kidney transplant recipients with type 2 diabetes who take GLP-1 agonists experience 49% lower risk of organ failure and 31% reduced mortality within five years. • While the anti-obesity medications demonstrated substantial benefits, researchers observed a 49% increased risk of diabetic retinopathy, highlighting the need for careful eye health monitoring in these patients. • The comprehensive analysis of 18,016 kidney transplant recipients provides the strongest evidence to date supporting GLP-1 agonists as safe and effective tools for managing diabetes in transplant patients.

FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups

• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability. • Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk. • The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.

GLP-1 Diabetes Drugs Show Promising Potential for Mental Health Treatment

• Oxford University researchers have conducted a comprehensive review examining the potential benefits of GLP-1 receptor agonists like semaglutide in treating various mental health conditions. • The study reveals promising preliminary evidence that GLP-1RAs could improve cognition, reduce addictive behavior, and alleviate depression and anxiety symptoms. • While clinical recommendations cannot yet be made, the findings open new research pathways for investigating GLP-1RAs as potential treatments for cognitive and psychiatric disorders.

GLP-1 Agonists Linked to Reduced Risk of 42 Health Conditions in Large Study

• A large observational study of nearly 2 million patients found that GLP-1 receptor agonists (GLP-1RAs) are associated with a reduced risk of 42 health conditions. • The study, which included 215,000 GLP-1RA users, showed benefits beyond glucose control and weight loss, including neurological and respiratory conditions. • While GLP-1RAs demonstrated broad benefits, the study also identified increased risks for certain conditions like kidney stones and low blood pressure. • Researchers emphasize the need for further studies to confirm these findings and understand the long-term effects of GLP-1RA therapy.

Hengrui Pharma's HRS9531 Shows Promising Weight Loss in Phase 2 Obesity Trial

• Hengrui Pharmaceuticals and Kailera Therapeutics reported positive Phase 2 results for HRS9531, a GLP-1/GIP receptor dual agonist, in overweight or obese adults. • Participants receiving the 8 mg dose of HRS9531 achieved a statistically significant 21.1% placebo-adjusted mean weight loss at 36 weeks. • The trial demonstrated a favorable safety profile, with most adverse events being mild and gastrointestinal-related during dose titration. • Hengrui is advancing HRS9531 into Phase 3 clinical trials for obesity and type 2 diabetes in China, with Kailera developing it globally as KAI-9531.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.

GLP-1 Receptor Agonists Show Promise in Curbing Alcohol Abuse, Especially in Obese Individuals

• A new study suggests GLP-1 receptor agonists (GLP-1 RAs) may reduce alcohol consumption by targeting the brain's reward center. • The effect was more pronounced in heavy drinkers with obesity (BMI over 30), indicating a potential therapeutic benefit in this population. • Clinical trials and observational studies showed GLP-1 RA use was associated with reduced alcohol consumption and fewer alcohol-related health issues. • These findings suggest GLP-1 RAs could be a future treatment option for excessive alcohol use, potentially reducing alcohol-related deaths.

GLP-1 Receptor Agonists Show Promise in Protecting Kidney Health

• A meta-analysis of 11 clinical trials reveals that GLP-1 receptor agonists significantly reduce the risk of kidney failure and worsening kidney function. • The study demonstrates a 16% reduction in kidney failure and a 22% reduction in the worsening of kidney function among patients treated with GLP-1s. • GLP-1 receptor agonists also showed a 14% reduction in cardiovascular events and a 13% reduction in all-cause mortality. • Researchers suggest GLP-1s could play a key role in kidney and heart-protective treatments for individuals with type 2 diabetes, obesity, or chronic kidney disease.
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