ZEALAND PHARMA AS

Zealand Pharma enrolls first participant in Phase 2b ZUPREME-1 trial of petrelintide for obesity/overweight, aiming to compare its effect on body weight, safety, and tolerability to placebo. The trial, set to enroll 480 participants across 33 sites, includes a 51-week period with primary endpoints focusing on body weight change.

The FDA is set to decide on ten drug applications, including Ionis' olezarsen for familial chylomicronemia syndrome, Lexicon's sotagliflozin for type 1 diabetes, AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC, Zealand Pharma's glepaglutide for short bowel syndrome, Rhythm Pharmaceuticals' Imcivree for genetic obesity in children, Checkpoint Therapeutics' cosibelimab for cutaneous squamous cell carcinoma, Mirum's chenodiol for cerebrotendinous xanthomatosis, Bristol Myers Squibb's subcutaneous Opdivo, and Neurocrine's crinecerfont for congenital adrenal hyperplasia.

Novo Nordisk's CagriSema, combining semaglutide with cagrilintide, could be a breakthrough in obesity treatment. Analysts highlight amylin's role in satiety and hedonic eating, potentially improving weight reduction quality. Phase II results showed a 15.6% weight drop with CagriSema, and Phase III trials are ongoing. Competitors like Lilly and Zealand Pharma also advance amylin-based therapies, with promising early results.

DiogenX appoints Dr Klara Owen as Chief Medical Officer, completing its management team. Owen brings extensive experience in diabetes and metabolic disorders from roles at Novo Nordisk and Zealand Pharma. She holds a medical degree, PhD, and MSc in Drug Development Science.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

Novo Nordisk plans to seek regulatory approval for semaglutide in treating MASH after positive Phase 3 trial results, showing significant improvement in liver scarring and MASH resolution. The drug demonstrated a safe profile and could become the first of its kind for MASH, a leading cause of liver transplants. Novo aims for approvals in the U.S. and Europe by H1 2025.

Demand for GLP-1 agonist drugs has surged, leading to supply shortages and increased manufacturing investments. The global GLP-1 receptor agonist market is expected to exceed $55 billion by 2031. Multiple companies, from startups to established players, are developing new GLP-1 drugs, including next-generation medicines with multiple drug targets.

Chapters cover methodology, executive summary, market variables, segmentation by disease, molecule, biological target, mechanism, and region, and competitive landscape.

Tulisokibart maintained clinical and endoscopic improvements in IBD patients through week 50 in phase II trial extensions, with 48% of ulcerative colitis patients and 56% of Crohn's disease patients achieving clinical remission. The drug was well-tolerated with no identified safety signals.

The global peptide therapeutics market is projected to grow from $42.1B in 2023 to $56.2B by 2030, driven by technological advancements, increasing demand for targeted treatments, and the rising incidence of chronic diseases. Peptide therapeutics offer high specificity and low toxicity, making them attractive for treating conditions like cancer and diabetes. Innovations in peptide engineering and delivery systems are enhancing their efficacy and stability, expanding their therapeutic potential across various diseases.