Eli Lilly and Co’s orforglipron is emerging as a promising oral glucagon-like peptide (GLP)-1 therapy, with upcoming clinical milestones in obesity and diabetes set to shape its market trajectory. As a wave of key catalysts—including FDA decisions and late-stage trial results—approaches in Q3 2025, the pharmaceutical landscape is poised for shifts driven by innovation, competitive positioning, and regulatory momentum, says GlobalData.
Eli Lilly’s clinical data with orforglipron in patients with diabetes supports the drug’s potential as an obesity treatment, as per the Insights Investigative News team at GlobalData.
The oral GLP-1 receptor agonist is being studied in several clinical trials. Key results from the obesity trials ATTAIN-1 (NCT05869903) and ATTAIN-2 (NCT05872620), and the ACHIEVE diabetes/cardiovascular studies, are expected throughout 2025.
Irena Maragkou, Senior Healthcare Researcher, GlobalData, comments, “Experts suggest that orforglipron’s superior bioavailability and better safety profile could help it gain a strong market share even though its efficacy might be lower than injectable GLP-1 therapies.”
GlobalData’s latest report, “Catalyst Monitor: Q3 2025,” delivers forward-looking intelligence derived from interviews with key opinion leaders (KOLs), covering trial initiations, completions, top-line results, regulatory filings, PDUFA dates, and expected approvals. The report covers 18 significant catalyst events that are expected to occur in Q3 2025.
Some of the catalysts covered in the report include FDA approval decisions for Ascendis Pharma’s Skytrofa for adult growth hormone deficiency (GHD), PTC Therapeutics’ sepiapterin for phenylketonuria, Lenz Therapeutics’ presbyopia treatment LNZ100, Outlook Therapeutics’ Lytenava (bevacizumab-vikg) for wet age-related macular degeneration (AMD).
Eli Lilly’s orforglipron is also being investigated as a treatment for diabetes and weight loss, obstructive sleep apnea, and hypertension. GlobalData’s consensus forecasts project global sales of $14.36 billion for orforglipron in 2031.
Maragkou adds: “Based on expert opinions, the oral GLP-1 receptor agonist is anticipated to deliver favorable Phase III results in obesity trials, following promising results from earlier diabetes studies.”
The Catalyst Monitor report also covers expert expectations for Ascendis Pharma’s Skytrofa, which has Prescription Drug User Fee Act (PDUFA) date of 27 July 2025. The therapy has shown superior efficacy to other once-weekly growth hormone treatments. Already approved in pediatric GHD since 2021, Skytrofa is forecast to generate $658 million in global sales by 2031.
The report also includes journalist coverage of other catalysts like Sun Pharmaceutical’s Ilumya (tildrakizumab) treatment for psoriatic arthritis, and AstraZeneca’s investigational drug baxdrostat for treatment-resistant hypertension.
Maragkou concludes, “As the industry navigates a pivotal quarter marked by regulatory approval decisions and late-stage trial readouts, the outcomes of these catalysts will not only influence individual asset trajectories but also reveal larger trends in treatment paradigms and disease landscapes.”