In an important new development Swiss-based Debiopharm entered a Phase 3 trial of a new Octreotide formulation. The company is currently recruiting patients for the study. Debio 4126 is a sustained-release formulation designed to improve the convenience of somatostatin analogue (SSA) therapy for the treatment of acromegaly. The clinical trial is testing a 3-month long-acting formulation of octreotide, a long-standing drug used to treat acromegaly. Approval of this new formulation would result in a substantial improvement in convenience and increase the available options acromegaly patients have to find the appropriate drug to treat their condition
A way to help: The Oxtend™-03 Clinical Trial
If you’re living with acromegaly, you know how critical treatment is and how more options improve the opportunity to control your IGF-1. The Oxtend™-03 trial offers you an opportunity to potentially contribute to an advancement that could make life easier for people with acromegaly.
About the study
This trial is testing Debio 4126, a new long-acting version of octreotide. If you’re currently managing your acromegaly with somatostatin analogs like octreotide or lanreotide, you’re already familiar with the regular injection schedule, typically every 4 weeks. Debio 4126 works differently: it only needs to be injected once every 3 months because it releases slowly and steadily in your body over time. Early testing in two completed trials has been promising, and now researchers need your help to confirm that this extended-release formulation is both safe and effective.
Why Your Participation Matters
Clinical trials don’t happen without people stepping forward. By participating, you’re not just potentially benefiting from a new treatment option, but you’re helping researchers gather the evidence needed to bring better therapies to everyone with acromegaly. Your experience, your data, and your commitment to the study process are invaluable contributions to medical science. Every participant helps answer crucial questions that move treatment, and options, forward.
What to Expect
The complete information and details on the trial can be found here. If you qualify to join the study, you’ll be randomly assigned to one of three groups. Two groups will receive Debio 4126 at different doses, and one group will receive a placebo, which is an inactive substance. This design helps researchers understand exactly how well the medication works and ensure it’s truly safe and effective. If you’ve been diagnosed with acromegaly and have been on a stable dose of octreotide or lanreotide for at least 6 months (with no dose changes in the past 12 weeks) and aren’t taking any other acromegaly medications, you may be eligible. Please note that a placebo rescue option will be offered if there is a loss of disease control.
If you’re interested in learning more, talk to your healthcare provider or click on ClinicalTrials.gov to see if you qualify. Trial centers are available in the following countries: Austria, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United Kingdom, United States.
Click here to learn about Debiopharm’s approach to drug development and commitment to give patients a voice.
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