For Patients

Improving the lives of patients – it’s at the heart of everything we do.

In everything that we do at Omeros, our primary focus is the patient. Rather than developing “me-too” products, we are tackling serious diseases and disorders to improve or save the lives of patients who are suffering. Our journey is a partnership – a partnership with physicians, regulators, and patients and their families – to develop the most effective and safe therapeutics possible. Targeting important receptors or enzymes never before drugged as well as indications with no approved treatments, we have a track record of succeeding where others have not and remain unrelenting in our efforts to benefit patients everywhere.

Clinical Trials Primer


Omeros clinical trials

Clinical trials explore new methods of diagnosing, preventing or treating diseases. These research studies give doctors and scientists important knowledge about diseases and treatments.

Drug development and FDA approval

Clinical trials often test the safety and efficacy of new drugs or combinations of drugs, which may lead to approval by the U.S. Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) and/or other international regulatory bodies.

Institutional Review Board (IRB) and clinical trial safety

Clinical trials are reviewed and approved by regulatory agencies and each hospital and clinic participating in a clinical trial approves those studies through an Institutional Review Board (IRB) or similar ethics committee, ensuring patient rights and safety are protected at all times.

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.1

Phase 1Researchers test a drug or treatment in a small group of people for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
Phase 2The new drug or treatment is given to a larger group of people to determine its effectiveness and to continue studying its safety.
Phase 3The new drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
Phase 4After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and its optimal use.


1. What are the different types of clinical research? US Food and Drug Administration website. clinicaltrials/ types/ default.htm. Updated January 4, 2018. Accessed April 8, 2019.