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Expanded Access Policy

Protagonist Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel peptide-based medicines to address significant unmet medical needs and making them available broadly to patients as quickly as possible by conducting the clinical trials necessary to gain approval by regulatory authorities. Participation in one of our clinical trials is the best and preferred route to access our investigational medicines.


“Expanded Access” programs provide a structure and pathway for when a patient with serious or immediately life-threatening disease is provided with treatment of an investigational medicine outside of a clinical trial, usually where currently approved therapies are unavailable or inadequate. At this time, Protagonist does not have any Expanded Access protocols and we do not provide access to our investigational medicines on an Expanded Access basis, so participation in our clinical trials is the only way to access our investigational medicines.


For information regarding clinical trials currently being conducted by Protagonist, including eligibility criteria and clinical site locations, please visit www.clinicaltrials.gov. If you are a physician interested in learning more about our investigational medicines, please contact [email protected].


This reflects our current policy on providing access to our new investigational medicines before they are fully approved for use via prescription. This policy is subject to change at any time and may vary depending on the specific investigational medicine of interest and its availability.

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Health Equity: Improving Access to Medicines, Ensuring Diverse Representation

Spotlight, Arturo Molina, MD, Chief Medical Officer

Dr. Molina, how are you helping to advance access to medicines?

At Protagonist, we work hard to meet the needs of the patient communities who are relying on us to innovate new and better medicines. Part of our commitment to them includes working to advance our medicines through clinical studies as quickly as possible and ensuring patients can access investigational therapies outside of our clinical trials, which has allowed some patients in critical need to access our therapies for several additional years after trials conclude.

We’re seeing a greater push for better representation in therapeutic innovation across the industry. How is Protagonist supporting diverse and equitable discovery and development?

Protagonist actively works to ensure we have strong patient representation in our clinical studies. We actively seek patients from across urban, suburban, and rural locations, from varying age groups and from among diverse backgrounds to ensure equitable patient representation in our study data.

We’re particularly concerned aging populations are left out of clinical studies, and we’re currently working to recruit older patients into our trials.