Patients are at the center of everything we do
One in five Americans suffer from GI diseases, resulting in millions of hospital visits and tens of billions in healthcare costs each year. GI diseases often have limited treatment options, creating urgency for new and innovative medicines. At Ironwood, we are on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.
Our Clinical Trials
Pre-Approval Access Policy
We are conducting clinical studies of investigational medicines for serious, rare disorders. We remain committed to making our medicines available as quickly as we can to appropriate patients following regulatory authority approval, which depends, in part on positive Phase III data from our clinical studies and the evaluation of these data by regulatory and reimbursement authorities.
Pre-approval access, sometimes known as Expanded Access or Compassionate Use refers to the provision of an investigational medicine outside of a clinical trial and ahead of regulatory or reimbursement body approval.
At this current time, we believe that participating in clinical studies is the safest way to access our new investigational medicines, under the close monitoring by a specialist clinical research team. Therefore, we do not provide access to our medicines through Pre-approval access programs, or outside of clinical studies more generally. This policy may be reviewed and amended in the future.
Details about our clinical studies, including eligibility requirements for participating in ongoing or planned studies are published in public databases such as www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
If you have further questions, please contact our Medical Information Team at [email protected].
We keep patients’ needs top of mind in all that we do. We’re committed to clinical trial diversity in all aspects, including race, sex, and age, because we understand how important it is in achieving meaningful data outcomes for our patients. Data generated in our clinical studies and insights we receive from our scientists, physicians, and patient-reported outcomes help drive our decision making.
Quality is also a key priority in our daily operations to develop high-quality transformational products that are safe and improve the lives of our patients. We are committed to implementing a culture that drives quality-focused behaviors and ensures decision-making based on scientific excellence, product quality, patient safety, and compliance with ethical standards and regulations.
We register all interventional trials conducted with patients prior to study initiation on www.clinicaltrials.gov and comply with other clinical trial disclosure requirements.