Expanded Access to Investigational Medicines Prior to Regulatory Approval

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Our goal is to provide access to our investigational therapies at the appropriate time and in the most clinically appropriate manner for patients.

Patients are at the center of our clinical programs designed to fully answer important scientific questions about the potential benefits and risks of our investigational drugs, and to obtain regulatory approval.

Gossamer Bio may provide access to its investigational medicines outside of enrollment in clinical trials on a case-by-case basis. If you have questions about our programs or eligibility for our clinical trials, please feel free to contact us.


Contact Information:

A treating physician may submit questions or requests regarding a patient’s eligibility for one of Gossamer Bio’s ongoing clinical trials by emailing [email protected].

Request Procedure:

Patients interested in obtaining access to a Gossamer Bio investigational therapy must do so via their physician. A licensed physician who believes their patient may benefit from access to a Gossamer Bio investigational therapy should contact us through the contact information above to make the request on behalf of the patient.

Anticipated Timing:

Gossamer Bio will acknowledge receipt of any questions or requests received from licensed physicians within ten (10) business days of receipt. Making a request does not guarantee the granting of access to an investigational drug by Gossamer Bio.

In the U.S., physicians may find additional information regarding expanded access to investigational therapies by visiting the U.S. Food and Drug Administration website: Expanded Access: Information for Physicians.

Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.

For information on Gossamer Bio’s clinical trials, please visit
www.clinicaltrials.gov