Enliven Therapeutics, Inc. Expanded Access Policy

Adopted June 2026

Enliven Therapeutics is committed to developing therapies for patients through a precision medicine approach. We conduct clinical studies to evaluate the safety and efficacy of investigational medicines, and the data generated from those studies are intended to support potential approval by health authorities and, if approved, broader patient access.

For that reason, participation in a clinical trial is generally the preferred way for patients to access an Enliven investigational medicine. In limited circumstances, however, Enliven may consider requests from treating physicians for access to an Enliven investigational medicine outside of a clinical trial through expanded access, sometimes referred to as compassionate use.

What Is Expanded Access?

Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease to receive an investigational medicine outside a clinical trial when there is no comparable or satisfactory treatment option and the patient cannot participate in an appropriate clinical trial. 

How to Submit a Request

A treating physician may submit a request on behalf of their patient to compassionate-use@enliventherapeutics.com. Requests must include the physician’s contact information and professional designation, the patient’s diagnosis, clinical status and relevant treatment history and the reason the patient cannot participate in an applicable Enliven clinical trial. Please do not submit patient-identifying information unless Enliven requests it through an appropriate process.

Who May Be Eligible?

Enliven may consider a request for an investigational medicine based on the following criteria:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option
• The patient is ineligible for, or cannot participate in, an applicable Enliven clinical trial
• The potential benefits to the patient outweigh the potential risks 
• Use of the investigational medicine will not interfere with Enliven’s clinical trials, regulatory review, or development plans
• Use of the investigational medicine would comply with applicable laws, regulations and industry standards
• The treating physician is properly licensed, qualified to oversee use of the investigational medicine, and able to comply with applicable medical, regulatory, consent, monitoring, safety reporting, drug supply, drug use, and Enliven requirements.

What to Expect After a Request Is Submitted

Enliven will acknowledge receipt of expanded access questions or requests within 10 business days of receipt. Enliven reviews eligible requests on a case-by-case basis and may ask the treating physician for more information. If Enliven supports a request, treatment may begin only after required regulatory, ethics committee or Institutional Review Board, informed consent, safety monitoring, and reporting requirements are completed, except where applicable law permits a different emergency process.

Clinical Trials and Important Considerations

Information about Enliven-sponsored clinical trials is available online. To find Enliven studies, search for “Enliven” or “Enliven Therapeutics” at https://clinicaltrials.gov. Patients and caregivers should speak with their treating physician about whether a clinical trial may be appropriate for them.

Expanded access is not guaranteed. Enliven may approve, deny, modify, or discontinue support for a request in its discretion, consistent with applicable laws and regulations, and may revise this policy at any time. Where permitted by local regulation, an investigational medicine supplied through expanded access may no longer be provided by Enliven when it becomes available through the local healthcare system.