Investigational medicines for patients who need hope
Updated March 2025
Chimerix Approach to Expanded Access
In cases where a clinical trial is not an option, a patient may qualify for access to a Chimerix investigational medicine through an expanded access pathway. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking expanded access to unapproved medicines. The following criteria must be met for a patient to be considered for an Expanded Access program:
- Providing investigational medicine through expanded access will not compromise the initiation, conduct or completion of a clinical study program that is required for approval of investigational medicines.
- The patient does not meet eligibility criteria related to current or past eligibility for certain Chimerix sponsored trials.
- The patient has a serious or immediately life-threatening disease for which no alternative therapies are currently available.
- There is adequate clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
- The expanded access program is authorized for the requested indication.
- There are adequate supplies of the drug available for use.
Physicians seeking expanded access to a Chimerix investigational product on behalf of their patient should review and access the information provided below on the US Expanded Access Program and the Managed Access Programs in select countries. If additional information is needed, an inquiry can be submitted to expandedaccess@chimerix.com. Chimerix will promptly acknowledge receipt of requests from treating physicians, generally within 24-48 hours of receiving the request for information. Requests must not include the patient’s name or specific identifying information. There is no guarantee that an expanded access request will be granted. Physicians who receive a Chimerix investigational medicine for their patients through the Expanded Access Program must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property. This policy is subject to change. Chimerix will revisit the policy periodically and amend it as appropriate.
ONC201
The ONC201 Expanded Access Program (EAP) has been made available in the United States and the ONC201 Managed Access Program (MAP) has been made available in the United Kingdom (UK), Spain, Germany, and Australia.
In the US, the EAP is open in select hospitals. A list of centers that are either open for enrollment in the US or in the process of initiating the program can be found on clinicaltrials.gov along with their contact information. Patients and their families can reach out directly to these centers to discuss eligibility, treatment options and enrollment timelines, as enrollment activities must be completed by the treating physician and their respective institutions in collaboration with Chimerix before a patient can be treated.
In the UK, Spain, Germany, and Australia, requests for Managed Access must be submitted by a qualified physician in those countries. The physician must assess whether the patient meets the eligibility criteria for the program. If you are a physician located in the UK, Spain, Germany or Australia, please contact MedicineAccess@clinigengroup.com.
For patients who live in a country where there is not a MAP available, they have the option to travel to another country where the MAP has opened and enroll under the treatment of a physician in that country. If you are a physician and have further questions on the EAP or MAP Programs at Chimerix, please contact expandedaccess@chimerix.com.
ONC206
Chimerix does not provide expanded access for ONC206
- How do patients apply to the ONC201 US Expanded Access Program?
- How do patients apply to the ONC201 Managed Access Program?
- How can I find out if a patient qualifies for the ONC201 Expanded Access Program?
- Is there an age requirement to participate in the ONC201 Expanded Access Program?
- Does the ONC201 Expanded Access Program include newly diagnosed patients? Does it include patients in progression?
- What is the cost to the patient for the ONC201 Expanded Access Program?
How does Chimerix use the information submitted?
Chimerix will use the information submitted to evaluate requests for access to its investigational medicines, and as described in its Privacy Policies.
How does Chimerix protect information submitted to its Expanded Access Program?
Chimerix has in place appropriate privacy and security policies which are intended to ensure, as far as reasonably possible, the security and integrity of all our information, including information submitted by you, whether the information is your personal information or pertains to another individual (e.g., the patient). However, as previously noted, requests for expanded access should not include patient identifiable information. For more information about Chimerix’s processing of personal data, including how, why, and on what lawful bases Chimerix processes personal data, please read our Privacy Notice.