Before You Search
The EA Navigator Company Directory* helps patients, caregivers and physicians identify, review, and connect with companies offering investigational therapies through expanded access, also known as compassionate use. To learn more about expanded access, please visit our patient and physician online guides.
Expanded access should be considered only in situations where the patient has exhausted all other treatment options, including access to investigational therapy through a clinical trial. If you have not already explored clinical trials for an investigational therapy of interest, please use the ClinicalTrials.gov buttons in the Company Directory to view a company’s current clinical trial listings. Refer to our ClinicalTrials.gov User Guide for help finding open clinical trials.
If no clinical trial is available, or the patient does not meet the criteria for the trial, expanded access may be an option. You can use the EA Navigator Company Directory to identify both multi-patient expanded access programs and single-patient expanded access options. Please note that this Company Directory includes only expanded access programs of companies listing their policies and contact information in the Directory. See ClinicalTrials.gov to find additional programs offered by other organizations, including companies not listed in the Company Directory.
How to Search
If you know the name of the company you want to explore, simply scroll down the page or click on the first letter of the company name in the alphabet list to move through the Directory.
If you do not know the company name, you can start your search by typing any word into the Search bar and clicking on the magnifying glass. As you type, suggestions may appear as options; these suggestions are key terms found within the Company Directory dataset. You can either click on a suggested word or continue typing. Generally, the condition, treatment, or company name will provide you with the best results. However, this is a free-text search so you can type in any word or combination of words and you will see results of any listings containing that word or words, ranked by relevance.
Keep in mind, you may see results that may not seem relevant to you. For example, if you type the phrase breast cancer, you will first see results with the phrase breast cancer, followed by additional results that contain either the word breast or cancer. Similarly, a search for multiple sclerosis may result in results that include multiple sclerosis, multiple, and sclerosis. As with many search functions, putting your terms in quotation marks will narrow your results, returning only exact matches; therefore a search for "multiple sclerosis" in quotations, will return results only for when the two words appear together. Note also, because this is a free-text search, your search term can be found anywhere on the page. For example, a search for "diabetes" might produce results that include diabetes as exclusion criteria, meaning that persons with diabetes would be excluded from that particular treatment regimen.
Your search results will appear on a new page with the company name and the brief title of the expanded access offering. Read through the list and click on the programs of interest to you. This will open the program page detailed below in Search Results.
If no results match your search criteria, you will receive a message that says “No results match your search. Please check the spelling and try again, or try searching a related term..." For example, if a search for the term "oncology" does not provide adequate results, try searching for "cancer."
TIP: If you are aware that a particular company is developing a drug or treatment, but no expanded access program is listed for that drug, it does not necessarily mean the company is unwilling to consider a request for access. Please contact the company directly to discuss the possibility of individual access. Contact information for each company is in the Directory.
As mentioned above, this Company Directory includes only expanded access listings of companies who have opted to provide their information in the Directory. If you are unable to find an expanded access listing that matches your specific disease or condition, try searching on ClinicalTrials.gov, which may provide additional results.
Once you click on the title of a study from the Search Results page, it will open a Details page with up to 18 different fields of information about the program. All information on this page is taken from ClinicalTrials.gov which in turns relies on individual companies or other organizations to provide details. The Foundation is not responsible for the accuracy or completeness of these study records.
As your cursor hovers on the left column over key field names, such as EA Type, a window will pop open with a brief description. Here’s a quick reference to all of the terms.
The name of the drug manufacturer or distributor
Often a longer title of the program, which may provide you with additional details
A short description from the company about this particular expanded access offering
A more complete explanation of the expanded access program
Either "Available", meaning that expanded access is available for this drug/intervention at this time, "Temporarily Not Available", meaning expanded access is not currently available from this drug/intervention, but could be available in the future, or "Approved for Marketing", meaning the investigational drug has been fully reviewed by the U.S. Food and Drug Administration (FDA) and is either on the market or will soon be. Please contact the company in question for additional information. Contact information can be found in the Company Directory.
There are three types of expanded access categorized by FDA regulations:
- Individual Patients: Allows a single patient access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation. To understand more about the single-patient expanded access process, please see the patient and physician guides on this website
- Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
- Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. In some cases, this population may consist of patients who were previously enrolled in a clinical trial for the same investigational product and are allowed to continuing taking the product after the formal end of the trial. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
A disease, disorder, syndrome, illness, or injury. Condition may also include health risks.
The specific type of treatment, such as drug, biological, medical device, procedure, and the name of the treatment, such as the drug name.
Information a company needs to know to determine if a patient qualifies for an expanded access offering. Criteria may include diagnosis, additional health problems, age, gender, or other factors.
Countries where the expanded access program is in operation. Please note that companies may support EA programs in multiple countries at one time, depending on local regulations and the stage of marketing approval.
For single patient access to a treatment, contact the company directly no matter the locations listed. The locations in this field may refer to intermediate-size treatment protocols already in place for single patients or groups of patients, but you should always contact the company first to confirm availability.
The name and contact information for the person at the company who can answer questions about expanded access. If multiple contacts are listed, reach out to the one directly at the company -- rather than a research institute -- first.
Sponsors are most often the company or companies that manufacture or distribute the drug. In some cases, the manufacturer is listed as a collaborator.
A researcher who is connected to the expanded access program, either associated with the manufacturer or the treatment site.
A unique identification code given to each clinical study record registered on ClinicalTrials.gov
Keywords and MeSH Terms
Words that are “key” for searching content of a listing – and may help refine your search
Components of a Company Listing
Company Name – the company that manufactures and/or distributes the drug
Company Contact—the phone number and/or email address provided by the company for expanded access; increasingly companies ask that initial queries be made using their webform which can be found on the company website
Company Acknowledgement – the typical number of hours, days or weeks it takes for the company to acknowledge receipt of your request (not to make a decision)
EA Webpage Button – takes you to the company’s expanded access web content, which in most cases includes the company’s’ expanded access policy and contact information
ClinicalTrials.gov Button – takes you to the “available,” “active, but not recruiting,” and “not yet recruiting” clinical trials posted for the specific company on ClinicalTrials.gov
Expanded Access Listing Box – contains expanded access program titles and links available from the company as posted on ClinicalTrials.gov. Clicking on any of the links in this box will open a new page with details for that particular program.
Additional Information Box – contains additional information provided by the company, which may include its full expanded access policy, contact details, or other relevant information.
*Inclusion of a company or therapy in the EA Navigator's Company Directory does not imply endorsement by the Reagan-Udall Foundation for the FDA