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If you know the name of a drug manufacturer, you can easily search using the alphabetical menu below. Or you can search in free text – simply type the disease, drug, company name, or other detail into the Search bar below and click on the magnifying glass. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (i.e.; “breast cancer”). See Search Tips for tips and definitions to make your searches more effective.

The web links in this directory are public information provided to the Foundation and the acknowledgement times listed are the number of days or hours for a company to acknowledge receipt of request, not to make a decision. Data contained in this directory is provided either directly by the company or by ClinicalTrials.gov for the companies listed in this directory.

The Expanded Access listings provided on this website are limited to those companies currently in the Company Directory and include listings for expanded access which are Available, Temporarily Not Available and Approved for Marketing, which in some cases includes treatments which have not yet reached the market. In addition, many companies are willing to consider expanded access requests even if they do not show active Expanded Access Listings in this directory. Contact the company to explore the possibility of individual access to an investigational therapy.

To learn more about clinical trials and expanded access, please visit our patient and physician guides on this website.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Company Name
Phone Number & Email
Company Acknowledgement

VelosBio Inc.

Expected Application Timeframe
5 business days
Single-Patient EA Policies/Criteria

VelosBio will review all requests for investigational drug access on a case-by-case basis, taking into consideration regulations and guidance issued by applicable health authorities. Among other criteria, VelosBio will consider whether:

  1. The patient has a serious, debilitating, or life-threatening medical condition for which no other medically appropriate treatment is available;
  2. The patient’s healthcare provider can provide an assessment of the benefits and risks of the proposed expanded access use that suggests that the potential benefits of access to the investigational therapy likely outweigh known potential risks in the context of the risks posed by the patient’s underlying medical conditions;
  3. The patient’s healthcare provider can provide relevant data (eg, medical records, etc.) to support the assessment of benefits and risks, considering standards of patient confidentiality appropriate for the situation;
  4. The patient’s healthcare provider is currently licensed with the appropriate practitioner licensing board;
  5. The patient’s healthcare provider is willing and able to support any regulatory procedures required by the relevant regulatory authority;
  6. The patient’s healthcare provider is willing to enter into an expanded access agreement with VelosBio;
  7. The patient’s healthcare provider will obtain informed consent from the patient or his/her legal guardian(s) for use of the investigational therapy;
  8. The patient’s healthcare provider will supervise administration of the investigational therapy in accordance with any procedures specified by VelosBio (which in some countries may include a protocol for use of the investigational therapy);
  9. The patient’s healthcare provider is willing and able to report any side effects of the investigational therapy and any other results as requested by VelosBio to assess benefits and risks of the expanded access use;
  10. The patient does not qualify to participate in any ongoing clinical trial sponsored by VelosBio in an accessible geographical location;
  11. Sufficient data exist to support the proposed expanded access use and the assessment of the benefits and risks of the expanded access use;
  12. Access would not impede or compromise the ongoing clinical development program or regulatory approval of the investigational therapy; and
  13. There is adequate supply of the investigational therapy to support access and such supply will not negatively affect a clinical trial or anticipated product launch

Requests for access to a VelosBio investigational therapy must be made by the patient’s treating physician. Whenever possible, the patient, the patient’s parent/legal guardian, or patient caregiver should work through the treating physician rather than contacting VelosBio directly.

To initiate a request for access to a VelosBio investigational drug, the physician should email info@velosbio.com. Such requests should aim to address Criteria 1-10 above. VelosBio will strive to respond to requests for access of an investigational product within five (5) business days of receiving a complete request that includes all necessary documentation.

Venatorx Pharmaceuticals, Inc.

Phone Number & Email
Expected Application Timeframe
Up to 24 hours
Single-Patient EA Policies/Criteria

Venatorx Pharmaceuticals (the “Company”) is focused on conducting clinical studies and obtaining regulatory approval of investigational medicines in support of its mission to develop safe and effective treatments for infectious diseases.  The best way for patients to get access to investigational medicines is by taking part in clinical trials.  Please search ClinicalTrials.gov for publicly available information related to Venatorx’s ongoing clinical trials. 

It is recognized that not all patients are eligible to enroll in clinical trials. However, at this time, Venatorx is not able to offer Expanded Access (“EA”) and will not accept EA requests. 

Venatorx recognizes the need for EA programs.  The Company is currently establishing the necessary processes and procedures, as well as putting in place resources and supplies so that an EA program may be established in the future.

If you have questions about Venatorx’s EA policy, please contact medinfo@venatorx.com.

Available Therapies via Single-Patient EA

Cefepime/VNRX-5133 (taniborbactam)

Viela Bio

Phone Number & Email
Expected Application Timeframe
24 hours
Single-Patient EA Policies/Criteria

At Viela Bio, we work every day to improve the lives of people impacted by serious, underserved, inflammatory and autoimmune diseases. We share the urgency of patients seeking new treatments for potentially life-altering diseases, and understand the interest in accessing our therapies outside of clinical trials and prior to regulatory approval.

Expanded access, also referred to as compassionate use, is a channel through which the US Food and Drug Administration (FDA) allows physicians to request investigational medicines for patients. We do not currently offer any expanded access programs, as we are focusing our resources – including supply of complex investigational medicines – on clinical trials and regulatory approval.

We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Information about all of our trials, including eligibility criteria and locations, is available at ClinicalTrials.gov.

If we are able to offer expanded access in the future, we will update this policy. If you have further questions, please email eap@vielabio.com.

Vitaeris Inc.

Expected Application Timeframe
5 business days
Single-Patient EA Policies/Criteria

Vitaeris’ objective is to provide access to clazakizumab at the appropriate time and in the correct manner for patients.
At this time, participation in a controlled clinical trial is the most appropriate way to access the use of clazakizumab. Clinical trials are controlled research studies in humans designed to determine if an investigational drug is safe and effective. Since the benefit:risk profile of clazakizumab has not been fully established, Vitaeris is not supporting expanded access to clazakizumab outside of clinical trials. Vitaeris is maintaining a focus on conducting well-controlled clinical trials that can support global health authority approvals.
Vitaeris is currently conducting a pivotal trial investigating the efficacy and safety of clazakizumab for the treatment of chronic active antibody-mediated rejection (CABMR) in kidney transplant subjects.