Begin Your Search

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.

4 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

Leap Therapeutics, Inc.

Expected Application Timeframe
5 business days
Esophageal Neoplasm
Adenocarcinoma of the Gastroesophageal Junction
GastroEsophageal Cancer
Squamous Cell Carcinoma
Gastric Adenocarcinoma
Endometrial Cancer
Uterine Cancer
Ovarian Cancer
Carcinosarcoma
Gastric Cancer

An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.

Disease/Category-Specific EA Policies/Criteria

https://www.leaptx.com/for-patients

Linnaeus Therapeutics

Phone Number & Email
Expected Application Timeframe
7 days
Single-Patient EA Policies/Criteria

Expanded Access Program Policy for LNS8801
LNS8801 is currently being developed for the treatment of advanced cancer and has fast track designation for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy. Linnaeus Therapeutics (Linnaeus) understands that advanced cancer patients with limited therapeutic options may desire to try promising experimental therapies such as LNS8801. 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 Linnaeus’s ongoing clinical trials.

It is recognized that not all patients are eligible to enroll in clinical trials. Linnaeus may consider requests for expanded access (sometimes called compassionate use) at this time due to limited drug supply.

Linnaeus hopes that in the near future it will be able to regularly consider requests so that patients in the United States with an immediately life-threatening condition or serious disease or condition who have exhausted other appropriate treatment options may, under the conditions described below and in accordance with applicable local law, have appropriate access to its investigational medicines in development before they are commercially available.

For more information regarding Linnaeus’ current and future expanded access policies please contact, medinfo@linnaeustx.com. Linnaeus anticipated being able to response to inquiries within one week.

Available Therapies via Single-Patient EA

LNS8801 - advanced cancers

Lion TCR

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

SCOPE
This policy applies to provision of access to Lion TCR’s investigational product(s) that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.

POLICY STATEMENTS
Any use of Lion TCR’s investigational product(s) outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including our policies and procedures.
In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Lion TCR when it becomes available via the local healthcare system.
Lion TCR may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country.

A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Lion TCR's investigational products by contacting the Company at clinicaltrials@liontcr.com . We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.
Lion TCR is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Lion TCR may require more detailed information in order to fully evaluate a request. Requests will be considered on a case-by-case basis.

Lion TCR will consider providing a requesting physician with pre-approval access to a specific investigational drug outside of a clinical trial, when the following conditions are met:

A. Patient Eligibility Criteria
To be eligible for access to an investigational product, patients must meet the following criteria:

  • Suffer from a serious or immediately life-threatening disease or condition.
  • Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
  • Are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
  • The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
  • Any other pertinent medical criteria for access to the investigational product, as established by the Lion TCR clinically or medically responsible individual.

B. Investigational Product Criteria
In addition to the patient eligibility requirements, the investigational product must meet the following criteria:

  • The product is under investigation in one or more clinical studies.
  • There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population.
  • The provision of the investigational product will not interfere with or compromise the clinical development of the product.


C. Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving an investigational product through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:

  • Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
  • Any requirements from Lion TCR in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.
Available Therapies via Single-Patient EA

LioCyx-M for hepatocellular carcinoma

Disease/Category-Specific EA Policies/Criteria

https://drive.google.com/file/d/1d9bjsBW4w7WpsBFcXEZT8fwd8OvB8GAx/view

Lumicell

Single-Patient EA Policies/Criteria

At Lumicell, our focus is on the development of pegulicianine. The goal of our current clinical study program is to enroll patients and obtain clinical data on pegulicianine that is required by the US Food and Drug Administration (FDA) and other regulatory authorities for review and approval of marketing applications for this investigational agent. We believe that focusing on clinical studies is the most appropriate way to achieve this goal; therefore, we do not currently offer access to pegulicianine outside of clinical studies and, at this time, we have no Expanded Access program (sometimes referred to as “compassionate use” or “pre-approval access”).
For information on participating in and status of pegulicianine clinical trials, please see: https://clinicaltrials.gov/ct2/home
If you have additional questions regarding this policy, please speak with your health care provider or contact: info@lumicell.com

Lundbeck

Phone Number & Email
Expected Application Timeframe
10 business days