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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 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

Hanmi Pharmaceutical Co., Ltd

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

Any use of Hanmi’s investigational products outside clinical trials should be made in accordance with local regulations and guidelines as well as Hanmi’s procedures and policies.
Hanmi will not grant access to Hanmi’s investigational products if the expanded access will interfere with the company’s ability to complete clinical trials as planned or will delay the drug development program.
Hanmi will grant access to Hanmi’s investigational products when there is an adequate supply of the investigational products to meet the needs of the expanded access without impairing clinical trials for drug development.
Hanmi will provide investigational product with 3 months’ treatment supply per case. In case treating physician judges that it is beneficial for patients to continue Hanmi’s investigational products, new apply should be made.
In general, where permitted by local regulation, an investigational product provided via expanded access according to local regulations and guidelines will no longer be provided by Hanmi once it becomes available on the market.
Hanmi may decide not to provide an investigational product under this policy if Hanmi decides to stop the drug development or not to launch in the concerned country(ies).

Available Therapies via Single-Patient EA

LAPS-Triple Agonist (also known as HM15211) is a long-acting Glucagon/GIP/GLP-1 triple agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker. The therapeutic indication is non-alcoholic steatohepatitis (NASH).

LAPSGLP-2 Analog (also known as HM15912) is a long-acting glucagon-like peptide-2 (GLP-2) analogue linked to a human immunoglobulin G4 fragment crystallizable. The therapeutic indication is short bowel syndrome in the pediatric and adult populations.

Disease/Category-Specific EA Policies/Criteria

HiberCell, Inc.

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

HiberCell, Inc. is committed to developing novel therapeutics that address the most common cause of cancer mortality: relapse and metastasis. HiberCell has multiple compounds in development focused on modulating the immunosuppressive tumor microenvironment and adaptive stress biology. Currently HiberCell has two therapies in clinical testing. One of its therapies, Imprime PGG, an innate immune modulator, has advanced into clinical testing (Phase 2). Clinical studies evaluating the safety and efficacy of Imprime PGG in combination with immune checkpoint inhibitors, tumor-targeting, and anti-angiogenic antibodies for the treatment of multiple cancers have been conducted. HiberCell’s second therapy,  HC-5404, an ER stress modulator PERKi treatment, has entered into clinical testing (Phase 1) and the first clinical study evaluating the dose, safety and efficacy of HC-5404 is underway. At this time, HiberCell does not have a compassionate use program; however, it will consider providing Imprime PGG or HC-5404 for individual patients (Single Patient IND) on a case-by-case basis. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and for whom there are no comparable or satisfactory alternative therapy options.

In determining whether single patient access is appropriate outside of a clinical trial, HiberCell will consider many factors, including: the strength of available efficacy and safety data; the patient’s medical condition and history; the benefit-risk profile of our drug in relation to the patient’s case; the potential impact on the clinical development program; and the ability and willingness of the patient’s physician to sponsor the treatment application.

If you are physician or a potential patient and your physician believes you may be a candidate for single patient access to Imprime PGG, please ask your doctor to contact Michele Gargano, VP Clinical Operations, HiberCell, at, who will respond within 5 working days.

Available Therapies via Single-Patient EA

Imprime PGG, for multiple oncology indications, in combination with checkpoint inhibitor, tumor-targeting- or anti-angiogenic antibodies

HC-5404 for the treatment of renal cell carcinoma and other solid tumors including gastric cancer, metastatic breast, and small-cell lung carcinoma, or other select tumors.

Disease/Category-Specific EA Policies/Criteria


Expected Application Timeframe
3 business days