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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 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

Parion Sciences, Inc.

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

We are unable to offer single patient expanded access at this time.


Phone Number & Email
Expected Application Timeframe
5 business days
Multiple Myeloma

Provide pre-approval single-patient Expanded Access (Compassionate Use) of elranatamab for patients with relapsed/refractory multiple myeloma

Atopic Dermatitis

This is a multi-center, expanded access protocol to provide access to the investigational product, abrocitinib, to adolescent and adult patients with moderate to severe atopic dermatitis who have inadequate treatment options with available and approved medicated topical and systemic therapies and who are otherwise ineligible for participation in clinical studies with abrocitinib.

Gastrointestinal Neoplasm

The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

Carcinoma, Renal Cell

The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

Metastatic Castration-Resistant Prostate Cancer

The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.


This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age <18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

Metastatic Merkel Cell Carcinoma

Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.

Inotuzumab Ozogamicin Expanded Access Program

Lorlatinib expanded access program

Single-Patient EA Policies/Criteria

Pharnext SAS

Expected Application Timeframe
Single-Patient EA Policies/Criteria

Pharnext develops innovative new medicines designed to address unmet medical needs of patients in major therapeutic areas. We are focused on creating new medicines that address important, real world concerns of patients and their families. We currently have investigational treatments in clinical trials for a number of different diseases, as described in the PRODUCTS section of our website at
Pharnext’s goal is to efficiently bring safe and effective medicines to all appropriate patients by conducting rigorous clinical trials and obtaining marketing approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA). Prior to such approval, participation in one of our clinical trials is the optimal way for patients to gain access to our investigational medicines. However, we understand that some patients may not be able to participate in a clinical trial and may seek access to investigational treatments before they are approved. These situations are often referred to in various ways, including expanded access, early access, pre-approval access, compassionate use and emergency use.
If early data from clinical trials suggest that an investigational treatment can offer benefits for patients facing serious or life-threatening conditions, Pharnext may consider requests to provide access outside of a clinical trial. Our top priority when evaluating requests for expanded access to investigational medicines is to ensure that we are not putting patients at risk of unnecessary harm.
Pharnext will consider an expanded access program, or a single request for expanded access of an investigational medicine, only if all of the following criteria are met:
• The patient’s licensed physician submits an unsolicited request for expanded access
• The patient to be treated has a serious or immediately life-threatening illness and there is no satisfactory alternative therapy
• There are no comparable or satisfactory alternative therapies approved and available to treat the disease or condition
• There is preliminary clinical evidence of effectiveness and acceptable safety of the investigational treatment for that patient’s condition
• The potential benefit of the investigational medicine to the patients is greater than the potential risk
• Staff and other required resources are available to provide the product and there is an adequate supply of the investigational medicine
• Providing the investigational medicine will not interfere with the timely completion of clinical trials that could lead to marketing approval and thereby could delay its availability to other patients
• Expanded access will only occur in a country where Pharnext expects to file for regulatory approval of the product
Patients interested in obtaining access to a Pharnext investigational therapy must do so via their physician. Physicians should contact Pharnext Medical Information Center at All requests will be carefully considered, and a written or oral response will be provided to the treating physician within two weeks of receiving a request. For further information on available expanded access programs, visit and search ‘expanded access programs’.

Available Therapies via Single-Patient EA


Disease/Category-Specific EA Policies/Criteria

NA - see above


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

Pharvaris is committed to serving patients’ health needs by developing safe and effective therapies and making them available for use as quickly as possible. We believe that controlled clinical trials provide the best path for Pharvaris to generate the safety and efficacy information needed to obtain regulatory approval so that we can make our medicines available to all patients.

Pharvaris always seeks to provide the quickest and broadest access to its medicines, balancing benefit and risk to all patients. We support the principle of expanded-access programs consistent with the best standards for safe and effective use of an investigational therapy, as well as our ability to logistically provide a product. Pharvaris will consider requests for expanded access from qualified physicians, balancing multiple factors.

When evaluating potential use of an investigational therapy, we will consider several factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines including both patient and scientific perspectives. Eligibility requirements include but are not limited to:

  • Sufficient scientific evidence to support both the safety and the efficacy of the compound’s mechanism for this indication
  • A serious or life-threatening illness, with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
  • Sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information
  • Support that providing the investigational drug will not interfere with clinical trials that could support the investigational drug’s development or regulatory approval for the treatment indication, which could affect future patient access
  • The evaluation of these, and other, questions may require additional investigation or interaction with the requesting physician, other clinical investigators, or regulatory authorities. Favorable answers alone provide no guarantee that Pharvaris will be able to provide pre-approval access to an experimental medicine.

Requests for access to investigational therapies must be made by a qualified and licensed physician to Pharvaris ( and will be evaluated by a core team. Pharvaris anticipates it will acknowledge receipt of such requests within five business days after receipt of an inquiry.

PolyPid Ltd

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

There are seriously ill patients who will not be eligible for our clinical trials and may be in a high risk to experience an infection post a surgical intervention. In these circumstances, POLYPID will consider providing the requesting surgeon with pre-approved access to D-PLEX, for the prevention of infection of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
• The patient is scheduled for an abdominal or a median sternotomy surgery for any reason;
• The patient is not eligible to participate in POLYPID clinical trials;
• The patient has a serious or life-threatening illness or condition and his/her likelihood to develop a serious infection due to surgical intervention is high;
• The patient has a disease or condition for which there is sufficient evidence of a projected benefit from the use of the D-PLEX and the benefit outweighs the known or anticipated risks;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting surgeon’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or a regulatory review or an approval of the investigational drug for broader patient access; and
• Adequate supply of the investigational drug is available and can be supplied in the appropriate timeline of request.

Available Therapies via Single-Patient EA

D-PLEX, a new formulation of Doxycycline for local administration that is intended for prevention of Surgical Site Infections (SSIs) post cardiac surgery with median sternotomy and post abdominal surgery.

Disease/Category-Specific EA Policies/Criteria


Expected Application Timeframe
1 month
Single-Patient EA Policies/Criteria

Patient Eligibility Criteria:
To be eligible for access to an investigational product, a patient must meet the following criteria:

  • Be an adult male with a confirmed diagnosis of X-linked adrenoleukodystrophy.
  • Have undergone standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
  • Are not eligible or able to participate in any planned or ongoing clinical trial of the investigational product(s).
  • Has manifestations of disease for which there is sufficient evidence of a projected benefit (e.g. based on prior positive clinical trial results) 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 Poxel.
  • Investigational Product Criteria

In addition to the patient eligibility requirements, the investigational product must meet the following criteria:

  • The product is in active clinical development.
  • 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, and that there is sufficient investigational product available to ensure that supply constraints will not impede continued use of the product(s) by patient(s) or the conduct of our clinical trials.

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

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

PXL065 for an adult male with a confirmed diagnosis of X-linked adrenoleukodystrophy.

Disease/Category-Specific EA Policies/Criteria

PRG Science and Technology Co., Ltd.

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

At PRG S&T, we commit to bringing new, innovative therapies to patients by conducting rigorous clinical trials and obtaining marketing approval by the FDA and other regulatory authorities. At this point of time, PRG S&T believes that participation in one of our clinical trials is the most appropriate way to access our investigational medicine. However, we may also provide our investigational medicine for use through expanded access program.

Requests for expanded access must be made by a physician on behalf of their patient. The eligibility for a patient to participate in the expanded access program will be reviewed and evaluated based on the patient’s medical information. The request for access to a PRG S&T investigational medicine will only be considered if the patient's treating physician is committed to, and supportive of, the requested treatment.

Questions with regards to the expanded access to PRG S&T investigational medicine may be sent to us via the contact information listed on our website. Should the circumstance permits change to our expanded assess policy, updates will be posted to this website.

Available Therapies via Single-Patient EA

Progerinin for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) and Werner Syndrome (WS)


Phone Number & Email
Single-Patient EA Policies/Criteria

The goal of our current clinical study program for PC945 is to enroll patients and obtain clinical data that is required by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), 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 PC945 outside of clinical studies and, at this time have no Expanded Access program (sometimes referred to as “compassionate use” or “pre-approval access”).

Purdue Pharma L.P.

Phone Number & Email
Expected Application Timeframe