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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.
Company Name
Phone Number & Email
Company Acknowledgement
Ractigen Therapeutics
Expected Application Timeframe
10 Business DaysSingle-Patient EA Policies/Criteria
Ractigen Therapeutics is at the forefront of developing small activating RNA(saRNA) drugs utilizing the RNA activation (RNAa) mechanism to up-regulate endogenous gene expression. RAG-01 is a pioneering saRNA drug engineered to target and activate the tumor suppressor gene p21 via the mechanism of RNAa. It is currently being investigated in a phase Ⅰ, open label, multi-center study in patients with non-muscle-invasive bladder cancer (NMIBC) who have failed Bacillus Calmette-Guérin (BCG) therapy. We are conducting the clinical trial aiming at gaining regulatory approval to make RAG-01 available to all eligible patients as quickly as possible.
Ractigen is not currently making its investigational products available on an expanded access basis anywhere in the world, as we believe that our clinical trials are the most appropriate way to access our investigational products. We encourage patients who are interested in accessing RAG-01 treatment to talk to their physician about participating in a clinical trial.
If we determine that expanded access to RAG-01 becomes appropriate in the future, this policy will be updated. If you have further questions, please feel free to contact us at expanded.access@ractigen.com with any questions.
Consistent with the 21st Century Cures Act, Ractigen Therapeutics may revise this policy at any time.
RadioMedix
Single-Patient EA Policies/Criteria
Currently, RadioMedix, Inc. and Orano Med, do not offer an expanded access program and are not accepting expanded access requests for AlphaMedix™. Our development resources are focused on conducting clinical trials that evaluate the safety and efficacy of our treatment.
Rapa Therapeutics, LLC
Phone Number & Email
Single-Patient EA Policies/Criteria
We do not plan to offer Expanded Access for our studies.
Recursion Pharmaceuticals, Inc.
Single-Patient EA Policies/Criteria
At Recursion Pharmaceuticals, we are committed to radically improving the lives of patients and their families by developing therapies that will make a lasting, positive, and transformative impact on diseases and conditions for which there are high unmet needs.
We believe that the best way to succeed in our mission is through well-designed clinical trials that determine the safety and effectiveness of investigational medicines. We understand that in some rare and specific circumstances, when enrollment into a clinical trial is not possible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines. When appropriate and through an expanded access protocol, Recursion will consider individual Expanded Access, sometimes called “Compassionate Use” or “Early Access”, requests for an investigational medicine outside of an ongoing clinical trial for the indication being investigated by the company.
There may be additional requirements, but to start, a licensed treating physician must submit the request for Expanded Access in writing by contacting ExpandedAccess@Recursion.com. The physician must be able and willing to obtain a treatment IND, or regional equivalent, and Institutional Review Board or Ethics Committee approval, for the patient prior to initiating treatment with our investigational medicine.
We will consider applications to provide the investigational drug that will not, among other things, compromise the scientific validity of our broader development programs, or interfere with or delay clinical trials or regulatory filings designed to make the drug available to a larger patient population.
We endeavor to respond to Expanded Access requests within one week after the steps for submission are completed.
It is important to remember that investigational medicinal products have not yet received regulatory approval; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product. For information on available clinical trials visit: www.ClinicalTrials.gov.
cts have not yet received regulatory approval;
thus, their potential risks and benefits are not yet established. Physicians and patients should consider all
possible benefits and risks when seeking access to an investigational medicinal product. For information on
available clinical trials visit:
Relmada Therapeutics
Expected Application Timeframe
N/AAvailable Therapies via Single-Patient EA
To provide expanded access of REL-1017 to patients with MDD who do not have access to other effective therapy and are not eligible for other clinical trials with REL-1017.
Inclusion Criteria:
• Patients with Major Depressive Disorder who may potentially benefit from treatment with REL-1017 as determined by the treating physician.
• Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory
alternative treatment is available to treat the disease or condition.
• Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
• Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated
risks.
• There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc.
Exclusion Criteria:
• History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
• History of allergy or hypersensitivity to methadone or related drugs.
• Pregnant or planning to become pregnant.
• Breast-feeding or planning to breast-feed.
RemeGen Co., LTD.
Expected Application Timeframe
7 DaysSingle-Patient EA Policies/Criteria
The following criteria are typically required before RemeGen would consider patients eligible for expanded access to a RemeGen investigational product. All criteria are subject to local laws and regulations.
• The patient suffers from a life threatening or serious disease or condition, where there is an unmet medical need that cannot be met by existing products.
• The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
• The investigational product is under active development (a dose and regimen has been defined and the product is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
• The benefit-risk profile of the drug in the indication and the patient population is deemed, to date, to be positive which typically occurs when RemeGen has decided to seek marketing approval in at least one major market globally.
• RemeGen has decided to seek marketing approval in at least one major market globally.
• The expanded access use of the investigational product will not jeopardize the development of the drug (for instance, granting access to an investigational unapproved drug through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
• The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.
RemeGen cannot approve expanded access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
We commit to a careful and fair evaluation of each request by the appropriate medical experts at RemeGen within the boundaries of local laws and regulations. All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from RemeGen (or our agent) within 7 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with RemeGen.
Available Therapies via Single-Patient EA
RC18 (telitacicept) for primary Sjögren’s syndrome
RemeGen Co., LTD.
Single-Patient EA Policies/Criteria
RemeGen Co., Ltd. is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen Co., Ltd.'s main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) , fusion protein and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, RemeGen Co., Ltd. has laboratory research facilities and offices in Beijing, Shanghai, Maryland and California.
Consistent with RemeGen's mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing.
We currently have a early-stage study for Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer. Our goal is to provide access to our medicine at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe enrollment in our ongoing clinical trials is the safest and most effective way of achieving this goal. We do recognize that some patients will not be eligible for our clinical trials and may wish to access our products through expanded access. However, at this time, we do not have the resources available to offer expanded access use of our investigational medicines. We encourage all patients and physicians who are interested in accessing our investigational medicine to visit the clinical trial https://clinicaltrials.gov to find out about enrolling in clinical trials.
Available Therapies via Single-Patient EA
RC88 monotherapy in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
RemeGen Co., LTD.
Expected Application Timeframe
7 daysSingle-Patient EA Policies/Criteria
Consistent with RemeGen’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, RemeGen will consider providing a requesting physician with pre-approval access to a specific RemeGen investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.
The following criteria are typically required before RemeGen would consider patients eligible for expanded access to a RemeGen investigational product. All criteria are subject to local laws and regulations.
• The patient suffers from a life threatening or serious disease or condition, where there is an unmet medical need that cannot be met by existing products.
• The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
• The investigational product is under active development (a dose and regimen has been defined and the product is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
• The benefit-risk profile of the drug in the indication and the patient population is deemed, to date, to be positive which typically occurs when RemeGen has decided to seek marketing approval in at least one major market globally.
• RemeGen has decided to seek marketing approval in at least one major market globally.
• The expanded access use of the investigational product will not jeopardize the development of the drug (for instance, granting access to an investigational unapproved drug through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
• The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.
RemeGen cannot approve expanded access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
We commit to a careful and fair evaluation of each request by the appropriate medical experts at RemeGen within the boundaries of local laws and regulations. All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from RemeGen (or our agent) within 7 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with RemeGen.
http://www.remegen.com/index.php?v=show&cid=113&id=1006
Available Therapies via Single-Patient EA
Telitacicept for patients with Generalized Myasthenia Gravis
RemeGen, Ltd.
Expected Application Timeframe
7 daysSingle-Patient EA Policies/Criteria
The following criteria are typically required before RemeGen would consider patients eligible for expanded access to a RemeGen investigational product. All criteria are subject to local laws and regulations.
• The patient suffers from a life threatening or serious disease or condition, where there is an unmet medical need that cannot be met by existing products.
• The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
• The investigational product is under active development (a dose and regimen has been defined and the product is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
• The benefit-risk profile of the drug in the indication and the patient population is deemed, to date, to be positive which typically occurs when RemeGen has decided to seek marketing approval in at least one major market globally.
• RemeGen has decided to seek marketing approval in at least one major market globally.
• The expanded access use of the investigational product will not jeopardize the development of the drug (for instance, granting access to an investigational unapproved drug through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
• The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.
Available Therapies via Single-Patient EA
Telitacicept for patients with moderate or severe SLE
Reneo Pharmaceuticals Inc.
Expected Application Timeframe
N/ASingle-Patient EA Policies/Criteria
Reneo is committed to developing promising new therapies to address the unmet medical needs of patients suffering from rare and seriously debilitating diseases. We currently have a late-stage clinical trial planned for the treatment of Primary Mitochondrial Myopathies (PMM) and early-stage studies for Glycogen Storage Disorder V (GSDV, also known as McArdle Disease) and Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD). Our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe enrollment in our ongoing clinical trials is the safest and most effective way of achieving this goal. We do recognize that some patients will not be eligible for our clinical trials and may wish to access our products through expanded access. However, at this time, we do not have the resources available to offer expanded access use of our investigational medicines. We encourage all patients and physicians who are interested in accessing our investigational medicines to visit the clinical trial section below to find out about enrolling in clinical trials.
Available Therapies via Single-Patient EA
N/A
Renibus Pharmaceuticals
Expected Application Timeframe
10 business daysSingle-Patient EA Policies/Criteria
Renibus Therapeutics will evaluate and respond to a request that it receives on a case-by-case basis.
Available Therapies via Single-Patient EA
RBT-9 for the treatment of COVID-19 at the early stage (Stage I) of infection in patients who are at high risk for disease progression.