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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.

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

Taiho Oncology, Inc

Expected Application Timeframe
24 hours
Advanced Cholangiocarcinoma

The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

Colorectal Cancer Metastatic

The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

Single-Patient EA Policies/Criteria

Taiho Oncology, Inc. (“Taiho”) is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. In such situations, Taiho may be able to provide pre‑approval access to an investigational drug through our Expanded Access Program. Expanded Access, also known as Compassionate Use, is the use of an investigational medical product intended to diagnose, monitor or treat a patient's disease or condition, prior to FDA approval and outside of use in a clinical trial. Taiho accepts requests for pre‑approval access to investigational cancer medicines from physicians only.

To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria*:

  • The patient is suffering from a serious or life‑threatening malignancy and has received available standard treatments without success
  • The patient is not eligible to participate in any ongoing clinical study of the Taiho investigational agent
  • The medicine requested is part of an active ongoing clinical development program at Taiho Oncology (US) as described on our website: www.taihooncology.com/us under the tab for ‘Our Science’
  • Provision of the investigational agent will not interfere with the ongoing Taiho development program, and the potential benefits to the patient outweigh the potential risks

A physician may click here to obtain an application form, submit the completed form, or submit questions about Taiho's Expanded Access Program, via email to ExpandedAccess@taihooncology.com. (For futibatinib specific requests, click here to obtain the application form).

* Note that meeting these criteria does not guarantee access to any investigational product.

Takeda Pharmaceuticals

Phone Number & Email
Expected Application Timeframe
3 business days
Carcinoma, Non-Small-Cell Lung

The purpose of this study is to provide expanded compassionate use access to mobocertinib, in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations and who have received at least 1 prior line of therapy for locally advanced or metastatic disease.

Gaucher Disease, Type 1

Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this treatment protocol is to observe the safety of velaglucerase alfa in patients with type 1 Gaucher disease who are either treatment naive (newly diagnosed) or who are currently being treated with the Enzyme Replacement Therapy (ERT) imiglucerase.

Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Chronic Myeloid Leukemia (CML)
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.

Disease/Category-Specific EA Policies/Criteria

EXPANDED ACCESS TO INVESTIGATIONAL DRUGS

https://www.takedaoncology.com/medicines/expanded-access-to-investigational-drugs/

TenNor Therapeutics (Suzhou) Limited

Expected Application Timeframe
NA
Available Therapies via Single-Patient EA

At this time, TenNor will not provide investigational drug outside of clinical studies and will reevaluate when sufficient preliminary safety and efficacy information has been obtained in clinical trials.

Rifasutenizol (formerly known as TNP-2198) is currently under clinical development for the treatment of Helicobacter pylori infection. Rifaquizinone (formerly known as TNP-2092) is currently under clinical development for the treatment of Prosthetic Joint infection (PJI) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI).


At this time, TenNor will not provide investigational drug outside of clinical studies and will reevaluate when sufficient preliminary safety and efficacy information has been obtained in clinical trials.

 

TFF Pharmaceuticals, Inc.

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

Voriconazole Inhalation Powder for Pulmonary Aspergillosis and other voriconazole-sensitive pulmonary fungal infections

 

Available Therapies via Single-Patient EA

TFF Pharmaceuticals is developing its two lead drug candidates, Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, through the conduct of clinical trials. We understand that in some cases, patients may have exhausted other therapeutic options and/or may not qualify for participation in clinical trials. In such cases, treating physicians may request the use of an investigational drug on an expanded access or compassionate use basis. It is important to remember that the potential risks of an investigational drug are not yet established and therefore the treating physician must weigh the potential risks of an investigational drug against its potential benefits before considering the use of an investigational drug.

At this point, TFF Pharmaceuticals will consider providing a requesting physician with access to a specific TFF Pharmaceuticals investigational drug on an expanded access/compassionate use basis when certain conditions are met.

TFF Pharmaceuticals will consider requests for expanded access to Voriconazole Inhalation Powder:
• The patient is deemed by the patient’s physician to have a serious or life-threatening condition, with no satisfactory alternative therapies available, or has had an unfavorable response to adequate standard of care therapy.
• The patient’s physician believes that the use of Voriconazole Inhalation Powder is in the patient’s best interest.
• If provided, the investigational drug will be used in accordance with applicable laws and regulatory requirements of the country where the patient is treated.
• The patient is ineligible for or otherwise unable to participate in a clinical trial.
• Making the investigational drug available to a patient will not negatively impact or delay the conduct of ongoing clinical trials or regulatory review or approval of the investigational drug for broader patient access.

The treating physician must submit a formal request for expanded access to TFF Pharmaceuticals at expandedaccess@tffpharma.com. The treating physician is responsible for obtaining local regulatory and/or ethics/IRB approval for the investigational use. The request for expanded access must include at a minimum the requesting physician’s name and contact information, the indication, and rationale for request. Product specific eligibility criteria may apply and the treating physician will be requested to provide additional information.
The medical reviewers at TFF Pharmaceuticals will evaluate each request based on the criteria above, and the overall assessment of potential benefits and risks in the given patient.

TFF Pharmaceuticals may require more detailed information in order to fully evaluate a request. Every effort will be made to provide a response to an expanded access request within 3 business days of the formal request, with approval, non-approval or a request for additional information.

Additional information on Expanded Access for Voriconazole Inhalation Powder

 

Indications:

Invasive Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis

Allergic Bronchopulmonary Aspergillosis
Aspergillus Tracheobronchitis
Aspergillus bronchial anastomotic infection

Other voriconazole-sensitive pulmonary fungal infections

 

Eligibility Criteria:

Inclusion Criteria:

  1. Male or female aged 18 years or older at screening.
  2. Diagnosed with pulmonary aspergillosis including Invasive Pulmonary Aspergillosis (IPA), Chronic Pulmonary Aspergillosis (CPA), Allergic Bronchopulmonary Aspergillosis (ABPA), Aspergillus tracheobronchitis and Aspergillus bronchial anastomotic infection. Pulmonary infections with voriconazole sensitive fungi other than Aspergillus such as but not limited to scedosporium and fusarium are also allowed.
  3. Patient has limited or no treatment options due to documented or anticipated intolerance, toxicity, contraindications, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional treatment guidelines.
  4. The treating clinician considers that the potential advantage of using Voriconazole Inhalation Powder outweighs the potential risks. In patients with disseminated fungal infection in addition to pulmonary infection, Voriconazole Inhalation Powder must be used as add-on therapy to the current SOC.
  5. The Sponsor agrees that the benefit:risk assessment is favorable for the use of Voriconazole Inhalation Powder in the patient.
  6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test (UPT) prior to first dose. Sexually active WOCBP and male patients must agree to use highly effective birth control or abstinence until 3 months after last dose.
  7. Patient succeeds in meeting training criteria on the use of the dry powder inhaler (DPI) and is willing and able to perform adequate inhalation technique for treatment duration in the opinion of the treating clinician or designee.
  8. Patient provides informed consent and agrees to follow the treatment regimen and safety and outcomes assessments.

 

Exclusion Criteria:

  1. Infection with fungi not responsive to voriconazole.
  2. Pregnant or breastfeeding.
  3. History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or excipients in Voriconazole Inhalation Powder.
  4. Patients with severe liver disease as defined by Child-Pugh Class C.
  5. Patients who are eligible and are able to participate in a clinical trial of Voriconazole Inhalation Powder.

TG Therapeutics, Inc.

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

TG Therapeutics is committed to bringing our investigational therapies for B-cell malignancies and autoimmune diseases to patients as fast as possible. We believe the best way for patients to access our investigational therapies is through participation in clinical trials, with the goal of obtaining regulatory approval of our products and allowing access to the broadest group of patients possible.

At this time, TG Therapeutics does not have a program to provide its investigational therapies to patients on an expanded access basis pursuant to section 561(b) of the U.S. Federal Food, Drug, and Cosmetic Act (FDCA). Because we do not currently have an expanded access program, we have not yet established procedures for making such requests or criteria for evaluating them. TG Therapeutics will update this policy if the company decides to make its investigational therapies available on an expanded access basis.

Patients may be able to access TG Therapeutics investigational therapies by participating in ongoing clinical trials. Whether or not a patient is eligible to enroll in any of our trials depends on a number of factors, including the specific requirements of each trial and the status of that trial. For more information about our trials, please visit Our Trials Overview or https://clinicaltrials.gov/ct2/results?cond=&term=%22tg+therapeutics%22&cntry=&state=&city=&dist.

TG is committed to responding to questions about its expanded access policy within five (5) business days of receipt. As noted above, at this time, we are not providing our investigational therapies on an expanded access basis.

Travere Therapeutics

Expected Application Timeframe
7 business days

Trellis Bioscience Inc.

Expected Application Timeframe
5 Business Days
Single-Patient EA Policies/Criteria

The objective of our development program is to conduct clinical trials and to obtain marketing approval by the FDA and other regulatory authorities. Participation in clinical trials is the first and most preferable route. If participation in clinical trials is not an option, physicians may consider a single-patient expanded access IND. Requests are considered on an individual basis. The general criteria used to evaluate such requests for individual patients are as follows: 1) The patient is diagnosed with PJI; 2) Assessment that the company has an adequate supply of the investigational medicine; and 3) A determination that expanded access will not interfere with the company’s ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients. The company may request additional information, including patient history, in order to fully evaluate the request. If the physician will be the sponsor for the IND, he or she is required to obtain necessary ethical and regulatory clearances, including informed consent, as well as provide reporting on treatment outcomes.

Available Therapies via Single-Patient EA

Prosthetic joint infection.

Treovir LLC

Phone Number & Email
Expected Application Timeframe
30 days
Available Therapies via Single-Patient EA

G207 for pediatric high grade gliomas

Trevi Therapeutics, Inc.

Expected Application Timeframe
5-7 business days
Single-Patient EA Policies/Criteria

Trevi Therapeutics, Inc. is currently unable to offer Expanded Access.

Available Therapies via Single-Patient EA

Currently, Trevi Therapeutics, Inc. does not have any investigational products available for Expanded Access.

Disease/Category-Specific EA Policies/Criteria

https://www.trevitherapeutics.com/patients-2/

Trinomab Biotech Co., Ltd

Single-Patient EA Policies/Criteria

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.

Trinomab Biotech Co., Ltd

Single-Patient EA Policies/Criteria

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.

Triumvira Immunologics, Inc.

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

Triumvira Immunologics, Inc. is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. Consistent with Triumvira, Inc.’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, Triumvira, Inc. will consider providing a requesting physician with pre-approval access to a specific investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’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 regulatory review or approval of the investigational drug for broader patient access; and
• Adequate supply of the investigational drug is available.

We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

Triumvira is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Triumvira may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Triumvira whose decisions are final. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to Partners@Triumvira.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 3 business days after receipt.

Available Therapies via Single-Patient EA

TAC01-CD19, autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.

Indication: B-Cell Lymphoma

TrueBinding Inc.

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

The FDA has developed a guidance whereby patients who have no treatment alternatives and cannot participate in a clinical trial may receive investigational treatments from companies.  This program is called Expanded Access.  In order to be eligible, patients must demonstrate that they have exhausted all available medications to treat their disorder, meaning they have taken available medications and have no further benefit, are intolerant to other medications, or have contraindications to other medications.  They must also demonstrate that there are either no clinical trials available in their locale, or that they are not eligible to participate in other clinical trials. The key decision for physicians and patients is whether they believe the benefits of treatment outweigh the risks.

 

TrueBinding has prepared an expanded access protocol for which treating physicians can apply on behalf of their patients.  Once enrolled in the protocol, patients receive monthly (every 28 days) IV infusions of TB006.  Treatment may continue indefinitely, however it may be discontinued whenever desired.  The protocol contains some patient monitoring suggestions, however other than adverse events there are no data to report to TrueBinding.

You may receive a copy of the protocol and the Investigator’s Brochure by contacting us.  A Confidentiality Disclosure Agreement will be sent to you.  Once executed, the documents will be sent.  If you have a patient who qualifies and is interested, you may apply for the program by accessing the application.  You will be notified of approval within 7 days of the application.  If the application is approved, you must participate in a short training session.  This covers preparation of the IV drug product, collection and reporting of adverse events, and other elements of Good Clinical Practices (GCPs).

 

When this is complete, drug will be sent to you.  You must provide IV administration supplies, including saline, tubing, and administration equipment. 

 

You may receive a copy of the protocol and the Investigator’s Brochure by contacting us.  A Confidentiality Disclosure Agreement will be sent to you.  Once executed, the documents will be sent.  If you have a patient who qualifies and is interested, you may apply for the program by accessing the application.  You will be notified of approval within 7 days of the application.  If the application is approved, you must participate in a short training session.  This covers preparation of the IV drug product, collection and reporting of adverse events, and other elements of Good Clinical Practices (GCPs).

 

When this is complete, drug will be sent to you.  You must provide IV administration supplies, including saline, tubing, and administration equipment. 

Available Therapies via Single-Patient EA

TrueBinding, Inc. is pleased to offer their lead pipeline compound, TB006, on a compassionate use basis to patients with Alzheimer’s disease (AD) and related dementias.  TB006 is a humanized monoclonal antibody which targets galectin-3 (Gal-3), an endogenous protein involved in a number of neurological and metabolic disorders.  There are two antibodies approved for AD, aducanumab (AduhelmÒ) and lecanemab (LeqembiÒ).  TB006 differs from these antibodies in two important ways.  First, the two approved antibodies are direct inhibitors of beta amyloid, the protein involved in the formation of neurofibrillary tangles and amyloid plaques in the brain.  TB006, by blocking the action of Gal-3, inhibits not only beta amyloid but precursors of other oligomers and neurofibrillary tangles such as tau, alpha-synuclein, and apolipoprotein E4.  Secondly, the two approved antibodies are indicated in AD patients who are in their early phase (MCI-early AD) and have PET imaging evidence of amyloid plaques.  TB006 is being studied in patients with established disease on the mild-moderate-severe (Mini Mental Status Exam score range of 24 or less) regardless of their amyloid status.

TVAX Biomedical

Expected Application Timeframe
48 hours
Single-Patient EA Policies/Criteria

TVAX Biomedical, Inc. (TVAX) is committed to developing immunotherapies for patients with serious cancers. Our goal is to provide access to our investigational therapies primarily through clinical trials. At this time, TVAX does not have any investigational immunotherapy product available for expanded access.

“Expanded Access” refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious condition in a patient. The US Food and Drug Administration has set forth guidelines when considering expanded access.

TVAX is not currently making its investigational immunotherapy product candidates available on an expanded access basis anywhere in the world. Requests for expanded access to TVAX Biomedical’s investigational immunotherapy product candidates must come from the patient’s treating physician because only physicians can enroll patients in a clinical trial or the expanded access program.

Certain therapies, like TVAX Immunotherapy, are made through complex manufacturing processes. TVAX seeks to retain the ability to make and supply product in a fair and equitable manner and in a volume that assures adequate manufacturing capacity for clinical trials and development programs. TVAX believes that participation in one of its’ clinical trials is the most appropriate way to access these investigational therapies.

At this time, TVAX is not currently making its unapproved therapies available on an expanded access or right to try basis. In the event TVAX decides to consider expanded access or right to try use, TVAX will evaluate and respond to each request that it receives on a case-by-case basis.

If you have questions, please speak with your physician or contact TVAX at info@tvaxbiomedical.com.

Consistent with the 21st Century Cures Act, TVAX may revise this policy at any time.