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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 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.
4SC
Expected Application Timeframe
5 daysSingle-Patient EA Policies/Criteria
4SC focuses on the development of novel small molecule drugs for the treatment of cancer in indications with a high unmet medical need. Such drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies and provide a better quality of life. 4SC’s current product pipeline includes two programs in clinical development: resminostat and domatinostat.
We understand the interest of patients in accessing resminostat or domatinostat outside of clinical trials and prior to regulatory approval. However, participation in one of our clinical trials is currently the most appropriate way to access our investigational therapies. 4SC has decided not to offer Expanded Access (EA) to any of our investigational products at this time and will not approve EA requests.
We recognize the need for Expanded Access programs, and we will re-evaluate the status of our policy based on data from ongoing and future clinical trials.
If you have additional questions, please consult your physician or contact medical.request@4sc.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
4TEEN4 Pharmaceuticals GmbH
Single-Patient EA Policies/Criteria
4TEEN4 Pharmaceuticals GmbH is developing invobenitug for the treatment of cardiogenic shock.
Currently, invobenitug is in clinical development and has not yet been approved by the US FDA or any other global health authority. Invobenitug is an “investigational drug”.
This phase of development means that more clinical studies are required and that health authorities have not yet found invobenitug to be safe and effective for its specific use.
4TEEN4 trusts that clinical trial programs are the primary way to access invobenitug at this point prior to regulatory approval and we encourage patients to speak with their doctors to determine potential benefits, risks and eligibility to participate in such a clinical trial.
Given the early stage of development of invobenitug as well as the emergency clinical setting in which cardiogenic shock occurs, 4TEEN4 is not currently offering access to invobenitug outside of clinical trials.
In the future, 4TEEN4 may reassess whether to provide expanded access for invobenitug as it advances further in clinical trials and more data to support safety and effectiveness become available.
Posting this policy by 4TEEN4 does not guarantee access to invobenitug for any individual patient.
You can find additional information about 4TEEN4’s ongoing clinical trials on our website and by accessing https://clinicaltrials.gov.
If you have additional questions, please speak with your treating physician or contact 4TEEN4 at info@4teen4.de.