4TEEN4 Pharmaceuticals GmbH
EA Policies for Single Patient

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.