Tagworks products are investigational and have not been approved as safe and effective by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory agency. The effectiveness of investigational products in treating the intended condition is uncertain. At this time, Tagworks is focused on conducting clinical trials with the goal of making these therapies broadly available to patients with unmet medical needs.
Expanded Access (also known as compassionate use) provides investigational medicines to patients with serious or life-threatening conditions who are not eligible for clinical trials and lack alternative treatment options. Currently, Tagworks does not accept applications for expanded access. Our investigational products can only be accessed through participation in the ongoing clinical trials. We encourage patients to consult with their healthcare providers and consider participation in Tagworks’ clinical trials, which remains the most appropriate way to access our investigational therapies.
Additional details regarding Tagworks’ active clinical trials can be found at www.clinicaltrials.gov.
ClinicalTrials.gov URL
Acknowledgement
3 business days
Tagworks Pharmaceuticals, BV
EA Policies for Single Patient