Clinical trials

Clinical trials are at the heart of our mission to develop groundbreaking medicines that improve lives. Discover more about them here.

Visit our Clinical Trials Portal

Clinical trials are a critical part of our journey to evaluate investigational treatments and seek approval from health authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

At Galapagos, we organize clinical trials in various therapeutic areas, conducting research that paves the way for innovative solutions.

Visit our Clinical Trials portal to explore the fascinating world of clinical trials. Discover how they’re set up and gain insights into what’s essential when considering participation.

Compassionate Use Program

Expanded Access

Galapagos is committed to advancing the development and commercialization of novel medicines. We highly encourage patients to take part in our clinical trials, as they play an indispensable role in generating the data needed for the evaluation and approval of investigational products.

In exceptional circumstances where patients are unable to participate in clinical trials and have exhausted all available treatment options, Galapagos may explore providing an investigational product through our “expanded access” program, also known as “compassionate use”.

For detailed information about our expanded access program, please refer to Galapagos’ policy on providing investigational products outside of clinical trials.

It’s important to note that at present, Galapagos does not have active compassionate use programs for any indications.

Innovating together!

Investigator Sponsored Research (ISR)

Galapagos supports external research activities that complement our product pipeline and clinical expertise, adding medical knowledge. This external research can supplement the comprehensive data generated in registration studies by supplying valuable information about the safety, efficacy, pharmacology and tolerability and economic value of our drug candidates and medicines.

Galapagos supports external research through unsolicited funding requests. These are evaluated through our Investigator Sponsored Research (ISR) process.

Note to Investigators

Dear Investigator,

Thank you for your interest in Investigator sponsored research (ISR). Kindly note that Galapagos is currently not supporting any new ISR proposals. New guidance on areas of interest and review timelines will be provided in due time. Please contact your local MSL should you want to further discuss.

Funding approval criteria

To be eligible for funding, the proposed research activity must be

  • in line with our product strategy and answering to named data gaps
  • intended to contribute knowledge to the medical community
  • budgeted reasonably and appropriately for the proposed work.

The ability and experience of the investigator(s) will be considered, and the feasibility of the study will be assessed.

Areas of interest & timelines

New guidance on areas of interest and review timelines will be provided in due time.

Process for ISR support

Your request will be reviewed by our cross-functional committee that may suggest to improve the scientific merit of the proposal and enhance consistency with Galapagos’ approval criteria described above. However, the study sponsor, the principal investigator will have full and final discretion and responsibility for all aspects of the study design, implementation, data analysis, and data dissemination, including compliance with all laws and regulations applicable to research sponsors.

The terms under which Galapagos will supply support are described in a signed contract. Galapagos gives no guarantees that the external research support supplied will fully fund the entirety of your work, and Galapagos is thus not liable for changes in budget after acceptance.

Our stories

More about our company, science and people

We curate a range of inspiring stories about how we are #LivingInnovation at Galapagos

Pipeline

Pioneering for patients!

We focus on the key therapeutic areas of immunology and oncology, where we have developed a deep scientific expertise in multiple drug modalities, including small molecules and cell therapies.

Galapagos Health

Explore our HCP Portal

Are you a healthcare professional? Visit our Galapagos Health portal for information about our therapeutic areas and indications, medical education, congresses and events and product information