Millendo’s mission is to develop transformative treatments for patients living with endocrine diseases where there is a significant unmet medical need. In order to bring safe and effective treatments to patients, we conduct clinical trials during which we collect data about our investigational drugs. These data are then submitted to regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency, so that the treatments can be approved for patient use and made widely available.
The most appropriate way of accessing Millendo’s investigational drugs is through participation in one of our clinical trials. If you are interested in participating in a clinical trial for one of our product candidates, please submit your interest using the form provided on the Contact Us page, selecting “Clinical Trials – Patients” from the drop-down menu. A member of the Millendo team will respond to your inquiry.
Expanded Access Programs (EAPs) enable some patients with serious or life-threatening diseases, who would not have otherwise met the enrollment criteria for the clinical trials in progress, to gain access to investigational treatments prior to their approval by regulatory agencies. Currently, Millendo does not offer EAPs for its product candidates.
Millendo acknowledges that there are rare cases where patients cannot participate in a clinical trial and may benefit from access to our investigational drugs. Therefore, Millendo will consider requests for Compassionate Use access to our investigational drugs on a case-by-case basis.
A patient may be considered for Compassionate Use access to an investigational treatment based upon the following criteria, which represent minimum requirements. Other conditions may apply based upon the specific investigational treatment and circumstances.
- The request for Compassionate Use is submitted by the patient’s treating physician, who is appropriately licensed, and must also agree to comply with safety and monitoring requirements
- The patient has an imminently serious or life-threatening illness with no comparable or satisfactory alternative therapies
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational medicine and the benefit outweighs the known or anticipated risks
- The investigational medicine is currently in clinical development and is currently being studied in humans
- There is agreement between the patient’s treating physician and the medical lead at Millendo that use of the investigational drug has reasonable potential to provide a benefit to the patient with an acceptable level of risk
- The investigational medicine required is available for treatment use, and providing it will not compromise the investigational medicine’s clinical development program, its regulatory approval process, nor its supply for other uses
- Any use of a Millendo investigational product outside a clinical study in any country must be in accordance with local laws and regulations governing such programs, including Millendo policies and procedures.
If you are a treating physician with a patient you believe meets the above criteria and are interested in access to an investigational drug, please submit your interest using the form provided on the Contact Us page, selecting “Compassionate Use” from the drop-down menu. A member of the Millendo team will respond to your inquiry.