At Janssen, we are often asked how patients with serious diseases may potentially obtain medicines not yet approved by government health authorities (investigational medicines).
“Pre-approval access” is the term used within Janssen for any access to an investigational medicine prior to its approval.
The main pathway for patient access to Janssen’s investigational medicines is to enroll in a clinical trial. Information about ongoing Janssen clinical trials can be found at Janssen Global Trial Finder and ClinicalTrials.gov.
If a clinical trial is not available or a patient does not qualify for a clinical trial, there may be another option. A patient’s treating physician may submit an individual request for access to an investigational medicine (also known as compassionate use). Janssen reviews each such request, and makes decisions on an individual basis by evaluating factors that include but are not limited to:
- The patient is not eligible or cannot participate in a clinical trial
- The patient must have a serious or life-threatening disease or condition
- No alternative therapies are available, or the patient must have exhausted all such therapies
- Potential benefits of the investigational treatment outweigh the potential risks
- Country-level laws and regulations
- Availability of medication supply
While all pre-approval access requests are considered in a fair and just manner, please understand, submitting a request does not guarantee that access will be granted. To learn more about our policies and procedures please click here.
The investigational medicines listed below may be considered for pre-approval access requests. To learn more about the active pre-approval access programs in the United States, please click each investigational medicine name to view the corresponding registration record on ClinicalTrials.gov.
For more information about the active pre-approval access programs outside of the United States, please contact your Janssen local country office by clicking here.
*This list is up-to-date as of September 8, 2020, and is subject to change.
Treating physicians who wish to submit a pre-approval access request may do so by visiting the Janssen Managed Access Portal.
For more information about the medicines listed above or any other Janssen medicine, please contact Janssen Medical Information via:
In the United States, please call 1-800-JANSSEN or email: [email protected].
Outside of the United States, please contact your Janssen local country office via our Contact Us page.