Investigational Medicines for Pre-Approval Access Requests (also known as Compassionate Use)

At Johnson & Johnson Innovative Medicine, we are often asked how patients with serious diseases may potentially obtain medicines under development and not yet approved by government health authorities (investigational medicines). “Pre-approval access” is the term used by J&J IM for any access to an investigational medicine prior to its approval. Other terms used to describe pre-approval access include “compassionate use”, “named patient programs” or, “expanded access”.

The preferred and primary pathway for access to our investigational medicines is to enroll in a clinical trial. Information about ongoing J&J IM clinical trials can be found at Global Trial Finder. Additional information about ongoing clinical trials outside of J&J IM can be found on these sites (please note this list may not be exhaustive): United States, European Union, United Kingdom, Australia/New Zealand, China, Japan, Brazil, and Africa.

If a clinical trial is not an option, a patient’s treating physician may submit an individual request for pre-approval access for an investigational medicine. J&J IM reviews each request and makes decisions by evaluating factors that include but are not limited to:

• The patient has a serious or life-threatening disease or condition
• The patient is not eligible or cannot participate in a clinical trial
• No alternative therapies are available, or the patient’s disease has exhausted all available therapies
• Potential benefits of the investigational treatment outweigh the potential risks
• Country/Territory laws and regulations
• Availability of medication supply

Please note that only treating physicians may submit a request but that does not guarantee that access will be granted.

The investigational medicines in the table below are currently potential options for eligible patients. Treating physicians who wish to submit a request may do so by registering on the Janssen Managed Access Portal. We’re committed to providing an answer within 5-10 business days, assuming all required medical information has been submitted.

The table below is updated monthly, is up to date as of June 1, 2024, and is subject to change.

Additional information about country specific processes for requesting investigational medicines may be found here.

For more information about the medicines listed above or any other Johnson & Johnson medicines, the Medical Information Scientific Engagement Team at Janssen Scientific Affairs, LLC, a Johnson & Johnson company, at 1-800-526-7736. We are available Monday-Friday 9 AM-8 PM EST.

Outside of the United States, please contact your Johnson & Johnson Innovative Medicine local country office via our Contact Us page.