Expanded Access

Accessing Investigational Medicines

We believe in supporting compassionate use of and expanded access to the investigational medicines we are developing for patients with serious or life-threatening diseases when and if it is appropriate to do so. This policy is at the core of our commitment to patients and health care providers.

If there is an urgent need for new treatment options prior to formal approval by regulatory health agencies, we will consider compassionate use access outside of a clinical trial when the following criteria are met:

  1. The patient must have a serious or life-threatening disease or condition.
  2. There must be an unmet medical need and alternative therapies are not available, or the patient must have exhausted all such alternative therapies.
  3. The patient is not eligible or cannot participate in an on-going or pending clinical trial.
  4. There is sufficient scientific evidence to demonstrate that the benefits of the investigational medicine outweigh the risks.
  5. Compassionate use access will not jeopardize the initiation, conduct, or completion of clinical investigations and the overall development program to support registration of the product.
  6. There is adequate supply of the investigational medicine.
  7. The treating physician making the request is licensed and qualified to administer the investigational medicine and agrees to comply with CymaBay requirements and local regulations governing pre-approval access and adhere to applicable laws and regulations.
  8. All necessary regulatory/ethics and institutional approvals have been obtained to allow administration.

Requests for access to investigation medicines must be made by a qualified and licensed physician through CymaBay Medical Information at expandedaccess@cymabay.com.

Our team will acknowledge such requests within approximately 5 business days of receipt of the request. All eligible requests will be evaluated by a review committee in a fair, unbiased manner.

Information about CymaBay clinical trials can be found here. This policy is not a guarantee of access to any investigational medicine. We reserve the right to revise or revoke this policy at any time.

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