Clinical trials

Clinical trials are fundamental to the development of innovative medicines and devices that treat and prevent illness. The success of clinical trials depends on the participation of volunteers. Participants in clinical trials gain access to new research treatments not yet available to the public while helping others by contributing to medical research.

If you are a patient looking for information about clinical trials, VIVUS posts information about ongoing clinical trials on a government-mandated web page at www.clinicaltrials.gov,, which is a National Institutes of Health registry of ongoing trials that are open and intended for patients with serious or life-threatening diseases. Registration of these trials in this registry is required by law.

Please contact us to learn more about how we work with dedicated and compassionate healthcare providers to identify and advance treatment options that address serious unmet medical needs.

Expanded Access Policy

Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the U.S. Federal Food, Drug, and Cosmetic Act for provision of such a drug on an expanded access basis. The following is VIVUS’ expanded access policy for its drugs that are intended to treat serious diseases:

1. (1) Contact Information. VIVUS is not making its unapproved drugs available on an expanded access basis at this time. If you have any questions about VIVUS’ expanded access policy, please contact VIVUS Medical Affairs at 1-888-998-4887 or email: vivus@druginfo.com.
2. (2) Request Procedures. VIVUS is not making its unapproved drugs available on an expanded access basis at this time.
3. (3) General Criteria. VIVUS is not making its unapproved drugs available on an expanded access basis at this time. In the event that VIVUS decides to consider expanded access requests for VIVUS’ investigational drugs in the future, VIVUS will evaluate and respond to each expanded access request on a case-by-case basis.
4. (4) Anticipated Timing. VIVUS anticipates acknowledging receipt of any expanded access questions or requests within five business days of receipt. As noted above, VIVUS is not making its unapproved drugs available on an expanded access basis at this time.
5. (5) Clinicaltrials.gov. VIVUS is not currently making its unapproved drugs available for expanded access use. In the event that VIVUS decides to make its products available on an expanded access basis, this policy will be updated with a hyperlink to the relevant expanded access record(s) on clinicaltrials.gov after such records become active.

As authorized by the 21st Century Cures Act, VIVUS may revise this expanded access policy at any time. Additionally, the posting of this policy by VIVUS shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

Our product development pipeline

With demonstrated clinical development and commercialization expertise, VIVUS is dedicated to addressing the therapeutic needs of patients with serious medical conditions and life-limiting diseases. Our development pipeline is evolving as we advance new compounds through the clinic and to the market.

VI-0106, our lead pipeline program, is being developed to treat pulmonary arterial hypertension (PAH). We expect that VI-0106 will be the first in a series of exciting pipeline opportunities. We are identifying and pursuing additional molecules that have preliminary safety and efficacy data that may allow us to reduce our development risk and move more quickly toward the market.

We invite dedicated and compassionate healthcare providers to join our clinical community. Please contact us to learn more about how we work with healthcare providers to identify and advance treatment options that address serious unmet medical needs.