IPM’s most clinically advanced microbicide candidate is dapivirine, also known as TMC120. Dapivirine is a highly potent ARV drug that acts as a non-nucleoside reverse transcriptase inhibitor (NNRTI).
How does dapivirine work?
As an NNRTI, dapivirine works by preventing HIV from replicating its genetic material after the virus enters a healthy cell.
What dosage forms of dapivirine are in development?
What is dapivirine’s clinical history?
Developed by Janssen Sciences Ireland UC (formerly Tibotec Pharmaceuticals), part of the Janssen Pharmaceutical Companies, dapivirine was initially tested as an oral treatment for HIV in 11 Phase I/II clinical trials. In 2004, Tibotec granted IPM a non-exclusive, royalty-free license to develop dapivirine as a microbicide for use in resource-poor countries, and IPM began its work on the monthly dapivirine ring. This agreement expanded in 2014, when Janssen granted IPM exclusive worldwide rights to dapivirine.
How is dapivirine being tested in IPM clinical trials?
IPM has studied the compound in 24 Phase I/II clinical trials in Africa, Europe and the United States. In all Phase I and Phase I/II studies to date, dapivirine has been found to be well-tolerated, providing the basis for larger studies that were designed to determine if IPM's dapivirine vaginal ring is safe and effective in preventing HIV. In 2012, IPM and clinical trial partner the Microbicide Trials Network (MTN) launched parallel Phase III long-term safety and efficacy studies of the monthly ring.
In February 2016, both studies found that the monthly dapivirine ring helped reduce women's HIV risk and was well-tolerated. Learn more about the Phase III results. In July 2016, two Phase IIIb open-label extension studies called DREAM and HOPE were launched to provide former Phase III participants with the ring for one year. Interim data from the open-label studies found increased ring use and suggest greater risk reduction compared to the Phase III studies. HOPE completed in October 2018 and DREAM completed in January 2019, with final results for both studies expected in 2019.
Could dapivirine be combined with other ARV microbicide candidates?
IPM developed a vaginal ring combining dapivirine with the drug maraviroc, an ARV that targets the CCR5 receptor and works by preventing the virus from attaching to healthy cells. The dapivirine-maraviroc ring was the first combination ARV ring to reach clinical trials. IPM is also exploring combinations with other potent ARVs such as DS003 and darunavir.
Could dapivirine be combined with drugs that combat other health risks?
IPM is also developing a three-month vaginal ring that combines dapivirine with a contraceptive hormone called levonorgestrel. This multipurpose prevention technology could provide women with a single, long-acting product that simultaneously prevents against the dual risks of HIV and unintended pregnancy.
Where can I get more information?
For information on current IPM clinical trials of dapivirine, visit our Clinical Trials page. For a bibliography of scientific papers and articles on IPM-supported research on dapivirine, visit our Publications & Media page.