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?
IPM is evaluating dapivirine-based products in three dosage forms: a monthly vaginal ring, now in parallel Phase III trials, a 90-day vaginal ring that combines dapivirine with a contraceptive, and a once-daily gel.
What is dapivirine’s clinical history?
Developed by Janssen Sciences Ireland UC (formerly Tibotec Pharmaceuticals), one 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 16 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 safe and well-tolerated, providing the basis for larger studies that will determine if the dapivirine-containing ring is safe and effective in preventing HIV. IPM and the Microbicide Trials Network (MTN) are conducting Phase III long-term safety and efficacy studies of the dapivirine vaginal ring as part of IPM's dapivirine ring licensure program, with results expected by 2016.
Could dapivirine be combined with other ARV microbicide candidates?
IPM is also developing dapivirine in combination with the drug maraviroc, an ARV that targets the CCR5 receptor and works by preventing the virus from attaching to healthy cells.
Could dapivirine be combined with drugs that combat other health risks?
IPM is also developing a 90-day vaginal ring that combines dapivirine with a contraceptive hormone called levonorgestrel. This multipurpose prevention technology could provide women with one product that 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.