Technology name
Last update: Jul 2026Dapivirine Monthly Vaginal Ring
Sponsor(s)
Type of technology
Intra-vaginal ring
Administration route
Topical (Vaginal)
Development state and regulatory approval
Dapivirine (DPV)
Marketed
Positive scientific opinion from the European Medicines Agency for use among women ages 18 and older in developing countries. in WHO guidelines
Description
Silicone matrix vaginal ring delivering dapivirine over one month.
Developer(s)
International Partnership for Microbicides
IPM's mission is to develop HIV prevention products and other sexual and reproductive health technologies for women, and to make them available and accessible where they are urgently needed.
Population Council
The Population Council is a leading research organization dedicated to building an equitable and sustainable world that enhances the health and well-being of current and future generations. We generate ideas, produce evidence, and design solutions to improve the lives of underserved populations around the world.
Johnson & JohnsonJohnson & Johnson
Technology highlight
The ring is made of a flexible silicone polymer and contains the ARV dapivirine, an NNRTI, which is dispersed in the silicone matrix and slowly released over the course of a month. The ring delivers dapivirine directly at the site of potential HIV infection, with low systemic absorption. Women insert the flexible, long-acting ring themselves into the vagina and replace it every month.
Illustration(s)
Technology main components
Dapivirine 25 mg and silicone
9 to 13 USD/ring
Safety, Efficacy and Evidence Summary
There were no safety concerns with long-term use of the ring in Phase III clinical studies. Data from two open-label (Phase IIIB) studies show a similar favorable safety profile as do 12 smaller safety studies.
Not provided
Not provided
Not provided
APIs compatibility profile
Dapivirine
Not provided
Not provided
< 10 wt%
1 single API : Still being investigated
Not provided
Dapivirine LogP = 5.6
Scale-up and manufacturing prospects
current scale: ~9000 rings future scale (2022 and beyond): ~45000 rings
injection molding machine mixer automated inspection machine automated packaging machine
GMP ISO class 8 area
HPLC tensile tester dissolution apparatus analytical balance
Excipients & delivery device(s)
silicone elastomer for extended use
excipient has been included in regulatory dossier for product
No residual solvent used
Silicone vaginal ring
Additional features
- Drug-eluting
- Removable
- Molded
- Room temperature storage
- At least 1 year shelf life
Releases dapivirine over a one-month period
Not Applicable
ICH Climate Zone IV (A/B)
5 years shelf life This product does not require specific temperature storage conditions. Store in the original package to protect from light.
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
Potential associated API(s)
Use of technology
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Self-administered
Monthly
Targeted user groups
- Adolescents
- Adults
- Female
Yes
Yes
Yes
Women at substantial risk of contracting HIV through receptive vaginal sex
microbicide
Marketed
Not provided
Prevention of HIV infection through vaginal sex
women older than 18 at substantial risk of contracting HIV through vaginal sex
1 month
Positive scientific opinion from the European Medicines Agency for use among women ages 18 and older in developing countries. in WHO guidelines
