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# Dare Bio Advancing Bacterial Vaginosis Therapy
- URL: https://www.fdaweb.com/dare-bio-advancing-bacterial-vaginosis-therapy/
- Published: 2019-08-12T12:00:00.000Z
- Updated: 2026-09-15T01:43:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144745

FDA has granted Dare Bioscience a qualified infectious disease product designation for its novel thermosetting hydrogel-containing clindamycin phosphate 2% and its use for treating bacterial vaginosis in women. The company says its thermosetting hydrogel formulation can result in better antibiotic delivery to the vaginal infection, which can lead to better clinical outcomes. In an investigator-initiated proof-of-concept study, the formulation demonstrated an 86% clinical cure rate in the evaluable subjects at the test-of-cure visit (day 7-14) after a single administration, it says. Dare intends to begin a pivotal Phase 3 clinical study in about 250 women in the fourth quarter.