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Xaciato FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 8, 2021.

FDA Approved: Yes (First approved December 7, 2021)
Brand name: Xaciato
Generic name: clindamycin phosphate
Dosage form: Vaginal Gel
Previous Name: DARE-BV1
Company: Daré Bioscience, Inc.
Treatment for: Bacterial Vaginosis

Xaciato (clindamycin phosphate) is a topical lincosamide antibacterial for the vaginally-administered treatment of bacterial vaginosis in female patients 12 years of age and older.

  • Xaciato is a thermosetting bioadhesive hydrogel formulation of clindamycin phosphate 2% for the treatment of bacterial vaginosis via a single application. It is a viscous liquid designed to undergo solution to gel (sol-to-gel) transition using body temperature as the trigger. This property allows the product to be more easily directed to the site of infection.
  • Xaciato is administered once intravaginally as a single dose at any time of the day.
  • Xaciato may cause serious adverse reactions including Clostridioides difficile-associated diarrhea. Common adverse reactions include vulvovaginal candidiasis and vulvovaginal discomfort.

Development timeline for Xaciato

Dec  7, 2021Approval FDA Approves Xaciato (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis
Aug  9, 2021Daré Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis
Dec  7, 2020Daré Bioscience Announces Positive Topline Results From DARE-BVFREE, a Phase 3 Trial of DARE-BV1 in Patients Diagnosed with Bacterial Vaginosis
Mar 10, 2020Daré Bioscience Receives FDA Fast Track Designation for DARE-BV1 for the Treatment of Bacterial Vaginosis
Aug 12, 2019Daré Bioscience Receives QIDP Designation from the FDA for DARE-BV1 for the Treatment of Bacterial Vaginosis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.