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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

DateArticle
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

See also

Xaciato (clindamycin phosphate) Consumer information

Further information

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

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