NDAVAGINALCREAM
Approved
Nov 2004
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
4
Data completeness
7/8 — Comprehensive
CLINDESSE (clindamycin phosphate) by Design Pharmaceuticals is [see clinical pharmacology, microbiology ()] . Approved for acne vulgaris, bacterial vaginosis. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLINDESSE is a vaginal cream formulation of clindamycin phosphate, a lincosamide antibiotic approved in 2004 for treating acne vulgaris and bacterial vaginosis. It works by inhibiting bacterial protein synthesis to eliminate susceptible pathogens. The vaginal route of administration provides localized delivery for gynecological infections.
$0.038MPart D
LOE Approaching7mo to LOEProduct is approaching loss of exclusivity with minimal current Part D claims, indicating a mature asset with likely declining commercial momentum and reduced headcount allocation.
Mechanism of Action
[see Clinical Pharmacology, Microbiology ()] .
Indications (2)
Clinical Trials (4)
Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris
Started Oct 2025
200 enrolled
Acne Vulgaris
Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
Started Jan 2017
22 enrolled
Actinic Keratosis
A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
Started Apr 2013
1,018 enrolled
Acne Vulgaris
W0265-104: A Single-Center, Evaluator-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial Evaluating the Photoallergic Potential of Topically Applied Clindamycin Phosphate 1.0% and Tretinoin 0.025% (CT Gel) in Healthy Volunteers
Started Nov 2008
64 enrolled
Acne Vulgaris
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.