TheraRadar
Data updated: May 26, 2026

CLEOCIN (clindamycin phosphate)

Infectious Disease Approved 1980-07-09

CLEOCIN is indicated for the treatment of Bacterial Vaginosis.

Source: FDA Label • Pfizer
6
Indications
--
Phase 3 Trials
45
Years on Market

Details

Status
Discontinued
First Approved
1980-07-09
Routes
TOPICAL, VAGINAL, ORAL
Dosage Forms
SWAB, SUPPOSITORY, FOR SOLUTION, CREAM, CAPSULE

CLEOCIN Approval History

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Original
New Indication
New Form
Label Update
77 FDA actions from 1980 to 2025 · 2 indication expansions
Nov 2025 SUPPL
Label · Labeling
Jul 2022 SUPPL
Label · Labeling
May 2022 SUPPL
Label · Labeling

What CLEOCIN Treats

1 indications

CLEOCIN is approved for 1 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bacterial Vaginosis
Source: FDA Label

CLEOCIN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

2

Same target(s), different indications — where else is this mechanism being explored?

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CLEOCIN

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CLINDESSE
CLINDAMYCIN PHOSPHATE
1 shared
PADAGIS US
Shared indications:
Bacterial Vaginosis
NUVESSA
METRONIDAZOLE
1 shared
CHEMO RESEARCH SL
Shared indications:
Bacterial Vaginosis
SOLOSEC
SECNIDAZOLE
1 shared
EVOFEM INC
Shared indications:
Bacterial Vaginosis
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT04469075 19-342 Ph 2 active not recruiting Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields
NCT04321070 CLPL 1907 Ph 1 completed Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
NCT00616330 CBC-302-602-622467 Ph 3 completed Vaginal Infection Study
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CLEOCIN FDA Label Details

Indications & Usage

FDA Label (PDF)

CLEOCIN is indicated for the treatment of Bacterial Vaginosis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.