TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

CLEOCIN

CLINDAMYCIN PHOSPHATE
Infectious Disease Approved 1980-07-09
6
Indications
--
Phase 3 Trials
45
Years on Market

Details

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

CLEOCIN Approval History

Loading approval history...

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 Competitors

Pro

3 other drugs also target 23S rRNA. Compare mechanisms, indications, and trial activity.

Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications โ†’ Date = Patent/exclusivity expiry

Competitors share the same molecular target (23S rRNA). Earlier expiry dates signal biosimilar/generic opportunities.

๐Ÿ”ฌ

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
โญ

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
๐Ÿ“Š

Trial Timeline

Full development history with FDA approval milestones

Loading...
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

Pro

Indications & Usage

FDA Label (PDF)

CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) mar...

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

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