TheraRadar
Data updated: May 26, 2026

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE (clindamycin phosphate)

Trial Activity: Expansion 1 active trials
Dermatology Approved 2017-04-20

Clindamycin phosphate is a topical medication that treats acne vulgaris. It is used for patients with skin breakouts, though physicians must carefully consider its use due to the risk of severe side effects like bloody diarrhea and colitis. This medication helps manage acne when a healthcare provider determines it is the most suitable option among available therapies.

Source: FDA Label • Baxter

How CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Works

The specific way clindamycin phosphate works to improve acne is currently unknown. While the medication is used to manage this condition, the exact biological mechanism of action has not been established.

Development Insights

Memorial Sloan Kettering Cancer Center conducting 1 trials (33%)
6 indications explored (Moderate)
glioblastoma (1 trials)
recurrent glioblastoma (1 trials)
skin toxicity (1 trials)
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2017-04-20
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
21 FDA actions from 2017 to 2022
Sep 2022 SUPPL
Label · Labeling
Feb 2021 SUPPL
Label · Labeling
Aug 2019 SUPPL
Label · Labeling

What CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Treats

1 indications

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acne Vulgaris
Source: FDA Label

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Competitive Set

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

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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
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Active Pipeline

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Key Completed Trials

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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.

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Acne Vulgaris.

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Data Sources

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment