ARESTIN (minocycline hydrochloride)
ARESTIN (minocycline hydrochloride) is indicated as an adjunct to scaling and root planing (SRP) procedures for the reduction of pocket depth in patients with adult periodontitis. It may be utilized as part of a comprehensive periodontal maintenance program that includes professional cleanings and diligent oral hygiene.
How ARESTIN Works
The specific mechanism by which ARESTIN reduces pocket depth when used as an adjunct to scaling and root planing is unknown. Minocycline, the active ingredient, is a member of the tetracycline class of antibiotics and exerts its bacteriostatic effect by inhibiting protein synthesis.
Details
- Status
- Prescription
- First Approved
- 2001-02-16
- Routes
- DENTAL
- Dosage Forms
- POWDER, EXTENDED RELEASE
ARESTIN Approval History
What ARESTIN Treats
1 indicationsARESTIN is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Periodontitis
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06246396 | IRB202301939 2R01HL132448-05A1 | Ph 4 | recruiting | Antihypertensive Mechanisms of Minocycline in Resistant Hypertension |
| NCT05826912 APT-TBI-01 | APT-TBI-01 | Ph 2 | enrolling by invitation | Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury |
| NCT02203552 results posted | OSU-13165 NCI-2014-00851 | Ph 2 | completed | Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer |
| NCT02297412 results posted | RU221408I NCI-2016-01592, RU221408I | Ph 2 | completed | Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel |
| NCT04076098 | RP139-02/18 | Ph 4 | completed | Locally Delivered Minocycline in Advanced Periodontitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ARESTIN FDA Label Details
Indications & Usage
FDA Label (PDF)ARESTIN is indicated for the treatment of Periodontitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.