TheraRadar
Data updated: Nov 8, 2026

MINOCYCLINE HYDROCHLORIDE · Novartis

Generic · see ARESTIN
Dermatology Approved 1971-06-30

MINOCYCLINE HYDROCHLORIDE is FDA-approved to treat 1 condition (same as ARESTIN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
33
Indications
--
Phase 3 Trials
55
Years on Market

Details

Status
Prescription
First Approved
1971-06-30
Routes
Oral, ORAL, INJECTION
Dosage Forms
Tablet, Extended Release, TABLET, EXTENDED RELEASE, TABLET, INJECTABLE, CAPSULE

Companies

Novartis IMPAX LABS Sun Pharma NEXUS REGCON HOLDINGS TORRENT PHARMOBEDIENT Lupin RISING ZYDUS PHARMS TRIAX PHARMS ZYDUS WATSON LABS TEVA Aurobindo Pharma ALKEM LABS LTD WATSON LABS CHARTWELL RX STRIDES PHARMA INTL Teva
Active Ingredient: MINOCYCLINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE Approval History

1983
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Original
New Indication
New Form
Label Update
658 FDA actions from 1982 to 2026
Oct 2026 SUPPL
Label · Labeling
Sep 2026 SUPPL
Label · Labeling
May 2026 SUPPL
Label · Labeling

What MINOCYCLINE HYDROCHLORIDE Treats

1 indications

MINOCYCLINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Periodontitis

Same approved indications as ARESTIN (same active ingredient).

Source: FDA Label
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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
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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

ClinicalTrials.gov ↗ Pro

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.

MINOCYCLINE HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

MINOCYCLINE HYDROCHLORIDE is FDA-approved to treat 1 condition — same approved indications as ARESTIN.

Looking for the branded version?

ARESTIN

Full clinical data, patents, trials, and competitive landscape for minocycline hydrochloride.

See ARESTIN

Data Sources

FDA Approval: ANDA090422 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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