TheraRadar
Data updated: May 26, 2026

MINOCYCLINE HYDROCHLORIDE

Dermatology Approved 1982-08-10
Jump to: Indications Approvals Trials Competitors Safety Patents
33
Indications
--
Phase 3 Trials
43
Years on Market

Details

Status
Discontinued
First Approved
1982-08-10
Routes
ORAL, INJECTION, Oral
Dosage Forms
TABLET, EXTENDED RELEASE, CAPSULE, INJECTABLE, TABLET, Tablet, Extended Release

Companies

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

MINOCYCLINE HYDROCHLORIDE Approval History

1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
649 FDA actions from 1982 to 2026
May 2026 SUPPL
Label · Labeling
Oct 2025 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling

What MINOCYCLINE HYDROCHLORIDE Treats

33 FDA approvals

Originally approved for its first indication in 1982 . Covers 33 distinct patient populations.

  • Other (33)
📋

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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

MINOCYCLINE HYDROCHLORIDE FDA Label Details

Looking for the branded version?

ARESTIN

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

See ARESTIN

Data Sources

FDA Approval: ANDA090024 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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