TheraRadar
Data updated: Jun 28, 2026

DEMECLOCYCLINE HYDROCHLORIDE · EPIC PHARMA LLC

Infectious Disease Approved 1960-01-14

Demeclocycline HCl tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae Lymphogranuloma venereum due to Chlamydia trachomatis Psittacosis (Ornithosis) due to Chlamydia psittaci Trachoma due to Chlamydia trachomatis , althou...

Source: FDA Label
NDA
Small Molecule
5
Indications
--
Phase 3 Trials
66
Years on Market

Details

Status
Prescription
First Approved
1960-01-14
Routes
ORAL
Dosage Forms
TABLET

DEMECLOCYCLINE HYDROCHLORIDE Approval History

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
18 FDA actions from 2004 to 2016
May 2016 SUPPL
Label · Labeling
Aug 2015 ORIGINAL
Update
Feb 2013 SUPPL
Label · Labeling

What DEMECLOCYCLINE HYDROCHLORIDE Treats

23 indications

DEMECLOCYCLINE HYDROCHLORIDE is approved for 23 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rocky Mountain Spotted Fever
  • Typhus Fever
  • Q Fever
  • Rickettsialpox
  • Tick Fevers
  • Mycoplasma pneumoniae Respiratory Tract Infection
  • Lymphogranuloma Venereum
  • Psittacosis
  • Trachoma
  • Inclusion Conjunctivitis
  • Nongonococcal Urethritis
  • Relapsing Fever
  • Chancroid
  • Plague
  • Tularemia
  • Cholera
  • Campylobacter fetus Infection
  • Brucellosis
  • Bartonellosis
  • Granuloma Inguinale
  • Escherichia coli Infection
  • Enterobacter aerogenes Infection
  • Haemophilus influenzae Respiratory Tract Infection
Source: FDA Label

DEMECLOCYCLINE HYDROCHLORIDE Competitive Set

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Drugs Similar to DEMECLOCYCLINE HYDROCHLORIDE

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CHARTWELL RX
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Rocky Mountain Spotted FeverTyphus FeverQ Fever +16 more
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Fresenius Kabi
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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.

DEMECLOCYCLINE HYDROCHLORIDE FDA Label Details

Indications & Usage

Demeclocycline HCl tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae Lymphogranuloma venereum due to Chlamydia trachomatis Psittacosis (Ornithosis) due to Chlamydia psittaci Trachoma due to Chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence Inclusion conjuncti...

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Data Sources

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