TheraRadar
Data updated: May 26, 2026

DOXYCYCLINE HYCLATE

Infectious Disease Approved 1973-07-17

DOXYCYCLINE HYCLATE is indicated for the treatment of Rocky Mountain Spotted Fever; Typhus; Q Fever; Rickettsialpox; Tick Fever; Respiratory Tract Infection; Lymphogranuloma Venereum; Psittacosis; Trachoma; Inclusion Conjunctivitis.

Source: FDA Label • PRINSTON INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
73
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-07-17
Routes
ORAL, INJECTION, Injection
Dosage Forms
TABLET, DELAYED RELEASE, CAPSULE, TABLET, INJECTABLE, CAPSULE, DELAYED RELEASE, Injectable, CAPSULE, COATED PELLETS

Companies

PRINSTON INC ZYDUS LIFESCIENCES ALEMBIC ACELLA GLAND MUTUAL PHARM WATSON LABS Hikma Viatris HEATHER CHARTWELL Teva HERITAGE PHARMOBEDIENT AJANTA PHARMA LTD SUPERPHARM WARNER CHILCOTT Sun Pharma RISING AMNEAL PHARMS CO STERISCIENCE Aurobindo Pharma AVET LIFESCIENCES SLATE RUN PHARMA KINDOS Dr. Reddy's HERITAGE PHARMA PRECISION DOSE INC ASPIRO WEST-WARD PHARMS INT CHANGZHOU PHARM AMNEAL STRIDES PHARMA INTL PVT FORM INTERPHARM IMPAX LABS INC AMNEAL PHARMS Lupin BIONPHARMA PRAXGEN ZHEJIANG YONGTAI TORRENT PH HEALTH HALSEY PAR PHARM CHARTWELL MOLECULAR BAUSCH EPIC PHARMA LLC QUAD PHARMS ZYDUS PHARMS NOVEL LABS INC ORYZA NESHER PHARMS Apotex MACLEODS PHARMS LTD STRIDES PHARMA RANBAXY PLIVA
Active Ingredient: DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE Approval History

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Original
New Indication
New Form
Label Update
1014 FDA actions from 1973 to 2026
Apr 2026 SUPPL
Label · Labeling
Mar 2026 SUPPL
Label · Labeling
Feb 2026 ORIGINAL
Update

What DOXYCYCLINE HYCLATE Treats

10 indications

DOXYCYCLINE HYCLATE is approved for 10 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rocky Mountain Spotted Fever
  • Typhus
  • Q Fever
  • Rickettsialpox
  • Tick Fever
  • Respiratory Tract Infection
  • Lymphogranuloma Venereum
  • Psittacosis
Source: FDA Label

DOXYCYCLINE HYCLATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONTEPO
MEITHEAL
2025 2 indic.
ENFLONSIA
Merck
2025 1 indic.
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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.

Drugs Similar to DOXYCYCLINE HYCLATE

3 of 16

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACTICLATE
DOXYCYCLINE HYCLATE
10 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +7 more
DOXY 200
DOXYCYCLINE HYCLATE
10 shared
Fresenius Kabi
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +7 more
MONODOX
DOXYCYCLINE
10 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +7 more
View all 16 similar drugs Pro
📋

Clinical Trial Registry

7 trials
Trial Sponsor ID Phase Status Title
NCT03508232 DOXY-STEMI Ph 2 completed Doxycycline to Protect Heart Muscle After Heart Attacks
NCT04504123 202001041 Ph 2 recruiting MMP-9 Inhibition for Recalcitrant Wet AMD
NCT04582383 SD-ACNE R34AR074733-01A1 Ph 4 active not recruiting Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
NCT03397004 HHT 160517448 Award Number W81XWH-17-1-0429 Ph 2 completed Doxycycline for Hereditary Hemorrhagic Telangiectasia
NCT05399290 results posted STUDY00003269 Ph 4 completed Subantimicrobial Doxycycline in Acne
NCT04451330 DUAL results posted RD.06.SPR.202394 Ph 4 completed A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
NCT00635609 results posted PR-08607 Ph 4 completed Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

DOXYCYCLINE HYCLATE FDA Label Details

Indications & Usage

FDA Label (PDF)

DOXYCYCLINE HYCLATE is indicated for the treatment of Rocky Mountain Spotted Fever; Typhus; Q Fever; Rickettsialpox; Tick Fever; Respiratory Tract Infection; Lymphogranuloma Venereum; Psittacosis; Trachoma; Inclusion Conjunctivitis.

Looking for the branded version?

ACTICLATE

Full clinical data, patents, trials, and competitive landscape for doxycycline hyclate.

See ACTICLATE

Data Sources

FDA Approval: ANDA207494 → Label: DailyMed → Trials: ClinicalTrials.gov →

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