TheraRadar
Data updated: May 26, 2026

ORACEA (doxycycline)

Dermatology Approved 2006-05-26

Oracea is a tetracycline-class medication that helps adult patients with the inflammatory lesions of rosacea, specifically papules and pustules. It is used to manage these specific skin symptoms rather than generalized redness, visible blood vessels, or the ocular components of the condition. This particular formulation is not used to treat or prevent bacterial infections or other microbial diseases.

Source: FDA Label • GALDERMA LABS LP • Tetracycline-class Drug
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ORACEA Works

Although Oracea belongs to the tetracycline class of drugs, the specific way it works to improve inflammatory rosacea lesions is currently unknown. It has not been established how the medication targets or reduces the papules and pustules associated with this skin condition.

Source: FDA Label
1
Indication
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2006-05-26
Patent Cliff
2027

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

GALDERMA LABS LP
Active Ingredient: DOXYCYCLINE

ORACEA Approval History

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
8 FDA actions from 2006 to 2025
Apr 2025 SUPPL
Label · Labeling
FDA Letter Label
Dec 2021 SUPPL
Label · Labeling
FDA Letter Label
Sep 2015 SUPPL
Mfg · Manufacturing (CMC)

What ORACEA Treats

1 indications

ORACEA is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rosacea
Source: FDA Label

ORACEA Competitive Set

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

Indication competitors

1

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

EMROSI
JOURNEY
2024 1 indic.

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 ORACEA

3 of 12

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

CLOBEX
CLOBETASOL PROPIONATE
1 shared
GALDERMA LABS LP
Shared indications:
Rosacea
EMROSI
MINOCYCLINE HYDROCHLORIDE
1 shared
JOURNEY
Shared indications:
Rosacea
EPSOLAY
BENZOYL PEROXIDE
1 shared
MAYNE PHARMA
Shared indications:
Rosacea
View all 12 similar drugs Pro
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Clinical Trial Registry

102 trials
Trial Sponsor ID Phase Status Title
NCT07498010 20251283 Ph 2 not yet recruiting Doxycycline Use in Post-Operative Seromas
NCT04310930 FORMaT U1111-1209-0672 Ph 2, Ph 3 recruiting Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
NCT06120140 COCOON 61186372NSC2007 61186372NSC2007, 2023-505863-35-00 Ph 2 active not recruiting Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
NCT01631617 120159 12-AR-0159 Ph 2 recruiting Effects of Treatments on Atopic Dermatitis
NCT06545656 results posted STUDY00007429 CDC-STUDY00007429 Ph 4 completed Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens
NCT01820910 IELSG39 Ph 2 completed Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment
NCT02874430 results posted 16D.317 JT 8988 Ph 2 terminated Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
NCT07544251 IRI26_02_SarecyclinevsDoxy Ph 4 recruiting Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
NCT03532464 CHLAZIDOXY CHUBX 2016/26 Ph 4 completed Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection
NCT03435952 2017-0719 NCI-2018-00757 Ph 1 active not recruiting Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT
NCT06582966 results posted STUDY00019944 5R01AI145971-04 Ph 4 completed Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya
NCT05840159 22-0019 5UM1AI148684-03 Ph 4 completed A Study of Doxycycline to Treat Chlamydial Infection
NCT07485010 FORMaT-EVOLVE FORMaT002 Ph 2 not yet recruiting Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
NCT05980871 results posted 202206138MIND Ph 4 terminated Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline
NCT02713607 867744 Ph 1, Ph 2 active not recruiting Lipidome and Microbiome Profile of Acne
NCT03076281 results posted 16D.703 JT 9611 Ph 2 terminated Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma
NCT05382208 DEPTH 22-02-307/22-04024723 DEPTH-001, UH3HL154944 Ph 2 active not recruiting Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
NCT01917721 2013-005 Ph 2 active not recruiting Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease
NCT07306234 DOMINO DOMINO KNIH Ph 4 not yet recruiting Doxycycline vs. Macrolide for MRMP (DOMINO)
NCT04838717 SY-DOXY APHP180588 2019-003278-21 Ph 3 completed Clinical Trial of Doxycycline VS BPG for Early Syphilis (SY-DOXY)
NCT07230028 DoBo DoBo 2025-523078-18-00 Ph 4 not yet recruiting Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.
NCT07164131 AD-CAP 24-006503 Ph 4 recruiting Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
NCT05853120 DOXY-PEP results posted STUDY00005552 75D30122C14484 Ph 4 completed Doxy-Post-exposure Prophylaxis
NCT05473520 Doxy-TB Phase III Doxy-TB Ph 3 recruiting Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis
NCT06446245 DIRECT 2024/00039 Ph 2 recruiting Adjunctive Doxycycline for Central Nervous System Tuberculosis
NCT04297592 22-001273 Ph 4 enrolling by invitation Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
NCT03162497 OPHT-030815 Ph 4 completed Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction
NCT06477185 TALF-TB Mak-SOMREC-2021-177 Ph 2 recruiting Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
NCT02864550 BritishCCDC2 Ph 4 completed Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex with Men (DaDHS)
NCT05874570 rjhy20230002 Ph 4 recruiting Doxycycline for Helicobacter Pylori Rescue Treatment
NCT05296629 MVOR-1 results posted DFD-29-CD-004 Ph 3 completed A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
NCT05343455 MVOR-2 results posted DFD-29-CD-005 Ph 3 completed A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
NCT05111002 results posted STUDY00012927 Ph 1, Ph 2 terminated Lefamulin for M. Genitalium Treatment Failures
NCT03474458 AC-012-EU Ph 2, Ph 3 terminated A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy
NCT04050540 dPEP-KE results posted STUDY00007487 R01AI145971 Ph 4 completed Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
NCT06422221 Doxycycline Regimen Ph 4 not yet recruiting An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
NCT02553473 results posted 2015-001481-25 Ph 3 completed Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
NCT03334682 FASCE RC16_0467 Ph 3 completed Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
NCT02775695 results posted PRO28944 Ph 2 completed Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer
NCT04860505 results posted STUDY00002242 0000058968 Ph 4 completed Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
NCT01874860 BCC-OHN-GI-13 Ph 2 completed Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients
NCT01872715 results posted GLI.04.SPR.US10233 Ph 4 completed Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
NCT01426269 results posted US10183 Ph 4 completed Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
NCT01308619 results posted US10150 Ph 4 completed Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo
NCT04167085 NOSTRIL results posted 16-001827 Ph 4 completed NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial
NCT04371952 DYNAMIC RC20_0191 Ph 3 withdrawn DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19)
NCT01756833 N-TA^3CT results posted HP-00051170 R01AG037120 Ph 2 completed Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
NCT05061732 B2021-376 Ph 4 recruiting Helicobacter Pylori Eradication and Follow-up
NCT02207556 DUAL results posted 22850 KL2TR001438, K23HL141445 Ph 2 completed Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
NCT02929121 LeDoxy-India LeDoxy2015_India Ph 3 completed A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in India

Showing 50 of 102 trials

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Key Completed Trials

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Trial Timeline

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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.

ORACEA FDA Label Details

Indications & Usage

FDA Label (PDF)

ORACEA is indicated for the treatment of Rosacea.

View full patent landscape →
1 OB patents · 1 families · 41 international docs across 9 countries

ORACEA Patents & Exclusivity

Latest Patent: Dec 2027

Patents (1 active)

US7749532 Expires Dec 19, 2027
Source: FDA Orange Book

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Revenue Insights

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  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 12 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA050805 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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