Data updated: May 26, 2026
MONODOX (doxycycline)
Infectious Disease
Approved 1989-12-29
MONODOX 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 • CHARTWELL RX
1
Indication
--
Phase 3 Trials
36
Years on Market
Details
- Status
- Prescription
- First Approved
- 1989-12-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MONODOX Approval History
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Original
New Indication
New Form
Label Update
80 FDA actions from 1989 to 2025
Aug 2016 SUPPL
Mfg
Jan 1994 SUPPL
Mfg
Jun 1992 SUPPL
Mfg
Mar 1992 SUPPL
Label
Feb 1992 SUPPL
Mfg
Nov 1991 SUPPL
Label
Sep 1991 SUPPL
Mfg
Dec 1989 ORIGINAL
New Form
What MONODOX Treats
10 indicationsMONODOX is approved for 10 conditions since its original approval in 1989. 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
MONODOX Competitive Set
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Clinical Trial Registry
101 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 |
| 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 |
| NCT02927496 LeDoxy-Mali | LeDoxy2015_Mali | Ph 3 | completed | A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali |
Showing 50 of 101 trials
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Completed studies with published results, ranked by significance
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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.
MONODOX FDA Label Details
Indications & Usage
FDA Label (PDF)MONODOX 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.