ACTICLATE (doxycycline hyclate)
ACTICLATE 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.
Details
- Status
- Prescription
- First Approved
- 2014-07-25
- Routes
- ORAL
- Dosage Forms
- TABLET
ACTICLATE Approval History
What ACTICLATE Treats
10 indicationsACTICLATE is approved for 10 conditions since its original approval in 2014. 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
ACTICLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 ACTICLATE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ACTICLATE FDA Label Details
Indications & Usage
FDA Label (PDF)ACTICLATE 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.