DOXY 100 (doxycycline hyclate) · Fresenius Kabi
DOXY 100 is an injectable antibiotic used for patients with a wide variety of bacterial infections, ranging from respiratory issues to tick-borne illnesses. It helps patients with conditions like Rocky Mountain spotted fever, pneumonia, and certain sexually transmitted infections. Healthcare providers prescribe it when bacteria are proven or strongly suspected to be susceptible to the drug, often relying on culture results to ensure the medication remains effective against resistant strains.
How DOXY 100 Works
This drug works by binding to the 30S ribosomal subunit within bacteria, which inhibits their ability to synthesize proteins. By stopping this protein production, the medication prevents the growth and spread of a broad range of Gram-positive and Gram-negative bacteria. This bacteriostatic effect allows the body to manage the infection more effectively.
Details
- Status
- Prescription
- First Approved
- 1983-12-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DOXY 100 Approval History
What DOXY 100 Treats
26 indicationsDOXY 100 is approved for 26 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rocky Mountain Spotted Fever
- Typhus Fever
- Q Fever
- Rickettsialpox
- Tick Fevers
- Mycoplasma pneumoniae Infection
- Psittacosis
- Ornithosis
- Lymphogranuloma Venereum
- Granuloma Inguinale
- Relapsing Fever
- Chancroid
- Cholera
- Brucellosis
- Escherichia coli Infection
- Enterobacter aerogenes Infection
- Haemophilus influenzae Infection
- Streptococcal Infection
- Staphylococcus aureus Infection
- Anthrax
- Gonorrhea
- Syphilis
- Yaws
- Vincent's Infection
- Amebiasis
- Trachoma
DOXY 100 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.
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Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
DOXY 100 FDA Label Details
Indications & Usage
FDA Label (PDF): To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline for Injection, US...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.