TheraRadar
Data updated: May 26, 2026

LYMEPAK (doxycycline hyclate)

Infectious Disease Approved 2018-06-15
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-06-15
Routes
ORAL
Dosage Forms
TABLET

Companies

CHARTWELL PHARMA
Active Ingredient: DOXYCYCLINE HYCLATE

LYMEPAK Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2025
Mar 2025 SUPPL
Label · Labeling
FDA Letter Label
Jan 2019 SUPPL
Label · Labeling
FDA Letter Label
Jun 2018 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What LYMEPAK Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
📋

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

Pro

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.

LYMEPAK FDA Label Details

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Data Sources

FDA Approval: NDA209844 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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