TheraRadar
Data updated: Jun 28, 2026

ACTICLATE CAP (doxycycline hyclate) · CHARTWELL RX

Infectious Disease Approved 2016-04-26

ACTICLATE CAP is FDA-approved to treat 28 conditions (same as DOXYCYCLINE HYCLATE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2016-04-26
Routes
ORAL
Dosage Forms
CAPSULE

Companies

CHARTWELL RX
Active Ingredient: DOXYCYCLINE HYCLATE

ACTICLATE CAP Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2016 to 2025
Mar 2025 SUPPL
Label · Labeling
FDA Letter Label
Mar 2020 SUPPL
Label · Labeling
FDA Letter Label
Dec 2019 SUPPL
Label · Labeling
FDA Letter Label

What ACTICLATE CAP Treats

28 indications

ACTICLATE CAP is approved for 28 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rocky Mountain Spotted Fever
  • Typhus
  • Q Fever
  • Rickettsialpox
  • Mycoplasma pneumoniae Infection
  • Lymphogranuloma Venereum
  • Psittacosis
  • Trachoma
  • Inclusion Conjunctivitis
  • Nongonococcal Urethritis
  • Relapsing Fever
  • Chancroid
  • Plague
  • Tularemia
  • Cholera
  • Brucellosis
  • Bartonellosis
  • Granuloma Inguinale
  • Anthrax
  • Gonorrhea
  • Syphilis
  • Yaws
  • Listeriosis
  • Vincent's Infection
  • Actinomycosis
  • Clostridium Infection
  • Amebiasis
  • Malaria

Same approved indications as DOXYCYCLINE HYCLATE (same active ingredient).

Source: FDA Label
📋

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

Pro

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.

ACTICLATE CAP FDA Label Details

Indications & Usage

FDA Label (PDF)

ACTICLATE CAP is FDA-approved to treat 28 conditions — same approved indications as DOXYCYCLINE HYCLATE.

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Data Sources

FDA Approval: NDA208253 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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