Overview
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. It is a second-generation tetracycline that was first discovered in 1967. Second-generation tetracyclines exhibit lesser toxicity than first-generation tetracyclines. Doxycycline is used to treat a wide variety of gram-positive and gram-negative bacterial infections. It is also used to treat acne and malaria.
Indication
Doxycycline is indicated for the treatment of various infections by gram-positive and gram-negative bacteria, aerobes and anaerobes, as well other types of bacteria, including: It is also used to treat infections caused by the following gram-negative microorganisms:
Associated Conditions
- Acinetobacter Infections
- Anthrax
- Bacterial Infection caused by Enterobacter aerogenes
- Bartonellosis
- Brucellosis
- Campylobacter Infection
- Chancroid
- Chlamydia Trachomatis Infection
- Early Lyme Disease
- Granuloma Inguinale
- Infection Due to Escherichia Coli
- Inhalational Anthrax
- Klebsiella Infections
- Lymphogranuloma Venereum
- Malaria caused by Plasmodium falciparum
- Nongonococcal urethritis
- Plague caused by Yersinia pestis
- Psittacosis
- Rectal infection caused by Chlamydia Trachomatis
- Relapsing fever caused by Borrelia recurrentis
- Respiratory Tract Infection Bacterial
- Rickettsial infectious disorders
- Severe Acne
- Sexually Transmitted Infections (STIs)
- Shigella Infection
- Trachoma inclusion conjunctivitis
- Tularemia
- Vibrio Cholerae Infection
- Acute Intestinal amebiasis
- Susceptible Bacterial Infections
- Uncomplicated endocervical infection
- Uncomplicated urethral infection
Research Report
A Comprehensive Monograph on Doxycycline (DB00254): Pharmacological Profile, Clinical Applications, and Safety Considerations
Introduction and Drug Identification
Overview and Classification
Doxycycline is a potent, broad-spectrum antibiotic belonging to the tetracycline class of antimicrobial agents.[1] Classified as a small molecule, it represents a significant advancement as a second-generation tetracycline, synthetically derived from its predecessor, oxytetracycline.[1] This specific chemical heritage confers a more favorable toxicity profile compared to first-generation tetracyclines, a factor that has contributed substantially to its widespread and enduring clinical use.[1]
The drug is approved for both human and veterinary applications and is also categorized as an investigational agent, reflecting a robust and ongoing pipeline of research into novel therapeutic uses.[1] Its clinical utility is notably multifaceted, extending well beyond its primary function as a bacteriostatic agent. Doxycycline possesses well-documented antiparasitic and anti-inflammatory properties, making it a versatile therapeutic tool capable of addressing a diverse range of pathological processes, from infectious diseases to chronic inflammatory conditions.[1]
Chemical and Physical Properties
The definitive identification of doxycycline is established through several key chemical and physical descriptors. It is uniquely identified by the Chemical Abstracts Service (CAS) Number 564-25-0 and the DrugBank Accession Number DB00254.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/17 | Phase 2 | Not yet recruiting | |||
2025/04/08 | Not Applicable | Not yet recruiting | Amina Aslam | ||
2025/03/25 | Phase 4 | Suspended | Westat | ||
2024/11/12 | Phase 2 | Recruiting | |||
2024/09/03 | Phase 4 | Completed | |||
2024/08/09 | Phase 4 | Completed | |||
2024/07/25 | N/A | Completed | |||
2024/06/27 | Phase 2 | Recruiting | |||
2024/06/21 | Phase 4 | Not yet recruiting | |||
2024/06/11 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Aphena Pharma Solutions - Tennessee, LLC | 71610-117 | ORAL | 100 mg in 1 1 | 10/31/2018 | |
H.J. Harkins Co., Inc. | 76519-1134 | ORAL | 100 mg in 1 1 | 3/11/2018 | |
A-S Medication Solutions | 50090-1462 | ORAL | 100 mg in 1 1 | 5/28/2025 | |
Tris Pharma Inc | 27808-234 | ORAL | 100 mg in 1 1 | 2/11/2022 | |
Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-996 | ORAL | 100 mg in 1 1 | 1/1/2023 | |
JG Pharma Inc. | 72143-211 | ORAL | 50 mg in 1 1 | 3/20/2019 | |
Bryant Ranch Prepack | 72162-2256 | ORAL | 20 mg in 1 1 | 12/27/2023 | |
RedPharm Drug, Inc. | 67296-0329 | ORAL | 100 mg in 1 1 | 3/1/2021 | |
Amneal Pharmaceuticals NY LLC | 69238-1100 | ORAL | 100 mg in 1 1 | 12/29/2023 | |
American Health Packaging | 62584-693 | ORAL | 100 mg in 1 1 | 9/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
APO-DOXY-TABS 100 mg | SIN08445P | TABLET, FILM COATED | 100 mg | 11/24/1995 | |
DOXYLINE CAPSULE 100 mg | SIN10340P | CAPSULE | 100 mg | 11/4/1998 | |
MICRODOX CAPSULE 100 mg | SIN08536P | CAPSULE | 100 mg | 2/5/1996 | |
DOXYLINE ENTERIC COATED CAPSULE 100 mg | SIN08388P | CAPSULE | 100 mg | 10/16/1995 | |
TETRADOX CAPSULE 100 mg | SIN06906P | CAPSULE | 100 mg | 3/20/1992 | |
DOXYCAP CAPSULE U.S.P. 100 mg | SIN08101P | CAPSULE | 100 mg | 4/5/1995 | |
DOXYMYCIN-100 CAPSULES 100 mg | SIN02205P | CAPSULE | 100mg | 6/29/1988 | |
MEDOMYCIN CAPSULE 100 mg | SIN00968P | CAPSULE | 100 mg | 5/10/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
APX-DOXYCYCLINE doxycycline100mg (as hydrochloride) tablet blister pack | 333669 | Medicine | A | 5/5/2020 | |
DOXIRIS doxycycline (as hydrochloride) 50mg tablet blister pack | 148805 | Medicine | A | 6/24/2008 | |
DOXSIG doxycycline 100mg (as hydrochloride) tablet blister pack | 148808 | Medicine | A | 6/24/2008 | |
DOXYLIN 100 doxycycline 100mg (as hyclate) tablet blister pack | 63509 | Medicine | A | 5/22/1998 | |
DOXSIG doxycycline (as hydrochloride) 50mg tablet blister pack | 148807 | Medicine | A | 6/24/2008 | |
APX-DOXYCYCLINE doxycycline (as hydrochloride) 50 mg tablet blister pack | 333670 | Medicine | A | 5/5/2020 | |
DOXYCYCLINE-WGR doxycycline (as hyclate) 100 mg tablet blister pack | 333671 | Medicine | A | 5/5/2020 | |
Doxycycline hyclate (as hydrochloride) 100 mg tablet bottle | 318991 | Medicine | A | 6/17/2019 | |
DOXYLIN 50 doxycycline 50mg (as hyclate) tablet blister pack | 63511 | Medicine | A | 5/22/1998 | |
DOXIRIS doxycycline 100mg (as hydrochloride) tablet blister pack | 148806 | Medicine | A | 6/24/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
RHO-DOXYCIN - CAP 100MG | rhodiapharm inc | 02144190 | Capsule - Oral | 100 MG / CAP | 12/31/1995 |
RHO-DOXYCIN TABS - 100MG | rhodiapharm inc | 02144204 | Tablet - Oral | 100 MG / TAB | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DOXICLAT 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Pierre Fabre Iberica S.A. | 50404 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
DOXIPIL 100 mg CAPSULAS DURAS | Laboratorio Reig Jofre, S.A. | 59345 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ORACEA 40 mg CAPSULAS DURAS DE LIBERACION MODIFICADA | Laboratorios Galderma S.A. | 73622 | CÁPSULA DURA DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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