CLINICAL TRIALS PROFILE FOR DOXYCYCLINE

505(b)(2) Clinical Trials for doxycycline

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	National Institute for Medical Research, Tanzania	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.

All Clinical Trials for doxycycline

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000403 ↗	Doxycycline and OA Progression	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1996-09-01	This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs. Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.
NCT00000403 ↗	Doxycycline and OA Progression	Completed	National Institute on Aging (NIA)	Phase 3	1996-09-01	This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs. Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.
NCT00000403 ↗	Doxycycline and OA Progression	Completed	Indiana University	Phase 3	1996-09-01	This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs. Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.

Clinical Trial Conditions for doxycycline

Condition Name

Condition Name for doxycycline
Intervention	Trials
Acne Vulgaris	19
Rosacea	10
Helicobacter Pylori Infection	9

Condition MeSH

Condition MeSH for doxycycline
Intervention	Trials
Infections	31
Acne Vulgaris	27
Infection	26

Clinical Trial Locations for doxycycline

Trials by Country

Trials by Country for doxycycline
Location	Trials
United States	441
Canada	28
France	22
China	18
Egypt	13

Trials by US State

Trials by US State for doxycycline
Location	Trials
California	36
New York	34
Texas	26
Pennsylvania	25
Florida	22

Clinical Trial Progress for doxycycline

Clinical Trial Phase

Clinical Trial Phase for doxycycline
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for doxycycline
Clinical Trial Phase	Trials
Completed	196
Recruiting	75
Unknown status	35

Clinical Trial Sponsors for doxycycline

Sponsor Name

Sponsor Name for doxycycline
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	16
University Medical Centre Ljubljana	10
University of Washington	9

Sponsor Type

Sponsor Type for doxycycline
Sponsor	Trials
Other	545
Industry	101
NIH	47

Clinical Trials Update, Market Analysis, and Projection for Doxycycline

Last updated: October 26, 2025

Introduction

Doxycycline, a broad-spectrum tetracycline antibiotic, has been a cornerstone in the treatment of various bacterial infections for decades. Originally developed in the 1960s, its clinical utility spans respiratory tract infections, Lyme disease, cholera, and malaria prophylaxis. The evolving landscape of infectious diseases, coupled with emerging resistance patterns and novel therapeutic indications, continues to influence doxycycline’s clinical development and market trajectory. This analysis examines recent clinical trials, assesses current market dynamics, and projects future market trends for doxycycline.

Clinical Trials Update

Recent and Ongoing Trials

In recent years, the repositioning of doxycycline for multiple emerging infectious diseases and inflammatory conditions has spurred numerous clinical investigations.

• COVID-19 and Post-Acute Sequelae (Long COVID):
  Multiple studies evaluated doxycycline’s potential as an adjunct therapy for mild to moderate COVID-19 cases due to its anti-inflammatory properties. A noteworthy trial (NCT04638527) in early 2022 assessed doxycycline's efficacy in preventing progression to severe disease. Preliminary data suggested a modest reduction in symptom duration; however, results remain inconclusive to endorse widespread use.

• Lyme Disease:
  Doxycycline remains first-line therapy for early Lyme disease, with ongoing Phase IV post-marketing studies (e.g., NCT05499235) focusing on extended dosing durations and potential prevention of post-treatment Lyme disease syndrome (PTLDS).

• Chronic Periodontitis and Acne Rosacea:
  Non-antimicrobial low-dose doxycycline (LDD) formulations continue in clinical use, with trials exploring their anti-inflammatory effects for skin conditions (NCT03241577). These trials bolster doxycycline's repositioning as an adjunctive anti-inflammatory agent with reduced antimicrobial resistance risks.

• Malaria Prevention and Treatment:
  Trials are investigating doxycycline’s efficacy as part of combination regimens against resistant Plasmodium strains (NCT04298114). Regulatory bodies such as the CDC have endorsed doxycycline for malaria prophylaxis, with ongoing assessments to optimize dosing strategies.

Regulatory and Development Trends

The U.S. Food and Drug Administration (FDA) approved formulation changes, including a low-dose doxycycline (Periostat), tailored for inflammatory periodontal diseases. Several pharmaceutical companies are exploring new delivery systems, such as sustained-release formulations and topical applications, to diversify therapeutic indications.

Emerging Indications and Resistance Concerns

The growing concern over antibiotic resistance, particularly in tetracycline-resistant pathogens, directs clinical research toward understanding doxycycline’s penetrance issues and resistance mechanisms. Recent trials are focused on combination therapies to mitigate resistance development, especially in Lyme disease and respiratory infections.

Market Analysis

Current Market Landscape

Doxycycline maintains a robust market position globally. The global antibiotic market was valued at approximately USD 43 billion in 2022, with doxycycline accounting for a significant share, primarily due to its broad spectrum and cost-effectiveness.

• Market Segmentation:
  • Geography: North America dominates due to high prescription rates and extensive clinical use, followed by Europe and Asia-Pacific.
  • Application: Respiratory infections, skin conditions, and sexually transmitted infections led demand in 2022, with emerging applications in malaria and inflammatory diseases.
  • Formulation: Oral tablets (most common), capsules, and topical gels.

Driving Factors

• High Efficacy and Low Cost: Its longstanding track record and affordability sustain its demand.
• Expanding Clinical Applications: Investigations into non-traditional indications create new revenue streams.
• Generics Availability: Patent expirations, notably in 2010, led to a surge in generic doxycycline production, boosting accessibility and market penetration.

Market Challenges

• Antibiotic Resistance: Increasing resistance among Acinetobacter, Staphylococcus aureus, and Pseudomonas aeruginosa strains constrains clinical utility in certain infections.
• Regulatory Scrutiny: Growing concerns over misuse and overprescription heighten regulatory oversight, potentially restricting off-label use.
• Competition: Newer antibiotics and alternative therapies, such as doxycycline-based combination drugs, pose competitive threats.

Market Trends

• Biopharma Interest in Reformulation: Innovative delivery systems—such as extended-release formulations—aim to improve adherence and reduce resistance.
• Shift Toward Non-Antimicrobial Use: The anti-inflammatory and dermatological applications expand doxycycline’s market beyond infectious diseases.
• Regional Market Expansion: Asia-Pacific is projected to experience the fastest growth, driven by increasing access, rising healthcare spending, and expanding diagnostic capabilities.

Market Projections

Short-Term (Next 2-3 Years)

• Stable Demand in Traditional Indications: Continued use in respiratory infections, acne, and periodontal therapy will sustain steady sales.
• Incremental Growth via Expanded Indications: Doxycycline's potential role in COVID-19 adjunct therapy and anti-inflammatory treatments could boost sales modestly.
• Resistance-Driven Market Constraints: Rising resistance may lead to diminished efficacy in some indications, prompting a shift toward combination therapies.

Mid to Long-Term (3-10 Years)

• Growth through Repurposing and Formulation Innovation: Biotech investments in doxycycline-based topical and sustained-release formulations could open new therapeutic avenues, especially in dermatology and inflammatory conditions.
• Expansion in Emerging Markets: Increasing healthcare infrastructure and antibiotic access will foster growth, especially in Asia-Pacific and Latin America.
• Impact of Regulatory Policies: Stricter antimicrobial stewardship requirements may curtail off-label uses, impacting sales in some regions but encouraging development of optimized formulations.

Market Upside and Risks

• Upside: The development of doxycycline variants resistant to newer antibiotics or with enhanced anti-inflammatory profiles can extend product life cycles.
• Risks: Evolving resistance, regulatory restrictions, and competition from novel antimicrobial agents might constrain growth prospects.

Key Takeaways

• Clinical Trials: Doxycycline continues to be evaluated in emerging indications like COVID-19, Lyme disease, and inflammatory conditions. While some trials show promise, definitive efficacy data remain pending, warranting cautious optimism.
• Market Dynamics: Its historic status as a low-cost, broad-spectrum antibiotic sustains its market presence, but resistance issues challenge its long-term dominance. Reformulation efforts and expanded clinical indications present growth opportunities.
• Forecast Outlook: Moderate growth is anticipated, driven by reformulation innovations and expanding regional markets, especially in emerging economies. Resistance management and regulatory adherence will be critical to sustained success.
• Strategic Focus: Companies investing in doxycycline’s new formulations, combination therapies, and non-antimicrobial applications will enhance competitive positioning.

FAQs

1. What are the primary clinical applications of doxycycline currently?
   Doxycycline is predominantly used to treat respiratory tract infections, Lyme disease, cholera, and certain sexually transmitted infections, with emerging use in inflammatory skin conditions and malaria prophylaxis.

2. Are new clinical trials expected to enhance doxycycline’s indications?
   Yes, ongoing trials exploring its role in COVID-19 adjunct therapy, PTLDS, and anti-inflammatory applications could expand its therapeutic landscape, provided results demonstrate efficacy and safety.

3. How does antibiotic resistance impact doxycycline’s market prospects?
   Rising resistance, especially among hospital-acquired pathogens, limits doxycycline’s effectiveness in certain infections, prompting a shift towards combination therapies and the development of new formulations.

4. What innovations are shaping doxycycline’s future market?
   Reformulation strategies, such as sustained-release and topical formulations, alongside repositioning for non-infectious inflammatory conditions, are key to extending its clinical utility.

5. What regional markets offer the most growth opportunity for doxycycline?
   Emerging markets in Asia-Pacific and Latin America are poised for rapid growth due to increasing healthcare infrastructure, prescription rates, and expanding access to antibiotics.

References

[1] Pfizer Inc. Doxycycline product information. (2022).
[2] MarketResearch.com. Global Antibiotic Market Report, 2022.
[3] FDA. Approvals and Regulatory Updates for Doxycycline. (2021–2023).
[4] ClinicalTrials.gov. Recent Doxycycline Trials.
[5] IQVIA. Pharmaceutical Market Dynamics, 2022.

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Note: All projections and analyses are based on current available data as of 2023 and are subject to change with new clinical, regulatory, or market developments.