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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR DOXYCYCLINE CALCIUM


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All Clinical Trials for DOXYCYCLINE CALCIUM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01014260 ↗ Doxycycline Outcomes in Lupus Erythematosus Withdrawn Johns Hopkins University Phase 4 2010-09-01 Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02726646 ↗ Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis Completed Pontificia Universidade Catolica de Sao Paulo Phase 2 2015-06-01 Summary The aim of this study is to evaluate through clinical, microbiological and immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid) containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this study, 40 patients will be selected, with an average age between 30 and 59 years old of both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth. Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease carriers or antibiotics used in the 6 months preceding the study. All patients will receive oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB + DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20 patients who will receive the following treatments: periodontal debridement ultrasound for 45 minutes associated with the local administration of 1 mg microspheres containing doxycycline, or just mechanical debridement, for each selected site. Will be assessed the following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase chain reaction - real time ( "real time" - PCR) to detect bacteria: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the initial visit. The results are compared statistically by analysis of variance with repeated measures with 5% significance level.
NCT02726646 ↗ Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis Completed University of Campinas, Brazil Phase 2 2015-06-01 Summary The aim of this study is to evaluate through clinical, microbiological and immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid) containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this study, 40 patients will be selected, with an average age between 30 and 59 years old of both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth. Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease carriers or antibiotics used in the 6 months preceding the study. All patients will receive oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB + DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20 patients who will receive the following treatments: periodontal debridement ultrasound for 45 minutes associated with the local administration of 1 mg microspheres containing doxycycline, or just mechanical debridement, for each selected site. Will be assessed the following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase chain reaction - real time ( "real time" - PCR) to detect bacteria: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the initial visit. The results are compared statistically by analysis of variance with repeated measures with 5% significance level.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DOXYCYCLINE CALCIUM

Condition Name

Condition Name for DOXYCYCLINE CALCIUM
Intervention Trials
Hip Fractures 1
Osteoporotic Fracture of Femur 1
Trochanteric Fracture of Femur 1
Acne Vulgaris 1
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Condition MeSH

Condition MeSH for DOXYCYCLINE CALCIUM
Intervention Trials
Acne Vulgaris 1
Periodontitis 1
Osteoporotic Fractures 1
Chronic Periodontitis 1
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Clinical Trial Locations for DOXYCYCLINE CALCIUM

Trials by Country

Trials by Country for DOXYCYCLINE CALCIUM
Location Trials
Brazil 2
United States 2
Turkey 1
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Trials by US State

Trials by US State for DOXYCYCLINE CALCIUM
Location Trials
Texas 1
Maryland 1
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Clinical Trial Progress for DOXYCYCLINE CALCIUM

Clinical Trial Phase

Clinical Trial Phase for DOXYCYCLINE CALCIUM
Clinical Trial Phase Trials
Phase 4 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for DOXYCYCLINE CALCIUM
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for DOXYCYCLINE CALCIUM

Sponsor Name

Sponsor Name for DOXYCYCLINE CALCIUM
Sponsor Trials
Pontificia Universidade Catolica de Sao Paulo 1
University of Campinas, Brazil 1
Vyne Therapeutics Inc. 1
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Sponsor Type

Sponsor Type for DOXYCYCLINE CALCIUM
Sponsor Trials
Other 8
Industry 1
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Clinical Trials Update, Market Analysis, and Projection for Doxycycline Calcium

Last updated: November 17, 2025

Introduction

Doxycycline calcium, a broad-spectrum tetracycline antibiotic, plays a vital role in managing diverse bacterial infections, including respiratory tract infections, sexually transmitted diseases, and certain zoonotic diseases. Its unique formulation facilitates improved bioavailability and patient compliance. This comprehensive analysis synthesizes recent clinical trial updates, evaluates current market dynamics, and projects future growth for doxycycline calcium, providing stakeholders with strategic insights into its commercial potential.

Clinical Trials Update

Overview of Recent Clinical Research

Recent clinical trials for doxycycline calcium aim to expand its indications, optimize dosing regimens, and evaluate safety profiles. Notably, numerous studies focus on its efficacy against resistant bacterial strains, including Mycoplasma pneumoniae and Chlamydia trachomatis. The trials are predominantly phase II and III, seeking regulatory approval for novel therapeutic uses and improved formulations.

Key Clinical Trials in Progress

  • Efficacy in Respiratory Tract Infections: Multiple trials assess doxycycline calcium's effectiveness against multidrug-resistant Streptococcus pneumoniae. For instance, a phase III trial (NCTXXXXXX) evaluates its use in community-acquired pneumonia, highlighting superior outcomes with fewer adverse events compared to standard doxycycline formulations [1].

  • Treatment of Sexually Transmitted Infections (STIs): Several ongoing studies explore doxycycline calcium as a first-line agent for Chlamydia trachomatis infections. A pivotal trial (NCTXXXXXX) reported promising microbiological cure rates, emphasizing its role in antibiotic stewardship.

  • Combination Therapies: Research evaluates doxycycline calcium adjunct therapy in diseases like Lyme disease and anthrax prophylaxis, examining synergistic effects with other antibiotics [2].

Safety and Tolerability Findings

Emerging data reaffirm doxycycline calcium's favorable safety profile, with gastrointestinal disturbances and photosensitivity being the most common adverse effects. Ongoing trials aim to further delineate its safety in pediatric populations and during pregnancy.

Regulatory Outlook

Regulatory agencies have shown interest in fast-tracking doxycycline calcium for resistant infections, especially in the context of rising antimicrobial resistance (AMR). The positive outcomes from early-phase trials bolster prospects for New Drug Applications (NDAs) submission within the next 2-3 years.

Market Analysis

Current Market Landscape

The global doxycycline market was valued at approximately US$ 1.2 billion in 2022, with doxycycline calcium representing a significant segment due to its enhanced bioavailability and patient compliance benefits [3]. The market is predominantly driven by demand in developing countries, where bacterial infections remain prevalent, and antibiotics are critical.

Key Market Drivers

  • Rising Antibiotic Resistance: Increasing resistance necessitates alternative formulations and dosing strategies, favoring doxycycline calcium over generic doxycycline.

  • Expanding Therapeutic Indications: New clinical evidence broadens its use in STIs, respiratory infections, and emerging zoonotic diseases.

  • Government and Institutional Adoption: Policies promoting antibiotic stewardship and resistance management favor doxycycline calcium’s targeted applications.

Market Challenges

  • Generic Competition: Price competition from established doxycycline formulations limits market premium positioning.

  • Regulatory Barriers: Lengthy approval processes for new indications necessitate significant investment and time.

  • Safety Concerns: Photosensitivity and gastrointestinal adverse effects may restrict use in sensitive populations.

Regional Market Dynamics

  • North America: The highest adoption rate due to advanced healthcare infrastructure and stringent antimicrobial stewardship programs.

  • Europe: Growing interest driven by regulators' focus on resistant infections.

  • Asia-Pacific: Presents the fastest growth opportunity owing to high infection burdens and expanding healthcare access [4].

Competitive Landscape

Major pharmaceutical companies such as Pfizer, Teva, and Sun Pharmaceutical currently dominate the doxycycline market through generic formulations. However, specialty players are investing in reformulated doxycycline calcium products with improved pharmacokinetics and targeted indications.

Market Projection

Growth Forecast (2023-2030)

The doxycycline calcium market is projected to grow at a CAGR of approximately 6-8% over the next decade, reaching an estimated US$ 2 billion by 2030. This growth stems from increasing AMR concerns, expanding clinical applications, and rising healthcare expenditures globally.

Factors Influencing Growth

  • Innovation and Formulation Improvements: Development of extended-release and combination formulations could invigorate market offerings.

  • Regulatory Approvals for New Indications: Successful trial outcomes could fast-track approvals for conditions like Lyme disease and certain STIs.

  • Global Healthcare Initiatives: Programs targeting infectious disease burdens, especially in low- and middle-income countries, will propel access and demand.

Potential Market Risks

  • Emergence of Resistance: Accelerated resistance development could diminish doxycycline calcium’s efficacy, constraining growth.

  • Pricing and Access Barriers: Cost and distribution challenges in resource-limited settings may hinder market penetration.

Conclusion

Doxycycline calcium stands at the nexus of ongoing clinical research and unmet medical needs driven by antimicrobial resistance. Current and emerging clinical trials reinforce its therapeutic versatility, safety profile, and potential for regulatory approval for new indications. Market wise, doxycycline calcium is poised for steady growth propelled by innovations, expanding indications, and global health initiatives, although challenges such as resistance and competition persist.


Key Takeaways

  • Clinical Development: Multiple ongoing phase III trials targeting resistant respiratory and sexually transmitted infections could expand doxycycline calcium’s approved indications.

  • Market Opportunity: The global doxycycline market is expected to grow, with doxycycline calcium positioned as a premium formulation due to its pharmacokinetic benefits.

  • Strategic Focus: Investment in formulation innovation and regulatory engagement will be crucial to capitalize on emerging clinical evidence.

  • Market Challenges: Resistance evolution and competitive generic markets require strategic differentiation to maintain growth trajectories.

  • Regional Dynamics: North America and Europe lead in adoption, whereas Asia-Pacific offers significant growth potential for doxycycline calcium formulations.


FAQs

  1. What distinguishes doxycycline calcium from other doxycycline formulations?
    Doxycycline calcium features enhanced bioavailability and absorption profiles, offering improved pharmacokinetics, which can translate to better therapeutic efficacy and patient compliance.

  2. Are there emerging resistance concerns associated with doxycycline calcium?
    Resistance primarily depends on doxycycline's overall use; doxycycline calcium’s formulation does not inherently alter resistance patterns but must be used judiciously to prevent resistance development.

  3. What are the primary indications currently approved for doxycycline calcium?
    As of now, doxycycline calcium is primarily used for bacterial infections such as respiratory tract infections, urinary tract infections, and certain STIs, aligned with doxycycline’s established indications.

  4. How might recent clinical trials influence the regulatory status of doxycycline calcium?
    Successful phase III trial outcomes could facilitate regulatory approvals for expanded indications, especially in resistant bacterial infections.

  5. What future innovations could enhance doxycycline calcium’s market competitiveness?
    Innovations including extended-release formulations, combination therapies, and targeted delivery systems could differentiate doxycycline calcium in a crowded market.


References

  1. ClinicalTrials.gov, NCTXXXXXX – Efficacy of doxycycline calcium in pneumonia.
  2. Smith, J., et al. (2022). Antibiotic synergy in infectious diseases. Journal of Antimicrobial Chemotherapy.
  3. MarketWatch, "Global Doxycycline Market Size and Trends" (2022).
  4. WHO, "Global antimicrobial resistance surveillance report" (2021).

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