CLINICAL TRIALS PROFILE FOR DOXYCYCLINE CALCIUM

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NCT01014260 ↗	Doxycycline Outcomes in Lupus Erythematosus	Withdrawn	Johns Hopkins University	Phase 4	2010-09-01	Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed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.

Clinical Trial Conditions for doxycycline calcium

Condition Name

Condition Name for doxycycline calcium
Intervention	Trials
Acne Vulgaris	1
Atrial Fibrillation	1
Bone Density, Low	1
Cardiovascular Disease	1

Condition MeSH

Condition MeSH for doxycycline calcium
Intervention	Trials
Acne Vulgaris	1
Periodontitis	1
Osteoporotic Fractures	1
Chronic Periodontitis	1

Clinical Trial Locations for doxycycline calcium

Trials by Country

Trials by Country for doxycycline calcium
Location	Trials
Brazil	2
United States	2
Turkey	1

Trials by US State

Trials by US State for doxycycline calcium
Location	Trials
Texas	1
Maryland	1

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

Clinical Trial Status

Clinical Trial Status for doxycycline calcium
Clinical Trial Phase	Trials
Completed	2
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for doxycycline calcium

Sponsor Name

Sponsor Name for doxycycline calcium
Sponsor	Trials
University of Campinas, Brazil	1
Vyne Therapeutics Inc.	1
Edward Lain, MD	1

Sponsor Type

Sponsor Type for doxycycline calcium
Sponsor	Trials
Other	8
Industry	1

Doxycycline Calcium: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 26, 2026

What is doxycycline calcium in the market context?

Doxycycline calcium is a doxycycline salt form used in antibacterial therapy. In practice, commercial and clinical activity tracks “doxycycline” products and their formulations (immediate-release and modified-release), with dosing schedules and labeling tied to indication rather than the salt form alone. As a result, market sizing and trial intensity are typically reported at the doxycycline (drug substance) and product (brand/generic) level, not separately for “doxycycline calcium” alone.

What is the current clinical trials landscape for doxycycline (doxycycline calcium context)?

Clinical development activity profile

Doxycycline is an established antibacterial with extensive history of use. Contemporary trial activity tends to cluster around:

• New label expansions (new populations, dosing regimens, adjunctive use with other agents)
• Comparative studies versus other tetracyclines or standard-of-care antibiotics
• Formulation work (modified-release or bioavailability improvements)
• Trials in endemic regions for specific infectious syndromes, often tied to guideline revisions and resistance trends

Active and recent trial evidence expectations (typical pattern)

For an established antibiotic like doxycycline, a meaningful “clinical trials update” in 2026 is usually less about discovering a new mechanism and more about:

• Conducting post-marketing or guideline-driven trials
• Updating evidence packages for specific indications (e.g., acne variants, respiratory infections where doxycycline is a recommended option, tick-borne illness protocols, and other off-label-to-label pathways depending on geography)

No complete, reliable, indication-level trial dataset specific to “doxycycline calcium” across registries is included here. Without registry-level extraction and filtering by “doxycycline calcium” as an exact substance, any enumerated “active trials” list would mix doxycycline salt forms and formulations and risk being materially inaccurate.

How does that translate into an investable clinical thesis?

For doxycycline-calcium-type products, the investable thesis usually depends on one of these levers:

• Lifecycle strategy: reformulation or line extensions that convert to payer-friendly differentiators (dose convenience, tolerability, or reduced dosing frequency)
• Geography and tender dynamics: antibiotics are heavily governed by government procurement and reimbursement policies
• Supply chain and manufacturing economics: doxycycline is commodity-like; margin is driven by capacity, cost position, and logistics
• Regulatory and labeling positioning: manufacturer-specific labeling for an indication can change market access even when the drug substance is the same

How big is the doxycycline market and what is the share dynamic?

Market structure

Doxycycline is a mature antibiotic with a large generic footprint. Brand presence exists but competes with high-volume generics. Market value is strongly influenced by:

• Generic pricing and tender rules
• Patent and exclusivity windows for specific branded formulations (where applicable)
• Demand cycles driven by seasonal respiratory infection patterns and regional outbreak management
• Resistance dynamics that shift guideline preference among tetracyclines and other antibiotic classes

Key commercial implications

• Pricing pressure is structurally high in most geographies once generics dominate.
• Volume is the primary growth lever; unit value grows slowly unless formulation differentiation or pricing policies allow premiumization.
• Differentiation is mostly formulation and access, not new biology.

Market projection logic for doxycycline-calcium exposure

For investors and R&D planners evaluating doxycycline calcium specifically, projection models should be built around:

1. Global antibiotic utilization trends (baseline demand growth)
2. Penetration of guideline-preferred regimens (where doxycycline remains a recommended option)
3. Generic pricing curves by region (tender price compression)
4. Regulatory friction and quality-related supply (e.g., manufacturing compliance events can temporarily alter supply-demand balance)

What does the projection look like by time horizon?

Near term (12-24 months)

• Growth is likely driven by volume stability rather than meaningful pricing increases.
• Any “market uplift” typically comes from procurement cycles, guideline updates, and formulation adoption.

Mid term (3-5 years)

• Growth becomes more dependent on:
  • Formulation-based conversions (modified release uptake)
  • Regional procurement cycles and tender award stability
  • Infection seasonality smoothing into steady baseline

Long term (5-10 years)

• Doxycycline growth is constrained by:
  • Long-established standard-of-care competition
  • Ongoing generic competition
  • Antimicrobial stewardship pressures that can shift use across antibiotic classes

What are the main risks to growth and margin?

1) Generic pricing and procurement

• Competitive tender pricing can rapidly compress margins.
• Bulk purchasing favors lowest cost producers that can maintain consistent supply.

2) Resistance and guideline rotation

• Resistance patterns influence how often tetracyclines are used relative to alternatives.
• Stewardship policies can reduce total antibiotic use even when doxycycline remains an option.

3) Manufacturing and quality system disruptions

• Antibiotic manufacturing is regulated and compliance-sensitive.
• Any supply shock can create short-term pricing spikes but also long-term market share loss if contracts are rerouted.

4) Regulatory labeling drift

• If a formulation does not hold favorable label language in key jurisdictions, uptake can stall versus alternative generic products with better-aligned claims.

What is the competitive landscape for doxycycline calcium exposure?

Because doxycycline calcium maps to doxycycline therapy in practice, competition includes:

• Generic manufacturers of doxycycline tablets/capsules and modified-release products
• Brand owners where specific formulations retain commercial positioning
• Regional distributors controlling tender access

In a commodity-like class, competitive advantage is typically:

• Cost of goods and reliability of supply
• Tender relationships and distribution reach
• Formulation convenience that improves adherence

How to interpret “clinical trials update” for doxycycline-calcium stakeholders

A usable clinical update for doxycycline is best framed by outcomes that move commercial access:

• Trials that lead to new or strengthened label language
• Trials that support guideline inclusion for a specific dosing schedule or population
• Comparative bioavailability studies that support switching for payers or providers

For established antibiotics, the majority of ongoing trials do not shift class demand materially; they refine sub-claims that affect formularies and prescribing behavior.

Market projection: practical scenarios

Base case

• Unit volumes hold with slow value growth.
• Share shifts between manufacturers occur via tender cycles rather than demand creation.

Upside case

• Formulation conversion (modified-release or dosing convenience) increases share for select producers.
• Guideline reaffirmation for certain indications increases consistent demand in targeted geographies.

Downside case

• Procurement pricing compresses further.
• Stewardship or guideline shifts reduce tetracycline preference for some indications.
• Supply disruptions lead to contract loss and slower recovery.

Key Takeaways

• Doxycycline calcium sits within a broader doxycycline market where commercial outcomes are driven by generic tender economics and formulation access more than by “salt form” differentiation.
• Clinical trial activity is likely focused on label refinements, comparative regimens, and formulation work; most trials are unlikely to create major new demand.
• Market growth in value is structurally constrained by generic competition; projections should emphasize volume stability, formulation conversion, and regional procurement dynamics.
• A robust projection model for doxycycline calcium exposure should be built on tender pricing curves, guideline-stated usage rates, and manufacturing supply reliability.

FAQs

1. Does “doxycycline calcium” have separate market drivers from doxycycline overall?
   No. Commercial demand and clinical evidence typically track doxycycline products and indications, with salt forms rarely treated as distinct market categories in practice.

2. What kind of clinical trials most matter for doxycycline products?
   Trials that support label expansions, new dosing regimens, or comparative evidence that changes formulary or guideline adoption.

3. How do generics affect doxycycline price and market value?
   Generics compress unit price and shift growth to volume and share movements tied to tender awards and distribution reach.

4. What are the biggest nonclinical risks?
   Procurement pricing pressure, manufacturing compliance and supply reliability, and stewardship or guideline shifts that change antibiotic class usage.

5. What is the most realistic growth lever for an established doxycycline product?
   Formulation and access, including modified-release uptake and jurisdiction-specific label positioning that improves prescribing and payer acceptance.

References

[1] World Health Organization. WHO Model List of Essential Medicines. WHO.
[2] FDA. Drug Development and Drug Interactions Databases; Labeling and prescribing information for doxycycline products. U.S. Food and Drug Administration.
[3] EMA. Assessment reports and product information for doxycycline-containing medicines. European Medicines Agency.
[4] IDSA. Guidelines and antibiotic stewardship guidance for bacterial infections where doxycycline is used. Infectious Diseases Society of America.
[5] GlobalData. Antibacterials market research datasets and doxycycline segment reporting (accessed via licensed market intelligence sources).