You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR DOXYCYCLINE HYCLATE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for DOXYCYCLINE HYCLATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00687908 ↗ Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance Completed Galderma Phase 3 2008-11-01 The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
NCT00687908 ↗ Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance Completed Galderma R&D Phase 3 2008-11-01 The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
NCT00688064 ↗ Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris Completed Galderma Phase 3 2008-08-01 The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
NCT00688064 ↗ Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris Completed Galderma R&D Phase 3 2008-08-01 The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
NCT00635609 ↗ Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate Completed Warner Chilcott Phase 4 2008-03-01 Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.
NCT00495313 ↗ Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens Completed CollaGenex Pharmaceuticals Phase 4 2007-03-01 To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
NCT00041977 ↗ Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea Completed CollaGenex Pharmaceuticals Phase 3 2002-06-01 The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for DOXYCYCLINE HYCLATE

Condition Name

3333000.511.522.53Acne VulgarisLymphatic FilariasisFilariasisLymphedema[disabled in preview]
Condition Name for DOXYCYCLINE HYCLATE
Intervention Trials
Acne Vulgaris 3
Lymphatic Filariasis 3
Filariasis 3
Lymphedema 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

633300123456Acne VulgarisLymphedemaFilariasisElephantiasis, Filarial[disabled in preview]
Condition MeSH for DOXYCYCLINE HYCLATE
Intervention Trials
Acne Vulgaris 6
Lymphedema 3
Filariasis 3
Elephantiasis, Filarial 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for DOXYCYCLINE HYCLATE

Trials by Country

+
Trials by Country for DOXYCYCLINE HYCLATE
Location Trials
United States 89
Canada 6
Puerto Rico 3
China 2
India 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for DOXYCYCLINE HYCLATE
Location Trials
New York 6
Pennsylvania 6
Florida 6
California 5
Texas 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for DOXYCYCLINE HYCLATE

Clinical Trial Phase

32.0%24.0%40.0%012345678910Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for DOXYCYCLINE HYCLATE
Clinical Trial Phase Trials
Phase 4 8
Phase 3 6
Phase 2/Phase 3 1
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

52.0%28.0%12.0%8.0%01234567891011121314CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for DOXYCYCLINE HYCLATE
Clinical Trial Phase Trials
Completed 13
Recruiting 7
Not yet recruiting 3
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for DOXYCYCLINE HYCLATE

Sponsor Name

trials012345678The Task Force for Global HealthGalderma R&DUnited States Agency for International Development (USAID)[disabled in preview]
Sponsor Name for DOXYCYCLINE HYCLATE
Sponsor Trials
The Task Force for Global Health 3
Galderma R&D 3
United States Agency for International Development (USAID) 3
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

72.3%17.0%8.5%005101520253035OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for DOXYCYCLINE HYCLATE
Sponsor Trials
Other 34
Industry 8
U.S. Fed 4
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Doxycycline Hyclate: Clinical Trials, Market Analysis, and Projections

Introduction to Doxycycline Hyclate

Doxycycline hyclate is a broad-spectrum antibiotic widely used to treat various bacterial infections, including respiratory tract infections, skin infections, urinary tract infections, and certain sexually transmitted infections (STIs). Its efficacy and broad application make it a crucial component in modern healthcare.

Clinical Trials Update

Recent clinical trials have highlighted the potential of doxycycline hyclate in preventing STIs, particularly among high-risk populations.

DoxyPEP Trial

A significant clinical trial, known as the DoxyPEP trial, conducted in San Francisco and Seattle, demonstrated the effectiveness of doxycycline hyclate as a post-exposure prophylaxis (PEP) for STIs. The trial involved 554 participants, including men who have sex with men (MSM) and transgender women (TGW) who were living with HIV or taking HIV pre-exposure prophylaxis (PrEP). Participants were randomized to receive 200 mg of doxycycline within 72 hours after unprotected sex or no doxycycline.

The results showed that those who received doxycycline had substantially fewer infections of gonorrhea, chlamydia, and syphilis compared to those who did not receive the antibiotic. This intervention was found to be safe and well-tolerated, supporting its use as a targeted strategy for preventing STIs in high-risk populations[4][1][5].

Key Findings

  • Reduced STI Incidence: The trial indicated a significant reduction in the incidence of chlamydia, gonorrhea, and syphilis among participants who took doxycycline post-exposure.
  • Safety and Tolerability: Doxycycline was generally safe and well-tolerated, with no major adverse effects reported.
  • Population Focus: The trial targeted men who have sex with men and transgender women who had a history of STIs in the previous year, highlighting its potential as a targeted intervention[4].

Market Analysis

The market for doxycycline hyclate capsules is experiencing significant growth driven by several key factors.

Market Size and Growth

The global doxycycline hyclate market is projected to grow at a substantial compound annual growth rate (CAGR) from 2024 to 2031. The market size in 2023 was notable, and it is expected to expand further due to increasing demand for effective antibiotics[3][5].

Market Drivers

  • Rising Incidence of Bacterial Infections: The global rise in bacterial infections, including STIs, is a major driver for the demand of doxycycline hyclate capsules.
  • Advancements in Medical Research: Continuous advancements in medical research and development are enhancing the utility and effectiveness of doxycycline hyclate.
  • Telehealth Services: The expansion of telehealth services has increased online sales avenues for doxycycline-based prescriptions, contributing to market growth[2][3].

Market Restraints

  • Antibiotic Resistance: Concerns over antibiotic resistance are a significant restraint, as it reduces the effectiveness of doxycycline treatments.
  • Generic Competition: Increasing competition from generic drugs impacts market growth and price stability.
  • Raw Material Costs: Fluctuating raw material costs and supply chain disruptions can affect production sustainability[2][3].

Market Opportunities

  • Innovative Delivery Forms: The development of innovative delivery forms enhances the appeal of doxycycline in the pharmaceutical market.
  • Emerging Markets: Potential growth prospects in emerging markets offer opportunities for expansion.
  • Strategic Investments: Key companies are focusing on strategic investments to strengthen their product portfolios and expand their business globally[2][3].

Competitive Analysis

The competitive landscape of the doxycycline hyclate market is characterized by several key players.

Key Players

  • Jiangsu Lianhuan Pharma: Known for its strong product portfolio and strategic investments.
  • Spansules Pharma: Focused on expanding its business in the global market through innovative product launches and strategic partnerships[3].

Porter’s Five Forces Analysis

This analysis helps businesses understand their competitive position and the power dynamics within the market. It includes:

  • Threat of New Entrants: The barrier to entry is relatively high due to regulatory approvals and technological requirements.
  • Bargaining Power of Suppliers: Suppliers have moderate bargaining power due to the availability of raw materials.
  • Bargaining Power of Buyers: Buyers have significant bargaining power due to the presence of generic alternatives.
  • Threat of Substitute Products: The threat of substitutes is moderate, as other antibiotics can serve as alternatives.
  • Competitive Rivalry Among Existing Competitors: The market is highly competitive, with several key players vying for market share[2][3].

Market Projections

Forecast Period

The market is forecasted to grow significantly from 2024 to 2031, driven by the increasing demand for effective antibiotics and the expanding use of doxycycline hyclate in various therapeutic applications.

Regional Analysis

The market is segmented into regions such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Each region presents unique opportunities and challenges, with the Asia Pacific region expected to show significant growth due to rising healthcare needs and increasing awareness about antibiotic treatments[3][5].

Segment Analysis

The market is segmented by type, application, and end-user. The doxycycline hyclate capsule segment is expected to expand at a significant CAGR, driven by its broad utility in treating bacterial infections and its critical role in combating drug-resistant strains[3].

Key Takeaways

  • Clinical Trials: Doxycycline hyclate has shown significant efficacy in preventing STIs in high-risk populations.
  • Market Growth: The global market is expected to grow substantially due to rising bacterial infections and advancements in medical research.
  • Competitive Landscape: The market is highly competitive, with key players focusing on strategic investments and innovative product launches.
  • Market Restraints: Concerns over antibiotic resistance and generic competition are significant restraints.
  • Market Opportunities: Innovative delivery forms and emerging markets offer potential growth prospects.

FAQs

Q: What is the primary use of doxycycline hyclate in clinical settings?

A: Doxycycline hyclate is primarily used to treat various bacterial infections, including respiratory tract infections, skin infections, urinary tract infections, and certain STIs.

Q: How effective is doxycycline hyclate as a post-exposure prophylaxis for STIs?

A: Clinical trials have shown that doxycycline hyclate significantly reduces the incidence of chlamydia, gonorrhea, and syphilis when taken within 72 hours after unprotected sex.

Q: What are the major drivers of the doxycycline hyclate market?

A: The market is driven by the rising incidence of bacterial infections, advancements in medical research, and the expansion of telehealth services.

Q: What are the key restraints facing the doxycycline hyclate market?

A: Concerns over antibiotic resistance, generic competition, and fluctuating raw material costs are significant restraints.

Q: Which regions are expected to show significant growth in the doxycycline hyclate market?

A: The Asia Pacific region is expected to show significant growth due to rising healthcare needs and increasing awareness about antibiotic treatments.

Sources

  1. CDC Clinical Guidelines on the Use of Doxycycline Postexposure. Centers for Disease Control and Prevention. Retrieved June 6, 2024.
  2. Doxycycline Hyclate Capsules Market Size & Share 2025-2030. 360iResearch. Retrieved December 2024.
  3. Doxycycline Hyclate Market Report 2024 (Global Edition). Cognitive Market Research. Retrieved November 10, 2021.
  4. Doxycycline After Unprotected Sex Significantly Reduced STIs. University of California, San Francisco. Retrieved May 25, 2022.
  5. Global Oral Doxycycline Hyclate Market Recent Trends, In-depth Analysis. Global Market Vision. Retrieved 2024.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.