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Last Updated: April 25, 2025

CLINICAL TRIALS PROFILE FOR VIBRAMYCIN


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All Clinical Trials for Vibramycin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00358462 ↗ Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2007-01-01 The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00358462 ↗ Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA) Completed University of Washington Phase 3 2007-01-01 The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00829764 ↗ Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2006-10-01 The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. following an overnight fast of at least 10 hours.
NCT00829790 ↗ Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions Completed Teva Pharmaceuticals USA Phase 1 2006-10-01 The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast meal began 30 minutes prior to each dose.
NCT01087476 ↗ Double-blind-randomized,Placebo Controlled Trial for Chemotherapy-associated Oral Mucositis Using Doxycycline Hyclate Unknown status Instituto Nacional de Cancerologia de Mexico Phase 2 2010-05-01 Background. Mucositis is a complication of chemotherapy with no effective treatment. Aim.To evaluate the efficacy of sub-microbial doses of doxycycline hyclate in preventing the development of oral mucositis in patients with acute leukemia (AL) treated with induction chemotherapy. Hypothesis. Doxycycline hyclate administration in sub-microbial dosage will reduce the incidence of oral mucositis in patients with AL who receive induction chemotherapy. Methods. Double-blind, randomized, placebo-controlled clinical trial. At the Cancer National Institute (INCan), adult patients (> 18 years of age) with acute leukemia of recent diagnosis, scheduled to receive induction chemotherapy will be enrolled in the study. Written informed consent from the patients will be obtained preceding inclusion in the study. At baseline and 3-times per week, during 21-days, patients will have an oral examination performed using the Oral Mucositis Assessment Scale (OMAS), oral pain, difficulty to swallow, and salivary flow measurements will be recorded. A sample size of 164 subjects has been calculated, 74 subjects in each arm of the study. The primary end point of this study to evaluate the efficacy will be the proportion of patients treated with doxycycline or placebo without oral lesions associated with OM, during the 21 days of follow-up. Efficacy will be evaluated if the proportion of complete response (CR) is significantly higher than the proportion of events in the placebo group. Additional secondary endpoints will be the partial resolution of the oral lesions, the incidence of infections and the mortality in the study groups during the 21 days of follow-up. Results will be analyzed by using Chi-squared test and Wilcoxon-Mann-Whitney rank sum test.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vibramycin

Condition Name

Condition Name for Vibramycin
Intervention Trials
Healthy 2
Malignant Neoplasms of Respiratory and Intrathoracic Organs 2
Cystic Fibrosis 2
Malignant Neoplasm of Breast 1
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Condition MeSH

Condition MeSH for Vibramycin
Intervention Trials
Infections 3
Infection 2
Communicable Diseases 2
Cystic Fibrosis 2
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Clinical Trial Locations for Vibramycin

Trials by Country

Trials by Country for Vibramycin
Location Trials
United States 55
Canada 1
Australia 1
Sweden 1
Egypt 1
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Trials by US State

Trials by US State for Vibramycin
Location Trials
Texas 7
New York 4
California 4
Ohio 3
Arizona 2
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Clinical Trial Progress for Vibramycin

Clinical Trial Phase

Clinical Trial Phase for Vibramycin
Clinical Trial Phase Trials
Phase 4 5
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Vibramycin
Clinical Trial Phase Trials
Completed 12
Unknown status 3
Recruiting 3
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Clinical Trial Sponsors for Vibramycin

Sponsor Name

Sponsor Name for Vibramycin
Sponsor Trials
M.D. Anderson Cancer Center 3
Teva Pharmaceuticals USA 2
BioMed Valley Discoveries, Inc 1
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Sponsor Type

Sponsor Type for Vibramycin
Sponsor Trials
Other 31
NIH 7
Industry 5
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Vibramycin (Doxycycline Hyclate): Clinical Trials, Market Analysis, and Projections

Introduction to Vibramycin

Vibramycin, known generically as doxycycline hyclate, is a broad-spectrum antibiotic derived from tetracycline. It is widely used for treating various bacterial infections, including acne, certain types of malaria, and uncomplicated urogenital Chlamydia trachomatis infections.

Clinical Trials Update

Recent and Ongoing Trials

Several clinical trials have been conducted and are ongoing to evaluate the efficacy and safety of doxycycline hyclate.

  • Uncomplicated Urogenital Chlamydia Trachomatis Infection: A non-inferiority trial compared the efficacy of WC2031 (a once-daily formulation of doxycycline hyclate) with Vibramycin (twice-daily doxycycline hyclate) for treating uncomplicated urogenital Chlamydia trachomatis infection. The trial showed that WC2031 had a microbiological cure rate of 94.9% compared to 83.7% for Vibramycin in the efficacy-evaluable population. However, when analyzed using the modified Intent-to-Treat (mITT) population, the cure rates were 79.3% for WC2031 and 83.7% for Vibramycin, indicating that WC2031 may be considered non-inferior to Vibramycin[1].

  • Other Clinical Trials: Various institutions, such as the Chinese University of Hong Kong and the Mahidol Oxford Tropical Medicine Research Unit, are conducting Phase 2 and Phase 3 trials to explore different aspects of doxycycline's efficacy and safety[2].

Market Analysis

Market Size and Growth

The doxycycline hyclate market is projected to grow significantly over the next few years. The market is expected to increase from USD 1.2 billion in 2023 to USD 1.8 billion by 2031, driven by its broad-spectrum efficacy and the increasing prevalence of infectious diseases[2].

Key Drivers

  • Expanding R&D Activities: Increased focus on drug development and innovation in the pharmaceutical industry is driving the demand for doxycycline hydrochloride API.
  • Demand for Generic Medicines: The growing need for affordable and effective generic medicines is boosting the usage of doxycycline hydrochloride API globally.
  • Veterinary Medicine Applications: The expanding list of applications in veterinary medicine is further amplifying the market potential for doxycycline hydrochloride API[5].

Market Restraints

  • Alternative Treatments and Generics: The presence of alternative treatments and the entry of generic competitors pose significant threats to the doxycycline hydrochloride API market.
  • Supply Chain Disruptions: Challenges in maintaining a consistent supply amidst fluctuating demand and excess supply issues can lead to decreasing demand for doxycycline hydrochloride API[5].

Market Opportunities

Sustainable Synthesis

  • Leveraging green chemistry for sustainable doxycycline hydrochloride API synthesis can help meet environmental standards and attract environmentally conscious consumers[5].

Antibiotic Resurgence

  • Capitalizing on the resurgence trend of antibiotics amid global health concerns can position doxycycline hydrochloride API favorably in the market[5].

Aging Population

  • Strategizing in the aging population market due to the growing prevalence of chronic diseases can open new avenues for doxycycline hydrochloride API[5].

Market Challenges

Regulatory Requirements

  • Stringent regulatory requirements, especially concerning quality and environmental impacts, pose significant challenges to the market growth of doxycycline hydrochloride API[5].

Cost-Effective Production

  • Maintaining cost-effective production in the face of fluctuating raw material prices is a critical challenge for manufacturers[5].

Competitive Pressures

  • The market is characterized by intense competition, with a focus on product quality, efficacy, and compliance being central to maintaining a competitive advantage[5].

Key Company Profiles

Several leading pharmaceutical companies are involved in the production and development of doxycycline hydrochloride API. These include:

  • Aurobindo Pharma Ltd.
  • Cadila Pharmaceuticals Ltd.
  • Cipla Inc.
  • Dr. Reddy's Laboratories Ltd.
  • Granules India Limited
  • Hainan Haiyao Co., Ltd.
  • Hovione Farmaciência SA
  • Jiangsu Caiqin Technology Development Co., Ltd.
  • Lupin Limited
  • Mylan N.V. (Viatris)
  • Novartis AG
  • Pfizer Inc.
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Zhejiang HISUN Pharmaceutical Co., Ltd.[5].

Future Outlook

The future of the doxycycline hydrochloride API market looks promising, driven by increasing demand for effective antibiotics, expanding applications in veterinary medicine, and the need for sustainable manufacturing processes.

"The necessity for doxycycline hydrochloride is underscored by its widespread application across various infections, providing comprehensive health solutions globally."[5]

Key Takeaways

  • Clinical Trials: Recent trials have shown that doxycycline hyclate formulations can be effective in treating uncomplicated urogenital Chlamydia trachomatis infections.
  • Market Growth: The market is projected to grow from USD 1.2 billion in 2023 to USD 1.8 billion by 2031.
  • Key Drivers: Expanding R&D activities, demand for generic medicines, and applications in veterinary medicine are driving market growth.
  • Market Restraints: Alternative treatments, generics, and supply chain disruptions are significant challenges.
  • Market Opportunities: Sustainable synthesis, antibiotic resurgence, and targeting the aging population offer new opportunities.
  • Key Companies: Several leading pharmaceutical companies are involved in the production and development of doxycycline hydrochloride API.

FAQs

What is the primary use of Vibramycin (doxycycline hyclate)?

Vibramycin is primarily used to treat various bacterial infections, including acne, certain types of malaria, and uncomplicated urogenital Chlamydia trachomatis infections.

What are the key drivers of the doxycycline hydrochloride API market?

The key drivers include expanding R&D activities, increasing demand for generic medicines, and growing applications in veterinary medicine.

What are the major challenges facing the doxycycline hydrochloride API market?

The major challenges include stringent regulatory requirements, maintaining cost-effective production, and competitive pressures from alternative treatments and generics.

Which companies are leading in the production of doxycycline hydrochloride API?

Leading companies include Aurobindo Pharma Ltd., Cadila Pharmaceuticals Ltd., Cipla Inc., Dr. Reddy's Laboratories Ltd., and others.

What is the projected market size of doxycycline hyclate by 2031?

The market is projected to grow to USD 1.8 billion by 2031 from USD 1.2 billion in 2023.

Sources

  1. FDA: 50795 Doxycycline Clinical PREA - FDA
  2. DrugPatentWatch: Generic DOXYCYCLINE INN entry, pharmaceutical patent expiration
  3. FDA: OWH Research Program Awards by Funding Year - FDA
  4. Oxford University Press: A Multicenter Open-Label Single-Arm Clinical Trial of ...
  5. 360iResearch: Doxycycline Hydrochloride API Market Size & Share 2025-2030

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