CLINICAL TRIALS PROFILE FOR MONODOX

All Clinical Trials for Monodox

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).
NCT00652704 ↗	Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions	Completed	Anapharm	Phase 1	1999-07-01	To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
NCT00652704 ↗	Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions	Completed	Par Pharmaceutical, Inc.	Phase 1	1999-07-01	To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
NCT00652795 ↗	Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions	Completed	Anapharm	Phase 1	2004-07-01	To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
NCT00652795 ↗	Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions	Completed	Par Pharmaceutical, Inc.	Phase 1	2004-07-01	To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
NCT00653380 ↗	Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions	Completed	Anapharm	Phase 1	1999-09-01	To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).

Clinical Trial Conditions for Monodox

Condition Name

Condition Name for Monodox
Intervention	Trials
To Determine Bioequivalence Under Fasting Conditions	3
To Determine Bioequivalence Under Fed Conditions.	2
To Determine Bioequivalence Under Fed Conditions	2
Urethritis	1

Condition MeSH

Condition MeSH for Monodox
Intervention	Trials
Disease	5
Urethritis	1
Disease Susceptibility	1
Rotator Cuff Injuries	1

Clinical Trial Locations for Monodox

Trials by Country

Trials by Country for Monodox
Location	Trials
Canada	5
United States	2

Trials by US State

Trials by US State for Monodox
Location	Trials
Pennsylvania	1
Washington	1

Clinical Trial Progress for Monodox

Clinical Trial Phase

Clinical Trial Phase for Monodox
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	5
N/A	1

Clinical Trial Status

Clinical Trial Status for Monodox
Clinical Trial Phase	Trials
Completed	6
Withdrawn	1

Clinical Trial Sponsors for Monodox

Sponsor Name

Sponsor Name for Monodox
Sponsor	Trials
Anapharm	5
Par Pharmaceutical, Inc.	5
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for Monodox
Sponsor	Trials
Industry	10
Other	2
NIH	1

Clinical Trials, Market Analysis, and Projections for Monodox and Similar Drugs

Introduction to Monodox and Related Drugs

Monodox, a brand name for the antibiotic doxycycline, is widely used for treating various bacterial infections, including acne, rosacea, and other skin conditions. Here, we will delve into the clinical trials, market analysis, and projections for Monodox and similar drugs, particularly focusing on their use in dermatological conditions.

Clinical Trials: Recent Developments

DFD-29 Clinical Trials for Rosacea

A significant development in the treatment of rosacea involves DFD-29, a new oral minocycline formulation. In two Phase 3 clinical trials (MVOR-1 and MVOR-2), DFD-29 demonstrated statistical superiority over both Oracea (doxycycline) and placebo in treating papulopustular rosacea in adults. These trials showed that DFD-29 achieved all co-primary and secondary endpoints with no significant safety issues. The drug resulted in a higher proportion of subjects achieving Investigator’s Global Assessment (IGA) treatment success and a greater reduction in total inflammatory lesion count compared to Oracea and placebo[1].

Implications for Monodox

While Monodox (doxycycline) is not the specific drug in these trials, the success of DFD-29 highlights the ongoing innovation in the treatment of dermatological conditions using tetracycline-class antibiotics. This innovation could influence the market dynamics and treatment paradigms for drugs like Monodox.

Market Analysis

Tetracycline Drugs Market

The global tetracycline drugs market, which includes Monodox, is driven by the high prevalence of infectious diseases and the presence of generics. Asia Pacific is the largest market for tetracycline drugs, driven by an increase in pharmaceutical manufacturers and the rise in bacterial infections such as MRSA and Clostridium difficile[5].

Impetigo Therapeutic Market

The Impetigo Therapeutic Market, another segment where tetracyclines are used, is expected to grow at a CAGR of 7.2% from 2022 to 2027. This growth is fueled by the increasing prevalence of impetigo, particularly in North America, and the preference for cost-effective and efficient medicines with fewer side effects[2].

Clinical Trials Market

The broader clinical trials market, which encompasses trials for various drugs including tetracyclines, is projected to grow from USD 54.39 billion in 2024 to USD 94.68 billion by 2034, at a CAGR of 5.7%. This growth is driven by the increasing R&D spending on pharmaceuticals and the adoption of advanced medical technologies[3].

Market Projections

Tetracycline Drugs Market Projections

The tetracycline drugs market is expected to continue its growth trajectory, driven by the increasing incidence of bacterial infections and the expanding healthcare infrastructure in regions like Asia Pacific. The market in Europe is also anticipated to grow, supported by initiatives like the Innovative Medicine Initiative (IMI) and public-private collaborations for new drug development[5].

Specific Projections for Monodox and Similar Drugs

Given the positive results from clinical trials like those for DFD-29, there is a potential shift towards more targeted and effective treatments for dermatological conditions. Monodox, as a well-established drug, may see continued use but could also face competition from newer formulations like DFD-29. The annual peak sales potential for DFD-29 is estimated at $300 million globally, indicating a significant market opportunity for innovative treatments in this space[1].

Key Challenges and Opportunities

Patient Recruitment and Regulatory Hurdles

Clinical trials face challenges such as patient recruitment and stringent regulatory guidelines. These factors can slow down the development and approval process for new drugs, including those in the tetracycline class. However, advancements in digital solutions and government initiatives are expected to streamline these processes[3].

Growing Demand for Novel Treatments

The increasing prevalence of chronic diseases and the growing elderly population are driving the demand for novel pharmaceuticals. This trend is expected to accelerate the growth of the clinical trials sector, including those focused on dermatological conditions[3].

Regional Market Insights

North America

North America, particularly the U.S., has a significant market share in the Impetigo Therapeutic Market and is expected to dominate the market due to the high prevalence of impetigo and other bacterial infections. The presence of key players in this region further propels market growth[2].

Asia Pacific

Asia Pacific is projected to continue dominating the tetracycline drugs market due to the increase in pharmaceutical manufacturers and the rise in bacterial infections. Countries like India and China are seeing a surge in clinical trials, which is expected to drive market growth in this region[5].

Key Takeaways

• Innovative Treatments: New formulations like DFD-29 are showing promising results in clinical trials, potentially changing the treatment paradigm for dermatological conditions.
• Market Growth: The tetracycline drugs market and Impetigo Therapeutic Market are expected to grow driven by increasing prevalence of bacterial infections and expanding healthcare infrastructure.
• Challenges: Patient recruitment and regulatory hurdles remain significant challenges for clinical trials.
• Regional Insights: North America and Asia Pacific are key regions driving market growth due to high prevalence of infections and increasing healthcare infrastructure.

FAQs

What are the recent clinical trial results for DFD-29?

DFD-29, a new oral minocycline formulation, demonstrated statistical superiority over Oracea (doxycycline) and placebo in treating papulopustular rosacea in two Phase 3 clinical trials, achieving all co-primary and secondary endpoints with no significant safety issues[1].

How does the market for tetracycline drugs look?

The global tetracycline drugs market is driven by the high prevalence of infectious diseases and is expected to continue growing, particularly in Asia Pacific, due to the increase in pharmaceutical manufacturers and the rise in bacterial infections[5].

What are the challenges facing clinical trials for new drugs?

Clinical trials face challenges such as patient recruitment and stringent regulatory guidelines, which can slow down the development and approval process for new drugs[3].

How is the Impetigo Therapeutic Market expected to grow?

The Impetigo Therapeutic Market is expected to grow at a CAGR of 7.2% from 2022 to 2027, driven by the increasing prevalence of impetigo and the preference for cost-effective and efficient medicines[2].

What is the projected growth of the clinical trials market?

The clinical trials market is projected to grow from USD 54.39 billion in 2024 to USD 94.68 billion by 2034, at a CAGR of 5.7%, driven by increasing R&D spending and the adoption of advanced medical technologies[3].

Sources

1. Journey Medical Corporation. Journey Medical Corporation Announces Positive Topline Results from its Two Phase 3 Clinical Trials Evaluating DFD-29 for the Treatment of Papulopustular Rosacea in Adults. Press Releases, July 11, 2023.
2. IndustryARC. Impetigo Therapeutic Market Report, 2022-2027.
3. Towards Healthcare. Clinical Trials Market Size, Trends & Go-To-Market Strategies. December 2024.
4. Cedars-Sinai. What You Need to Know: Taking Doxycycline for Safer Sex. November 2, 2023.
5. Transparency Market Research. Tetracycline Drugs Market Insight and Trends 2025.