CLINICAL TRIALS PROFILE FOR SOLODYN

All Clinical Trials for SOLODYN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00473083 ↗	Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer	Completed	Hoffmann-La Roche	Phase 2	2009-01-01	The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach. Hypothesis: Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients. Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients. Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.
NCT00473083 ↗	Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer	Completed	British Columbia Cancer Agency	Phase 2	2009-01-01	The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach. Hypothesis: Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients. Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients. Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.
NCT01048983 ↗	Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	Withdrawn	National Cancer Institute (NCI)	Phase 1/Phase 2	1969-12-31	The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.
NCT01048983 ↗	Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	Withdrawn	M.D. Anderson Cancer Center	Phase 1/Phase 2	1969-12-31	The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

Clinical Trial Conditions for SOLODYN

Condition Name

Condition Name for SOLODYN
Intervention	Trials
Head And Neck Cancer	2
Lung Cancer	2
Myeloma	2
Back Pain Lower Back Chronic	1

Condition MeSH

Condition MeSH for SOLODYN
Intervention	Trials
Lung Neoplasms	4
Carcinoma, Non-Small-Cell Lung	3
Neoplasms, Plasma Cell	2
Multiple Myeloma	2

Clinical Trial Locations for SOLODYN

Trials by Country

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Trials by Country for SOLODYN
Location	Trials
United States	30
Canada	4
Germany	4

Trials by US State

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Trials by US State for SOLODYN
Location	Trials
Texas	11
Michigan	2
Massachusetts	2
North Carolina	2
Delaware	1

Clinical Trial Progress for SOLODYN

Clinical Trial Phase

Clinical Trial Phase for SOLODYN
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	12
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for SOLODYN
Clinical Trial Phase	Trials
Completed	11
Active, not recruiting	3
Recruiting	2

Clinical Trial Sponsors for SOLODYN

Sponsor Name

Sponsor Name for SOLODYN
Sponsor	Trials
M.D. Anderson Cancer Center	11
National Cancer Institute (NCI)	10
University of Texas Southwestern Medical Center	1

Sponsor Type

Sponsor Type for SOLODYN
Sponsor	Trials
Other	25
NIH	11
Industry	4

Solodyn: Clinical Trials, Market Analysis, and Projections

Introduction to Solodyn

Solodyn, a brand name for minocycline hydrochloride extended-release tablets, is a prescription antibiotic used primarily for the treatment of moderate to severe acne and other dermatological conditions. Here, we will delve into the current clinical trials related to similar drugs, market analysis, and projections for the dermatological drugs market, which includes Solodyn.

Clinical Trials Context

While Solodyn itself is an established drug, ongoing clinical trials for similar medications provide valuable insights into the evolving landscape of dermatological treatments.

DFD-29: A Comparative Study

Journey Medical Corporation is currently developing DFD-29, a minocycline hydrochloride modified release capsule, in collaboration with Dr. Reddy’s Laboratories. This drug is being developed for the treatment of rosacea and has shown promising results in clinical trials.

• Bioavailability and Safety: Studies have demonstrated that DFD-29 has a lower systemic exposure compared to Solodyn (105 mg), indicating a potentially safer profile with similar efficacy[4].
• Enrollment and Timeline: The enrollment for the pivotal Phase 3 program of DFD-29 has reached 96%, with topline data expected in the first half of 2023 and a New Drug Application (NDA) submission anticipated in the second half of 2023[1].

Market Analysis for Dermatological Drugs

The global dermatological drugs market is experiencing significant growth, driven by several key factors.

Market Size and Growth

• The global dermatological drugs market was valued at USD 23.9 billion in 2024 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 10.1% from 2025 to 2030[2].

Segmentation and Regional Insights

• The market is segmented by therapy, type, route of administration, drug class, distribution channel, and region. Key regions include North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa (MEA)[2].
• Regional Growth: North America dominates the market, but the Asia Pacific region is expected to grow at the fastest CAGR due to the availability of FDA-approved facilities, low costs of clinical trials, and a large patient pool[2].

Key Submarkets

• The market includes submarkets such as skin infection drugs, dermatitis drugs, acne drugs, psoriasis drugs, and other dermatological drugs. Acne drugs, which include Solodyn, are a significant segment within this market[5].

Market Projections for Solodyn and Similar Drugs

Revenue Forecasts

• The acne drugs market, which includes Solodyn, is expected to see sustained growth. According to forecasts, the overall dermatological drugs market will continue to expand, driven by rising demand, expanding healthcare coverage, and the success of biological and antibacterial drugs[5].

Leading Companies and Market Dynamics

• Companies like AbbVie, Galderma, GlaxoSmithKline, Johnson & Johnson, LEO Pharma, and Pfizer are key players in the dermatological drugs market. These companies are involved in various strategic acquisitions, restructuring, and the development of new drugs, which influences market dynamics[5].

Emerging Economies

• Emerging economies, particularly in South America and Asia, are expected to achieve high revenue growth due to growing affluence and increasing government support for healthcare[5].

Impact of Generic and Biosimilar Competition

IP Protection and Generic Competition

• The expiration of patents for branded drugs like Solodyn can lead to increased competition from generic versions. This competition can affect the revenue of branded drugs but also expands access to treatments for a broader patient population[5].

Future Trends and Opportunities

Technological Advancements

• Advances in drug delivery systems, such as the modified release capsules of DFD-29, are improving the safety and efficacy profiles of dermatological drugs. These advancements are likely to drive future growth in the market[4].

Patient-Centric Approaches

• Patient-centric trial designs and the adoption of virtual and decentralized clinical trials are enhancing patient participation and satisfaction. These approaches are expected to continue shaping the market by improving trial efficiency and diversity[3].

Key Takeaways

• Clinical Trials: Ongoing trials for drugs like DFD-29 indicate a focus on safety and efficacy, with potential new treatments emerging for conditions like rosacea.
• Market Growth: The global dermatological drugs market is projected to grow significantly, driven by increasing demand and technological advancements.
• Regional Insights: North America currently dominates the market, but the Asia Pacific region is expected to grow rapidly.
• Competition: Generic and biosimilar competition will continue to impact the market, but innovative drug delivery systems and patient-centric approaches will drive future growth.

FAQs

What is Solodyn used for?

Solodyn is used primarily for the treatment of moderate to severe acne and other dermatological conditions.

How does DFD-29 compare to Solodyn?

DFD-29 has shown a lower systemic exposure compared to Solodyn, indicating a potentially safer profile with similar efficacy.

What is the projected growth rate of the dermatological drugs market?

The global dermatological drugs market is expected to grow at a CAGR of 10.1% from 2025 to 2030.

Which regions are expected to drive the growth of the dermatological drugs market?

North America currently dominates the market, but the Asia Pacific region is expected to grow at the fastest CAGR.

How does generic competition affect branded drugs like Solodyn?

Generic competition can reduce the revenue of branded drugs but also increases access to treatments for a broader patient population.

Sources

1. Journey Medical Corporation. "Journey Medical Corporation Announces Positive Comparative PK Data for DFD-29 vs. Solodyn®."
2. Grand View Research. "Dermatological Drugs Market Size | Industry Report, 2030."
3. BioSpace. "Oncology Clinical Trials Market Size Expected to Reach USD 22.11 Bn by 2033."
4. Journey Medical Corporation. "Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg)."
5. PR Newswire. "Dermatological Drugs Market Forecast 2015-2025 Opportunities for Leading Companies."