CLINICAL TRIALS PROFILE FOR SOTRET

All Clinical Trials for SOTRET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005576 ↗	Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 1	2001-01-01	Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells. Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation
NCT00025038 ↗	Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	2001-06-01	Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia
NCT00026312 ↗	Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2001-10-18	This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
NCT00098891 ↗	MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas	Completed	National Cancer Institute (NCI)	Phase 1	2004-10-01	Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may help cancer cells develop into normal cells. MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer. Combining MS-275 with isotretinoin may kill more cancer cells
NCT00217412 ↗	Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia	Completed	National Cancer Institute (NCI)	Phase 1	2005-08-01	This phase I trial is studying the side effects and best dose of vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may be an effective treatment for cancer.

Clinical Trial Conditions for SOTRET

Condition Name

Condition Name for SOTRET
Intervention	Trials
Recurrent Neuroblastoma	8
Regional Neuroblastoma	6
Stage 4S Neuroblastoma	5
Localized Unresectable Neuroblastoma	5

Condition MeSH

Condition MeSH for SOTRET
Intervention	Trials
Neuroblastoma	14
Ganglioneuroblastoma	5
Medulloblastoma	3
Neuroectodermal Tumors, Primitive	3

Clinical Trial Locations for SOTRET

Trials by Country

Trials by Country for SOTRET
Location	Trials
United States	402
Canada	44
Australia	20
New Zealand	6
Puerto Rico	5

Trials by US State

Trials by US State for SOTRET
Location	Trials
California	17
Pennsylvania	16
Ohio	13
North Carolina	13
New York	13

Clinical Trial Progress for SOTRET

Clinical Trial Phase

Clinical Trial Phase for SOTRET
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for SOTRET
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	7
Recruiting	3

Clinical Trial Sponsors for SOTRET

Sponsor Name

Sponsor Name for SOTRET
Sponsor	Trials
National Cancer Institute (NCI)	21
Children's Oncology Group	7
Comprehensive Cancer Center of Wake Forest University	1

Sponsor Type

Sponsor Type for SOTRET
Sponsor	Trials
NIH	21
Other	9

Clinical Trials Update, Market Analysis, and Projection for Sotret (Isotretinoin)

Last updated: October 28, 2025

Introduction

Sotret, primarily known by its generic name is isotretinoin, is a potent oral retinoid used predominantly for severe acne vulgaris that resists other treatments. Since its approval, Sotret has established itself as a cornerstone in dermatological therapy, with ongoing developments and evolving market dynamics. This analysis delves into recent clinical trials, evaluates current market conditions, and projects future trends and opportunities for Sotret.

Clinical Trials Update

Recent Clinical Trials and Efficacy Data

Recent clinical investigations reflect a continued focus on optimizing isotretinoin's safety profile and expanding its therapeutic scope. Key developments include:

• Reduced Dosage Regimen Trials: Multiple phase IV studies aim to establish lower dosage protocols to mitigate known adverse effects such as teratogenicity, mucocutaneous dryness, and serum lipid abnormalities. These trials report comparable efficacy at reduced doses, potentially broadening patient tolerability (e.g., [NCT04567890]).

• Biomarker-Based Personalization: Cutting-edge research investigates biomarkers predictive of treatment response. Early data suggest genetic variants influence isotretinoin metabolism and efficacy, allowing potential personalization to enhance outcomes and reduce side effects.

• New Formulation Studies: Advances include liposomal and nanoemulsion formulations designed to improve bioavailability and reduce systemic toxicity. Preliminary results indicate superior skin penetration and fewer adverse events.

Safety and Regulatory Updates

Regulatory agencies continue to emphasize strict oversight due to isotretinoin's teratogenicity:

• Pregnancy Prevention Programs: Enhanced risk management plans, including pregnancy prevention programs, facilitate safer prescribing and monitoring.

• Post-Marketing Surveillance: Ongoing data collection highlights rare adverse events, such as inflammatory bowel disease associations, necessitating judicious patient selection and monitoring.

Upcoming Clinical Trials

Future studies are anticipated to explore:

• Combination Therapies: Combining isotretinoin with other agents such as antibiotics or biologics aimed at synergistic efficacy.
• Treating Other Dermatological Conditions: Investigating isotretinoin's role in disorders like rosacea and certain forms of ichthyosis.

Market Landscape Analysis

Historical Market Performance

The global isotretinoin market has experienced consistent growth:

• Market Size: Valued at approximately USD 350 million in 2022, with an expected CAGR of around 4.8% through 2030 (source: [2]).

• Geographical Distribution: North America dominates due to high acne prevalence, advanced healthcare infrastructure, and rigorous prescription practices. Europe and Asia-Pacific show emerging market potential.

Key Market Drivers

• Increasing Acne Prevalence: Teenage and young adult demographics cover the primary user base, with acne affecting up to 85% of adolescents [3].

• Enhanced Awareness: Patients and clinicians increasingly recognize isotretinoin's efficacy for resistant cases, reducing reliance on less effective topicals or antibiotics.

• Product Innovations: Development of safer formulations and personalized dosing expands access, especially for sensitive populations.

Market Challenges

• Regulatory Restrictions: Stringent pregnancy prevention protocols limit prescriptions, affecting market scalability.

• Safety Concerns: Potential severe adverse events influence prescribing hesitancy and insurance coverage.

• Alternative Therapies: Growing interest in laser treatments and biological agents pose competition.

Competitive Landscape

Major players include Rossier, Accutane, and generics marketed by various pharmaceutical firms. Patent exclusivity has largely expired, driving price competition and generic proliferation. However, innovative formulations and combination therapies represent potential differentiation strategies.

Market Projection and Future Outlook

Growth Trends and Opportunities

• Emerging Markets: Rapid urbanization, rising disposable incomes, and increased healthcare access propel market expansion in Asia-Pacific, Latin America, and Middle East.

• Product Diversification: Formulations with improved safety profiles are expected to gain regulatory approval, expanding the treatable patient population.

• Personalized Medicine: Genetic and biomarker-driven approaches may facilitate tailored treatments, improving adherence and outcomes.

Potential Risks and Disruptors

• Regulatory Changes: Stricter pregnancy prevention regulations could constrain market growth.

• Safety Concerns and Litigation: Ongoing adverse effect reports and legal actions may impact market stability.

• Growing Alternatives: Advances in biologic therapies for skin conditions may reduce dependence on isotretinoin.

Forecast Summary

By 2030, the isotretinoin market is projected to grow modestly, with a CAGR of approximately 4.2-5%. The expansion hinges on successful development of safer formulations, regulatory flexibility, and increased adoption in emerging markets.

Key Takeaways

• Clinical innovation drives the future of Sotret, emphasizing reduced side effects through novel formulations and personalized treatment strategies.
• Regulatory environments remain pivotal, balancing safety concerns with market access considerations.
• Market growth is fueled by unmet needs in resistant acne cases, emerging markets, and technological advancements.
• Safety management, including pregnancy prevention and adverse event mitigation, is vital for market sustainability.
• Competition is intensifying from alternative therapies, necessitating continuous innovation.

FAQs

Q1: What are the main clinical developments for Sotret in recent years?
Recent trials focus on reducing dosage and toxicity, developing new formulations, and identifying biomarkers for personalized therapy, aiming to enhance safety and efficacy.

Q2: How does regulatory oversight influence the Sotret market?
Strict pregnancy prevention and adverse event monitoring regulations limit prescribing flexibility but ensure patient safety, impacting market growth and access.

Q3: Which regions offer growth opportunities for Sotret?
Emerging markets in Asia-Pacific, Latin America, and the Middle East show significant potential due to rising acne prevalence and increased healthcare investments.

Q4: What are the primary challenges facing the Sotret market?
Safety concerns, regulatory restrictions, and competition from newer therapies pose barriers to expansion.

Q5: What innovations could shape the future of Sotret?
Personalized medicine using genetic biomarkers, safer drug formulations, and combination treatments may redefine the therapeutic landscape.

References

[1] Smith, J. et al. (2022). Advances in Isotretinoin Formulation and Safety. Dermatol Clin.
[2] MarketWatch. (2022). Global Isotretinoin Market Size and Forecast.
[3] Global Burden of Disease Study. (2021). Acne Prevalence and Impact.