CLINICAL TRIALS PROFILE FOR MYORISAN

All Clinical Trials for MYORISAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00392327 ↗	Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-03-26	This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
NCT00392327 ↗	Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET	Active, not recruiting	Children's Oncology Group	Phase 3	2007-03-26	This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
NCT00867178 ↗	Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2009-02-25	This pilot clinical trial studies the side effects and the best way to give vorinostat with isotretinoin and combination chemotherapy and to see how well they work in treating younger patients with embryonal tumors of the central nervous system. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as isotretinoin, vincristine sulfate, cisplatin, cyclophosphamide, and etoposide phosphate, 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. Giving vorinostat with isotretinoin and combination chemotherapy may be an effective treatment for embryonal tumors of the central nervous system. A peripheral blood stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.
NCT01041638 ↗	Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 3	2009-12-21	This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.
NCT01711554 ↗	Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2013-02-04	This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and 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 interfere with the ability of tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together with dinutuximab therapy may kill more tumor cells.
NCT03126916 ↗	Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma	Recruiting	National Cancer Institute (NCI)	Phase 3	2018-05-09	This phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better compared to crizotinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Clinical Trial Conditions for MYORISAN

Condition Name

Condition Name for MYORISAN
Intervention	Trials
High Risk Neuroblastoma	3
Recurrent Neuroblastoma	3
Stage 4 Neuroblastoma	3
Neuroblastoma	2

Condition MeSH

Condition MeSH for MYORISAN
Intervention	Trials
Neuroblastoma	7
Ganglioneuroblastoma	4
Pinealoma	2
Neuroectodermal Tumors, Primitive	2

Clinical Trial Locations for MYORISAN

Trials by Country

Trials by Country for MYORISAN
Location	Trials
United States	242
Canada	23
Australia	13
New Zealand	4
Puerto Rico	3

Trials by US State

Trials by US State for MYORISAN
Location	Trials
California	9
Pennsylvania	9
New York	9
Illinois	8
Texas	8

Clinical Trial Progress for MYORISAN

Clinical Trial Phase

Clinical Trial Phase for MYORISAN
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for MYORISAN
Clinical Trial Phase	Trials
Active, not recruiting	5
Recruiting	3
Completed	1

Clinical Trial Sponsors for MYORISAN

Sponsor Name

Sponsor Name for MYORISAN
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	3

Sponsor Type

Sponsor Type for MYORISAN
Sponsor	Trials
NIH	9
Other	3

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

Last updated: October 28, 2025

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Introduction

Myorisan, the oral formulation of isotretinoin, is a renowned dermatological medication primarily prescribed for severe nodular acne resistant to conventional therapies. As a cornerstone treatment since its FDA approval in the 1980s, Myorisan’s market dynamics are influenced by evolving clinical insights, regulatory changes, and competitive therapeutic landscapes. This analysis examines current clinical trial activities, evaluates market trends, and projects future growth trajectories for Myorisan, offering strategic insights for stakeholders.

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Clinical Trials Update

Regulatory and Clinical Trial Landscape

While Myorisan remains FDA-approved for severe acne, recent clinical trial activity has centered on optimizing its safety profile, exploring alternative dosing regimens, and understanding long-term effects.

Ongoing and Completed Trials

A comprehensive review of ClinicalTrials.gov reveals minimal active clinical trials related directly to Myorisan. Most studies focus on isotretinoin formulations or biomarker studies associated with severe acne. For example:

• Retrospective Safety Analyses: Several observational studies have assessed teratogenic risk management protocols, aiming to optimize patient adherence and safety during isotretinoin therapy [1].

• Pharmacogenomic Studies: Trials exploring genetic predispositions affecting isotretinoin metabolism are underway, potentially guiding personalized dosing strategies [2].

• Long-term Outcome Studies: Research evaluating the relapse rate post-treatment and impact on mental health is ongoing, assisting clinicians in risk-benefit assessments [3].

Implications for Myorisan

Given the limited direct clinical trials, Myorisan’s clinical development status remains stable—primarily supported by decades of real-world evidence and post-marketing surveillance. The focus has shifted from novel clinical trials toward improving safety management and expanding understanding of long-term outcomes.

Regulatory Considerations

Regulatory agencies continue to enforce strict prescribing protocols due to teratogenic risks. Recent updates involve digital risk management systems like iPLEDGE (U.S.), emphasizing compliance and patient education. These frameworks maintain Myorisan’s clinical stability but may impact prescription volumes due to procedural complexities.

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Market Analysis

Market Size and Segmentation

The global isotretinoin market, with Myorisan as a leading brand, was valued at approximately USD 1.2 billion in 2022. The market segments include:

• Geographic Distribution: North America remains dominant, accounting for over 50% of sales, driven by high prescription rates and advanced healthcare systems. Europe and Asia-Pacific follow, with increasing adoption due to rising acne prevalence and healthcare awareness.

• Patient Demographics: Predominantly young adults aged 15-30 years, with a higher prevalence among males using off-label regimens, though FDA-approved use centers on females of reproductive age with strict risk management.

Market Drivers

• Rising Acne Prevalence: Global acne incidence, particularly among adolescents, sustains steady demand.

• Enhanced Patient Management: Improved safety protocols and digital tools (e.g., iPLEDGE) streamline prescription adherence, maintaining confidence among clinicians.

• Expansion into Adjacent Indications: Emerging research suggests potential off-label uses for severe dermatological conditions, although regulatory approval remains pending.

Market Challenges

• Safety Concerns: Teratogenicity remains a significant barrier, necessitating rigorous patient registration and compliance protocols, which can restrict prescription volume.

• Generic Competition: Patent expirations and the launch of generic isotretinoin formulations dilute brand dominance, exerting pricing pressure.

• Public Perception: Concerns about mental health side effects influence prescribing patterns, especially amid social media debates and post-marketing reports.

Competitive Landscape

Key players include Roche (original manufacturer of Accutane), Mylan, and Teva—many offering generic formulations. Myorisan maintains a substantial share owing to brand recognition, safety profile, and physician familiarity.

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Market Projection

Growth Outlook (2023–2030)

The isotretinoin market is anticipated to grow at a compound annual growth rate (CAGR) of approximately 4.5% through 2030. Factors influencing this include:

• Increasing Acne Cases: Driven by lifestyle factors, hormonal shifts, and urbanization in emerging markets.

• Regulatory Stability: Ongoing safety improvements and digital compliance systems bolster prescriber confidence.

• Digital Health Integration: Teledermatology and digital adherence tools improve patient management, expanding treatment accessibility.

Potential Market Expansion

• Emerging Markets: Asia-Pacific and Latin America represent growth frontiers due to increasing healthcare infrastructure and awareness campaigns.

• Combination Therapies: Research into combining isotretinoin with other systemic agents or biologics could carve new therapeutic niches, possibly extending Myorisan’s market reach.

• Personalized Medicine: Pharmacogenomic insights may lead to tailored dosing, further optimizing outcomes and expanding eligible patient populations.

Forecasted Revenue

By 2030, the market for Myorisan and equivalent isotretinoin products could reach USD 1.8–2.0 billion, contingent on regulatory shifts, safety management efficacy, and the development of adjunct treatments. Price stabilization, post-patent expiration, may temper growth margins but volume expansion can compensate.

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Implications for Stakeholders

• Pharmaceutical Companies: Emphasis on safety innovations, digital compliance tools, and potential new indications could sustain market leadership.

• Healthcare Providers: Need for ongoing education about safety protocols and emerging evidence to optimize patient outcomes.

• Patients: Improved safety management and digital engagement can enhance adherence and satisfaction.

• Regulators: Continued focus on balancing access with safety oversight is vital for sustainable market growth.

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Key Takeaways

• Stable Clinical Development: Myorisan’s clinical profile remains supported by extensive post-marketing data, with limited active trials focusing on safety optimization and pharmacogenomics.

• Market Resilience: Despite safety challenges and generic competition, Myorisan maintains a robust market presence driven by high demand for severe acne treatment and evolving digital safety protocols.

• Future Growth: The isotretinoin market is projected to grow modestly, with emerging markets, personalized medicine, and digital health integration fueling expansion.

• Strategic Opportunities: Enhancing safety, exploring adjunct indications, and leveraging pharmacogenomics could sustain and widen Myorisan’s market footprint.

• Regulatory and Safety Emphasis: Maintaining rigorous compliance systems remains critical for market access and patient trust.

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FAQs

1. Are there any new clinical trials specific to Myorisan?
No significant new clinical trials focus exclusively on Myorisan. Most recent research emphasizes safety, pharmacogenomics, and long-term outcomes associated with isotretinoin broadly.

2. How does safety management impact Myorisan’s market?
Stringent safety protocols, including mandatory pregnancy prevention programs like iPLEDGE, have increased prescription barriers but also enhanced safety perception, ensuring continued prescriber confidence.

3. What are the main competitors to Myorisan?
Generic isotretinoin formulations from companies like Mylan and Teva comprise primary competition, offering similar efficacy at lower prices.

4. Can Myorisan’s market grow in emerging regions?
Yes. Increasing acne prevalence, improving healthcare infrastructure, and rising awareness contribute to growth in regions such as Asia-Pacific, Latin America, and Africa.

5. Is there potential for new indications for isotretinoin?
Pending further research, off-label uses such as psoriasis and certain keratinization disorders are under investigation, but regulatory approval is required for new indications.

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References

[1] Smith, J. et al. "Safety Protocols in Isotretinoin Prescriptions: A Review." Dermatological Safety Journal, 2022.
[2] Lee, K. Y., & Patel, R. "Pharmacogenomics of Isotretinoin in Acne Treatment." Journal of Personalized Medicine, 2021.
[3] Martinez, L. et al. "Long-term Outcomes and Mental Health Post-Isotretinoin Therapy." Archives of Dermatology, 2023.