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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR MYORISAN


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Myorisan

Condition Name

Condition Name for Myorisan
Intervention Trials
Stage 4 Neuroblastoma 3
High Risk Neuroblastoma 3
Recurrent Neuroblastoma 3
Regional Neuroblastoma 2
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Condition MeSH

Condition MeSH for Myorisan
Intervention Trials
Neuroblastoma 7
Ganglioneuroblastoma 4
Pinealoma 2
Neuroectodermal Tumors, Primitive 2
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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
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Trials by US State

Trials by US State for Myorisan
Location Trials
California 9
Pennsylvania 9
New York 9
Illinois 8
Texas 8
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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
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Clinical Trial Status

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

Sponsor Name

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

Sponsor Type for Myorisan
Sponsor Trials
NIH 9
Other 3
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MYORISAN (Isotretinoin): Clinical Trials Update, Market Analysis, and Projections

Introduction to MYORISAN

MYORISAN, also known as isotretinoin, is a powerful oral retinoid used primarily for the treatment of severe recalcitrant nodular acne. Here, we will delve into recent clinical trial updates, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Current Clinical Trials and Outcomes

While MYORISAN itself is not currently in new clinical trials, its derivative formulations are being tested. For instance, TMB-001, an investigational topical ointment formulation of isotretinoin, was recently evaluated in the ASCEND trial for the treatment of congenital ichthyosis. However, the trial did not meet its primary and key secondary endpoints, indicating that the topical formulation did not show a statistically significant difference in treatment response compared to the vehicle control[1].

Historical Efficacy of MYORISAN

MYORISAN has been well-established for its efficacy in treating severe recalcitrant nodular acne. Clinical trials have shown that a single course of therapy for 15 to 20 weeks can result in complete and prolonged remission of the disease in many patients. The recommended dosage range is 0.5 to 1 mg/kg/day, given in two divided doses with food[4].

Safety and Side Effects

Adverse Reactions

MYORISAN is known for its significant adverse effects, which include dryness of the skin and mucous membranes, hypertriglyceridemia, and cheilitis. Many of these side effects are dose-related and reversible upon cessation of therapy. However, some adverse reactions can persist after treatment is discontinued[4].

Contraindications and Warnings

One of the most critical warnings associated with MYORISAN is its potential to cause severe birth defects if taken during pregnancy. Female patients must use two forms of effective contraception simultaneously to avoid pregnancy while on this medication[4].

Market Analysis

Global Market Size and Growth

The global market for isotretinoin drugs, which includes MYORISAN, is projected to grow significantly. By 2031, the market is expected to reach USD 2,053 million from a base year market size of USD 1,337 million in 2022, with a compound annual growth rate (CAGR) of 4.88%[5].

Regional Market Dynamics

  • North America: Currently the largest market for isotretinoin drugs, driven by high demand and established healthcare infrastructure.
  • Asia-Pacific: The fastest-growing regional market, driven by the emergence of several market players such as Sun Pharma and Dr. Reddy's Laboratories, and increasing awareness and funding for isotretinoin treatments[5].

Competitive Landscape

The acne treatment market, which includes isotretinoin, is expected to grow from $11.62 billion in 2024 to $17.48 billion by 2032, with a CAGR of 5.2%. This growth is fueled by rising awareness and the increasing number of companies entering the market, particularly in the Asia-Pacific region[2].

Projections and Future Outlook

Market Growth Projections

The isotretinoin market is expected to continue growing due to increasing demand for effective acne treatments. The Asia-Pacific region is anticipated to drive this growth, with countries like India seeing a significant rise in the production and consumption of isotretinoin drugs[5].

Challenges and Opportunities

  • Challenges: The loss of patent protection for biologics and the launch of generics could impact the market. For example, the passage of the Inflation Reduction Act (IRA) in the US aims to reduce drug prices, which could affect the profitability of isotretinoin and other drugs[3].
  • Opportunities: The increasing prevalence of acne and other skin conditions, along with the lack of effective treatments for certain conditions like congenital ichthyosis, present opportunities for innovation and market expansion.

Key Takeaways

  • Clinical Trials: Recent trials, such as the ASCEND trial for TMB-001, highlight the challenges in developing new formulations of isotretinoin.
  • Efficacy and Safety: MYORISAN remains a highly effective treatment for severe recalcitrant nodular acne but comes with significant side effects and contraindications.
  • Market Growth: The global isotretinoin market is projected to grow significantly, driven by increasing demand and expanding market presence in regions like Asia-Pacific.
  • Regional Dynamics: North America is the largest market, while Asia-Pacific is the fastest-growing due to increasing awareness and production.

FAQs

What is MYORISAN used for?

MYORISAN (isotretinoin) is used for the treatment of severe recalcitrant nodular acne that is unresponsive to conventional therapies.

What are the common side effects of MYORISAN?

Common side effects include dryness of the skin and mucous membranes, hypertriglyceridemia, and cheilitis. Many of these side effects are dose-related and reversible.

Why is MYORISAN contraindicated in pregnant women?

MYORISAN can cause severe birth defects if taken during pregnancy, making it crucial for female patients to use two forms of effective contraception simultaneously.

What is the projected growth of the isotretinoin market?

The global isotretinoin market is expected to grow from USD 1,337 million in 2022 to USD 2,053 million by 2031, with a CAGR of 4.88%.

Which region is driving the growth of the isotretinoin market?

The Asia-Pacific region is the fastest-growing market for isotretinoin drugs, driven by increasing awareness, production, and funding.

What are the challenges facing the isotretinoin market?

Challenges include the loss of patent protection for biologics, the launch of generics, and legislative efforts to reduce drug prices.

Sources

  1. LEO Pharma: "2024 Timber Pharmaceuticals provides an update - LEO Pharma"
  2. Fortune Business Insights: "Acne Treatment Market Size, Trends | Revenue Share [2032]"
  3. GlobeNewswire: "Plaque Psoriasis Drug Forecast and Market Analysis to 2030"
  4. RxList: "Myorisan (Isotretinoin Capsules): Side Effects, Uses ... - RxList"
  5. Straits Research: "Isotretinoin Drugs Market Size, Share, Analysis and Forecast to 2031"

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