CLINICAL TRIALS PROFILE FOR ZENATANE

All Clinical Trials for Zenatane

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.

Clinical Trial Conditions for Zenatane

Condition Name

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

Condition MeSH

Condition MeSH for Zenatane
Intervention	Trials
Neuroblastoma	7
Ganglioneuroblastoma	4
Neuroectodermal Tumors	2
Medulloblastoma	2

Clinical Trial Locations for Zenatane

Trials by Country

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

Trials by US State

Trials by US State for Zenatane
Location	Trials
California	9
Pennsylvania	9
New York	9
Texas	8
Tennessee	8

Clinical Trial Progress for Zenatane

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Zenatane

Sponsor Name

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

Sponsor Type

Sponsor Type for Zenatane
Sponsor	Trials
NIH	9
Other	3

Zenatane (Isotretinoin): Clinical Trials, Market Analysis, and Projections

Introduction to Zenatane

Zenatane, a generic version of Accutane, is an isotretinoin-based medication approved by the U.S. Food and Drug Administration (USFDA) for the treatment of severe acne, including nodular and conglobate acne, which are unresponsive to conventional therapies. Here, we will delve into the clinical aspects, market analysis, and future projections for Zenatane.

Clinical Use and Indications

Zenatane is specifically designed for patients with severe acne that has not responded to other treatments. It is a retinoid, derived from vitamin A, which works by reducing the size of the oil glands in the skin, thereby decreasing the amount of oil produced and the bacteria that can cause acne[5].

Special Prescribing Requirements

Due to its teratogenic effects, Zenatane is only available under a special restricted distribution program called iPLEDGE. This program requires prescribers, pharmacies, and patients to be registered and meet specific criteria to minimize fetal exposure. Female patients must undergo regular pregnancy tests and use two forms of contraception to prevent pregnancy while taking the medication[2][5].

Market Analysis

Current Market Size and Growth

The isotretinoin drugs market, which includes Zenatane, was valued at USD 1.25 billion in 2023. This market is projected to grow to USD 1.81 billion by 2032, with a compound annual growth rate (CAGR) of 4.14% during the forecast period (2024-2032)[3].

Key Drivers

The growth of the isotretinoin market is driven by several factors:

• Increasing Prevalence of Acne: The rising prevalence of acne among teens and young adults, often due to hormonal imbalances, stress, and poor diet, is a significant driver.
• Neuroblastoma Cases: Although less common, the use of isotretinoin in treating neuroblastoma also contributes to market growth[3].

Market Share and Sales

Dr. Reddy's Laboratories, the manufacturer of Zenatane, has seen significant sales from this product. In the twelve months ending March 2019, the U.S. sales of Zenatane and its therapeutic equivalents were approximately $525 million[2].

Clinical Trials and Safety

While Zenatane itself is not currently under clinical trials for new indications, its safety profile is well-documented. Here are some key points:

Safety Profile

Zenatane has a well-known safety profile, with the most critical concern being its teratogenicity. Other potential side effects include dry skin, joint pain, and increased risk of depression. The iPLEDGE program is designed to mitigate the risk of fetal exposure[2][5].

Comparison with Other Treatments

In the context of acne treatment, Zenatane is often reserved for severe cases due to its potential side effects. However, its efficacy in treating resistant acne makes it a valuable option for patients who have not responded to other treatments.

Market Projections

Future Growth

The isotretinoin market, including Zenatane, is expected to continue growing due to the increasing prevalence of acne and the consistent demand for effective treatments. The projected CAGR of 4.14% indicates a steady and significant growth trajectory over the next decade[3].

Competitive Landscape

The market for isotretinoin is competitive, with several generic versions available. Dr. Reddy's Laboratories, with its re-launch of Zenatane, has ensured a consistent supply of this medication in the U.S. market. The company's ability to commercialize the first softgel dosage product from its own manufacturing plant has been a key factor in maintaining market share[2].

Regulatory Environment

FDA Approvals and Restrictions

Zenatane is approved under a special restricted distribution program due to its teratogenic effects. The FDA closely monitors the distribution and use of this medication to ensure patient safety. Any changes in regulatory requirements or additional safety measures could impact the market dynamics[2][5].

Patient Impact and Access

Patient Access Programs

Dr. Reddy's Laboratories has emphasized the importance of bringing this medication back to the market to ensure consistent access for patients. The re-launch of Zenatane has been welcomed by patients and healthcare providers due to the limited supply and options previously available[2].

Cost and Affordability

The cost of Zenatane can be a significant factor for patients. However, as a generic version of Accutane, it is generally more affordable than the brand-name alternative. This affordability, combined with the efficacy of the medication, makes it a viable option for many patients.

Key Takeaways

• Market Growth: The isotretinoin market, including Zenatane, is projected to grow at a CAGR of 4.14% from 2024 to 2032.
• Clinical Use: Zenatane is used for severe acne and is available under a special restricted distribution program due to its teratogenic effects.
• Safety Profile: The medication has a well-documented safety profile, with teratogenicity being the most critical concern.
• Regulatory Environment: The FDA closely monitors the distribution and use of Zenatane to ensure patient safety.
• Patient Access: The re-launch of Zenatane has improved access to this medication for patients with severe acne.

FAQs

Q: What is Zenatane used for?

A: Zenatane is used for the treatment of severe acne, including nodular and conglobate acne, which are unresponsive to conventional therapies.

Q: Why is Zenatane only available under a special program?

A: Due to its teratogenic effects, Zenatane is only available under the iPLEDGE program to minimize fetal exposure.

Q: What are the potential side effects of Zenatane?

A: Potential side effects include dry skin, joint pain, and an increased risk of depression. The most critical concern is its teratogenicity.

Q: How is the market for isotretinoin drugs projected to grow?

A: The market is projected to grow from USD 1.30 billion in 2024 to USD 1.81 billion by 2032, with a CAGR of 4.14%.

Q: Who manufactures Zenatane?

A: Zenatane is manufactured by Dr. Reddy's Laboratories.

Sources

1. FDA Places Partial Clinical Holds on 3 Trials Evaluating Azenosertib ... - Onclive
2. Dr. Reddy's Laboratories Announces the Re-Launch of Zenatane ... - Biospace
3. Isotretinoin Drugs Market Share - Market Research Future
4. Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical ... - Zentalis Pharmaceuticals
5. Dr. Reddy's Laboratories Limited : Dr. Reddy's Announces the Launch of Zenatane ... - Marketscreener