Last Updated: June 11, 2026

CLINICAL TRIALS PROFILE FOR ZENATANE


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

Clinical Trial Conditions for ZENATANE

Condition Name

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

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

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

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

Sponsor Name

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

Sponsor Type for ZENATANE
Sponsor Trials
NIH 9
Other 3
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Last updated: May 30, 2026

Zenatane clinical trials update, market analysis, and forecast for 2026-2036

Zenatane market and trial signals cannot be mapped to a specific, identifiable FDA/EMA product and sponsor using the information provided. Producing an “update + market + projection” with patents, trials, milestones, and quantified forecasts requires an unambiguous drug identity (active ingredient, brand/company, geography, and regulatory status). Without that, any pipeline, commercial, or exclusivity timeline would be non-actionable.

What is Zenatane and what active ingredient does it contain?

No data is available to tie “Zenatane” to a unique active ingredient, dosage form, NDC/MA number, or marketing authorization holder.

Which regulators have reviewed Zenatane (FDA, EMA, MHRA)?

No regulatory filings or approvals can be confirmed from the provided prompt.

What is Zenatane’s ATC/indication class?

No indication or therapeutic class can be confirmed.

What clinical trials exist for Zenatane, and what are the latest results?

No trial registry entries can be confirmed from the provided prompt. Without sponsor, indication, trial IDs, and endpoints, a clinical trials update would not be verifiable.

Which NCT/ClinicalTrials.gov studies are active or recruiting?

No NCT identifiers are provided, so study status cannot be summarized.

What are the most recent readouts (phase, date, endpoints)?

No phase, readout dates, or endpoint results are provided.

What safety signals have been reported for Zenatane?

No adverse event summaries or DSMB outcomes can be mapped.

When does Zenatane lose exclusivity or face generic/biosimilar entry risk?

No Orange Book, patent list, pediatric exclusivity, or biologics exclusivity status can be determined without knowing the authorized product and NDA/BLA number.

What patents protect Zenatane?

No patent numbers, assignees, or expiration dates can be identified from the provided prompt.

What is the Orange Book status of Zenatane?

No Orange Book listings can be confirmed.

Have any Paragraph IV challenges been filed against Zenatane?

No litigation or certification (IV, I, II, III) can be confirmed.

What market share and revenue does Zenatane have today?

No commercial data is provided, and Zenatane’s product identity is not established to support market sizing, pricing, reimbursement, or sales attribution.

Which companies sell competing products in Zenatane’s indication?

No comparators can be identified.

What payer coverage and pricing dynamics apply to Zenatane?

No payer or pricing data is available.

How large is the addressable market for Zenatane, by geography and segment?

No indication and no approved labeling can be confirmed, so TAM/SAM/SOM cannot be calculated.

US vs EU vs ROW: how does demand differ?

No geography-specific epidemiology or reimbursement assumptions can be mapped to Zenatane.

Which patient segments drive demand (line of therapy, biomarkers, severity)?

No indication or biomarker strategy can be confirmed.

What is the revenue forecast for Zenatane through 2036?

No forecasting inputs (approved label, dosing, uptake curve, competitor entry, price trend) can be identified from the provided prompt.

Base case, bull case, bear case: what is the projection range?

No model inputs can be substantiated.

What adoption drivers and barriers change the forecast?

No trial results, endpoints, or differentiated attributes can be verified.

How does Zenatane compare with similar drugs in the same class?

No therapeutic class or comparable products can be established.

Comparative efficacy endpoints: what is better or non-inferior?

No efficacy data is provided.

Comparative safety endpoints: what tolerability profile does it have?

No safety data is provided.

What patent litigation affects Zenatane’s launch timing?

No litigation records (Docket numbers, parties, settlement dates) can be confirmed.

What settlement agreements exist that could delay generic entry?

No settlements can be identified.

Key Takeaways

  • Zenatane’s market and clinical trial profile cannot be produced from the provided prompt because the drug identity is not established.
  • No exclusivity, patent, regulatory, or trial data can be mapped to Zenatane without a specific active ingredient and authorized product reference.

FAQs

  1. What does “Zenatane” refer to (brand, active ingredient, or development code) and which regulator approved it?
  2. Is Zenatane listed in the FDA Orange Book, and what are the key patent expiration dates?
  3. Which Phase 2/3 studies for Zenatane have the most recent readouts, by NCT and site?
  4. Has any company filed a Paragraph IV challenge for Zenatane, and what settlement terms were reached?
  5. What are the current and forecasted sales trends for Zenatane by geography and payer mix?

References

  1. (No cited sources available from the provided prompt.)

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