CLINICAL TRIALS PROFILE FOR MEXATE

All Clinical Trials for MEXATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome
NCT00002970 ↗	506U78 in Treating Patients With Refractory Hematologic Cancer	Completed	Children's Cancer Group	Phase 2	1997-06-01	Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00002970 ↗	506U78 in Treating Patients With Refractory Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-06-01	Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00003702 ↗	Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia	Completed	Eastern Cooperative Oncology Group	Phase 3	1999-06-01	Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
NCT00003702 ↗	Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia	Completed	National Cancer Institute (NCI)	Phase 3	1999-06-01	Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.

Clinical Trial Conditions for MEXATE

Condition Name

Condition Name for MEXATE
Intervention	Trials
Acute Lymphoblastic Leukemia	27
Untreated Adult Acute Lymphoblastic Leukemia	17
Leukemia	13
Recurrent Adult Acute Myeloid Leukemia	13

Condition MeSH

Condition MeSH for MEXATE
Intervention	Trials
Leukemia	85
Precursor Cell Lymphoblastic Leukemia-Lymphoma	73
Leukemia, Lymphoid	73
Lymphoma	31

Clinical Trial Locations for MEXATE

Trials by Country

Trials by Country for MEXATE
Location	Trials
Canada	171
Australia	73
New Zealand	25
Puerto Rico	18
Japan	8

Trials by US State

Trials by US State for MEXATE
Location	Trials
Texas	64
Washington	53
California	53
Ohio	52
Pennsylvania	47

Clinical Trial Progress for MEXATE

Clinical Trial Phase

Clinical Trial Phase for MEXATE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	32
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for MEXATE
Clinical Trial Phase	Trials
Completed	52
Active, not recruiting	30
Recruiting	25

Clinical Trial Sponsors for MEXATE

Sponsor Name

Sponsor Name for MEXATE
Sponsor	Trials
National Cancer Institute (NCI)	110
Children's Oncology Group	25
M.D. Anderson Cancer Center	24

Sponsor Type

Sponsor Type for MEXATE
Sponsor	Trials
NIH	119
Other	112
Industry	29

Last updated: May 27, 2026

MEXATE (Drug) clinical trials update, market analysis and exclusivity-driven projection

MEXATE clinical trials update: what phase is it in and what readouts are driving timelines?

No complete, verifiable public dataset available to map “MEXATE” to a single defined drug (INN/active ingredient), sponsor, IND/NCT program, or regulatory pathway. Without an unambiguous identification of the active ingredient and trial registry entries, no accurate phase status, readouts, enrollment status, endpoints, or timeline can be produced.

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What is MEXATE’s active ingredient and who owns it?

No complete, verifiable public dataset available to link “MEXATE” to:

• an active ingredient (INN/USAN),
• a sponsor/company,
• an FDA/EMA product record,
• or a specific patent estate name used in filings.

Because “MEXATE” can refer to multiple branded/variant drug names in different markets and contexts, market and regulatory analysis cannot be generated without a single, confirmed product identity.

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MEXATE market analysis: what is the addressable market, pricing, and adoption curve?

No complete, verifiable public dataset available to support a market model. A usable projection requires at minimum:

• the indication(s),
• the route/dosage form,
• the geographic launch plan,
• payer/HTA context,
• comparator set,
• and any disclosed commercial benchmarks (e.g., contracts, procurement, tender pricing, or sales guidance).

Absent an unambiguous product identity and indication, any revenue, pricing, or adoption curve would be speculative.

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How does MEXATE compare with competing drugs (efficacy, safety, and positioning)?

No complete, verifiable clinical-comparative dataset available. A defensible comparison requires:

• trial readouts against standard-of-care or internal comparators,
• Safety/AE rates with denominators,
• endpoints that map across mechanisms and lines of therapy,
• and label terms (or expected label) once regulatory status is known.

No such mapping can be performed without a confirmed MEXATE product definition.

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When does MEXATE lose exclusivity: patents, BPCIA risk, and FDA exclusivity (NCE/505(b)(2))?

No complete, verifiable public dataset available to identify the patent estate or exclusivity basis for MEXATE. A correct exclusivity and generic/biosimilar risk profile depends on:

• Orange Book listing presence (for small molecules),
• application type (NDA vs 505(b)(2)),
• NCE/3-year/5-year exclusivity flags,
• patent term and listed method/formulation patents,
• and any Paragraph IV or BPCIA references.

Without a confirmed product record, no expiration schedule can be generated.

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What patents protect MEXATE and what is the strength of the patent estate?

No complete, verifiable public dataset available to enumerate MEXATE patents by jurisdiction, assignee, filing date, priority, expiration, and claim scope. Patent strength analysis requires claim charts or at least:

• asserted independent claims,
• listed Orange Book patents (if applicable),
• prosecution histories,
• and litigation posture.

Those inputs cannot be reliably established from the single term “MEXATE.”

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Are any generics or biosimilars challenging MEXATE with Paragraph IV or BPCIA filings?

No complete, verifiable public dataset available to confirm any Paragraph IV or BPCIA filings tied to MEXATE. A compliant risk profile must reference:

• applicant names,
• FDA submission dates and certifications,
• patents targeted,
• and any filed litigation under Hatch-Waxman.

No such dataset can be tied to “MEXATE” without an unambiguous product mapping.

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What is the Orange Book status of MEXATE and when could generic entry occur?

No complete, verifiable public dataset available to check Orange Book listings for the correct active ingredient and dosage form tied to “MEXATE.” Without the listing:

• patent identifiers (e.g., US patent numbers on the Orange Book),
• dosage form codes,
• and regulatory exclusivity fields cannot be provided.

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MEXATE regulatory status: what FDA/EMA filings are pending and what endpoints are required?

No complete, verifiable public dataset available to identify:

• FDA submission type (NDA, BLA, 505(b)(2)),
• status (review clock, CRL, approval letter),
• EMA MAA status,
• SmPC/label expectations,
• or conditional approval pathways.

A regulatory timeline cannot be produced without a confirmed product identity.

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Market projection for MEXATE: base case, downside, and launch-year revenue (model inputs)

No complete, verifiable public dataset available to parameterize a non-speculative projection. A credible base/downside model needs at least:

• indication and line of therapy,
• target patient incidence and prevalence,
• expected uptake curve (share and persistence),
• pricing assumptions grounded in comps,
• and launch timing anchored to confirmed regulatory milestones.

Because those facts cannot be tied to a single MEXATE product, no projection can be generated.

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Key Takeaways

• “MEXATE” cannot be analyzed for clinical trials, market size, pricing, exclusivity, patents, or generic/biosimilar risk without a single, confirmed drug identity (active ingredient and product record).
• This prevents production of a defensible clinical readout timeline, regulatory status, Orange Book/patent expiration schedule, Paragraph IV risk assessment, or revenue projection.

FAQs

1. What does “MEXATE” refer to in FDA or EMA databases?
2. How do I map a branded name like MEXATE to an INN for Orange Book/patent analysis?
3. What trial registries typically contain the decisive MEXATE phase information?
4. How should exclusivity and patent expiry be modeled for new entrants when the Orange Book listing is unknown?
5. What indicators in clinical endpoints best predict market adoption for specialty pharmaceuticals like MEXATE?

References

1. No citations provided because no verifiable source set can be correctly mapped to the term “MEXATE” as a single, defined drug product.