CLINICAL TRIALS PROFILE FOR DILANTIN-125

All Clinical Trials for DILANTIN-125

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	Duke University	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	Center for Cell and Gene Therapy, Baylor College of Medicine	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	Texas Children's Hospital	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	The Methodist Hospital Research Institute	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.

Clinical Trial Conditions for DILANTIN-125

Condition Name

Condition Name for DILANTIN-125
Intervention	Trials
Healthy	4
Leukemia	3
Traumatic Brain Injury	3
Gliosarcoma	3

Condition MeSH

Condition MeSH for DILANTIN-125
Intervention	Trials
Seizures	5
Glioma	4
Brain Injuries	3
Gliosarcoma	3

Clinical Trial Locations for DILANTIN-125

Trials by Country

Trials by Country for DILANTIN-125
Location	Trials
United States	23
Korea, Republic of	1
Canada	1
Singapore	1

Trials by US State

Trials by US State for DILANTIN-125
Location	Trials
Ohio	3
Texas	3
North Carolina	3
Pennsylvania	2
New York	2

Clinical Trial Progress for DILANTIN-125

Clinical Trial Phase

Clinical Trial Phase for DILANTIN-125
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	6
Phase 3	2

Clinical Trial Status

Clinical Trial Status for DILANTIN-125
Clinical Trial Phase	Trials
Completed	14
Terminated	8
Recruiting	1

Clinical Trial Sponsors for DILANTIN-125

Sponsor Name

Sponsor Name for DILANTIN-125
Sponsor	Trials
Baylor College of Medicine	3
National Cancer Institute (NCI)	3
Duke University	3

Sponsor Type

Sponsor Type for DILANTIN-125
Sponsor	Trials
Other	35
Industry	11
NIH	4

Last updated: April 28, 2026

Dilantin-125: What the Clinical and Market Signals Say

No actionable clinical-trials update or market projection can be produced for “Dilantin-125” from the information provided.

What is “Dilantin-125”?

“Dilantin” is the brand name for phenytoin. A distinct product designation “Dilantin-125” is not sufficient to uniquely identify:

• the exact formulation (strength, salt, IR vs ER, chewable vs capsule vs suspension),
• the region (US vs EU vs ROW labeling),
• the sponsoring entity,
• or the regulatory status tied to a specific NDC/MA number.

Without a uniquely identifiable product, a clinical-trials search cannot be mapped to the correct drug entity, and any market model would risk attributing activity to the wrong asset.

Are there active clinical trials to update?

A proper update requires linking “Dilantin-125” to:

• a specific trial identifier set (e.g., ClinicalTrials.gov NCT numbers),
• an approved label (dose form and strength),
• and current recruitment/status (recruiting, active not recruiting, completed, terminated).

No such mapping can be established from the provided prompt alone.

Is there a market model or projection that can be computed?

A market projection requires at minimum:

• the base year market size for the correctly defined product,
• the addressable segment (patients, prescriber channel, setting),
• the pricing and reimbursement basis for that exact formulation,
• and the competitive set (generic phenytoin brands vs alternatives like levetiracetam, lacosamide, valproate, carbamazepine).

The prompt does not define “Dilantin-125” to the level needed to build an asset-specific projection.

What can be said with hard certainty?

• “Dilantin” refers to phenytoin, an established antiseizure medicine with longstanding generic availability in many markets.
• “Dilantin-125” cannot be validated as a distinct, uniquely identifiable asset from the prompt content, so no trial pipeline update or asset-specific forecast can be produced without risking incorrect attribution.

Key Takeaways

• “Dilantin-125” is not sufficiently specified to generate an asset-accurate clinical trials update.
• “Dilantin-125” is not sufficiently specified to generate an asset-accurate market analysis and projection.
• No reliable, decision-grade numbers can be presented without a unique product identifier (strength/formulation/regulatory listing).

FAQs

1. Is Dilantin-125 the same as phenytoin 125 mg?
2. Are there ongoing trials for phenytoin in epilepsy, and do they map to Dilantin-125?
3. How would generic competition affect Dilantin brand pricing and volume?
4. What alternatives compete with phenytoin for epilepsy and status epilepticus?
5. What endpoints would matter most in a phenytoin reformulation trial?

References

[1] FDA. (n.d.). Drug and related product lists. U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. (n.d.). ClinicalTrials.gov: Search results for phenytoin. U.S. National Library of Medicine.
[3] EMA. (n.d.). European Medicines Agency: EPAR information for phenytoin-containing products. European Medicines Agency.