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ODT2 Test formulation

Phase 1

Migraine | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Jun 10, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

ODT2 Test formulation · 1 trial · 1 indication

Phase 1 1
NCT07594769A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy AdultsMigraine
RECRUITING36 Analytics
PHASE1RECRUITING
A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults
MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations
Pre-dose to 72 hours
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) of the test and reference formulations
Pre-dose to 72 hours
Maximum observed plasma concentration (Cmax) of test and reference formulations
Pre-dose to 72 hours

Secondary Endpoints

Number of participants with treatment emergent adverse events (TEAEs)
From baseline up to 36 days after last dose of study intervention
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment Sequence 1EXPERIMENTAL -
Treatment Sequence 2EXPERIMENTAL -

Interventions

NameTypeDescription
ODT2 Test formulationDRUGTest Formulation
ODT Reference formulationDRUGReference Formulation
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. 2. Hav...

Countries:Belgium
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Competitive Landscape -Migraine 30 trials

Recent Changes (Last 90 Days)

LOWJun 10, 2026NCT07594769Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 10, 2026NCT07594769Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about ODT2 Test formulation

What is ODT2 Test formulation used for?

ODT2 Test formulation is an investigational small molecule being developed for the treatment of migraine. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in healthy adults to evaluate its properties before potential use in patients with migraine.

Who is developing ODT2 Test formulation?

ODT2 Test formulation is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational drug for the treatment of migraine, with the asset currently in Phase 1 development.

What phase is ODT2 Test formulation in?

ODT2 Test formulation is currently in Phase 1 clinical development. This is an early stage of testing, meaning the drug is investigational and has not been approved for use. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's blood levels and safety profile in healthy adults.

What clinical trials is ODT2 Test formulation in?

ODT2 Test formulation is being studied in one active Phase 1 clinical trial with the identifier NCT07594769. This trial is titled 'A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults' and is recruiting 36 participants in Belgium. The study is enrolling healthy volunteers aged 18 years and older.

Is ODT2 Test formulation being studied in a randomized controlled trial?

Yes, the ongoing Phase 1 clinical trial for ODT2 Test formulation is randomized and controlled. The study is designed to compare the blood levels of two different dosage formulations of the drug in healthy adult volunteers. The trial is not double-blinded, but it includes a control group for comparison.

Is ODT2 Test formulation FDA approved?

ODT2 Test formulation is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of migraine. The drug is being studied in a clinical trial to assess its blood levels and safety in healthy adults, and it has not yet completed the clinical development process required for regulatory approval.