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ODT #2 with water

Phase 1

Migraine | Small molecule | Neurology |Pfizer, Inc.|Trials Updated: Sep 4, 2026

ODT #2 with water development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2009

ODT #2 with water target and mechanism

ModalitySmall molecule

Also known as ODT2 Test formulation

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

ODT #2 with water clinical trials

ODT #2 with water · 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
COMPLETED36 Analytics
PHASE1COMPLETED
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 43 trials

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Recent Changes (Last 90 Days)

MEDIUMOct 5, 2026NCT07594769TRIAL_REMOVED: changed
MEDIUMOct 5, 2026NCT07594769TRIAL_REMOVED: changed
MEDIUMOct 5, 2026NCT07594769TRIAL_REMOVED: changed
HIGHSep 4, 2026NCT07594769Status: RECRUITING → COMPLETED
HIGHSep 4, 2026NCT07594769Status: RECRUITING → COMPLETED

Frequently asked questions about ODT #2 with water

What is ODT #2 with water?

ODT #2 with water is an investigational small molecule formulation being developed by Pfizer, Inc. for migraine. It is an orally disintegrating tablet formulation studied in a Phase 1 clinical trial comparing blood levels of two dosage formulations of the study medicine in healthy adults.

What is ODT #2 with water used for?

ODT #2 with water is being studied for migraine, which falls within the neurology therapeutic area. The completed Phase 1 trial enrolled healthy adult volunteers rather than migraine patients, so the study evaluated the formulation in healthy participants.

Who makes ODT #2 with water?

Pfizer, Inc. is the developer of ODT #2 with water. Pfizer trades on the New York Stock Exchange under the ticker symbol PFE.

What phase is ODT #2 with water in?

ODT #2 with water is in Phase 1 clinical development. It is an investigational formulation and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is ODT #2 with water in?

ODT #2 with water has been studied in one completed Phase 1 trial, NCT07594769, titled A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults. The trial enrolled 36 healthy adults in Belgium and was randomized and controlled.

Is ODT #2 with water the same as ODT2 Test formulation?

Yes, ODT #2 with water is also known as ODT2 Test formulation. Both names refer to the same Pfizer investigational small molecule formulation studied for migraine in the completed Phase 1 trial NCT07594769.