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Danuglipron

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06541678A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.PHASE1 COMPLETED 16 — — Dec 23, 2024Mar 10, 2025Aug 3, 20251 United States
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Study Endpoints
Primary Endpoints
AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.

Cmax: to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

Maximum observed plasma concentration

AUCinf (if data permits otherwise AUClast): to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.

Cmax: to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

Maximum observed plasma concentration

Secondary Endpoints
Number of Participants With Treatment Emergent Adverse Events Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Day 1 up to approximately Day 47
Number of Participants With Clinical Laboratory Abnormalities Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Day 1 up to approximately Day 47
Number of Participants With Clinically Significant Change from Baseline Vital Signs Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Day 1 up to approximately Day 47
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period 1: DanuglipronACTIVE_COMPARATORParticipants will receive a single 20 mg dose of danuglipron on Day 1.
Period 2: Cyclosporine + DanuglipronEXPERIMENTALParticipants will receive a single 20 mg dose of danuglipron and a single 600 mg dose of cyclosporine on Day 1.
Period 3: Itraconazole + DanuglipronEXPERIMENTALParticipants will receive itraconazole daily for 6 days plus a single dose of danuglipron on Day 4.
Interventions
NameTypeDescription
DanuglipronDRUGMR Tablet
CyclosporineDRUGCapsule
ItraconazoleDRUGOral solution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female 18 years of age 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, blood pressure, pulse rate...

Countries:United States
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