Recent Updates
Recently added Catalysts

Vonoprazan

Phase 3

Erosive Esophagitis | Small molecule | Other |Phathom Pharmaceuticals, Inc.|Last Updated: Mar 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,042
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04124926Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive EsophagitisPHASE3 COMPLETED 1,027 — — Oct 28, 2019Aug 24, 2021Jul 29, 2022157 United States, Bulgaria +4
NCT06391177A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice DailyPHASE1 COMPLETED 15 — — May 7, 2024Sep 19, 2024Mar 25, 20251 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8
Week 8

A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.

Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24
Week 24

A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.

Area Under Drug Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Following the Morning Dose of Vonoprazan in Breast Milk
Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).

AUC from time 0 to 24 hours post-dose, calculated as: the sum of the product of the concentration of the interval and the width of the interval.

Maximum Drug Concentration (Cmax) of Vonoprazan in Breast Milk
Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).

Maximum observed concentration after dosing.

Minimum Drug Concentration (Cmin) of Vonoprazan in Breast Milk
Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).

Minimum observed concentration after dosing.

Average Drug Concentration (Cavg) of Vonoprazan in Breast Milk
Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).

Average concentration, calculated as: AUC0-24/tau (tau=the difference between the end time of the last interval and dosing time).

Time to Cmax (Tmax) of Vonoprazan in Breast Milk
Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).

Time to maximum observed concentration (actual midpoint of the interval in which Cmax was observed).

Secondary Endpoints
Healing Phase: Percentage of 24-hour Heartburn-free Days
Day 1 to Week 8
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2
Week 2
Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3
Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Healing Phase: Vonoprazan 20 mgEXPERIMENTALParticipants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks.
Healing Phase: Lansoprazole 30 mgACTIVE_COMPARATORParticipants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks.
Maintenance Phase: Vonoprazan 10 mgEXPERIMENTALParticipants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks.
Maintenance Phase: Vonoprazan 20 mgEXPERIMENTALParticipants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks.
Maintenance Phase: Lansoprazole 15 mgACTIVE_COMPARATORParticipants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks.
Vonoprazan 20 mg Once DailyEXPERIMENTALParticipants will be administered once-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4).
Vonoprazan 20 mg Twice DailyEXPERIMENTALParticipants will be administered twice-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4).
Interventions
NameTypeDescription
VonoprazanDRUGOver-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
LansoprazoleDRUGOver-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites157

Inclusion Criteria: 1. The participant is ≥18 years of age at the time of informed consent signing. 2. In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements. 3. The participant signs and dates a written, informed...

Countries:United StatesBulgariaCzechiaHungaryPolandUnited Kingdom
Unlock Eligibility Criteria