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AN2-502998

Phase 1

Healthy Volunteers | Small molecule | Other |AN2 Therapeutics, Inc.|Last Updated: Apr 30, 2026

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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07024589First-in-Human Trial of Oral AN2-502998PHASE1 COMPLETED 72 — — Aug 4, 2025Mar 14, 2026Apr 30, 20261 Australia
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Study Endpoints
Primary Endpoints
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence, relatedness, and severity of adverse events

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of physical exam abnormalities

Evaluate Change in Vital Signs from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in blood pressure, pulse, respiratory rate, and temperature

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in 12-lead ECG parameters from baseline

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in clinical laboratory measurements from baseline

Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence, relatedness, and severity of adverse events

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of physical exam abnormalities

Evaluate Change in Vital Signs from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in blood pressure, pulse, respiratory rate, and temperature

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in 12-lead ECG parameters from baseline

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in clinical laboratory measurements from baseline

Characterize the PK Profile of AN2-502998: Maximum Plasma Concentration
Day 1 through last follow-up (3 Days after last dose)

Determination of the maximum plasma concentration (Cmax)

Characterize the PK Profile of AN2-502998: Time to Maximum Plasma Concentration
Day 1 through 3 days after last dose

Determination the time to maximum plasma concentration (Tmax)

Characterize the PK Profile of AN2-502998: Terminal Half-Life
Day 1 through 3 days after last dose

Determine the apparent terminal half-life (t½)

Characterize the PK Profile of AN2-502998: Area Under Plasma Concentration Curve
Day 1 through 3 days after last dose

Area under plasma concentration-time curve from zero to a designated dosing interval

Characterize the PK Profile of AN2-502998: Apparent Plasma Clearance
Day 1 through 3 days after last dose

Apparent plasma clearance of drug after extravascular administration CL/F

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Single Ascending Dose (SAD)EXPERIMENTALParticipants will be randomized in a 3:1 ratio to receive a single dose of either AN2-502998 or placebo.
Multiple Ascending Dose (MAD)EXPERIMENTALParticipants will be randomized in a 3:1 ratio to receive multiple doses of either AN2-502998 or placebo.
Interventions
NameTypeDescription
AN2-502998DRUGOral Capsule
PlaceboDRUGOral Capsule
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female aged 18 to 55 years, inclusive, at Screening 2. Willing and able to provide written informed consent 3. Willing and able to comply with all trial assessments and adhere to the protocol schedule 4. BMI between ≥18 and \<32 kg/m2 (inclusive); BMI is calculated as...

Countries:Australia
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Recent Changes (Last 90 Days)
MEDIUMMay 31, 2026NCT07024589TRIAL_REMOVED: changed
MEDIUMMay 31, 2026NCT07024589TRIAL_REMOVED: changed
MEDIUMMay 31, 2026NCT07024589TRIAL_REMOVED: changed
HIGHMay 26, 2026NCT07024589Status: RECRUITING → COMPLETED
LOWMay 24, 2026NCT07024589studyFirstPostDate: changed