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AN2-502998

Phase 1

Undisclosed | Small molecule | Other |AN2 Therapeutics, Inc.|Trials Updated: Apr 30, 2026

AN2-502998 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

AN2-502998 clinical trials

AN2-502998 · 1 trial · 1 indication

Phase 1 1
NCT07024589First-in-Human Trial of Oral AN2-502998Healthy Volunteers
COMPLETED72 Analytics
PHASE1COMPLETED
First-in-Human Trial of Oral AN2-502998
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about AN2-502998

What is AN2-502998?

AN2-502998 is an oral small molecule drug candidate developed by AN2 Therapeutics, Inc. It has been evaluated in a first-in-human Phase 1 clinical trial in healthy adult volunteers. The specific disease indications being pursued for AN2-502998 have not been publicly disclosed.

Who is developing AN2-502998?

AN2-502998 is being developed by AN2 Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol ANTX. The company is the sponsor of the clinical program evaluating this oral small molecule candidate.

What phase is AN2-502998 in?

AN2-502998 is in Phase 1 development. Its first-in-human Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is AN2-502998 in?

AN2-502998 has been studied in one clinical trial: NCT07024589, a first-in-human Phase 1 trial of oral AN2-502998. The trial enrolled 72 healthy adult volunteers in Australia and has been completed. It was randomized, double-blind, and controlled.

What is AN2-502998 used for?

AN2-502998 does not yet have a disclosed therapeutic use. It has only been tested in healthy volunteers in a completed Phase 1 trial, and the specific disease indications it may treat have not been publicly announced.