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AG-236

Phase 1

Healthy Participants | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: May 29, 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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07075640A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy ParticipantsPHASE1 ACTIVE NOT_RECRUITING 24Jul 7, 2025Aug 31, 2026May 29, 20261 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
Up to Day 57
Secondary Endpoints
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236
Predose and multiple time points postdose from Day 1 to Day 57
Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236
Predose and multiple time points postdose from Day 1 to Day 57
Maximum Observed Plasma Concentration (Cmax) of AG-236
Predose and multiple time points postdose from Day 1 to Day 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Group AEXPERIMENTALParticipants will receive a single dose of AG-236 at dose level 1 or placebo on Day 1 under fasted conditions.
Treatment Group BEXPERIMENTALParticipants will receive a single dose of AG-236 at dose level 2 or placebo on Day 1 under fasted conditions.
Treatment Group CEXPERIMENTALParticipants will receive a single dose of AG-236 at dose level 3 or placebo on Day 1 under fasted conditions.
Interventions
NameTypeDescription
AG-236DRUGSubcutaneous (SC) Injection
PlaceboDRUGSC Injection
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Male or female, of any race, between 18 and 55 years of age, inclusive. 1. Females must be of nonchildbearing potential. 2. Males must agree to use contraception. 3. Males must agree not to donate sperm during the study and for 90 days or 5-half-lives of AG-236 in plasma...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07075640lastUpdatePostDate: changed
LOWMay 29, 2026NCT07075640lastUpdatePostDate: changed
LOWMay 29, 2026NCT07075640lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07075640Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07075640studyFirstPostDate: changed