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AG-236

Phase 1

Healthy Participants | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: Jul 30, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

AG-236 · 1 trial · 1 indication

Phase 1 1
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 ParticipantsHealthy Participants
ACTIVE NOT_RECRUITING24 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants
Healthy ParticipantsUnlock trial analytics

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 to 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)

LOWJul 30, 2026NCT07075640lastUpdatePostDate: changed
LOWJul 30, 2026NCT07075640lastUpdatePostDate: changed
LOWJun 23, 2026NCT07075640lastUpdatePostDate: changed
LOWJun 23, 2026NCT07075640lastUpdatePostDate: changed

Frequently asked questions about AG-236

What is AG-236 used for?

AG-236 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development to evaluate its safety, tolerability, and how it is absorbed, broken down, and eliminated from the body. It is not approved for any medical condition.

Who makes AG-236?

AG-236 is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AGIO. The company is conducting a Phase 1 clinical trial to assess the drug's safety and pharmacokinetics in healthy participants.

What phase is AG-236 in?

AG-236 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is designed to evaluate its safety, tolerability, and how the body processes the drug in healthy participants.

What clinical trials is AG-236 in?

AG-236 is being studied in one active Phase 1 clinical trial, NCT07075640. This trial is a randomized, double-blind, controlled study in healthy participants in the United States, with an enrollment of 24 individuals aged 18 years and older. The study is active but not currently recruiting.

Is AG-236 the same as any other drug?

No alternative names for AG-236 have been reported. It is identified solely by its code name AG-236 in clinical trial registries and is being developed by Agios Pharmaceuticals. No other names or aliases are associated with this investigational drug.