Last reviewed 2026-05-31 · How we verify

AG881 Formulation 1

Agios Pharmaceuticals, Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

AG881 Formulation 1 is a Small molecule drug developed by Agios Pharmaceuticals, Inc.. It is currently in Phase 1 development.

AG881 Formulation 1 was studied in a Phase 1 clinical trial to compare its relative bioavailability with another formulation, AG881 Formulation 2. The study also evaluated the effect of food and the medication omeprazole on the pharmacokinetics of AG881 Formulation 1.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	AG881 Formulation 1
Sponsor	Agios Pharmaceuticals, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881 (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

AG881 Formulation 1 CI brief — competitive landscape report
AG881 Formulation 1 updates RSS · CI watch RSS
Agios Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about AG881 Formulation 1

What is AG881 Formulation 1?

AG881 Formulation 1 is a Small molecule drug developed by Agios Pharmaceuticals, Inc..

Who makes AG881 Formulation 1?

AG881 Formulation 1 is developed by Agios Pharmaceuticals, Inc. (see full Agios Pharmaceuticals, Inc. pipeline at /company/agios-pharmaceuticals-inc).

What development phase is AG881 Formulation 1 in?

AG881 Formulation 1 is in Phase 1.

Manufacturer: Agios Pharmaceuticals, Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing