AG-181

Phase 1Small molecule

AAgios Pharmaceuticals, Inc.

AG-181 is one of 16 small molecule programs targeting Phenylketonuria. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

PhenylketonuriaActive, not recruiting

PhenylketonuriaPhase 1

Active, not recruiting

Competition

Competitive Landscape

29 competitors in Phenylketonuria

#DrugCompanyPhaseTrials

Avelox

Bayer

Approved

—2

L-Carnitine

IIperboreal Pharma Srl

Approved

1 3

BMN 333

BioMarin Pharmaceutical

Phase 2

1 4

CEB-01

BioMarin Pharmaceutical

Phase 3

1 5

PTC923

PPTC Therapeutics

Phase 3

2 6

Kuvan

BioMarin Pharmaceutical

Preclinical

5 7

Immunosuppression

NNational Heart, Lung, and Blood Institute (NHLBI)

Phase 2

1 8

Kuvan

BioMarin Pharmaceutical

Preclinical

5 9

Tetrahydrobiopterin

OOrphanetics Pharma Entwicklungs GmbH

Phase 1

1 10

Kuvan

BioMarin Pharmaceutical

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 1Recruiting

Phenylketonuria

NCT07241234

Clinical

Trials by Indication[1]

Phenylketonuria1 trial

A Phase 1b, Open-label, Multicenter, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of AG-181 in Subjects With Phenylketonuria

Recruiting·AAgios Pharmaceuticals, Inc.·Phase 1·NCT07241234·20 enrolled

Unspecified1 trial

Single and Multiple Ascending Dose Study and Food Effect Study for AG181

Completed·AAgios Pharmaceuticals, Inc.·Phase 1·NCT06286033·88 enrolled

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for AG-181. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AG-181 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AG-181. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Agios Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: AAgios Pharmaceuticals, Inc.

AG-181

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Phenylketonuria1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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