AG-181 / Agios Pharmaceuticals - LARVOL DELTA

Phase 1 SAD/MAD study for AG-181 in healthy subjects and phase 1b design in phenylketonuria (SSIEM 2026) - P1 | "AG-181 was generally well tolerated in healthy subjects, with favorable PK supporting the phase 1b, open-label, multicenter evaluation of AG-181 in patients with PKU, scheduled to begin in 2026."

Clinical • P1 data • Alzheimer's Disease • Cognitive Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Phenylketonuria • Rare Diseases

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Agios Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metabolic Disorders • Phenylketonuria • Rare Diseases

AG181-C-002: Evaluation of AG-181 in Subjects 18 to 69 Years of Age With Phenylketonuria (clinicaltrialsregister.eu) - P1 | N=10 | Not yet recruiting | Sponsor: Agios Pharmaceuticals Inc.

New P1 trial • Metabolic Disorders • Phenylketonuria • Rare Diseases

AG181-C-001: Single and Multiple Ascending Dose Study and Food Effect Study for AG181 (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Agios Pharmaceuticals, Inc. | Recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Oct 2025 | Trial primary completion date: Mar 2026 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Participants With Phenylketonuria (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Agios Pharmaceuticals, Inc.

New P1 trial • Metabolic Disorders • Phenylketonuria • Rare Diseases

AG181-C-001: Single and Multiple Ascending Dose Study and Food Effect Study for AG181 (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Agios Pharmaceuticals, Inc. | Trial completion date: Oct 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date

AG181-C-001: Single and Multiple Ascending Dose Study and Food Effect Study for AG181 (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Agios Pharmaceuticals, Inc. | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date

AG181-C-001: A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Agios Pharmaceuticals, Inc. | Trial completion date: Sep 2025 ➔ Jun 2025 | Trial primary completion date: Sep 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date

AG181-C-001: Single and Multiple Ascending Dose Study and Pilot Food Effect Study for AG-181 (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Agios Pharmaceuticals, Inc.

New P1 trial