🏛️ Verified NIH Record • Updated 2026-08-26
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria (NCT07241234)
A Phase 1b, Open-label, Multicenter, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of AG-181 in Subjects With Phenylketonuria
🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Agios Pharmaceuticals, Inc.
🩺 Plain-English Summary (8th-Grade Level)
The primary purpose of this study is to assess the safety and tolerability of AG-181 in subjects with Phenylketonuria (PKU).
Who can join: Review the eligibility criteria below.
Location: Indiana University — Indianapolis, Indiana
Age range: 18 Years to 69 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Indiana University — Indianapolis, Indiana
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- University of Texas Southwestern Medical Center (UTSW) — Dallas, Texas
- Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie — Szczecin, West Pomeranian Voivodeship
📞 Contact the Study Coordinator
Phone: (833) 228-8474
Email: medinfo@agios.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Phenylketonuria
- A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria — Aurora, Colorado
- Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq — Chevy Chase, Maryland
- A Phase 1/Phase 2 Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Intravenous Administration of SAR444836 in Adult Participants With Phenylketonuria — San Francisco, California
- Immune Modulation During Palynziq® Treatment in Adults (IMPALA) — Los Angeles, California
- A Study of JNT-517 in Participants With Phenylketonuria (PKU) — Los Angeles, California
Explore by condition: All Phenylketonuria clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.