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SYNB1934

Phenylketonuria (PKU)

Phase 3Completed; Did Not Meet Primary EndpointNCT05764239

Key Facts

Indication

Phenylketonuria (PKU)

Phase

Phase 3

Status

Completed; Did Not Meet Primary Endpoint

Company

Synlogic

About Synlogic

Synlogic Therapeutics is a clinical-stage biotech company developing Synthetic Biotics—engineered living microbes designed as targeted, orally administered therapeutics. The company's mission is to leverage synthetic biology to create transformative treatments for diseases with high unmet need, such as Phenylketonuria (PKU) and Homocystinuria (HCU). Its strategy involves advancing its modular platform through clinical proof-of-concept, though it currently faces significant financial and execution risks as a micro-cap public entity. Recent pipeline prioritization and workforce reductions reflect a focused but constrained operational strategy.

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Therapeutic Areas

Metabolic Disorders Rare Diseases

Other Phenylketonuria (PKU) Drugs

Drug	Company	Phase	Status
PKU Treatment	Cycle Pharmaceuticals	Commercial	Active
NB-20X	Nerai Biosciences	Pre-clinical	Active
NGGT002	NGGT	Phase 1/2 (inferred)	Active
SOM1311	SOM Biotech	Preclinical	Active
Repinatrabit	Otsuka	Open-Label Extension	Active
PER303	Perseo Pharma	Preclinical	Active
Engineered Native Bacteria Platform	Endure Biotherapeutics	Pre-clinical	Active
JNT-517	JCR Pharmaceuticals	Phase 1	Active
PALYNZIQ (pegvaliase-pqpz)	BioMarin Pharmaceutical	Approved/Marketed	Active (Label expansion)
PTC923 (sepiapterin)	PTC Therapeutics	Phase 3	Active