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SAR444836

Phase 1

Phenylketonuria | Small molecule | Metabolic |Sanofi|Last Updated: Sep 23, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

SAR444836 · 1 trial · 1 indication

Phase 1 1
NCT05972629A 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 PhenylketonuriaPhenylketonuria
ACTIVE NOT_RECRUITING32 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
Phenylketonuria
NCT0597262932
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs)
From Baseline to Week 260

Secondary Endpoints

Proportion of participants with sustained plasma level of Phe<360 μmol/L for ≥4 weeks without dietary Phe restriction at Week 24, 48, and Week 96 or Early Termination Visit following SAR444836 administration
From Baseline to Week 96
Change from baseline in plasma level of Phe at Week 24, 48, and Week 96 or Early Termination Visit following SAR444836 administration
From Baseline to Week 96
Change from baseline in dietary protein intake at Week 24, 48, and Week 96 or Early Termination Visit following SAR444836 administration
From Baseline to Week 96
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR444836EXPERIMENTALParticipants will receive a single dose of SAR444836 on Day 1

Interventions

NameTypeDescription
SAR444836DRUGInfusion pump, intravenous infusion (IV)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Adult males, and females of non-childbearing potential, 18-65 years of age at the time of informed consent. * Participants must have uncontrolled classical PKU due to PAH deficiency (despite Phe-restricted dietary management or Palynziq) in the judgement of the Investigator. *...

Countries:United StatesArgentinaBrazilIsraelTurkey (Türkiye)
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Competitive Landscape -Phenylketonuria 12 trials

CompanyTickerTrialsLead PhaseDrugs
BioMarin Pharmaceutical Inc.BMRN5PHASE3Pegvaliase
PTC Therapeutics, Inc.PTCT2PHASE3PTC923
Sanofi SA Sponsored ADRSNY1PHASE1SAR444836
Agios Pharmaceuticals, Inc.AGIO1PHASE1AG-181
Illumina, Inc.ILMN1 - Undisclosed
Q32 Bio IncQTTB1 - HMI-102
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Frequently asked questions about SAR444836

What is SAR444836 used for?

SAR444836 is an investigational small molecule being developed for the treatment of phenylketonuria (PKU), a metabolic disorder. It is administered as a single intravenous dose and is currently in Phase 1/Phase 2 clinical development for adult patients with PKU.

Who makes SAR444836?

SAR444836 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in early-stage clinical trials for the treatment of phenylketonuria.

What phase is SAR444836 in?

SAR444836 is in Phase 1/Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with phenylketonuria.

What clinical trials is SAR444836 in?

SAR444836 is being studied in a single open-label clinical trial with the identifier NCT05972629. This Phase 1/Phase 2 study evaluates the safety, tolerability, and efficacy of a single intravenous administration of SAR444836 in adult participants with phenylketonuria. The trial is active but not recruiting participants.

How does SAR444836 work?

SAR444836 is a small molecule designed to treat phenylketonuria, a metabolic disorder. While the specific molecular target has not been disclosed, the drug is administered intravenously and is being evaluated for its ability to address the underlying metabolic deficiency in adult patients with PKU.

Is SAR444836 the same as any other drug?

SAR444836 is a unique investigational compound developed by Sanofi. No alternative names have been reported for this drug. It is being studied specifically for the treatment of phenylketonuria and is not known to be identical to any other approved or investigational medication.