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Glucopyranosyl Lipid A

Phase 1

Food Allergy | Small molecule | Other |Sanofi|Trials Updated: Apr 25, 2022

Glucopyranosyl Lipid A target and mechanism

ModalitySmall molecule

Also known as Glucopyranosyl Lipid A (GLA)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Glucopyranosyl Lipid A clinical trials

Glucopyranosyl Lipid A · 1 trial · 1 indication

Phase 1 1
NCT03463135A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent PatientsFood Allergy
COMPLETED27 Analytics
PHASE1COMPLETED
A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
Food AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events (AEs)
Up to Week 52

Number of participants with AEs

Secondary Endpoints

Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels
Baseline to Day 85
Assessment of PD parameter: Peanut-specific serum IgG levels
Baseline to Day 57
Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels
Baseline to Day 57, Baseline to Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR439794 [PE SLIT + GLA)]EXPERIMENTALGLA repeated doses then SLIT PE escalating doses once daily for 12 weeks
Placebo for GLA + SLIT PEEXPERIMENTALPlacebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks
Placebo for GLA + Placebo for SLIT PEPLACEBO_COMPARATORPlacebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks

Interventions

NameTypeDescription
Glucopyranosyl Lipid A (GLA)DRUGPharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)DRUGPharmaceutical form:Solution Route of administration: Sublingual
Placebo for GLADRUGPharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
Placebo for SLIT PEDRUGPharmaceutical form:Solution Route of administration: Sublingual
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Eligibility Criteria

Age Range12 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria : * Male or female patients, between 18 and 55 years of age, inclusive and adolescents between 12 and 17 years of age (after enrollment of 20 adult patients completed the 6 weeks dose escalation period and the safety and tolerability is deemed acceptable). * Physician-diagnosed p...

Countries:United States
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Frequently asked questions about Glucopyranosyl Lipid A

What is Glucopyranosyl Lipid A used for?

Glucopyranosyl Lipid A is being studied for the treatment of food allergy, specifically peanut allergy. It was evaluated in a Phase 1 clinical trial in peanut allergic adult and adolescent patients. It is an investigational agent and is not approved for any indication.

Who is developing Glucopyranosyl Lipid A?

Glucopyranosyl Lipid A is being developed by Sanofi, which trades under the ticker SNY. The company sponsored the Phase 1 study of the agent in peanut allergic patients.

What phase is Glucopyranosyl Lipid A in?

Glucopyranosyl Lipid A is in Phase 1 clinical development. The single Phase 1 trial has been completed, and no active trials are currently listed. It remains an investigational agent and has not been approved by the FDA.

What clinical trials is Glucopyranosyl Lipid A in?

Glucopyranosyl Lipid A has been evaluated in one completed Phase 1 trial, NCT03463135. The study assessed the tolerability and safety of repeated sublingual daily administration of SAR439794 in peanut allergic adult and adolescent patients, enrolling 27 participants in the United States.

Is Glucopyranosyl Lipid A the same as GLA?

Yes, Glucopyranosyl Lipid A is also known as GLA. The abbreviation GLA refers to the same investigational agent being developed by Sanofi for food allergy.