Recent Updates
Recently added Catalysts

Glucopyranosyl Lipid A

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Glucopyranosyl Lipid A

What is Glucopyranosyl Lipid A used for?

Glucopyranosyl Lipid A is an investigational small molecule being developed for food allergy, specifically studied in peanut allergic adult and adolescent patients. It is administered sublingually on a daily basis. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does Glucopyranosyl Lipid A target?

The specific molecular target of Glucopyranosyl Lipid A is not disclosed in available information. It is being studied as a sublingual daily treatment for peanut allergy, a form of food allergy, in adult and adolescent patients. The drug's mechanism of action has not been publicly detailed.

Who makes Glucopyranosyl Lipid A?

Glucopyranosyl Lipid A is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical development for the treatment of food allergy, specifically peanut allergy.

What phase is Glucopyranosyl Lipid A in?

Glucopyranosyl Lipid A is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 clinical trial has been completed, and the drug is not yet available for commercial use.

What clinical trials is Glucopyranosyl Lipid A in?

Glucopyranosyl Lipid A has been studied in one completed Phase 1 clinical trial, identified as NCT03463135. This trial assessed the tolerability and safety of SAR439794 after repeated sublingual daily administration in peanut allergic adult and adolescent patients. The trial enrolled 27 participants in the United States.

Is Glucopyranosyl Lipid A the same as SAR439794?

Yes, Glucopyranosyl Lipid A is also known as SAR439794. The Phase 1 clinical trial NCT03463135 evaluated SAR439794, which is the same drug as Glucopyranosyl Lipid A, in peanut allergic patients. This alternative name may be used in clinical trial registries and scientific literature.