Venglustat

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Abdominal PainFabry DiseaseGaucher Disease Type 1

19 competitors in Abdominal Pain

#DrugCompanyPhaseTrials

1

Elavil

AstraZeneca

Approved

12

Niacor

AbbVie

Approved

—3

Lopid

Pfizer

Approved

—4

MS Contin

HHikma Pharmaceuticals LLC

Approved

15

Xylocaine

MMEDRx USA, Inc.

Approved

16

Dilaudid

RRhodes Pharmaceuticals, L.P.

Approved

17

Chirocaine

PPurdue Pharma LP

Approved

—8

Marcaine

IInnocoll

Approved

—9

Naropin

FFresenius Kabi USA, LLC

Approved

—10

Proair HFA

GGlaxo Dba Glaxosmithkline

Approved

—Show 10 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Adult3 trials

A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants

Completed·Sanofi·Phase 1·NCT06421714·8 enrolled

A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants

Completed·Sanofi·Phase 1·NCT06418620·9 enrolled

A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants

Completed·Sanofi·Phase 1·NCT06418607·65 enrolled

Parkinson's Disease1 trial

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

Terminated·Sanofi·Phase 2·NCT02906020·273 enrolled

Double-blind1 trial

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of Venglustat in Late-onset GM2

Terminated·Sanofi·Phase 3·NCT04221451·75 enrolled

Hepatic Impairment1 trial

A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function

Completed·Sanofi·Phase 1·NCT05718258·26 enrolled

Autosomal Dominant Polycystic Kidney Disease1 trial

Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat

Terminated·Sanofi·Phase 3·NCT04705051·24 enrolled

7 more indications

Abdominal pain1 trial

A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease

Active, not recruiting·Sanofi·Phase 3·NCT05206773·122 enrolled

Renal Impairment1 trial

Effect of Venglustat in Patients With Renal Impairment

Completed·Sanofi·Phase 1·NCT03687554·24 enrolled

Treatment1 trial

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients

Terminated·Sanofi·Phase 2/3·NCT03523728·478 enrolled

Metabolism1 trial

Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects

Completed·Sanofi·Phase 1·NCT05238714·6 enrolled

Gaucher's Disease Type III1 trial

A Phase 3, Multicenter, Multinational, Randomized, Double-blind, Double-dummy, Active-comparator Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 (GD3) Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ERT)

Active, not recruiting·Sanofi·Phase 3·NCT05222906·43 enrolled

Gaucher disease type 11 trial

A 4-part, Open-label, Multicenter, Multinational Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic, and Exploratory Efficacy of Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension

Active, not recruiting·Sanofi·Phase 2·NCT02843035·12 enrolled

Fabry Disease1 trial

A Randomized, Open-label, Parallel-group, 18-month Phase 3 Study to Evaluate the Effect of Venglustat Compared With Usual Standard of Care on Left Ventricular Mass Index in Participants With Fabry Disease and Left Ventricular Hypertrophy

Active, not recruiting·Sanofi·Phase 3·NCT05280548·104 enrolled

Details

Drug Info

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