Lorelco

(Probucol)

ApprovedSmall molecule

Sanofi

Lorelco is one of 269 small molecule programs targeting Hyperlipidemia. It is currently in Approved.

Indications

Total Trials

Active Trials

268

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HyperlipidemiaActive, not recruiting

Diabetic NephropathyActive, not recruiting

AtherosclerosisActive, not recruiting

Cerebral InfarctionActive, not recruiting

Iga NephropathyActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

NephropathyActive, not recruiting

Ischemic StrokeActive, not recruiting

Heart DiseaseActive, not recruiting

HyperlipidemiaPhase 3

Active, not recruiting

Diabetic NephropathyApproved

Active, not recruiting

AtherosclerosisApproved

Active, not recruiting

Cerebral InfarctionApproved

Active, not recruiting

Iga NephropathyApproved

Active, not recruiting

Chronic Kidney DiseasePreclinical

Active, not recruiting

NephropathyPreclinical

Active, not recruiting

Ischemic StrokeApproved

Active, not recruiting

Heart DiseaseApproved

Active, not recruiting

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Lorelco

Sanofi

Approved

1 2

Aranesp

Amgen

Preclinical

40 3

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

16 4

Uloric

Takeda

Preclinical

3 5

Sovaldi

Gilead

Preclinical

1 6

Glucotrol

Pfizer

Preclinical

1 7

Vemlidy

Gilead

Preclinical

1 8

Flomax

Activase

Miochol

BBausch Health Americas, Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

ART

NCT06225752

Post-ApprovalRecruiting

Ischemic Stroke

NCT03753555

Q4 2027

Recruiting

Ischemic Stroke

NCT06604117

Clinical

Trials by Indication[1]

Ischemic stroke4 trials

Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke

Recruiting·XXuanwu Hospital, Beijing··NCT06604117·200 enrolled

The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques

Recruiting·GGeneral Hospital of Shenyang Military Region·Phase 4·NCT03753555·100 enrolled

PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage

Unknown status·—·Phase 4·NCT01013532·1,600 enrolled

Show 1 more trial

PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study

Unknown status·—·Phase 4·NCT02483169·800 enrolled

Tics3 trials

Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

Completed· Otsuka logo

Otsuka·Phase 1·NCT01590901·12 enrolled

Pharmacokinetics Study for Probucol

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 4·NCT01000467·30 enrolled

Safety and Pharmacokinetics of Probucol and Cilostazol

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 4·NCT00549978·32 enrolled

Diabetic Nephropathy1 trial

A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy

Completed· Otsuka logo

Otsuka·Phase 4·NCT01252056·353 enrolled

Chronic Kidney Disease1 trial

Expanded Access Program for R007 (Probucol) Tablets in Adults With Mitochondrial Disease and Chronic Kidney Disease

Available·RRiboNova Inc.··NCT06931834

Nephropathy1 trial

Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

Unknown status·GGuangdong Provincial People's Hospital·N/A·NCT00655330·170 enrolled

7 more indications

Atherosclerosis1 trial

Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

Completed· Otsuka logo

Otsuka·Phase 4·NCT00823849·200 enrolled

ART1 trial

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

Recruiting·FFirst Affiliated Hospital of Wannan Medical College·Phase 3·NCT06225752·5,452 enrolled

Cerebral Infarction1 trial

Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject

Completed· Otsuka logo

Otsuka·Phase 4·NCT00823875·200 enrolled

Efficacy1 trial

Dosage and Efficacy of Probucol-induced apoE to Negate Cognitive Deterioration

Completed·—·Phase 1/2·NCT02707458·23 enrolled

IgA Nephropathy1 trial

A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

Completed·GGuangdong Provincial People's Hospital·Phase 4·NCT00426348·75 enrolled

Heart Disease1 trial

Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease

Completed·SSeoul National University Hospital·Phase 4·NCT01291641·342 enrolled

Hyperlipidemia1 trial

Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Completed· Otsuka logo

Otsuka·Phase 3·NCT01349010·264 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

LORELCO

NDA NDA017535

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Probucol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Probucol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Probucol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA017535). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Sanofi

Lorelco

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Ischemic stroke4 trials

Tics3 trials

Diabetic Nephropathy1 trial

Chronic Kidney Disease1 trial

Nephropathy1 trial

Atherosclerosis1 trial

ART1 trial

Cerebral Infarction1 trial

Efficacy1 trial

IgA Nephropathy1 trial

Heart Disease1 trial

Hyperlipidemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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