REGN7508

Phase 3Small molecule

Regeneron

REGN7508 is one of 8 small molecule programs targeting Peripheral Artery Disease (PAD). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Peripheral Artery Disease (PAD)Recruiting

Venous Thromboembolism (VTE)Recruiting

End-Stage Kidney Disease (ESKD)Not yet recruiting

CatheterActive, not recruiting

Peripheral Artery Disease (PAD)Phase 3

Recruiting

Venous Thromboembolism (VTE)Phase 3

Recruiting

End-Stage Kidney Disease (ESKD)Phase 1

Not yet recruiting

CatheterPhase 2

Active, not recruiting

Competition

Competitive Landscape

5 competitors in Catheter

#DrugCompanyPhaseTrials

REGN7508

Regeneron

Phase 3

1 2

REGN9933

Regeneron

Phase 2

1 3

Inhaled Nitric Oxide

LLee's Pharmaceutical Limited

Preclinical

1 4

No Heparin

TThe University of Texas Health Science Center at San Antonio

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Not yet recruiting

End-Stage Kidney Disease (ESKD)

NCT07759167

Q2 2027

Phase 2Recruiting

Atrial Fibrillation (AF)

NCT07175428

Phase 3Recruiting

Venous Thromboembolism (VTE)

NCT07015905

Q3 2027

Phase 3Recruiting

Symptomatic Venous Thromboembolism (VTE)

NCT07213778

Q2 2029

Phase 3Recruiting

Atrial Fibrillation (AF)

NCT07430956

Clinical

Trials by Indication[1]

Atrial Fibrillation (AF)3 trials

A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07430956·2,628 enrolled

A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07626411·15,364 enrolled

A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT07175428·1,200 enrolled

Venous Thromboembolism (VTE)3 trials

A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07015905·2,000 enrolled

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07493304·1,600 enrolled

A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

Not yet recruiting· Regeneron logo

Regeneron·Phase 3·NCT07697599·1,908 enrolled

Catheter1 trial

A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT06299111·195 enrolled

Adult1 trial

A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

Completed· Regeneron logo

Regeneron·Phase 2·NCT06454630·179 enrolled

Gastrointestinal1 trial

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants

Completed· Regeneron logo

Regeneron·Phase 1·NCT06444178·224 enrolled

5 more indications

Intravenous1 trial

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

Completed· Regeneron logo

Regeneron·Phase 1·NCT05603195·80 enrolled

Thrombosis1 trial

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07410117·1,120 enrolled

Symptomatic Venous Thromboembolism (VTE)1 trial

A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07213778·2,000 enrolled

Peripheral Artery Disease (PAD)1 trial

A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07318610·7,050 enrolled

End-Stage Kidney Disease (ESKD)1 trial

A Master Protocol for a Phase 1b Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 and REGN7508, Factor XI Monoclonal Antibodies, and REGN9533, a Factor XII Monoclonal Antibody, in Participants With End-Stage Kidney Disease on Hemodialysis

Not yet recruiting· Regeneron logo

Regeneron·Phase 1·NCT07759167·36 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for REGN7508. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — REGN7508 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for REGN7508. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Regeneron company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Regeneron

REGN7508

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q2 2029

Trials by Indication[1]

Atrial Fibrillation (AF)3 trials

Venous Thromboembolism (VTE)3 trials

Catheter1 trial

Adult1 trial

Gastrointestinal1 trial

Intravenous1 trial

Thrombosis1 trial

Symptomatic Venous Thromboembolism (VTE)1 trial

Peripheral Artery Disease (PAD)1 trial

End-Stage Kidney Disease (ESKD)1 trial

References

Drug Info

Quick Facts

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