Wayrilz

(Rilzabrutinib)

Phase 3Small molecule

GGenzyme, a Sanofi Company

Wayrilz is one of 113 small molecule programs targeting Immune Thrombocytopenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

112

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Immune ThrombocytopeniaActive, not recruiting

Sickle Cell DiseaseRecruiting

Immunoglobulin G4 Related DiseaseRecruiting

AutoimmuneRecruiting

ChronicActive, not recruiting

Warm Autoimmune Hemolytic AnemiaActive, not recruiting

Focal Segmental GlomerulosclerosisRecruiting

Immune ThrombocytopeniaPhase 3

Active, not recruiting

Sickle Cell DiseasePhase 3

Recruiting

Immunoglobulin G4 Related DiseasePhase 3

Recruiting

AutoimmunePhase 3

Recruiting

ChronicPhase 3

Active, not recruiting

Warm Autoimmune Hemolytic AnemiaPhase 3

Active, not recruiting

Focal Segmental GlomerulosclerosisPhase 2

Recruiting

Competition

Competitive Landscape

98 competitors in Sickle Cell Disease

#DrugCompanyPhaseTrials

Campath

GGenzyme, a Sanofi Company

Phase 3

13 2

Ritalin

Novartis

Phase 3

2 3

Aqvesme

AAgios Pharmaceuticals, Inc.

Phase 3

4 4

Toradol

JJavelin Pharmaceuticals

Phase 3

2 5

Wayrilz

GGenzyme, a Sanofi Company

Phase 3

1 6

Fludara

Sanofi

Phase 2

9 7

Cellcept

Roche

Phase 2

6 8

PIASKY

Roche

Phase 3

2 9

Tepadina

Jazz Pharmaceuticals

Phase 2

4 10

Rapamune

PPrism Pharmaceuticals

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Chronic

NCT07216079

Q1 2028

Phase 2Recruiting

Focal Segmental Glomerulosclerosis

NCT06500702

Q4 2028

Phase 3Recruiting

Sickle Cell Disease

NCT06975865

Phase 3Recruiting

Immune Thrombocytopenia

NCT07007962

Q4 2029

Phase 3Recruiting

Autoimmune

NCT07086976

Phase 2Active, not recruiting

Warm Autoimmune Hemolytic Anemia

NCT05002777

Clinical

Trials by Indication[1]

Immune Thrombocytopenia3 trials

A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)

Completed·PPrincipia Biopharma, a Sanofi Company·Phase 2·NCT03395210·86 enrolled

Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

Active, not recruiting·PPrincipia Biopharma, a Sanofi Company·Phase 3·NCT04562766·232 enrolled

A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT07007962·60 enrolled

ART1 trial

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Completed·PPrincipia Biopharma, a Sanofi Company·Phase 1·NCT04748926·24 enrolled

Tics1 trial

Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects

Completed·PPrincipia Biopharma, a Sanofi Company·Phase 1·NCT06444191·23 enrolled

Pemphigus1 trial

A Study of PRN1008 in Patients With Pemphigus

Terminated·PPrincipia Biopharma, a Sanofi Company·Phase 3·NCT03762265·131 enrolled

Moderate Hepatic Impairment1 trial

A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)

Completed·PPrincipia Biopharma, a Sanofi Company·Phase 1·NCT06444204·29 enrolled

10 more indications

Warm Autoimmune Hemolytic Anemia1 trial

Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT05002777·22 enrolled

IgG4 Related Disease1 trial

Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants

Completed·PPrincipia Biopharma, a Sanofi Company·Phase 2·NCT04520451·27 enrolled

Asthma1 trial

Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma

Completed· Sanofi logo

Sanofi·Phase 2·NCT05104892·196 enrolled

Chronic1 trial

Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT07216079·4 enrolled

Autoimmune1 trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Period and Long-term Extension to Assess the Efficacy and Safety of Rilzabrutinib in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT07086976·90 enrolled

Chronic Spontaneous Urticaria1 trial

A Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Phase 2 Study of Rilzabrutinib Followed by an Open-label Extension Phase in Patients With Moderate-to-severe Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment

Completed· Sanofi logo

Sanofi·Phase 2·NCT05107115·160 enrolled

Sickle Cell Disease1 trial

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Flexible-adaptive, Group Sequential Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06975865·192 enrolled

Immunoglobulin G4 Related Disease1 trial

A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active IgG4-related Disease

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT07190196·124 enrolled

Focal Segmental Glomerulosclerosis1 trial

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT06500702·84 enrolled

Atopic Dermatitis1 trial

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Proof-of-concept Study Evaluating Efficacy and Safety of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Who Are Inadequate Responders or Intolerant to Topical Corticosteroids

Completed· Sanofi logo

Sanofi·Phase 2·NCT05018806·124 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 29, 2025

WAYRILZ

NDA NDA219685

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Rilzabrutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rilzabrutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rilzabrutinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219685). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Wayrilz. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GGenzyme, a Sanofi Company

Patent Landscape[5]

Patent Cliff

Mar 1, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9580427Mar 1, 2033

9994576Sep 6, 2033

9266895Sep 6, 2033

8940744Sep 6, 2033

12178818Oct 13, 2040

1 more patents

11708370Feb 20, 2041

Wayrilz

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q4 2028

Q4 2029

Trials by Indication[1]

Immune Thrombocytopenia3 trials

ART1 trial

Tics1 trial

Pemphigus1 trial

Moderate Hepatic Impairment1 trial

Warm Autoimmune Hemolytic Anemia1 trial

IgG4 Related Disease1 trial

Asthma1 trial

Chronic1 trial

Autoimmune1 trial

Chronic Spontaneous Urticaria1 trial

Sickle Cell Disease1 trial

Immunoglobulin G4 Related Disease1 trial

Focal Segmental Glomerulosclerosis1 trial

Atopic Dermatitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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