Wayrilz

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

AsthmaAtopic DermatitisSickle Cell DiseaseImmune ThrombocytopeniaChronic Spontaneous UrticariaFocal Segmental GlomerulosclerosisPemphigusWarm Autoimmune Hemolytic AnemiaImmunoglobulin G4 Related Disease

1050 competitors in Asthma

#DrugCompanyPhaseTrials

1

Wayrilz

GGenzyme, a Sanofi Company

Phase 3

12

Veramyst

GSK

Preclinical

463

Xolair

Roche

Preclinical

254

Singulair

AstraZeneca

Preclinical

175

Nucala

GGlaxo Dba Glaxosmithkline

Preclinical

356

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

307

Asmanex

Novartis

Preclinical

58

Celexa

AbbVie

Preclinical

19

Atrovent

Boehringer Ingelheim

Preclinical

210

Aciphex

Akero Therapeutics

Preclinical

2Show 12 more competitors

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

Timeline

Expected Milestones

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·Phase 3·NCT07007962·60 enrolled

Warm Autoimmune Hemolytic Anemia2 trials

A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia

Recruiting·Sanofi·Phase 3·NCT07086976·90 enrolled

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

Active, not recruiting·Sanofi·Phase 2·NCT05002777·22 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

Asthma1 trial

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

Completed·Sanofi·Phase 2·NCT05104892·196 enrolled

Chronic Spontaneous Urticaria1 trial

Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine

Completed·Sanofi·Phase 2·NCT05107115·161 enrolled

9 more indications

Focal Segmental Glomerulosclerosis1 trial

A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Recruiting·Sanofi·Phase 2·NCT06500702·84 enrolled

Chronic1 trial

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

Active, not recruiting·Sanofi·Phase 3·NCT07216079·4 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

Pemphigus1 trial

A Study of PRN1008 in Patients With Pemphigus

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

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

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·Phase 2·NCT05018806·124 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·Phase 3·NCT07190196·124 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·Phase 3·NCT06975865·192 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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