Wayrilz

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Immune ThrombocytopeniaRenal ImpairmentWarm Autoimmune Hemolytic AnemiaChronic

54 competitors in Immune Thrombocytopenia

#DrugCompanyPhaseTrials

1

Promacta

GSK

Approved

142

Rituxan

Roche

Approved

133

Decadron

AAspen Global Incorporated

Approved

214

Oncovin

Eli Lilly

Approved

15

Plaquenil

Jazz Pharmaceuticals

Approved

16

Rayos

RRoxane Laboratories

Approved

67

Imuran

LLegacy Health System

Approved

18

Doptelet

AAkarx

Phase 3

69

Vyvgart

Argenx

Phase 3

510

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

3Show 37 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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

Completed·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

Tics1 trial

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

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

Warm Autoimmune Hemolytic Anemia1 trial

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

Active, not recruiting·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

12 more indications

Asthma1 trial

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

Completed·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·Phase 3·NCT07216079·4 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

Renal Impairment1 trial

An Open-label, Multi-center, Phase 1 Pharmacokinetic and Tolerability Study of Rilzabrutinib Given as a Single Oral Dose in Participants With Severe Renal Impairment and in Matched Participants With Normal Renal Function

Recruiting·Sanofi·Phase 1·NCT07853131·16 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

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·Phase 3·NCT07086976·90 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·Phase 2·NCT06500702·84 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

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·Phase 2·NCT05107115·160 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

Unspecified1 trial

A Phase-1, Open-label, One-sequence, Two-treatment Period, Cross-over, Drug-drug Interaction Study to Evaluate the Effect of Oral Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Substrates in Healthy Participants

Active, not recruiting·Sanofi·Phase 1·NCT07855250·14 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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