Rilzabrutinib

Generic Name: Rilzabrutinib

Drug Type: Small Molecule

Chemical Formula: C_₃₆H_₄₀FN_₉O_₃

CAS Number: 1575591-66-0

Unique Ingredient Identifier: 5G1WE425BI

Background: Rilzabrutinib is an oral, reversible covalent inhibitor of Bruton's tyrosine kinase being investigated for the treatment of immune disorders, such as immune thrombocytopenic purpura.

Clinical Trials

The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease

Phase 3

Recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Rilzabrutinib
Drug: Placebo

First Posted Date: 2025-05-16

Last Posted Date: 2025-05-16

Lead Sponsor: Sanofi

Target Recruit Count: 192

Registration Number: NCT06975865

Locations: 🇬🇧
Investigational Site Number : 8260002, London, London, City Of, United Kingdom

A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Phase 2

Recruiting

Conditions: Glomerulonephritis Minimal Lesion
Focal Segmental Glomerulosclerosis

Interventions: Drug: frexalimab
Drug: SAR442970
Drug: rilzabrutinib
Drug: placebo

First Posted Date: 2024-07-15

Last Posted Date: 2025-05-09

Lead Sponsor: Sanofi

Target Recruit Count: 84

Registration Number: NCT06500702

Locations: 🇪🇸
Investigational Site Number : 7240002, Córdoba, Spain
🇪🇸
Investigational Site Number : 7240003, Valencia, Spain
🇺🇸
Investigational Site Number : 8400015, Orange, California, United States

and more 36 locations

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

Phase 1

Completed

Conditions: Hepatic Function Abnormal
Healthy Volunteers

Interventions: Drug: Rilzabrutinib

First Posted Date: 2024-06-05

Last Posted Date: 2024-06-05

Lead Sponsor: Principia Biopharma, a Sanofi Company

Target Recruit Count: 29

Registration Number: NCT06444204

Locations: 🇺🇸
Investigational Site Number: 0001, Orlando, Florida, United States
🇺🇸
Investigational Site Number: 0002, Miami, Florida, United States

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

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Rilzabrutinib

First Posted Date: 2024-06-05

Last Posted Date: 2024-06-05

Lead Sponsor: Principia Biopharma, a Sanofi Company

Target Recruit Count: 23

Registration Number: NCT06444191

Locations: 🇺🇸
Investigational Site Number: 0001, Glendale, California, United States

A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Phase 1

Completed

Conditions: Autoimmune Disorder
Healthy Volunteers

Interventions: Drug: Rilzabrutinib amorphous form
Drug: Rilzabrutinib crystalline form

First Posted Date: 2024-04-02

Last Posted Date: 2024-04-30

Lead Sponsor: Sanofi

Target Recruit Count: 28

Registration Number: NCT06342700

Locations: 🇺🇸
Nucleus Network Site Number : 8400001, Saint Paul, Minnesota, United States

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

Phase 2

Completed

Conditions: Chronic Spontaneous Urticaria

Interventions: Drug: placebo
Drug: rilzabrutinib

First Posted Date: 2021-11-04

Last Posted Date: 2024-07-19

Lead Sponsor: Sanofi

Target Recruit Count: 161

Registration Number: NCT05107115

Locations: 🇪🇸
Investigational Site Number :7240007, Pozuelo de Alarcón, Madrid, Spain
🇪🇸
Investigational Site Number : 7240006, Pamplona, Navarra, Spain
🇪🇸
Investigational Site Number :7240006, Pamplona, Navarra, Spain

and more 125 locations

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

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: Rilzabrutinib
Drug: placebo

First Posted Date: 2021-11-03

Last Posted Date: 2024-03-07

Lead Sponsor: Sanofi

Target Recruit Count: 196

Registration Number: NCT05104892

Locations: 🇪🇸
Investigational Site Number : 7240004, Santander, Cantabria, Spain
🇧🇬
Investigational Site Number : 1000004, Kozloduy, Bulgaria
🇧🇬
Investigational Site Number : 1000003, Sevlievo, Bulgaria

and more 48 locations

Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis

Phase 2

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo
Drug: Rilzabrutinib

First Posted Date: 2021-08-24

Last Posted Date: 2024-06-21

Lead Sponsor: Sanofi

Target Recruit Count: 124

Registration Number: NCT05018806

Locations: 🇺🇸
Integrative Skin Care of MS/SKYCRNG Site Number : 8400011, Ridgeland, Mississippi, United States
🇵🇱
Investigational Site Number : 6160005, Gdansk, Pomorskie, Poland
🇵🇱
Investigational Site Number : 6160002, Lodz, Poland

and more 28 locations

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

Phase 2

Active, not recruiting

Conditions: Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions: Drug: rilzabrutinib

First Posted Date: 2021-08-12

Last Posted Date: 2025-05-21

Lead Sponsor: Sanofi

Target Recruit Count: 22

Registration Number: NCT05002777

Locations: 🇺🇸
University of Southern California_Investigational Site Number: 8400009, Los Angeles, California, United States
🇺🇸
TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006, Santa Ana, California, United States
🇺🇸
The Lundquist Institute_Investigational Site Number: 8400005, Torrance, California, United States

and more 24 locations

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: rilzabrutinib SAR444671

First Posted Date: 2021-02-10

Last Posted Date: 2022-04-25

Lead Sponsor: Principia Biopharma, a Sanofi Company

Target Recruit Count: 24

Registration Number: NCT04748926

Locations: 🇦🇺
Investigational Site, Adelaide, Australia

Drug Development Updates

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