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Compound · clinical trials

Rilzabrutinib clinical trials

Also listed in trial records as SAR444671
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 7 trials in our USA, UK and China registers that name Rilzabrutinib as an intervention. Synced 25 Sep 2026
7Current trials
5Recruiting now
2Lead sponsors
3Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Rilzabrutinib is named as an intervention in 7 current clinical trials in our USA, UK and China registers. 5 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Sanofi (6). The most-studied condition is Immune Thrombocytopenia.

Trials by status

  • Recruiting571%
  • Active, closed229%

Trials by phase

  • Phase 3571%
  • Phase 2229%
01

Clinical trials of Rilzabrutinib

7 trials
StudyPhaseStatusLead sponsorRegisters
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
NCT06975865 · ClinicalTrials.gov ↗ · Sickle Cell Disease
Phase 3 Recruiting Sanofi UK, USA
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
NCT07007962 · ClinicalTrials.gov ↗ · Immune Thrombocytopenia
Phase 3 Recruiting Sanofi USA
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
NCT07086976 · ClinicalTrials.gov ↗ · Autoimmune Haemolytic Anaemia
Phase 3 Recruiting Sanofi USA, China
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
NCT07190196 · Immunoglobulin G4 Related Disease
Phase 3 Recruiting Sanofi UK, USA, China
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
NCT06500702 · ClinicalTrials.gov ↗ · Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Phase 2 Recruiting Sanofi UK, USA, China
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
NCT04562766 · ClinicalTrials.gov ↗ · Immune Thrombocytopenia
Phase 3 Active, closed Principia Biopharma, a Sanofi Company UK, USA, China
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
NCT05002777 · ClinicalTrials.gov ↗ · Warm Autoimmune Hemolytic Anemia (wAIHA)
Phase 2 Active, closed Sanofi UK, USA, China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Rilzabrutinib across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Rilzabrutinib on the HPRA medicines list.

  • WAYRILZ 400 mg film-coated tabletsSanofi B.V. · EU/1/25/1974/001-003
All 1 Irish product →

Supply shortages

No entry for Rilzabrutinib in the EMA, FDA or German BfArM shortage lists we track.

Recent approvals

  • WayrilzEMA · 22 Dec 2025 · Sanofi B.V.
03

Conditions studied with Rilzabrutinib

7 conditions
Immune Thrombocytopenia2Immunoglobulin G4 Related Disease1Sickle Cell Disease1Focal Segmental Glomerulosclerosis1Glomerulonephritis Minimal Lesion1Warm Autoimmune Hemolytic Anemia (wAIHA)1Autoimmune Haemolytic Anaemia1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Sanofi6
Principia Biopharma, a Sanofi Company1
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA75
Clinical trials in UK53
Clinical trials in China53

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Rilzabrutinib trials

How many clinical trials are testing Rilzabrutinib?

7 current trials in our USA, UK and China registers name Rilzabrutinib (also registered as SAR444671) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Rilzabrutinib trials recruiting patients?

Yes. 5 of the 7 trials are recruiting: 5 with sites in USA, 3 with sites in UK and 3 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Rilzabrutinib clinical trials?

Sanofi (6) and Principia Biopharma, a Sanofi Company (1). The number in brackets is how many trials each organisation leads.

Is Rilzabrutinib licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Rilzabrutinib, for example WAYRILZ 400 mg film-coated tablets (Sanofi B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Rilzabrutinib shortage?

Not in the lists we track: Rilzabrutinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Rilzabrutinib works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Rilzabrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Rilzabrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.