Rilzabrutinib clinical trials
Also written SAR444671 and PRN1008.
How each study uses rilzabrutinib is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 29 Aug 2025 · WAYRILZ · NDA 219685 (FDA, Drugs@FDA)
- European Union
- 22 Dec 2025 · Wayrilz · EMEA/H/C/006425 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
22 studies that test it; most in 2025 (6)
| Year | Studies |
|---|---|
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 5 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 | 3 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 22 · Other 0
Often tested with
Tested in the same studies.
Related medicines
As reviewed, each with the page that says it.
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 7, 3 in phase 3
Studies that test rilzabrutinib, phase 3 first.
- Nov 2026Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in JapanPhase 3 · Sanofi
- Jul 2027The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell DiseasePhase 3 · Sanofi
- Nov 2027Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line TreatmentPhase 3 · Sanofi
- Nov 2026An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 InhibitionPhase 1 · Sanofi
- Dec 2026A 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 DiseasePhase 2 · Sanofi
- Feb 2027A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' DiseasePhase 2 · Sanofi
- Apr 2027Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal FunctionPhase 1 · Sanofi
Studies
Open first, then newest update. How each study uses rilzabrutinib is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 22
- 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 DiseaseRecruitingPhase 2SanofiNCT06500702Written as rilzabrutinib
- Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line TreatmentRecruitingPhase 3SanofiNCT07007962Written as rilzabrutinib
- Phase 2 and 3 Placebo Controlled & Long-term Extension Study of Rilzabrutinib in Adults With iCVID to Evaluate Efficacy, Safety, and TolerabilityNot yet recruitingPhase 2/3SanofiNCT07923305Written as rilzabrutinib
- A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' DiseaseRecruitingPhase 2SanofiNCT06984627Written as Rilzabrutinib dose 1
- Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal FunctionRecruitingPhase 1SanofiNCT07853131Written as rilzabrutinib
- 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 AnemiaRecruitingPhase 3SanofiNCT07086976Written as rilzabrutinib
- A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related DiseaseRecruitingPhase 3SanofiNCT07190196Written as Rilzabrutinib
- The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell DiseaseRecruitingPhase 3SanofiNCT06975865Written as Rilzabrutinib
- Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in JapanActive, not recruitingPhase 3SanofiNCT07216079Written as rilzabrutinib
- An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 InhibitionActive, not recruitingPhase 1SanofiNCT07855250Written as Rilzabrutinib
- Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)CompletedPhase 3Principia Biopharma, a Sanofi CompanyNCT04562766Written as Rilzabrutinib
- Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 AntihistamineCompletedPhase 2SanofiNCT05107115Written as rilzabrutinib
- Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic DermatitisCompletedPhase 2SanofiNCT05018806Written as Rilzabrutinib
- Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)Active, not recruitingPhase 2SanofiNCT05002777Written as rilzabrutinib
- A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)CompletedPhase 2Principia Biopharma, a Sanofi CompanyNCT03395210Written as Rilzabrutinib
- Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease ParticipantsCompletedPhase 2Principia Biopharma, a Sanofi CompanyNCT04520451Written as rilzabrutinib
- A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy ParticipantsCompletedPhase 1SanofiNCT06342700Written as Rilzabrutinib crystalline form
- Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian SubjectsCompletedPhase 1Principia Biopharma, a Sanofi CompanyNCT06444191Written as Rilzabrutinib
- A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)CompletedPhase 1Principia Biopharma, a Sanofi CompanyNCT06444204Written as Rilzabrutinib
- Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe AsthmaCompletedPhase 2SanofiNCT05104892Written as Rilzabrutinib
What changed recently
From the registry's own updates since Oct 16, 2026.
Started recruiting1
Newly registered1
Codes
What other systems call rilzabrutinib · ClinicalTrials.gg INT002152
- MeSH (NLM) C000731875rilzabrutinibOne source NLM
- UNII (FDA) NWN58M4F5TRILZABRUTINIBConfirmed FDA, NLM
- NCI Thesaurus C174769RilzabrutinibOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000731875 | rilzabrutinib | One source NLM |
| UNII (FDA) | NWN58M4F5T | RILZABRUTINIB | Confirmed FDA, NLM |
| NCI Thesaurus | C174769 | Rilzabrutinib | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.