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rilzabrutinib

Sold as Wayrilz for other conditions

TypePill StagePhase 2 Latest updateUpdated recently. Jul 13, 2026Phase 2 results posted
Picture from the US label: NDC 58468-0251-0 Rx only Press and hold here 1 WAYRILZ™ (rilzabrutinib) tablets 400 mg per tablet 2 Pull out blister card Each blister pack…
From the labelA picture from the US label, as DailyMed publishes it.

What stands out

New approach in eczema

  • Blocks BTK, an enzyme immune cells rely on to work
Derived from US label · UniProt Q06187 ·
11 US eczema labels (Cibinqo, Eucrisa, Adquey, Dupixent, Ebglyss, Nemluvio, Zoryve, Opzelura, Vtama, Adbry, Rinvoq)
· This is a summary of public records for informational purposes only. It is not medical advice.

Results

Trial: NCT05018806
Clear or almost clear skinAfter 16 weeks
Twice daily cohort: Placebo18 people
22 in 100
Three times daily cohort: Placebo31 people
13 in 100
Twice daily cohort: Rilzabrutinib27 people
7 in 100
Three times daily cohort: Rilzabrutinib48 people
15 in 100
02040
Eczema score (EASI) at least 75% betterAfter 16 weeks
Twice daily cohort: Placebo18 people
28 in 100
Three times daily cohort: Placebo31 people
29 in 100
Twice daily cohort: Rilzabrutinib27 people
30 in 100
Three times daily cohort: Rilzabrutinib48 people
19 in 100
02040
NCT05018806 · Ages 18+ · Results posted Jul 2026 · This is a summary of trial data for informational purposes only. It is not medical advice.
Trial: NCT05018806
Itch score at least 4 points betterAfter 16 weeks
Twice daily cohort: Placebo18 people
11 in 100
Three times daily cohort: Placebo31 people
13 in 100
Twice daily cohort: Rilzabrutinib27 people
19 in 100
Three times daily cohort: Rilzabrutinib48 people
21 in 100
02040
NCT05018806 · Ages 18+ · Results posted Jul 2026 · This is a summary of trial data for informational purposes only. It is not medical advice.
What is IGA?
  • IGA stands for Investigator's Global Assessment.
  • IGA is a static 5-point measure of disease severity based on an overall assessment of the skin lesions on a 5-point scale (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). Higher score indicated higher severity.As this trial registered it · NCT05018806
What is EASI?
  • The EASI index is a validated investigator-administered scoring system used to measure the severity of clinical signs in AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) were each assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe).As this trial registered it · NCT05018806 (the full definition is there)
What is the itch score?
  • NRS stands for Numerical Rating Scale.
  • The PP-NRS is a simple assessment tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: For itch intensity, "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at…As this trial registered it · NCT05018806 (the full definition is there)
Why this trial?

rilzabrutinib has one trial with posted results, and NCT05018806 compared the drug with placebo on a result this page charts.

History

Earliest recorded event: Sep 9, 2021. This timeline shows events collected by Eczema Radar and may not include the treatment’s full history. Study details reflect the latest registry record available here.

  • Jul 13, 2026Phase 2 results postedProof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT05018806
  • Aug 29, 2025First FDA approvalFirst FDA approval of the drug (not for eczema). FDA approval letter
  • Jun 23, 2023Phase 2 trial completedProof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT05018806
  • Sep 9, 2021Phase 2 trial startedProof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT05018806

Sources

From the FDA
Trials
For patients