Wednesday, July 8, 2026

Drug profile · INN

rilzabrutinib

rilzabrutinib (WAYRILZ) is a tyrosine-protein kinase btk inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved NMPA: clinical trials Nervous system (NOT) Not yet assigned
US status approved
Patents linked 1
Pipeline programs 11
News articles 0
Drug details — rilzabrutinib
US status
approved
Class
Nervous system (NOT)
Route
ORAL
Patents
1
Programs
11
Data quality
0.84

Quick answer

rilzabrutinib (WAYRILZ) is a tyrosine-protein kinase btk inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN rilzabrutinib
Brand WAYRILZ
Mechanism Tyrosine-protein kinase BTK inhibitor
Target Tyrosine-protein kinase BTK
Therapeutic class Nervous system (NOT)
Route ORAL
Formulation TABLET
ATC code Not yet assigned

Mechanism of action

Tyrosine-protein kinase BTK inhibitor

Primary target: Tyrosine-protein kinase BTK

Approval history

Authority Status Date
FDA approved
EMA approved
NMPA clinical trials

Pipeline programs

  1. EFC17093 Phase 3 · Anaxis Pharma · Immune Thrombocytopenia (ITP)
  2. EFC17359 Phase 3 · Sanofi-Aventis U.S · Immune system diseases
  3. EFC17360 - LUMINA 3 Phase 3 · Sanofi-Aventis U.S · Autoimmune haemolytic anaemia
  4. EFC17872 Phase 3 · Sanofi-Aventis U.S · Blood and lymphatic diseases
  5. Rilzabrutinib Phase 3 · Principia Biopharma · Immune Thrombocytopenia
  6. Rilzabrutinib Phase 3 · Sanofi-Aventis U.S · immune thrombocytopenia (ITP)
  7. ACT18064 Phase 2 · Sanofi-Aventis U.S · Immune system diseases
  8. Rilzabrutinib Phase 2 · Anaxis Pharma · Immune Thrombocytopenia

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)

Related patents

  1. US 9580427

    Kinase inhibitors

    Expires Mon Feb 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is rilzabrutinib?

rilzabrutinib (WAYRILZ) is a tyrosine-protein kinase btk inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for rilzabrutinib?

WAYRILZ is a marketed brand name for rilzabrutinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of rilzabrutinib?

rilzabrutinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.