Wednesday, July 8, 2026

Drug profile · INN

erdafitinib

erdafitinib (BALVERSA) is a fibroblast growth factor receptor inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01EN01
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — erdafitinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

erdafitinib (BALVERSA) is a fibroblast growth factor receptor inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN erdafitinib
Brand BALVERSA
Mechanism Fibroblast growth factor receptor inhibitor
Target Fibroblast growth factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EN01

Mechanism of action

Fibroblast growth factor receptor inhibitor

Primary target: Fibroblast growth factor receptor

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Erdafitinib Intravesical Delivery System Phase 2 · Janssen Cilag International · Non-Muscle Invasive Bladder Neoplasms
  2. 42756493BLC1003 Phase 1 · Janssen-Cilag International N.V · Localized Bladder Cancer

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is erdafitinib?

erdafitinib (BALVERSA) is a fibroblast growth factor receptor inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for erdafitinib?

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

What is the US approval status of erdafitinib?

erdafitinib 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.